Narcan should be made available over the counter, FDA experts say

A Food and Drug Administration advisory committee today endorsed over-the-counter sales of the overdose reversal drug Narcan.

The recommendation would make the nasal spray used to counteract fentanyl and opioid overdoses more accessible to consumers who could buy the medication at stores without a prescription or pharmacist's recommendation. The FDA usually follows its advisory committee's recommendation but is not obligated to do so. The federal agency is expected to decide by March 29.

Why is retail Narcan important?

All states have standing orders that allow a person to get naloxone from a pharmacist without a doctor’s prescription, but consumers must approach a pharmacist and ask for the medication before purchasing.

Dr. Bobby Mukkamala, chair of the American Medical Association's substance use and pain care task force, said a retail version of the drug would make it easier for people to access.

“Making naloxone over the counter is a safe and vital step to ending the nation’s overdose epidemic," Mukkamala said. “Individuals should be able to pick up a package of naloxone without having to face the potential stigma or shame of having to ask for this life-saving medication."

When will the drug be available for purchase?

Emergent Biosolutions has not said how soon the drug might be available or how much it will cost if the FDA approves retail sales.

Narcan and its generic version, naloxone, is widely distributed by community organizations that seek to slow the nation's spiraling overdose epidemic. Community health departments, schools, police and fire departments often carry the drug.

More:More than 107,000 Americans died from overdoses last year. This drug is behind most deaths.

Earlier this week, the Centers for Disease Control and Prevention estimated 106,840 overdose deaths over the 12-month period ending in September 2022. Most of these deaths are caused by illicitly manufactured fentanyl as well as street drugs methamphetamine, heroin and cocaine.

Dr. Rahul Gupta, director of the White House Office of National Drug Control Policy, on Wednesday cited the use of naloxone as one factor that helped slow the number of overdose deaths. He said the drug was used by emergency medical service personnel on more than 393,000 calls over the 12-month period ending in September 2022

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at alltuck@usatoday.com

Covid-19 vaccine authorization for younger children delayed as FDA ...

CNN —

Parents will have to keep waiting to find out when their youngest children can get a Covid-19 vaccine.

Pfizer and BioNTech filed a request with the US Food and Drug Administration in the first week of February for an emergency use authorization of their vaccine in children 6 months to 5 years old. The FDA’s Vaccines and Related Biological Products Advisory Committee was scheduled to meet February 15 to go over data from vaccine trials and make a recommendation on whether a two-dose vaccine regimen should be authorized.

But the FDA announced Friday that it had postponed the meeting because “new data have recently emerged.”

The data supported the safety of the vaccines but showed disappointing effectiveness, the Washington Post reported Friday.

The agency needs to see data from an ongoing trial of a third vaccine dose in these younger children in order to move forward with emergency use authorization, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a news briefing.

Pfizer and BioNTech said Friday that they expect to have data on three doses available in early April.

Information came in “so rapidly” during the Omicron wave “that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action,” Marks said.

“The data that we saw made us realize that we needed to see data from a third dose as in the ongoing trial in order to make the determination that we could proceed with doing an authorization.”

The delay is a sharp change of pace.

There are about 18 million children ages 6 months through 4 years in the United States who would be eligible for the vaccine. Jeff Zients, the White House’s coronavirus response coordinator, said Wednesday that planning was well underway to roll out vaccines, needles and syringes as soon as the FDA made an authorization decision. A US Centers for Disease Control and Prevention planning document posted online had said deliveries could begin as soon as February 21.

Winding path to authorization

In December, Pfizer said that the vaccine appeared to protect the youngest children – infants and toddlers up to 2 – at the same levels seen in teens and young adults, slashing symptoms in 90% of kids who got the shot. However, the 3-microgram dose did not produce the same immune response in 2- to 5-year-olds.

The dose for infants and young children is about one-third of the dose given to children age 5 to 11 and a tenth the size of the dose given to people 12 and older.

At the time, the company decided to expand its trial to include a third dose, rather than the two doses older children and adults receive in a primary vaccine series.

But high rates of infection and illness among children from the Omicron variant have allowed the company to quickly accumulate trial data. At the start of February, while it continued to investigate a third dose, the company said it had decided to submit for authorization of the two-dose vaccine “with pediatric Covid-19 cases surpassing 10 million and at the request of the FDA.”

In a news release Friday, Pfizer said it continues to share data from its child vaccine trial with the FDA.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer’s news release said. “This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen.”

Pfizer said the study’s independent data monitoring committee supports the continuation of the trial. It believes that the data collected indicates that the vaccine is well-tolerated and supports a potential three-dose regimen.

After the FDA postponed the meeting of its vaccine advisers, Marks said it’s important for the agency to stay nimble in the face of a quickly pandemic.

“What we’re dealing with is taking the approach that we very much should take as a public health agency, which is to constantly take in the data that come to us and adjust to that,” Marks said. “So what we’re doing now is adjusting to this, and yes, some of this was late-breaking, but that’s what our job is, it’s to adjust to it.”

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA vaccine committee, said he is glad things played out this way.

If the committee had met on Tuesday and voted no, “that would have sent the message to the general public that something’s wrong with this vaccine. And then [if] we come back a few months later and vote yes, people may still be suspicious or less likely to take the vaccine up,” he said.

“My word to parents who have young children is that this is not a ‘no’; it’s a ‘not yet,’ ” he added.

Dr. William Schaffner, professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, said that with cases and hospitalizations going down across the country, there is a little more breathing room to look at the data and determine the right vaccine schedule up-front.

“Let’s take a step back and take a deep breath. When we recommend ‘should we do vaccines for all children aged 6 months to 4 years of age,’ we want to be able to communicate to the parents exactly what they can expect regarding effectiveness and safety,” said Schaffner, a vaccine advisers to the CDC. “If that takes us a few more days to secure those data, analyze them, think about them and then present them, let’s take a few more days, because we want to be able to do this in the best possible way we can.”

FDA says it will move as fast as it can

The Covid-19 case load among children has been “extremely high” during the Omicron surge, the American Academy of Pediatrics says. There have been over 7 million child cases reported since September, and more than half of them have come this year.

Children have a lower risk of serious outcomes from a Covid-19 infection compared with elderly or immunocompromised adults. But about 1% of children who catch Covid-19 will be hospitalized. Infections can also lead to long-term consequences in children as they do in adults, increasing the risk for diabetes, autoimmune disease and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care.

Dr. Helen Talbot, an associate professor of medicine in the Division of Infectious Diseases at Vanderbilt, called the decision to delay the meeting “heart-wrenching.”

“I think as a scientist, they’re going to have more data sooner than they thought and that we’ll get to see and analyze and really get to delve into the data that’s coming,” said Talbot, who is a vaccine adviser to the CDC. “But I can imagine parents with kids less than 5 years of age are just so frustrated, and they’re just so ready to have their kids vaccinated.”

Marks said he understands that parents are eager to get protection for their young children, and the agency is “absolutely committed to moving as rapidly as we can once we have a submission.”

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“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well, and in looking over the data, I think parents can feel reassured that we have set a standard by which we feel that if something does not meet that standard, we can’t proceed forward.”

While the additional data are gathered, that means “parents will have to rely on what they’ve come to do well, which is they’re using masking procedures, and they’re making sure that they’re vaccinated and taking those types of precautions with their youngest children,” Marks said. “We will do our part, obviously, to move as fast as we can when we have the data, but for now, we’ll have to ask parents to help to continue to do what they’ve been doing.”

Jen Christensen Brenda Goodman Jamie Gumbrecht

FDA advisers vote in favor of authorizing Covid-19 vaccines for ...

CNN —

Vaccine advisers to the US Food and Drug Administration voted unanimously on Wednesday in favor of expanding the emergency use authorizations for the Moderna and Pfizer/BioNTech Covid-19 vaccines to include children as young as 6 months.

All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to the question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?”

And all the committee members voted yes in response to the question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3 micrograms each dose) outweigh its risks for use in infants and children 6 months through 4 years of age?”

The FDA, which typically follows the committee’s decisions, will now decide whether to authorize the vaccines for emergency use in the youngest children.

However, shots can’t be given until the US Centers for Disease Control and Prevention’s own vaccine advisers have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.

The CDC’s vaccine advisers are expected to vote Saturday. The White House has said shots could begin as early as next week.

Children younger than 5 are the only age group not currently eligible to be vaccinated against Covid-19. About 17 million kids will become eligible for Covid-19 vaccines once they’re authorized for this age group.

“To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing,” said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.

‘Benefits seem to clearly outweigh the risks’

“The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care,” committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said of the Moderna vaccine.

Committee member Dr. Art Reingold added that even though the risk of Covid-19 hospitalization and death is lower for young children than for adults, children already get vaccinations to protect them against diseases for which their risk is low.

“If we have a vaccine with benefits that outweigh the risks, then making it available to people is a reasonable choice,” said Reingold, of the University of California, Berkeley.

“I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases are pretty close to zero,” he said, such as polio and measles.

The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, FDA official Dr. Peter Marks said at Wednesday’s meeting.

“There still was, during the Omicron wave, a relatively high rate of hospitalization during this period,” said Marks, director of the FDA’s Center for Biologics Evaluation and Research. “That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse.”

Marks said the number of deaths for children 4 and under during the first two years of the pandemic “also compares quite terribly to what we’ve seen with influenza in the past.”

“We are dealing with an issue where I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important,” he said, adding that “vaccine-preventable deaths are ones we would like to try to do something about.”

Marks said the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths.

Moderna vaccine ‘well-tolerated’ in youngest children

The Moderna vaccine is already authorized for adults. In a meeting Tuesday, the FDA’s advisers voted unanimously in favor of expanding the emergency use authorization to include older children and teens, ages 6 to 17, saying it would also offer more benefits than risks.

Moderna’s Covid-19 vaccine, when given as a 25-microgram dose, is “well-tolerated” in children ages 6 months to 5, said Dr. Rituparna Das, Moderna’s vice president of Covid-19 vaccines clinical development, during Wednesday’s meeting as she described the safety profile of the vaccine among this age group and adverse reactions.

“Pain was the most common event,” Das said. “Young children’s events included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting and chills. For infants and toddlers, events included fever, irritability, crying, sleepiness and loss of appetite.”

These reactions were more common after the second dose of vaccine and resolved within two or three days, Das said, adding that fever was an important assessment of the vaccine’s safety for this age group.

Fever after any dose of vaccine happened in about a quarter of the children, but more often after the second dose, and one incident of febrile seizure was considered to be related to vaccination, Das told the committee members. The child who had the seizure remained in the vaccine study and got a second dose of vaccine with no serious events.

No deaths or cases of myocarditis or pericarditis were reported among vaccine recipients, Das said.

“In summary, mRNA-1273 was well tolerated,” she said, using the technical name of Moderna’s vaccine. “Local and systemic reactions were seen less frequently in these youngest groups.”

Concern over number of doses

VRBPAC member Dr. Paul Offit said in Wednesday’s meeting that children who get the Pfizer/BioNTech vaccine will have to complete a three-dose series to get sufficient protection.

” ‘Do the benefits outweigh the risks’ is something I can support, but I do have some concerns about this vaccine,” said Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania.

Committee member Dr. Jeannette Lee of the University of Arkansas for Medical Sciences also mentioned concern that some children might not complete all three doses and that uptake of the vaccine will be slow.

“Three doses will certainly benefit. I have a lot of concern that many of these kids will not get a third dose,” she said. “My concern is that you have to get the three doses to really get what you need.”

Data from a phase 2/3 trial of the Pfizer vaccine included 1,678 children who had received a third dose during the period when the Omicron coronavirus variant dominated. The vaccine appeared to be safe and had a strong immune response. The data has not been peer-reviewed or published in a medical journal.

Antibody levels tested one month after the third dose showed that the vaccine produced a similar immune response as two doses in 16- to 25-year-olds, the companies said.

In FDA briefing documents, it was noted that among young children who had received the vaccine in trials, there were no cases of anaphylaxis, myocarditis or pericarditis, and the most common adverse reactions among children 6 months to 23 months were irritability, drowsiness, decreased appetite and tenderness at the injection site. For children 2 to 4 years old, the most common adverse reactions were fatigue and pain and redness at the injection site.

Will these children get vaccinated?

There is already slow uptake of Covid-19 vaccines among children in the United States.

“Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

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Barouch, who is not a member of the FDA advisory committee, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there were “striking” differences in how many adults are fully vaccinated compared with children and teens.

Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC, compared with about:

Covid-19 vaccinations begin for US children under 5 | CNN

CNN —

Dr. Sarah Schaffer DeRoo described in one word how she felt after getting her 7-month-old son vaccinated against Covid-19: thrilled.

Her active baby boy sat in her lap at a vaccine clinic hosted by Children’s National Hospital in Washington, DC, while receiving his first dose of Covid-19 vaccine. The shot was administered in his thigh. He cried for a few seconds but then his attention turned toward a golden retriever that was on site as a comfort dog provided by the hospital.

“I’m feeling really thrilled that we have this opportunity,” DeRoo, a pediatrician at Children’s National Hospital in Washington, DC, told CNN’s Suzanne Malveaux on Tuesday about her son’s vaccination.

DeRoo added that her family now will feel more comfortable participating in certain activities, knowing that their youngest son has started his Covid-19 vaccine series.

“It will certainly allow us to have more freedom with our personal lives and what we do,” DeRoo said. “And for the baby, we’ll feel like we have cloaked him in as much protection as we can.”

Covid-19 vaccinations for children younger than 5 are beginning Tuesday across the United States, marking a milestone in the nation’s fight against the disease.

Last week, the US Food and Drug Administration expanded the emergency use authorizations for Moderna’s vaccine to include children 6 months through 17 years and Pfizer/BioNTech’s for children 6 months through 4 years.

Then on Saturday, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on Covid-19 vaccinations for children under 5, clearing the way for vaccinations to be administered in that age group.

About 17 million kids under the age of 5 are now eligible for Covid-19 vaccines.

“This is a big day. We’ve been waiting a long time for children to have access to the vaccine. We now have every age group, 6 months and above, in the country which is now eligible to get protection from the Covid-19 vaccine. And I’ll tell you as a dad of a 4-year-old, this is a big deal for my family as well,” US Surgeon General Dr. Vivek Murthy told CNN’s Brianna Keilar on Tuesday morning.

As of the end of Tuesday, the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has delivered approximately 2.7 million doses of vaccine for children under 5 nationwide.

“Another 1 million doses have been shipped and will soon be received by administration sites,” Tim Granholm, an HHS spokesperson, wrote in an email to CNN on Wednesday morning.

“HHS has received orders for approximately 4.2 million doses to date,” Granholm wrote. “We will continue to deliver vaccines expeditiously as we fulfill orders and take new ones. We made 10 million doses of vaccine available for ordering initially, with millions more available soon, so supply should not be a barrier to someone getting their young child vaccinated.”

Vaccines given in child-sized doses

Under the FDA’s authorization, the Moderna vaccine can be given as a two-dose primary series, with doses given four weeks apart, at 25 micrograms each dose, to infants and children 6 months through 5 years of age.

While the FDA has authorized Moderna’s vaccine for children ages 6 to 17, the CDC has not yet recommended it for that age group, so those shots can’t be administered yet. The FDA authorization would allow children ages 6 to 11 to receive doses are 50 micrograms each. For those ages 12 and older, it would be administered as 100-microgram doses.

The Pfizer/BioNTech vaccine now can be given as a three-dose primary series, at 3 micrograms each dose, for use in infants and children 6 months through 4 years. The vaccine is administered as a two-dose primary series at 10 micrograms per dose for children 5 to 11 and at 30 micrograms per dose for adolescents and adults ages 12 and older.

Completing the Pfizer/BioNTech vaccine series is a longer process, as the first two doses are administered three weeks apart, and then the third dose is given eight weeks later.

Dr. Jeannette Lee of the University of Arkansas for Medical Sciences, who serves on the FDA’s vaccine advisory committee, expressed concern about children not completing all three doses.

“Three doses will certainly benefit. I have a lot of concern that many of these kids will not get a third dose,” Lee said. “My concern is that you have to get the three doses to really get what you need.”

As for children who might turn from age 4 to 5 at any point while completing their Pfizer/BioNTech vaccine series, the CDC recommends two options. The child could complete the two-dose primary series authorized for children ages 5 to 11, or they could complete the three-dose series for younger kids, but each of doses 2 and 3 may be either the dosage for younger children or ages 5 to 11.

The FDA’s Vaccines and Related Biological Products Advisory Committee determined that the benefits of both vaccines outweigh the risks and noted that the vaccines have been “well-tolerated” among the children who got them in clinical trials.

According to clinical trial data, common side effects for both vaccines include pain at the injection site, headache, fever, chills and fatigue. The vaccines appeared to elicit similar immune responses in children as has been seen in adults.

Where young children can get vaccinated

Pediatricians’ offices and pharmacies are the main sites where young children could get vaccinated.

“We know that parents are going to want to get their children vaccinated in pediatricians’ offices. Some people will go to a pharmacy, some people will go to a children’s hospital or some sort of a community health center,” Dr. Ashish Jha, the White House’s Covid-19 response coordinator, said Monday on CBS.

“But the bottom line is, I think a majority of parents are going to want to get their child vaccinated in their pediatrician’s office,” Jha said. “So, many pediatricians are going to be offering the vaccine.”

As for the pharmacy locations offering these child-sized vaccines, CVS and Walgreens have announced plans to provide vaccinations.

CVS will begin administering Pfizer’s Covid-19 vaccines to children under five on Tuesday, a communications representative told CNN.

“We will begin administering the Pfizer-BioNTech Covid-19 vaccine for eligible children 18 months through four years of age at our 1,100 MinuteClinic locations starting on Tuesday,” Matt Blanchette, senior manager of retail communications with CVS Pharmacy, told CNN in an email.

“MinuteClinic is located inside select CVS Pharmacy stores in 35 states and Washington, DC,” Blanchette said. Appointments will be available on a rolling basis according to vaccine supply.

Blanchette said children over 5 will still be able to access Covid-19 vaccines in CVS pharmacies.

On Saturday, Walgreens announced in a news release that appointments for vaccinations in young children will be available starting June 25. Walgreens will be vaccinating children 3 and older at “select” locations, and appointments can be scheduled online.

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Hy-Vee pharmacies will have Covid-19 vaccinations available for children under 5 once doses are available, a communications representative told CNN on Monday.

“Hy-Vee anticipates receiving its allocations for the newly approved age groups in the coming days,” Tina Potthoff, senior vice president of communications, wrote in an email.

“As soon as we receive vaccine and our appointment scheduler is open for these age groups, we will post an update on our COVID-19 vaccine landing page, post on our Hy-Vee store Facebook pages, and contact media outlets in our eight-state region to make them aware of our pediatric hubs that are accepting appointments.”

Due to federal regulations, she wrote, Hy-Vee will only be providing vaccinations to children 3 and older.

“Under the PREP Act, retail pharmacies, including Hy-Vee pharmacies, are only authorized to administer vaccines to patients ages 3+,” Potthoff wrote in the email. “Patients younger than age 3 should visit their pediatrician or health care provider to receive the COVID-19 vaccine.”

FDA authorizes Covid-19 vaccines for younger children | CNN

CNN —

The Moderna and Pfizer/BioNTech Covid-19 vaccines are now authorized for emergency use in young children. The US Food and Drug Administration expanded the authorizations for the vaccines Friday to include children as young as 6 months.

However, shots can’t be given until the US Centers for Disease Control and Prevention’s vaccine advisers have voted on whether to recommend them – a vote is scheduled for Saturday – and CDC Director Dr. Rochelle Walensky has signed off on that recommendation. The White House has said vaccinations for younger children may begin next week.

Moderna’s vaccine is now authorized for use in children 6 months through 17 years and Pfizer/BioNTech’s for children 6 months through 4 years. About 17 million kids under the age of 5 are now are eligible for Covid-19 vaccines.

Pfizer's vaccine for children under 5 being manufactured. Pfizer

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Dr. Robert M. Califf said in a news release. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

Previously, the Pfizer/BioNTech vaccine was authorized for people 5 and older and approved for 16 and up, and Moderna’s vaccine was authorized only for adults.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called Covid-19 vaccines for younger age groups a “milestone.”

“It is a bit of a milestone to bring down the age range for these vaccines as we work through this,” Marks said Wednesday in a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

In that meeting, the committee members voted unanimously in favor of expanding the authorizations to include children as young as 6 months.

“To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing,” said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.

“I’m really pleased that we’ve reached this kind of milestone,” said committee member Dr. Ofer Levy, of the Precision Vaccines Program at Boston Children’s Hospital, who also likened the moment to when Covid-19 vaccines previously were authorized for other age groups.

“I recall our first vote a year ago or more on the first Pfizer authorization,” Levy said. “I was one of the 17 votes in favor. I remember those early discussions – even then, should the 16- and 17-year-olds be included? At that point, that was a controversial topic that was being discussed. And here we are now, as a committee unanimously recommending authorization down to 6 months of age. So we’ve come a long way.”

Will the youngest children get vaccinated?

Many public health experts worry that even though the Covid-19 vaccines are now authorized for younger age groups, parents of these children might not take their kids to receive the vaccinations.

There is already slow uptake of Covid-19 vaccines among children in the United States.

“Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

Barouch, who is not involved in the FDA’s decision, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there were “striking” differences in how many adults are fully vaccinated compared with children and teens.

Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC, compared with about:

60% of adolescents 12 to 17

64% of adults 18 to 24

67% of adults 25 to 39

75% of adults 40 to 49

82% of adults 50 to 64

94% of adults 65 to 74

88% of adults 75 and older

“We are planning and preparing for the rollout of pediatric vaccines. Of course, there’s a lot of work to be done to look at uptake of this vaccine. Some of the polls and surveys that have gone out to the public have indicated an ongoing lessening of parents considering giving their children these vaccines over time,” said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials.

According to a Kaiser Family Foundation’s Vaccine Monitor survey, published in May, only 18% of parents of children under 5 said they would vaccinate their child against Covid-19 as soon as a vaccine was available.

“I think the more the pandemic is in the rearview mirror for some people – or they believe it is – then the less compelled they will be to do this, and so we have a big public health education campaign ahead of us,” Freeman said. “Also, health departments at the local level will be looking to understand the landscape of their community in terms of how many providers, pediatricians and pharmacies have actually signed up to give out the vaccine.”

‘Benefits seem to clearly outweigh the risks’

Under the FDA’s authorization, the Moderna vaccine can be given as a two-dose primary series, at 25 micrograms each dose, to infants and children 6 months through 5 years of age. For older children, ages 6 to 11, the doses are administered at 50 micrograms.

Vials of Pfizer/BioNTech's vaccine for younger children being filled. Pfizer

The Pfizer/BioNTech vaccine now can be given as a three-dose primary series, at 3 micrograms each dose, for use in infants and children 6 months through 4 years.

The FDA’s vaccine advisers have determined that the benefits of both vaccines outweigh the risks and that the vaccines have been “well-tolerated” among the children who received them in clinical trials.

“The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care,” committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said of the Moderna vaccine.

Committee member Dr. Art Reingold added that even though the risk of Covid-19 hospitalization and death is lower for young children than for adults, children already get vaccinations to protect them against diseases for which their risk is low.

“If we have a vaccine whose benefits outweigh the risks, then making it available to people is a reasonable choice. I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases are pretty close to zero,” such as polio and measles, said Reingold, of the University of California, Berkeley.

The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, Marks said.

“There still was, during the Omicron wave, a relatively high rate of hospitalization during this period,” he said. “That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse.”

Marks said the number of deaths for children 4 and under during the first two years of the pandemic “also compares quite terribly to what we’ve seen with influenza in the past.”

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“We are dealing with an issue where I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important,” he said, adding that “vaccine-preventable deaths are ones we would like to try to do something about.”

He added that the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths in all ages.

FDA puts strict limits on Johnson & Johnson Covid-19 vaccine | CNN

CNN —

The US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren’t appropriate or accessible and those who opt for J&J because they wouldn’t otherwise get vaccinated.

The FDA said in a statement that the change is being made because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

“We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

The agency confirmed to CNN that the updated authorization also applies to booster doses.

The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for certain people. Examples of people who may still get the vaccine include:

Those who had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna

Those with personal concerns about the mRNA vaccines who would remain unvaccinated without the J&J vaccine

Those with limited access to mRNA Covid-19 vaccines

As of Thursday, more than 18.7 million doses of the J&J vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention. Of those who are considered fully vaccinated, 7.7% got this vaccine.

After a meeting in December, the CDC’s vaccine advisory committee issued an updated recommendation on Johnson & Johnson’s vaccine, saying it makes a “preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged ≥18 years in the United States.”

The committee cited the same concerns over TTS.

Both the CDC and the FDA previously recommended a pause in the use of this vaccine over reports of TTS. The pause was lifted, but that move came with a warning over the rare clotting events.

Johnson & Johnson said in a statement at the time, “The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. … We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”

In an updated fact sheet on the vaccine, the FDA says that 15% of TTS cases have been fatal.

The agency’s updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths.

Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. The highest rate of TTS has been in women 30 to 49 years of age. About eight cases per 1 million doses of vaccine administered have been in women in this age group.

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Cases of TTS typically begin one or two weeks after vaccination. Symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like headaches or blurred vision, or red spots just under the skin called petechiae beyond the site of vaccination.

The new warning on the vaccine’s fact sheet says “The Janssen Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening.”

CDC recommends Covid-19 vaccines for children as young as 6 ...

CNN —

US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on Covid-19 vaccinations for children under 5 on Saturday, clearing the way for vaccinations to be administered soon.

This move comes after vaccine advisers to the CDC voted unanimously on Saturday in support of recommending the Moderna and Pfizer/BioNTech Covid-19 vaccines to children as young as 6 months.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19. We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,” Walensky said in a statement. “I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

Vaccinations may not begin until Tuesday in some places.

President Joe Biden praised the CDC’s decision to recommend the vaccines on Saturday.

“Today is a monumental step forward in our nation’s fight against the virus, with virtually every American now eligible for the protections that COVID-19 vaccines provide,” Biden said in a written statement, adding: “For parents all over the country, this is a day of relief and celebration.”

Walensky signed off on the administration of two doses of Moderna’s vaccine in children ages six months to 5 years, and three doses of Pfizer’s vaccine in children ages six months to 4 years. The CDC’s Advisory Committee on Immunization Practices (ACIP) noted on Saturday that if any Pfizer vaccine is given, then the vaccination series needs to contain three doses.

“We’ll be monitoring inventory as the vaccines are delivered starting Monday to clinics, pharmacies and other clinical settings to determine when the search for the under-five vaccines will be available on vaccines.gov,” Dr. Kevin Chatham-Stephens, the Pediatric Vaccine Planning and Implementation Lead with the CDC’s Vaccine Task Force, said in ACIP’s meeting.

“Parents and caregivers can reach out to the child’s pediatrician or family practice doctor or a local health department, pharmacy, et cetera to ask if they have the vaccine, understanding that not every clinic or pharmacy will get their vaccine on Monday.”

The Moderna and Pfizer/BioNTech Covid-19 vaccines are now authorized for young children

On Friday, the US Food and Drug Administration expanded the emergency use authorizations for Moderna’s vaccine to include children 6 months through 17 years and Pfizer/BioNTech’s for children 6 months through 4 years.

The CDC’s vaccine advisers will be discussing use of the Moderna vaccine in older children ages 6 to 17 years of age at their meeting June 23.

About 17 million kids under the age of 5 are now are eligible for Covid-19 vaccines.

Covid-19 is the leading cause of infectious disease-related death in people up to 19 years old, but data shows that those deaths can be prevented through vaccination, Dr. Matthew Daley said in Friday’s ACIP meeting.

“Covid-19 is the leading cause of death among infectious diseases for people ages 0 to 19 years. And Covid-19 is the seventh most common of all causes of death for people ages 0 to 19 years,” Daley, senior investigator with the Institute for Health Research at Kaiser Permanente Colorado, told the committee.

“Through March of 2022, unvaccinated people 5 years of age and older had 10 times the risk of dying from Covid-19 compared to those vaccinated with at least the primary series,” Daley said, adding that in other words, the data “provide real-world evidence that most deaths from Covid-19 are preventable through vaccination.”

In Saturday’s ACIP meeting, Dr. Veronica McNally said she was “struck” by the impact Covid-19 has had on children.

“I am struck by these numbers: 2 million cases, 20,000 hospitalizations and over 200 deaths. And I am also concerned that there’s really an underappreciation for the potential severity of a respiratory virus in kids in this age and an unclear understanding sometimes in parents about the long-term consequences, including MIS-C,” McNally said.

Will the youngest children get vaccinated?

Many public health experts worry that even though the Covid-19 vaccines are now authorized for younger age groups, parents of these children might not take their kids to get them.

“The hard work only continues,” after recommending the vaccine, Daley said, citing the importance of communicating to parents “how vitally important these vaccines are to protect children’s lives.”

There is already slow uptake of Covid-19 vaccines in children.

“Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, said Wednesday.

Barouch, who is not involved in the FDA’s or CDC’s decisions, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there were “striking” differences in how many adults are fully vaccinated compared with children and teens.

Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC, compared with about:

60% of adolescents 12 to 17

64% of adults 18 to 24

67% of adults 25 to 39

75% of adults 40 to 49

82% of adults 50 to 64

94% of adults 65 to 74

88% of adults 75 and older

“We are planning and preparing for the rollout of pediatric vaccines. Of course, there’s a lot of work to be done to look at uptake of this vaccine. Some of the polls and surveys that have gone out to the public have indicated an ongoing lessening of parents considering giving their children these vaccines over time,” said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials.

According to a Kaiser Family Foundation’s Vaccine Monitor survey published in May, only 18% of parents of children under 5 said they would vaccinate their child against Covid-19 as soon as a vaccine was available.

“I think the more the pandemic is in the rearview mirror for some people – or they believe it is – then the less compelled they will be to do this, and so we have a big public health education campaign ahead of us,” Freeman said. “Also, health departments at the local level will be looking to understand the landscape of their community in terms of how many providers, pediatricians and pharmacies have actually signed up to give out the vaccine.”

Pediatrics groups support ACIP’s recommendation

The American Academy of Pediatrics and the National Association of Pediatric Nurse Practitioners (NAPNAP) both released statements Saturday in support of a vote to recommend Covid-19 vaccines in children as young as six months.

Speaking in the CDC meeting on Saturday, Dr. Bonnie Maldonado, chair of the AAP Committee on Infectious Diseases, said it would be important to focus distribution equitably.

“As of June 8, 23 million children ages five to 17 have received two doses of Covid vaccine. But another 26 million in this age group have yet to receive any doses. Our work is cut out for us. We must also all work together to reduce disparities and address barriers to vaccination in every community so that all children and families can benefit from the protection of these vaccines,” she said.

Patsy Stinchfield, with NAPNAP, also spoke in support of the recommendation but asked ACIP to stress the importance of vaccination in this age group.

“I was a bit dismayed with some of the headlines coming out after the VRBPAC decision emphasizing quote, it’s up to the parents. This can be misinterpreted to consider this vaccine in young children as optional. We don’t say to parents of a baby with a cardiac defect, ‘it’s up to you for your child to have open heart surgery.’ We say, ‘your child needs open heart surgery’,” she said.

“We don’t get out of pandemics with ‘it’s-up-to-you’-type strategies,” she said.

‘Benefits seem to clearly outweigh the risks’

Under the FDA’s authorization, the Moderna vaccine can be given as a two-dose primary series, at 25 micrograms each dose, to infants and children 6 months through 5 years of age. For older children, ages 6 to 11, the doses are 50 micrograms each.

The Pfizer/BioNTech vaccine now can be given as a three-dose primary series, at 3 micrograms each dose, for use in infants and children 6 months through 4 years.

Dr. Paul Offit, a vaccine adviser to the FDA, said Wednesday that children who get the Pfizer vaccine will have to complete a three-dose series to get sufficient protection.

” ‘Do the benefits outweigh the risks’ is something I can support, but I do have some concerns about this vaccine,” said Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania.

Dr. Jeannette Lee of the University of Arkansas for Medical Sciences, who also serves on the FDA’s vaccine advisory committee, agreed.

“Three doses will certainly benefit. I have a lot of concern that many of these kids will not get a third dose,” she said. “My concern is that you have to get the three doses to really get what you need.”

According to clinical trial data, common side effects for both vaccines include pain at the injection site, headache, fever, chills and fatigue. The vaccines appeared to elicit similar immune responses in children as has been seen in adults.

The FDA’s Vaccines and Related Biological Products Advisory Committee determined that the benefits of both vaccines outweigh the risks and noted that the vaccines have been “well-tolerated” among the children who got them in clinical trials.

“The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care,” committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said in a discussion about the Moderna vaccine.

The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“There still was, during the Omicron wave, a relatively high rate of hospitalization during this period,” he said. “That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse.”

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Marks said the number of deaths for children 4 and under during the first two years of the pandemic “also compares quite terribly to what we’ve seen with influenza in the past.”

“We are dealing with an issue where I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important,” he said, adding that “vaccine-preventable deaths are ones we would like to try to do something about.”

He added that the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths in all ages.

FDA advisers vote to include an Omicron-specific component for a ...

CNN —

The US Food and Drug Administration’s independent Vaccines and Related Biological Products Advisory Committee voted Tuesday to support recommending inclusion of an Omicron-specific component for a Covid-19 booster vaccine.

Twenty-one voting members of the FDA’s independent committee voted on the question:

“Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”

Nineteen of the members voted yes, two voted no.

“I voted in favor of Omicron because I think it’s important to broaden immunity,” said Dr. Wayne Marasco, a professor of medicine with the department of cancer immunology and virology Dana-Farber Cancer Institute Harvard Medical School. “I will say that I was pretty impressed today that we can do better.”

“I think this is a step in the right direction, but we have to reevaluate this as we move forward,” he added.

The committee felt that a modified vaccine would offer broader protection to match the coronavirus strain that is in circulation now.

Two Omicron subvariants, BA.4 and BA.5, are now dominating transmission of Covid-19 in the United States, according to the US Centers for Disease Control and Prevention.

Future US Covid-19 vaccines will be different

This means that the Covid-19 vaccine people in the US will get in the future will be different. The committee does not determine how, and the committee was not asked to vote on what sublineage to include or whether the booster should be monovalent vaccine or a bivalent vaccine, which would include two strains.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there will be a conversation going forward to determine who needs another booster and what that booster will look like. Marks noted that a bivalent vaccine targeting the BA.4 and BA.5 Omicron subvariants seemed to be the preference of the committee.

When the FDA’s independent vaccine advisers had met in April, they agreed that they had to develop a framework for how the country can keep up with the evolving virus with an appropriate vaccine strategy.

The FDA said in May that the “new normal” may include an annual Covid-19 and flu shot for people in the fall. Cases are expected to rise again in the fall and winter.

Challenging work ahead

Dr. Arnold Monto, the acting chair of the independent vaccine advisers committee, suggested determining what goes into the booster will not be easy.

“I think we have done the best we can in a difficult situation with imperfect data and inability to say what is going to follow what looks like Omicron 4 or 5 wave,” said Monto. “We’ve looked at the options that are available and come up with a set of recommendations and some advice that FDA can follow.”

Moving forward to create a vaccine to best fight a virus that changes quickly is “uncharted territory”

“Looking in the past doesn’t help us a great deal to look in the future for this virus which has baffled a lot of us and made predictions almost irrelevant,” Monto added.

What the companies are working on

Current Covid-19 vaccines are based on the coronavirus that emerged in late 2019, but Pfizer and Moderna have been working on updated versions of the vaccines. The current vaccines are not as effective against the variants in circulation.

Moderna presented details about its bivalent Covid-19 vaccine booster, mRNA-1273.214, which the company said elicits “potent” immune responses against the Omicron subvariants BA.4 and BA.5.

Moderna’s bivalent booster vaccine candidate contains components of both Moderna’s original Covid-19 vaccine and a vaccine that targets the Omicron variant.

Pfizer/BioNTech also presented data to the committee that showed that their two Covid-19 vaccine boosters targeting Omicron showed a substantially higher immune response than its current Covid-19 vaccine. Preliminary lab studies suggest the vaccines could neutralize the Omicron BA.4 and BA.5.

Another vaccine maker, Novavax, has committee support for emergency use authorization in the United States, but the FDA has not yet authorized its vaccine. Novavax told the committee that it has been developing variant-specific updated versions of its Covid-19 vaccine as well as a Covid-19 and flu combination vaccine.

Broader is better

The World Health Organization told the independent committee of vaccine advisers Tuesday that the vaccination strategy going forward should probably be based around a vaccine that would offer as broad a kind of protection as possible, rather than just continuing with the vaccines that were made against the original strain that is no longer in circulation.

“I still think there’s value in increasing the breath of immunity and I will reiterate that we’re not trying to match what may circulate,” said Dr. Kanta Subbarao with the World Health Organization Collaborating Center for Reference and Research on Influenza and the University of Melbourne. “It is not so much to match what is likely to circulate because there’s so much uncertainty about the trajectory of this evolution.”

Including Omicron in a future vaccine would help because Omicron is the most distinct of the variants of concern that have emerged she said, but a standalone vaccine that would match just Omicron would not likely be broad enough to protect against other variants going forward.

“We’re trying to increase the breadth of the immune response without losing the benefit from the index vaccine that’s performed so well,” she added.

“We simply don’t have enough information on any of the other variants, but I could make a strong case based on our experience with influenza that using a virus to boost that is antigenitically as far as possible, is a better strategy than something that is partway there,” she added.

The longer that Omicron is the dominant variant circulating in the world, the odds are that whatever comes after it will come from Omicron.

“At least that’s a realistic possibility,” Jerry Weir, director of the Division of Viral Products in FDA’s vaccine research office, told the committee.

Future Covid-19 vaccine strategy

Going forward, as the committee determines how to create a process for the future if people will need regular Covid-19 boosters, members agreed that there needed to be better central coordination on studies and on what the plans should be going forward.

“Without such a plan, we’re going to be playing Whack a Mole as this virus evolves, because it’s going to continue to evolve,” said committee member Dr. Bruce Gellin, chief of global public health strategy with the Rockefeller Foundation.

“We’ll get better at this, but we still need to get ahead of it,” he said.

Weir, with the FDA, tried to help the committee keep what they have accomplished in perspective.

“I think we’ve made enormous progress in this whole endeavor over the last few months, but I’ll remind you that the sort of parallel track of influenza strain selection, which works very well, was a process that was honed over many, many years and so we probably have quite a bit of work. This is a different virus. We have a lot of work to do on the strain selection process for Covid vaccines.”

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Several committee members also were concerned about the lack of data concerning what should go into future pediatric vaccines.

“In terms of extrapolating available data, I am very hesitant to extrapolate that from adults into children,” said committee member Dr. Archana Chatterjee, who is dean of Chicago Medical School. “I think the pediatric studies need to be done and they need to be done now.”

Following the VRBPAC vote, the FDA will rule on the updated vaccine. Next a panel of independent experts that advise the CDC will take a closer look at the available data and make a recommendation, and the head of the CDC would decide if they should sign off on it.

Pediatrician answers your questions on Pfizer Covid-19 booster for ...

CNN —

The US Food and Drug Administration gave emergency use authorization for booster doses of Pfizer/BioNTech’s Covid-19 vaccine for children ages 12 to 15 Monday.

The agency also shaved four weeks off the waiting period for the booster after the administration of the second dose, from at least six months to at least five months for everyone 12 and older.

“The FDA expanded emergency use to a whole group of people, children aged 12 to 15, who were not previously eligible for boosters,” said pediatrician and child development expert Dr. David Hill, former chair of the American Academy of Pediatrics Council on Communications and Media.

“Additionally, the FDA recommended boosters for some children ages 5 to 11 who are severely immunocompromised, meaning that particularly vulnerable children down to age 5 can now get the booster vaccine,” said Hill, who is a co-host on the AAP’s flagship podcast, “Pediatrics on Call.”

CNN asked Hill questions that parents and caregivers will want answered as they wait for formal recommendation of boosters, expected later this week after the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, meets Wednesday and a final go-ahead from CDC Director Dr. Rochelle Walensky.

This conversation has been edited and condensed for clarity.

CNN: You mentioned that children down to age 5 who are immunocompromised are also eligible for the booster. How is that defined?

Dr. David Hill: What they are giving us as an example is a child who’s had a solid organ transplant, for example, like a kidney or liver transplant. But they are also saying children with equivalent degrees of immunocompromise – for example, there are hereditary conditions that may lead to fairly severe degrees of immunocompromise. Those children are almost certainly already being seen by an immunologist or an infectious disease specialist.

If you are a parent who thinks that your child may qualify for the booster based on their immune status, check in with a doctor who is managing their condition and see what they say.

CNN: When will boosters for this age group be available?

Hill: That is a great question. What we know is that there is one more step: a meeting of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, called the ACIP. The CDC has said that they are anticipating a meeting later this week. Once the ACIP signs off on this, then implementation should occur very quickly.

There can be delays in terms of ordering and stocking the vaccine in various locations.

CNN: How will I know if the booster will be in stock in my area?

Hill: I know that the availability of vaccines continues to vary by location and demand. I have not seen specific reports on where shortages might exist. I do know that you can check in with local health care authorities or your health department to find the best place to get the booster administered.

CNN: What do I need to bring to the appointment?

Hill: Definitely bring your child’s vaccine card. The booster needs to occur at least five months after the child’s second dose of Pfizer or Moderna vaccine, so facilities will be looking for some evidence as to when that second dose was administered.

Many states now have a statewide vaccine registry. If the location where you got your booster participates in the statewide registry, there may actually be an electronic document that should be available throughout the state, so that’s another source of confirmation.

And then there is your child’s electronic health record, which track vaccines. The electronic health records sometimes have to be adjusted to accommodate the development of a new vaccine or a new vaccine schedule, and the vendors who program those records are usually very responsive, to make sure that the systems are ready when the CDC approves the booster.

CNN: How does this dose compare to the original vaccine doses and what are the side effects?

Hill: It should be the same. I haven’t seen that there is any difference in the dose for the booster compared to the first two vaccines.

The common side effects from the booster remain the same as they are for the first two vaccines, so obviously there may be pain or redness or swelling at the injection site. Some people will experience fatigue or headaches, they may have muscle or joint pains, they may have chills.

One thing that seems a little bit more common with the booster dose is swollen lymph nodes in the armpit of the arm where the dose was given. Lymph nodes are our body’s way of responding to infection or inflammation, so it’s not unusual with any inflammatory response to see some lymph nodes swelling. But that seems to be a little more common with the booster dose.

The good news, in terms of side effects, is that none of the children studied so far have developed cardiomyopathy. That doesn’t surprise us, because you probably need to get millions of shots before you think a single case of cardiomyopathy, and of course we haven’t given millions of third vaccines in this age group yet. But it’s very heartening that, of the people who have been studied, there has not been a single case.

CNN: Would you advise parents and caregivers to keep their child home from school the day after their booster shot?

Hill: I think most children will be able to go to school the following day. But if childcare is difficult for you, it would probably be good to have a backup plan in case your child were to feel too bad or to have a fever that would keep them out of school.

CNN: How long before that boost of immunity kicks in after the booster shot?

Hill: What we know so far from boosters in other age groups is that it looks like a significant boost in the immunity you already have occurs in the first seven days and is maximized by about 14 days. It’s not a switch that clicks on after seven to 14 days, however, it’s kind of a curve that goes up over that two weeks.

CNN: Do we know how well the boosters protect against the Delta or Omicron variants?

Hill: We do have data on how well the boosters protect against Delta and Omicron, and they appear to protect extremely well. Now when you say protect, it’s very important to ask, protect against what? People will say, “Oh, you know, I got the vaccine, and I still contracted Covid-19.” Yes, that may happen. In fact, that is guaranteed to happen to a certain number of people.

What you want to know is, are you are less likely to be hospitalized? Are you less likely to die? And the answer is yes. The effectiveness of these vaccines against serious, life-threatening illness is extraordinarily high.

It’s no different than the question people have with flu vaccines: It’s not uncommon to get vaccinated against the flu and then get a mild case of influenza. That can happen. But the vaccine against flu has always been strongly protected against hospitalization and death, and this is a similar situation. Data on the endpoints that count – such as “Will I be alive next year? Will I be able to breathe?” – are extraordinarily positive.

CNN: Parents often see comments online about how the vaccine – including the booster – may harm their child’s development. What are the facts?

Hill: There are absolutely no data suggesting that these vaccines had any negative impact on child development at all. The side effects that we’re aware of are temporary, fairly mild, comparatively speaking, and none of them are permanent.

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There is still this concern of cardiomyopathy, particularly in older teenagers. But even when we have seen children get this incredibly rare side effect, the vast majority have recovered with no long-term health issues. I think we can feel very good that, on the balance, the vaccine is a tremendous positive.

Vulnerable Americans are desperate to find this Covid-19 drug ...

CNN —

Soon after the US Food and Drug Administration gave the green light to Evusheld, a new drug to prevent Covid-19, pharmacist Tom Henry alerted his blog readers. He was thrilled because finally, there was a drug that could protect people like him who are immune-compromised and had a weak response, or no response at all, to their vaccinations.

“Exciting news – FDA grants emergency use authorization [to Evusheld],” Henry wrote in a post published December 18.

A few weeks later, a reader wrote back that she’d been able to find the drug.

“Congratulations on getting this medication,” Henry responded. “I know it is in short supply.”

But Henry, a retired Air Force lieutenant colonel and a pharmacist with multiple advanced degrees, was unable to find Evusheld. He contracted the virus and died from complications of Covid-19 on February 9.

In the State of the Union address this month, President Joe Biden said that “if you’re immunocompromised or have some other vulnerability, we have treatments. … We’re leaving no one behind or ignoring anyone’s needs as we move forward.”

But a CNN investigation raises questions about the way federal and state governments have distributed Evusheld and why, more than three months into the rollout, many immune-compromised people are still having trouble getting it.

CNN’s investigation found that as the Omicron variant ripped through the United States, infecting and killing Americans, including some who might have been saved with timely access to Evusheld, thousands of boxes of the drug have been sitting on pharmacy shelves.

CNN also found that the government distributed Evusheld, a drug that was developed by AstraZeneca with the support of the US government, to unlikely places such as a spa that offers Botox and another location that does eyelash extensions.

Then, last week, the US Department of Health and Human Services removed at least dozens of locations that have Evusheld from an online locator, which means millions of immune compromised patients and their doctors can no longer find them.

“This whole thing is sad. It’s just very, very sad,” said Henry’s widow, Meli Rockhold. “It reminds me of the government response to Katrina. It’s just a cluster – I can’t say that next word.”

A leading researcher on Covid-19 and the immune-compromised emphasized that Evusheld, a monoclonal antibody, is the only prevention available for immune-compromised people – transplant patients and some cancer patients, for example, or people who take certain medications for rheumatoid arthritis and other conditions – who had a weak response to the Covid-19 vaccines.

“For people who did everything they could but didn’t have an adequate response to the vaccines, [Evusheld] is their only hope, and to deny them that because of a disorganized and chaotic distribution and education rollout is just terrible,” said Dr. Dorry Segev, a transplant surgeon and epidemiologist at NYU Langone Health.

Janet Handal, who runs an advocacy organization for people who are immune-compromised, says she hears every day from people who can’t find Evusheld.

“It’s just a tragedy that this is happening because there is such a great need for Evusheld, and there’s so many people who don’t have it,” said Handal, the founder of the Transplant Recipients and Immunocompromised Patient Advocacy Group.

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The federal government distributes Evusheld and other Covid-19 medicines to states based on their population. States then distribute the drugs to various locations.

“We make these allocations to states and territories on a weekly basis, with states and territories ultimately determining how best to distribute the product within their jurisdictions,” according to a statement to CNN from an official with HHS. “We encourage jurisdictions to distribute the product in ways that ensure it reaches immunosuppressed patients such as prioritization of medical centers where these populations typically receive care.”

The head of an association of state health officials noted that state health departments are managing the distribution of five different Covid-19 drugs, including Evusheld.

“I think most state health departments do not want to be in the medical supply chain business. That’s not their core competency,” said Michael Fraser, the CEO of the Association of State and Territorial Health Officials. “It’s a complex problem, and it’s happening in real time.”

Fraser added that state health departments are looking forward to the time when the private sector starts distributing Covid-19 drugs.

‘It’s just a waste’

On March 10, Avi Patel walked out the front door of his Florida pharmacy and unexpectedly found himself in possession of 192 boxes of Evusheld.

“All of a sudden, I see [these] huge boxes arriving at my doorstep. It just popped up,” said Patel, a pharmacist who owns Lemon Bay Drugs East in Englewood, Florida.

Two weeks later, Patel hasn’t used a single one of those 192 boxes.

“It’s just a waste,” Patel said.

CNN interviews with dozens of US pharmacies reveal that Patel’s situation is not unique: Many of them have used up none or very little of the Evusheld that their state health departments sent them.

To see how much Evusheld is sitting unused on pharmacy shelves, CNN in February downloaded an HHS database of sites that have Evusheld. CNN identified 59 retail pharmacies and the number of boxes of the drug they had received. Each patient needs two boxes for a full course of treatment.

On March 16-21, CNN confirmed with 58 of those pharmacies the number of boxes they had received and how many boxes they had remaining.

In total, these 58 pharmacies have received 5,372 boxes of Evusheld from the federal government, which is enough to treat 2,686 patients. Most of the shipments were in January and February and some in March.

As of CNN’s calls last week, the pharmacies had used up 1,376 of those 5,372 boxes. That means about three-quarters of the drug the pharmacies received, or 3,996 boxes, is still unused. That’s enough to treat 1,998 patients.

Red Rock Pharmacy in Tempe, Arizona, received 480 boxes of Evusheld by early February. It has not used up a single box.

The De Queen Health and Wellness Pharmacy in De Queen, Arkansas, received 264 boxes by March 3 and has used just two of them.

Dr. Aziz Pharmacy in Indianapolis hasn’t used any of the 72 boxes they received by January 27.

Trieu Bao, pharmacist and co-founder of Soleil Pharmacy in Glen Burnie, Maryland, said he hasn’t used any of the 96 boxes that were sent to him before March 1, and they’ve asked the state to stop sending the drug because of lack of space to store it.

The issue, according to pharmacists, doctors and patient advocates, is that unlike the Covid-19 vaccines, pharmacists need a prescription before giving Evusheld, and those prescriptions have been slow in coming.

“Pharmacists aren’t allowed to administer Evusheld [without a prescription], so to send this many is ridiculous,” said Patel, the Florida pharmacist.

“Pharmacies don’t know what to do with it,” added Michael Hogue, dean of the Loma Linda University School of Pharmacy and a liaison representative from the American Pharmacists Association to the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. “They’re getting Evusheld from states, but pharmacists don’t have the authority to prescribe it, so their hands are tied.”

Hogue said distributing the drug to pharmacists “really doesn’t make a whole lot of sense” and that the federal government has had “a not very well-thought-out plan on how to distribute Evusheld.”

To increase access to the drugs, patients and pharmacists have tried to educate their doctors about Evusheld.

“We’ve had people in our group call their doctor and ask about Evusheld and been told, ‘What’s that?’ ” said Handal, the founder of the advocacy group for immune-compromised patients.

“My experience is, most doctors have no clue about these treatment options,” said Harsh Patel, pharmacist and co-founder of Queens Pharmacy in Charlotte, North Carolina, which has not used any of the 24 boxes it received by late January.

Doctors don’t know about Evusheld partly because it came out at a time when there was an “avalanche” of news about other Covid-19 drugs, said Dr. William Schaffner, a liaison representative from the National Foundation for Infectious Diseases to the CDC’s vaccine advisory committee.

HHS began distributing Evusheld on December 17, and around that time, the FDA authorized a different monoclonal antibody drug that often gets confused with Evusheld, even though the other drug, bebtelovimab, treats Covid-19 and Evusheld is for prevention. Also around this time, two other monoclonal drugs were taken out of circulation, and the FDA authorized two antiviral medications.

“No one knows about Evusheld,” said Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. “I think it’s very sad.”

Even if a doctor does know about Evusheld, locating it can be complicated. Some doctors’ offices have it, but most do not. Some pharmacies have it, but not large retail chains such as CVS and Walgreens, where many Americans get their prescriptions. That means doctors have to know to search for the federal government locator website that lists some – but not all – of the locations that carry it.

“There’s never been a mechanism that says ‘hear ye, hear ye, we have a new way to protect your immune-compromised patients against Covid, and here’s how you get it for your patients,’ ” Schaffner said.

If immune-compromised patients want to advocate for themselves and find a pharmacy with Evusheld, they must defy a government warning in large bold type on top of its online locator that tells patients “the therapeutics locator is intended for provider use” and that “patients should not contact locations directly unless instructed to do so by their healthcare provider.”

If a patient defies the warning and uses the locator, it’s of limited use because it’s missing at least dozens of locations that have Evusheld.

Of the 59 pharmacies with Evusheld that CNN identified on the HHS database in February, HHS removed 30 on March 16, even though all of them still had Evusheld when CNN contacted them last week. Together, these 30 pharmacies that the government removed from public view have more than 2,400 boxes of Evusheld, and now doctors and patients now have no way of finding them.

Among the pharmacies with Evusheld that HHS removed from its locator are Prescriptions Unlimited, DeliveRxd, Red Rock Pharmacy, Queens Pharmacy and Lemon Bay Drugs East, which all have Evusheld.

HHS’s response

At a March 2 meeting among HHS and state health officials, Dr. Derek Eisnor, the federal government’s lead official on allocation and distribution of Covid-19 drugs, said the “utilization rate is low” for Evusheld.

At a March 9 meeting among HHS officials and national health care and medical associations, Eisnor said the agency was “somewhat dismayed” about the low utilization numbers.

At that meeting, Cicely Waters, director of external affairs for the HHS’s Assistant Secretary for Preparedness & Response, read a question from one of the attendees.

“[Are] there any successful ways to connect prescribers to patients that want product?” Waters read. “I’ve heard of news stories about patients who want Evusheld and sites that have product, but there’s still no way to get it to those patients.” The attendee then asked HHS for its thoughts on “closing that treatment gap.”

“It’s frustrating,” Eisnor answered. “It’s really a question of what are the best mechanisms to get that patient in front of that provider and as expeditiously as possible, and so I think some of this is obviously going to depend on the location and the site or the institution. But it is – it is frustrating.”

An HHS spokesperson told CNN that the agency has done two dozen meetings recently with states, providers and others “to not only encourage greater utilization but to do education about how the product works and who it’s for and answer questions about how best to manage supply to target those at high-risk.”

“We continue to engage provider and advocacy groups that support immunocompromised patients to help increase overall awareness and utilization of Evusheld. In addition to the dozens of engagements we’ve held with these groups, we have also created virtual resources as well as a platform for clinician peer-to-peer sharing of best practices, case studies, and administration models,” an HHS official wrote in another email.

The official said HHS removed a site from its locator if it has “less than five patient courses” of Covid-19 therapeutics. Of the 30 pharmacies that CNN found had been removed from the locator, pharmacists at 29 of them told CNN they had more than five boxes left of Evusheld. Most of them had considerably more, and several had hundreds of boxes left each.

HHS also said that “if a location goes seven days without reporting their product on hand and utilization amounts, that location is removed from the map since we cannot confirm product availability at that location.” The official added that removing “numerous” locations from the map last week “helped improve data reliability and overall product access.”

The official did not explain how removing sites from the locator that collectively have thousands of boxes of Evusheld improves product access.

“That makes no sense whatsoever,” said Handal, the founder of the advocacy group for immune-compromised people. “How could anybody even say that with a straight face?”

Evusheld sent to sites offering beauty treatments

CNN also reached out to the two locations offering beauty treatments that received Evusheld from the government.

Twenty-four boxes of Evusheld were sent to a location in Las Vegas that, in a cached version of its website, describes itself as a “premier medical spa chosen by the stars to help them look younger,” with services such as Botox and “facial rejuvenation.” CNN was unable to find a current website or contact information for anyone at this location.

Shannon Litz, a spokeswoman for the Nevada Department of Health and Human Services, told CNN that “the Nevada State Board of Pharmacy has reviewed this inquiry and determined it is in compliance, as the medication is being used by the physician in a different part of his practice.”

“We did an inquiry on it, and they’re operating within the rules of the EUA and the federal program,” said Dave Wuest, executive secretary of the Nevada State Board of Pharmacy. “There was a physician that was licensed there at the time that we sent the medicine there.”

But a Google Maps search of the address listed for the location shows an outdoor strip mall, with no indication of the business existing. Wuest said the location may have closed, and it would be up to the provider to notify the state if it had.

“Things change,” Wuest said. “I’m going to send somebody to the location and see if there’s a practitioner there.”

Twenty-four Evusheld boxes were sent to Integrative Medicine, Laser, and Aesthetics, in Carmel, Indiana, which offers, along with some health services, eyelash extensions and facial hair removal. The medicine was delivered prior to January 28, according to the HHS database.

None of those boxes has been used, according to Sarah Wygant, a medical assistant and paramedic at Integrative Medicine, Laser, and Aesthetics.

“Once the Evusheld product was offered, this provider met the necessary requirements to receive an allocation, which included having a physician providing oversight,” Megan Wade-Taxter, a spokeswoman for the Indiana Department of Health, wrote in an email CNN.

A ‘Hunger Games’-like competition for Evusheld

While many pharmacies have too much Evusheld, several medical centers say they don’t have nearly enough for their immune-compromised patients.

The Mayo Clinic in Rochester, Minnesota, has received 2,352 boxes of Evusheld, according to now removed HHS data, and the hospital has between 10,000 to 15,000 patients who could benefit, said Dr. Raymund Razonable, an infectious disease expert who heads up the hospital’s monoclonal antibody program.

To prioritize who gets the medication, Mayo has set up a tiered priority system – and the 2,352 boxes doesn’t even cover the first tier, which has 3,000 patients, he said.

“Things are tough right now. There’s not enough supply,” Razonable said.

The Moffitt Cancer Center in Tampa, Florida, has received enough Evusheld for just over 500 patients, according to spokeswoman Kim Polacek, and there are “potentially thousands” of Moffitt patients who could benefit from the drug, according to Dr. Robert Keenan, Moffitt’s chief medical officer.

“When you know there is a therapy that’s been developed but you don’t yet have the ability to give it to a patient, that’s an awful thing to have to tell the patient and an awful thing to have to deal with,” Keenan said.

CNN spoke with some medical centers that said they are not feeling strapped for Evusheld and have been able to get it to the patients who need it.

But some patients eligible for Evusheld have described a “Hunger Games”-like endeavor to find the drug.

“It’s almost like we are in a game and competing,” said Michele Nadeem-Baker, who has chronic lymphocytic leukemia and has not been able to get Evusheld from her doctors in Boston. “It’s almost Darwinian and survival of the fittest.”

Dr. Brian Koffman, a retired family doctor in Claremont, California, who has CLL, said he’s “one of the lucky ones” who’s been able to get Evusheld. He writes a blog to help other CLL patients and describes the roller coaster of emotions that many immune-compromised patients go through upon learning about Evusheld and then not being able to find it.

“There’s this light at the end of the tunnel that says ‘we have a way out’ [but then] ‘oh, sorry, you can’t get it,’ ” Koffman said.

Without protection against the virus, many immune-compromised people who did not get a full response from the vaccine and can’t find Evusheld are left to stay at home, still on lockdown after more than two years.

“We’re doing everything we can to rejoin society,” said Doreen Zetterlund of Los Angeles, who has CLL and has been trying unsuccessfully to get the drug. “[Evusheld] is the one last piece that will help us.”

Keenan, the chief medical officer at Moffitt, remembers Henry, the pharmacist who was unable to get Evusheld and died from Covid-19. Henry got care for his chronic lymphocytic leukemia at Moffitt, and he was the center’s chief pharmacy officer in 2018.

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Moffitt didn’t start administering Evusheld until January 24, Keenan said. That would have been too late for Henry, since by that time, he was already sick with Covid.

“Here’s Tom Henry – you couldn’t get more sophisticated about medications, [yet] he succumbs to Covid,” added Koffman, the family physician and the chief medical officer of the CLL Society. “Even when you’re [an] expert, you may not survive this.”

Now, Henry’s family – and the CLL patients he helped – wonder whether Henry might be alive today if he’d been able to get Evusheld in December, when he first excitedly told his readers about the new drug.

“Would he be alive today, doing the great work that [he’d] been doing?” said Diane Langan, a CLL patient in Syracuse, New York, who followed Henry’s blog. “It’s been very discouraging and very, very disheartening.”

Elizabeth Cohen Danielle Herman
Elizabeth Cohen
Danielle Herman


Divers uncover a surprising discovery near the wreck of the Titanic

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The wreck of the Titanic sits in two parts at the bottom of the North Atlantic Ocean, slowly decaying nearly 4,000 meters (13,000 feet) below the surface, but it’s not alone. A sonar blip detected around 26 years ago has now revealed there’s much more to this underwater area than previously thought.

P.H. Nargeolet, a veteran Nautile submersible pilot and Titanic diver, originally picked up the blip on echo sounding equipment in 1996, but its origins have remained unknown.

Video Ad Feedback Watch footage from first Titanic dive in 14 years (2019) 01:02 - Source: CNN

In an expedition to the Titanic shipwreck earlier this year, Nargeolet and four other researchers went to the blip’s previously recorded location to search for the mysterious object it represented. Due to the blip’s magnitude, Nargeolet had believed he was looking for another shipwreck — he instead found a rocky reef, made up of various volcanic formations, and thriving with lobsters, deep-sea fish, sponges and several species of coral that could be thousands of years old.

“It is biologically fascinating. The animals that live there are very different to the animals that are found otherwise living in the abyssal ocean,” said Murray Roberts, a professor of applied marine biology and ecology at the University of Edinburgh in Scotland and one of the researchers on the expedition. “(Nargeolet) did a really important piece of scientific work. He thought it was a shipwreck, and it turned out, in my mind, even more amazing than a shipwreck.”

The abyssal plain is a term used to describe the ocean floor at a water depth of 3,000 to 4,000 meters (around 12,000 feet), which makes up 60% of Earth’s surface, according to Roberts. It is thought to be a featureless, muddy seabed without much structure. On a few occasions, divers have observed rocky formations on the plain. Since the recent discovery near the Titanic, Roberts now believes such features might be more common than previously thought.

Rocky areas may also help explain the distances that sponges and corals travel across the ocean floor, which has always been a mystery to scientists. Within the muddy environment where they are typically observed, there are few hard surfaces for these species to latch onto in order to grow and reproduce.

Video Ad Feedback He found the Titanic. Here's his next mission 11:53 - Source: CNN

“Sometimes they turn up in places where we think, ‘Well, how did they get there? They don’t live long enough to get there,” Roberts said. “But if there are more of these rocky places, these stepping stones, than we ever thought, I think it could help us understand the distribution of these species across the ocean.”

The researchers are currently working on analyzing images and videos taken of the reef during their dive, and they intend to share their findings to improve the scientific community’s collective knowledge of deep-sea life. Roberts also hopes to link this discovery to a wider Atlantic Ocean ecosystem project he leads, called iAtlantic, that will allow for further study and protection of the fragile ecosystem within the reef.

There is another sonar blip near the Titanic that Nargeolet is hoping to identify on a future expedition. It was recorded in the same survey he performed years ago, in between the wreck of the Titanic and the newly uncovered reef — now named the Nargeolet-Fanning Ridge after him and the 2022 expedition’s mission specialist Oisín Fanning. Nargeolet expects whatever it is to be even bigger than this reef.

OceanGate Expeditions and their foundation — which, along with Fanning, provided the financial support for Nargeolet’s dive this year — will continue its longitudinal research work of the Titanic and surrounding areas in 2023.

“The marine life … was so beautiful. It was really unbelievable, because I was never expecting to see that in my life,” Nargeolet said. “I’ll be very happy to continue to look at the Titanic.”