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.

FDA advisers support Novavax's Covid-19 vaccine for authorization ...

CNN —

Vaccine advisers to the US Food and Drug Administration decided Tuesday that authorizing Novavax’s Covid-19 vaccine – which uses different technology from the three vaccines currently in use in the US – for emergency use in adults would be beneficial.

Most of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to a question of whether the benefits of Novavax’s vaccine, given as a two-dose primary series, outweigh its risks in people 18 and older, based on available evidence. Twenty-one members voted yes, one abstained, and none voted no.

If the full FDA gives the vaccine the green light, it will become the fourth Covid-19 vaccine authorized in the United States.

Novavax’s vaccine is made using small laboratory-built pieces of the coronavirus to stimulate immunity. This protein-based approach is a more traditional one for vaccine development than the mRNA vaccines from Pfizer/BioNTech and Moderna.

Committee member Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine, said he sees the vote as an opportunity.

“This is a different technology. It’s a more traditional protein-based vaccine,” Portnoy said. “The vaccine deserves the opportunity to be given and studied.”

“Certainly, the benefits outweigh the risks for a primary series,” committee member Dr. Michael Nelson, asthma, allergy and clinical immunology division chief at the University of Virginia School of Medicine, said of the vote.

“I think this group was in full recognition that this is probably a three-dose series and then will need to accumulate data supporting the need for booster doses and subsequent doses to probably make it a three-dose vaccine,” he said, hinting at how discussions might continue for the vaccine to be used as a booster shot.

Ahead of Tuesday’s meeting, an FDA briefing document found that although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, myocarditis and pericarditis – inflammation of the heart muscle and inflammation of tissue surrounding the heart – happened in six people after vaccination. For five of them, the inflammation emerged within just two weeks of getting the vaccine. In one person, it happened 28 days later.

The cases were similar to myocarditis after the mRNA Covid-19 vaccines developed by Pfizer/BioNTech and Moderna, and they raise “concern for a causal relationship” with Novavax’s vaccine, according to the FDA document.

Novavax said in a statement that there wasn’t a substantial difference in rates of myocarditis between clinical trial participants who got the vaccine (0.007%) and those who got a placebo (0.005%).

Novavax seeks US authorization

In November, Indonesia became the first country to grant emergency use authorization of Novavax’s vaccine. It has also been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.

In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use.

Novavax is prepared to ship doses of its vaccine from the Serum Institute in India when the FDA authorizes it.

“Our hope is that the FDA takes the recommendation of this VRBPAC committee … along with all the manufacturing data that we’ve given them and with the results of their inspection of our plant in India, and can reach a decision. We hope that’s soon,” Stanley Erck, Novavax’s president and chief executive officer, told CNN on Tuesday.

The company’s first shipment to the United States will be “a few million” doses, he said.

As for who could receive the vaccine, “there are tens of millions of people who have not had their primary vaccine for one reason or another,” Erck said. “That’s one market for us.”

He added that other markets for the vaccine include children and, eventually, people who need booster doses to maintain protection against Covid-19.

Novavax’s request for authorization was based on data including the results of two large clinical trials that demonstrated an overall efficacy of about 90% and a “reassuring safety profile,” according to the company. The trials were conducted before the Omicron coronavirus variant dominated in the United States.

“The Advisory Committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” Erck said in a statement after Tuesday’s meeting.

“We have heard in today’s VRBPAC meeting the significant support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” he said. “We look forward to the FDA decision.”

Overall, the uptake of Covid-19 vaccinations – especially booster doses – in the United States has been slow, and one FDA official described it as a “very serious” problem in Tuesday’s meeting.

“We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.

Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and a member of VRBPAC, asked in the meeting why there is a need for another Covid-19 vaccine in the United States when three have been authorized or approved: those from Pfizer/BioNTech, Moderna and Johnson & Johnson’s Janssen.

“The Janssen vaccine is currently not being used as a frontline vaccine the same way as the mRNA vaccines, which leaves the issue of vaccines for those who might not want to take an mRNA vaccine because of concerns they might have,” Marks responded, referring to the vaccines developed by Pfizer/BioNTech and Moderna.

“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccine,” Marks said.

More than two-thirds of the US population is fully vaccinated with at least their initial series, but Novavax officials have said that they plan to seek authorization of the vaccine for use as a booster dose too – and it can be used in people who got another vaccine type as their initial series.

Protein-based vaccines like Novavax’s work by getting the body’s immune system to recognize little modified pieces of the virus it’s targeting. In this case, that means pieces of the coronavirus spike protein.

When the genetic sequence for the virus that causes Covid-19 was published, scientists around the world quickly identified it as a coronavirus because of the “spike proteins” on its surface. These spikes form large protrusions, giving coronaviruses the appearance of wearing crowns, and “corona” is the Latin word for “crown.”

Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells – specifically, cells from the fall armyworm – prompting them to produce the coronavirus spike protein. These virus-like nanoparticles were harvested to make Novavax’s vaccine.

Overall, the vaccine relies on recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.

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“The whole idea of the vaccine is to show the immune system something that looks, tastes and acts like a virus, with the exception that it doesn’t make you sick. So we made the spike protein. We put it in a particle – basically, like a soap bubble – and it’s the size of the virus,” Dr. Gregory Glenn, president of research and development for Novavax, told CNN last year.

“It’s not infectious. We never touch the coronavirus itself,” Glenn added. “Then that is given to people, and they make an immune response that’s very much focused just on the spike – and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures.”

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:

CDC signs off on updated Covid-19 boosters | CNN

CNN —

Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, signed off Thursday on the recommendation of the agency’s independent vaccine advisers in favor of updated Covid-19 vaccine boosters from Pfizer/BioNTech and Moderna.

The CDC’s Advisory Committee on Immunization Practices voted 13 to 1 earlier in the day to recommend updated mRNA boosters for Americans this fall.

Walensky’s decision means the shots could be available by Friday, according to pharmaceutical manufacturers, which began shipping the new doses after the US Food and Drug Administration authorized them Wednesday.

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The updated boosters have instructions that tell our cells to make antibodies against two strains of the virus that causes Covid-19: the original strain and the BA.4 and BA.5 Omicron subvariants, which share the same spike.

Pfizer/BioNTech’s updated vaccine is a 30-microgram dose authorized for people 12 and older. Moderna’s updated vaccine is a 50-microgram dose authorized for people 18 and older.

The CDC said in the statement that it “also expects to recommend updated COVID-19 boosters for other pediatric groups” in the coming weeks.

People are eligible for the updated boosters as long as they have completed all primary doses in their vaccine series. The committee recommended that the new boosters be given at least two months after the last dose of any Covid-19 vaccine and up to three months after an infection.

The new formulations do not replace shots for the primary series.

The boosters were approved based on studies in mice bred to have human ACE-2 receptors – the doors the coronavirus uses to get into our cells – but clinical trial data showing how well they may work in humans won’t be available for another month or two.

This is similar to the way annual flu shots are studied and approved, but it’s the first time for Covid-19 vaccines.

In approving the vaccines, regulators also reviewed data behind different two-strain boosters. Those carry instructions to fight the original strain of the Omicron variant, BA.1, along with the original virus. Those boosters have been studied in about 1,400 people. They have been authorized for use in the UK and Canada but will not be available in the US.

Several of the committee members said Thursday that they were uncomfortable recommending a vaccine with no human data to back it.

“We’re been extrapolating the data that has been seen with the bivalent BA.1, and hopefully, we’ll have similar data for BA.4 and BA.5,” said Dr. Pablo Sanchez, a pediatrician at Ohio State University and a member of the committee.

“So I’m just concerned about that extrapolation. And because and ultimately, I really don’t want to establish a precedent of recommending a vaccine that we don’t have clinical data,” said Sanchez, who voted against the recommendation.

That prompted a quick rebuttal from government experts who work with the committee.

“I just would like to remind the committee that every year, we use influenza vaccines that are based on new strains without clinical studies being done,” said Dr. Melinda Wharton, associate director for vaccine policy at the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. Doran Fink, deputy director of the FDA’s Division of Vaccines and Related Products Applications, said, “I do appreciate the amount of discomfort that I’m hearing from committee members who are being asked to take this leap with the Covid vaccines that they haven’t been asked to make previously with the Covid vaccines.

“FDA felt very comfortable with the approach of extrapolating the safety and effectiveness or rather the known and potential benefits,” Fink said. “We recognize that we’ve taken a different path than the regulatory authorities have in Europe and Canada.”

Fink said the US chose to go this route based on feedback from its independent advisory group and projections for the viruses that may be circulating in this country over the fall and winter.

On Thursday, the committee saw new modeling data that suggested there were substantial risks to waiting to roll out new boosters.

According to the CDC’s forecasts, boosters given to US adults in September could prevent 137,000 more hospitalizations and 9,700 deaths than if the boosters were held until November.

New analyses on the cost-effectiveness of the boosters suggest that the US could save at least $63 billion in medical costs between August and March 31 if as many people get these boosters as got flu shots during the 2021-22 season.

In the studies that looked at the shot targeting BA.1 along with the original, the boosters broadened immunity against many variants, and they were proven to be better than the older single-strain boosters because they made higher levels of antibodies.

Moderna presented tantalizing data suggesting that the two-strain shots it developed against the Beta variant might extend the length of protection people get from their vaccines, which currently drops off significantly after about four months. It said a study on these results was being prepared for publication

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In mice bred to have human ACE-2 receptors, the two-strain vaccines against BA.4 and BA.5 protected better against infections in their lungs, compared with the original vaccine.

About two-thirds of the total US population is vaccinated against Covid-19 with an initial series, according to data from the CDC. But less than half of those with their initial series – and less than a third of the total population – has also gotten a booster.

FDA advisers vote in favor of authorizing Moderna Covid-19 vaccine ...

CNN —

Vaccine advisers to the US Food and Drug Administration decided unanimously Tuesday in favor of expanding the emergency use authorization of Moderna’s Covid-19 vaccine to include older children and teens, ages 6 to 17, saying it would offer more benefits than risks.

All 22 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to two questions of whether the benefits of the vaccine – when given as two 100-microgram doses for ages 12 to 17 and two 50-microgram doses for ages 6 to 11 – outweigh its risks, based on the available scientific evidence.

“The questions are whether the data support us voting for an emergency use authorization, and I would say that that is probably true,” committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University, said in Tuesday’s meeting.

“I am supportive of these two voting questions,” said member Dr. Hank Bernstein, a professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell.

“A third dose will likely be indicated due to evolving variants that are going to continue since so many people are continue to be unvaccinated, even with the primary series,” he said. “I think adding this vaccine, making it more available to families, is good. Families like more choice.”

The FDA, which typically follows the committee’s decisions, will now decide whether to authorize the vaccine for emergency use in these age groups. The Moderna vaccine is already authorized for adults.

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.

Questions emerge around a third dose

The committee members voted on the benefits of Moderna’s vaccine as a two-dose primary series for children and teens, but discussions could continue on if or when booster doses might be needed for younger ages.

“I’m comfortable saying that I think the benefits clearly outweigh the risks, but I say that with the comfort being provided that there will be a third dose,” member Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, said in Tuesday’s meeting.

Pfizer/BioNTech’s Covid-19 vaccine is already authorized for use as a booster dose in children as young as 5.

Offit said three doses of vaccine are needed to help protect against coronavirus variants, such as Omicron’s BA.1 and BA.2 subvariants.

“I disagree with the term ‘booster dose.’ The third dose is not a booster dose for the Omicron subvariants,” Offit said. “This is a three-dose primary series.”

Language about the future need for additional doses could be included in the emergency use authorization for the vaccine, Chatterjee said.

Yet “the importance of additional doses as the pandemic progresses cannot be minimized,” she added.

“It’s something for our FDA colleagues to maybe take note of,” she said. “They can certainly put language in the authorization document to suggest that additional doses might be needed in these children that will be receiving only two doses to start with.”

For children and teens ages 6 to 17, Moderna found in clinical trials that two doses of its vaccine provided a similar immune response as two doses in adults, according to a FDA briefing document.

Moderna’s vaccine has been estimated to be 93.3% effective against symptomatic Covid-19 among adolescents ages 12 to 17 when the original coronavirus and the Alpha variant were dominant.

The vaccine was estimated to be 76.8% effective against symptomatic Covid-19 for children ages 6 to 11 when the Delta variant was dominant. However, the FDA also noted that for children in that age group, the “vaccine efficacy could not be reliably determined due to the small number of COVID-19 cases accrued during the study.”

The vaccine was also found to be safe in all age groups, with adverse reactions described as “mostly mild to moderate in severity, generally of short duration,” and happening more frequently after the second dose than the first, according to the FDA briefing document.

Injection site pain was the most commonly reported adverse reaction. As for serious adverse events, the document described them as infrequent and didn’t raise any concerns. No deaths were reported.

Although there were no known cases of myocarditis or pericarditis associated with the vaccine, they are acknowledged as one of the known risks and have been reported mostly in males ages 18 to 24.

Up next: Vaccines for younger kids

The vaccine advisers are scheduled to meet again Wednesday to consider amending the emergency use authorization of Moderna’s vaccine to include even younger children, ages 6 months through 5 years old.

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They will also discuss amending the authorization of the Pfizer/BioNTech vaccine to include ages 6 months through 4 years.

The safety of Covid-19 vaccines for younger children will be an important part of those discussions, an FDA official said Tuesday.

“These vaccines will essentially extend down to the younger age ranges of as low as 6 months,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, told the committee. “Obviously, the safety in this population is of paramount importance, and I think there’ll be a fair amount of discussion by the committee on this particular area.”

The White House has said vaccines for the youngest children could start next week if the FDA and CDC authorize them.

FDA advisers to weigh expanding Covid-19 vaccines to younger ...

CNN —

Several months after older children became eligible to get vaccinated against Covid-19, the United States might be just days away from offering vaccines to those younger than 5.

The US Food and Drug Administration’s independent Vaccines and Related Biological Products Advisory Committee is set to meet Tuesday and Wednesday to discuss amending the emergency use authorization (EUA) of Moderna’s and Pfizer/BioNTech’s Covid-19 vaccines to include younger ages.

Children under 5 – about 18 million people – are the only US age group that isn’t eligible to get a Covid-19 vaccine.

The Moderna vaccine is authorized for use in adults, but on Tuesday, the advisers will discuss including children 6 through 17; on Wednesday, they will consider expanding the authorization to infants and children ages 6 months through 5.

The Pfizer/BioNTech vaccine is approved for people 16 and older, and it’s authorized for use in children as young as 5. At Wednesday’s meeting, advisers will discuss amending the EUA to include child-size doses of the vaccine for infants and children ages 6 months through 4.

According to FDA briefing documents posted Sunday, an agency review found that data supports the effectiveness of the Pfizer/BioNTech Covid-19 vaccine, given as a three-dose series, in preventing the disease in children 6 months through 4 years old. According to another document, a FDA review found that Moderna’s Covid-19 vaccine is also safe and effective in younger kids.

In their meetings Tuesday and Wednesday, VRBPAC members will vote on whether the benefits of the Moderna and Pfizer/BioNTech vaccines outweigh risks for younger children.

What’s next after vaccine advisers meet

After the FDA vaccine advisers vote, the agency will consider their decision and weigh whether it should authorize the vaccines.

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 and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.

The White House has said vaccines for the youngest children could start next week.

The rollout of vaccines for this group could mirror that for older children, as pediatricians’ offices will play a significant role in helping get shots into arms.

Some in-pharmacy clinics also are preparing to administer more vaccines.

“We plan to provide COVID-19 vaccinations to children 18 months through four years of age at our national network of 1,100 MinuteClinic locations once the FDA and CDC have provided guidance and inventory is received,” CVS spokesperson Matt Blanchette said in an emailed statement Monday.

“Our MinuteClinic clinicians comprised of board-certified Family Nurse Practitioners, Physician Associates, and Nurses, have significant experience providing vaccinations to a younger population as well as private exam rooms, which will make the process easier for kids, parents, and guardians,” the statement says.

Children under 5 typically have lower Covid-19 case rates than other age groups. But in the first week of June, hospitalization rates among these kids were slightly higher than among adults under the age of 50 and four times higher than those of other children.

At least 481 US children under the age of 5 have died of Covid-19, according to the CDC.

Pfizer’s data

People 5 and older are already eligible for Pfizer/BioNTech’s two-dose Covid-19 vaccine and a booster dose – but in Wednesday’s meeting, VRBPAC members will discuss whether to add younger children to the emergency use authorization.

According to a briefing document, Pfizer’s three-dose Covid-19 vaccine for children younger than 5 appears to be safe and generated an immune response in trials that’s comparable to the response in older people.

One trial included more than 4,500 children ages 6 to 23 months and 2 to 4 years. Some got three 3-microgram shots, with the second shot coming three weeks after the first and the third shot given at least eight weeks after the second. The rest got a placebo.

The FDA briefing document says the Pfizer vaccine for this age group induced responses comparable to what has been seen in 16- to 25-year-olds. There weren’t enough Covid-19 cases to establish vaccine efficacy in the study, but the FDA noted that this vaccine is known to be less protective against the Omicron variant.

A preliminary analysis put vaccine efficacy for children younger than 5 at 80.4%, with three Covid-19 cases in the vaccine group and seven in the placebo group. All the cases happened while the Omicron variant was dominant in the United States.

“Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group,” the FDA said in its analysis.

There were no cases of anaphylaxis. There were also no cases of myocarditis or pericarditis – inflammation of the heart muscle and inflammation of tissue surrounding the heart – reported among more than 3,000 vaccine recipients in the trial, but it wasn’t a large enough group to rule out the risk.

The most common adverse reactions among children 6 to 23 months were irritability, drowsiness, lack of appetite and tenderness at the injection site. For children 2 to 4 years old, the most common adverse reactions were pain or redness at the injection site and fatigue.

It’s not clear how long the vaccine will be effective; the agency noted that the evaluation period was limited and that protection is known to wane over time in older ages. The agency also said it’s “likely that a booster dose will be needed in addition to the three-dose primary series to increase robustness, breadth, and duration of protection.”

Moderna’s data

The immune response and safety profile of Moderna’s Covid-19 vaccine also appear to be favorable for the youngest children, according to the FDA briefing documents.

VRBPAC members will discuss Moderna’s vaccine on Tuesday and Wednesday, evaluating whether it should be authorized for younger ages.

In trials evaluating more than 6,000 children 6 months to under 6 years old, Moderna scientists found that two 25-microgram doses of vaccine, given 28 days apart, yielded a similar immune response as the two-dose vaccine series does in adults 18 to 25.

For children and teens ages 6 to 17, Moderna found that two doses of its vaccine provided a similar immune response as two doses in adults.

The vaccine was also found to be safe in all age groups, with adverse reactions described as “mostly mild to moderate in severity, generally of short duration,” and happening more frequently after the second dose than the first, according to the document. Injection site pain was the most commonly reported adverse reaction. As for serious adverse events, the document described them as infrequent and didn’t raise any concerns. No deaths were reported.

Although there were no known cases of myocarditis or pericarditis associated with the vaccine, it is acknowledged as one of the known risks and has been reported mostly in males ages 18 to 24.

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The FDA did not require the vaccine makers to submit vaccine efficacy data for emergency use authorization for young children, but Moderna’s vaccine has been estimated to be 93.3% effective against symptomatic Covid-19 among teens ages 12 to 17 when the original coronavirus and the Alpha variant were dominant.

The vaccine was estimated to be 76.8% effective against symptomatic Covid-19 for children ages 6 to 11 when the Delta variant was predominant. However, the FDA also noted that for children in that age group, the “vaccine efficacy could not be reliably determined due to the small number of COVID-19 cases accrued during the study.”

The vaccine was tested during a time when the Omicron variant was dominant. It was estimated to be 36.8% effective against symptomatic Covid-19 for children ages 2 to 5 and 50.6% protective for children 6 months to 23 months.

Vaccine efficacy estimates “were generally consistent” with what has been seen in adults, according to the FDA briefing document.

Covid-19: FDA advisers to weigh risks and benefits of Novavax's ...

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After more than a year with two types of Covid-19 vaccines in use in the United States, another will be up for consideration by the US Food and Drug Administration next week.

The FDA’s vaccine advisers are set to meet Tuesday to consider Novavax’s coronavirus vaccine for the nation.

Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine’s efficacy was 90.4% overall against mild, moderate or severe Covid-19 for a period of 2½ months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.

Those efficacy numbers were collected before the emergence of the Omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against Omicron.

In an announcement published in December, the company reported that the vaccine had “broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.”

Novavax’s vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.

Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis – inflammation of the heart muscle and inflammation of tissue surrounding the heart – associated with the vaccine.

“Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373,” the FDA’s briefing document says.

The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.

An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna Covid-19 vaccines now used in the United States.

In a statement Friday, Novavax addressed the heart inflammation concerns specifically: “We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections.” It said that the rate of myocarditis in vaccinated participants was similar to the placebo group: 0.007% and 0.005%, respectively.

The company added, “we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.”

The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine’s clinical trials.

In its briefing document, the FDA summarized, “The known benefits among vaccine recipients 18 years of age and older relative to placebo are reduction in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination.”

In Tuesday’s meeting, the FDA’s vaccine advisory committee members will vote on the question “Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?”

‘We believe our vaccine offers a differentiated option’

In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.

In November, Indonesia became the first country to grant emergency use authorization of Novavax’s vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.

Even though most adults in the United States have been vaccinated against Covid-19, the head of the company has said that it sees Novavax’s vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person’s initial doses.

Novavax’s vaccine was developed as a protein subunit vaccine, a more traditional type of technology than the mRNA used for the Moderna and Pfizer vaccines. Other examples of subunit vaccines are the hepatitis B and pertussis vaccines.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the Covid-19 pandemic,” Novavax CEO Stanley Erck said in a statement in January.

Novavax’s protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.

Protein-based vaccines like Novavax’s work by getting the body’s immune system to recognize little modified pieces of the virus it’s targeting. In Novavax’s case, that means pieces of the coronavirus spike protein.

When the genetic sequence for the virus that causes Covid-19 was published, scientists around the world quickly identified it as a coronavirus because of the “spike proteins” on its surface. These spikes form large protrusions, giving coronaviruses the appearance of wearing crowns, and “corona” is the Latin word for “crown.”

Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells – specifically, cells from the fall armyworm – prompting them to produce the coronavirus spike protein.

These virus-like nanoparticles were harvested to make Novavax’s vaccine.

“The whole idea of the vaccine is to show the immune system something that looks, tastes and acts like a virus, with the exception that it doesn’t make you sick. So we made the spike protein. We put it in a particle – basically, like a soap bubble – and it’s the size of the virus,” Dr. Gregory Glenn, president of research and development for Novavax, told CNN last year.

“It’s not infectious. We never touch the coronavirus itself,” Glenn added. “Then that is given to people, and they make an immune response that’s very much focused just on the spike – and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures.”

Novavax starts Phase 3 trial of Omicron-specific booster

As Novavax seeks emergency use authorization of its NVX-CoV2373 vaccine, it also is studying a separate vaccine that specifically targets the Omicron variant, called NVX-CoV2515. The company announced this week that it has started a Phase 3 trial of this vaccine, assessing its safety and efficacy as a booster shot.

“The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine,” Novavax said in a news release.

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The trial will analyze the Omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.

Two doses of either the Omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.

Similarly, two doses of the Omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.

Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.

The trial will last about 10 months, and initial results are expected in the second half of this year.

Jacqueline Howard Nadia Kounang
Jacqueline Howard
Nadia Kounang

CDC signs off on boosters for 5-11-year-olds | CNN

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The US Centers for Disease Control and Prevention signed off on boosters for 5- to 11-year-olds following the independent vaccine advisers recommendation for an additional dose of the Pfizer/BioNTech Covid-19 vaccine following a primary series.

The CDC’s vaccine advisers voted 11-1, with 1 abstention Thursday to support recommending a booster dose, which the US Food and Drug Administration authorized earlier this week.

The recommendation they voted on was: “A single Pfizer/BioNTech Covid-19 vaccine booster dose is recommended for persons ages 5-11 years at least 5 months after the primary series, under the FDA’s Emergency Use Authorization.”

The CDC’s Advisory Committee on Immunization Practices endorsed the booster for children at least five months after they received their two-dose series. This would be a third dose for healthy children and a fourth dose for children who are immunocompromised.

The committee voted for the booster after hearing details about Pfizer’s application to the FDA to expand access to the boosters for this age group. Waning antibody levels have been seen in children who have received a primary vaccination series, and booster doses achieved antibody levels higher than what was seen after the primary series.

The company said data from its clinical trials showed it raised Omicron-fighting antibodies by 36 times in this age group. The trial that included 4,500 children ages 5 through 11 saw no new safety issues, according to the company.

“Overall, the benefits of Covid vaccines continue to outweigh the risks as we continue to see, regardless of what age group is highlighted, receipt of the Covid vaccine primary series continues to be critically important for the prevention of severe Covid-19 morbidity and mortality and overall Covid-19 vaccine booster doses have been shown to increase protection against all outcomes in those 12 and over,” said Dr. Sara Oliver, a pediatric infectious disease specialist and the lead for the Covid-19 vaccines ACIP Work Group. “It’s likely that children ages 5 through 11 would benefit from a Covid-19 vaccine booster dose.”

The Omicron variant of the coronavirus has been tough on kids. Studies from the New York State Department of Health and the CDC found that the effectiveness of two doses of Pfizer’s vaccine for children ages 5 to 12 fell significantly during the Omicron surge, falling from 68% to about 12% against infection. Two doses of the vaccine did seem to keep kids out of the hospital.

While not at the same levels as during the Omicron wave, Covid-19 cases among children have been increasing. The number of new Covid-19 cases among children in the US grew nearly 76% last week from two weeks prior, the American Academy of Pediatrics said Monday.

According to the latest report from the CDC, 1,547 children have died of Covid-19 in the US and 364 of them were in the 5-11 year-old age range.

The American Academy of Pediatrics says that almost 13.2 million kids in the US have tested positive for Covid-19 during the pandemic, with more than 5.3 million of those cases coming this year. Those numbers are probably undercounted, as testing has fallen off in much of the country.

Looking at electronic health records, with more than 700,000 doses administered, there were no real safety problems found with the Pfizer vaccine in children, according to a presentation given to the committee.

Anaphylaxis rates in children ages 5-11 following the Pfizer vaccination were comparable to the rate seen in people ages 12 and older. In the three months after the initial vaccine series, there were 10 potential cases of myocarditis or pericarditis, both types of heart inflammation, but four of those cases were determined not be related to the vaccination, the CDC said in its presentation.

“The general picture is that myocarditis associated with mRNA vaccination relative to viral myocarditis tends to be clinically mild and patients have good prognosis and a fairly short recovery period,” the CDC’s Dr. Tom Shimabukuro told the committee.

The rates were also lower in this age group than were seen in adolescence. The rate was also lower after a booster dose.

Most children, if they experienced any problems with the vaccine were considered non-serious, like pain at the injection site. This was similar to adults’ reaction after their second dose.

Vaccination is an important protection for children. The risk of dying from Covid-19 for children 12 years and older in February of 2020 was 20 times higher among unvaccinated children, compared to those with the primary vaccine series and a booster dose.

While scientists initially believed that Covid-19 didn’t impact children nearly as much as it did adults, deaths from Covid-19 in 5 -11-year-olds were greater than for a number of other pediatric vaccine preventable diseases. In 2020, it was one of the leading causes of death for children in this age range.

“It’s important to highlight that vaccine coverage for these other conditions, these other diseases, is relatively high, indicating that most parents accept vaccination for Hepatitis A, meningococcal, varicella, rubella and rotavirus even though deaths from these diseases are relatively rare,” said Dr. Matt Daley, who is chair of the COVID 19 vaccines workgroup and a senior investigator with the Institute for Health Research Kaiser Permanente Colorado.

Parents should also keep in mind that a child who gets Covid-19 can, like adults, develop long-Covid, Daley said, even after a child has a mild case of Covid-19. Long Covid symptoms can last for years after the initial infection. People who were previously vaccinated were less likely to have symptoms between 12 and 20 weeks after infection compared to those that were unvaccinated, the CDC said.

Children ages 5 - 11 were also the most vulnerable age group to develop multisystem inflammatory syndrome in children, also known as MIS-C, a rare but serious Covid-19-related condition. Among this age group, there have been 3,800 MIS-C cases and 16 deaths, according to the CDC’s presentation.

“Data do not suggest potential safety concerns regarding a Pfizer/BioNTech COVID-19 vaccine booster for children five to seven years of age beyond those previously identified in older age groups,” said Dr. Helen Keipp Talbot in her safety findings presentation to the committee.

Talbot was the one expert who voted against the booster dose for this age group. While she is in favor of vaccinating children against Covid-19, she thinks public health leaders should concentrate on the low vaccination rate among this age group instead of focusing on boosters.

“I really want children to be vaccinated,” said Talbot, an associate professor of medicine at Vanderbilt University. “We really need to spend our time and effort on educating the 70% who have not been (vaccinated). Boosters are great once we’ve got everyone their first round and I think that needs to be a priority.”

In the 5-11 age group, only 35% of children have had one dose and only 28% are fully vaccinated according to the CDC.

Following the ACIP vote, CDC Director Dr. Rochelle Walensky will decide whether to sign off on the ACIP recommendation.

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Walensky, who gave opening remarks in the meeting advocated for more people of all ages to get the Covid-19 vaccine.

“There are too many who do not have the protection necessary as we face yet another increase in cases and hospitalizations,” she told the committee. “We all hoped to never see the death tolls rise this high, reaching a number that was unfathomable when we first learned of this virus.”

“The sadness I feel for lives lost, the families devastated and the communities changed is steep,” Walensky added. “We have the tools we need to protect these people from severe disease and prevent any more tragic deaths.”

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

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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 to consider whether Omicron-specific vaccines are ...

CNN —

The United States is preparing for the possible need to update its Covid-19 vaccines.

The US Food and Drug Administration’s independent Vaccines and Related Biological Products Advisory Committee is set to meet Tuesday to discuss whether the composition of Covid-19 vaccines should be modified to target a specific coronavirus strain, and if so, which strain should be selected.

That means the Covid-19 vaccinations that people receive in the future could be somewhat or completely different formulations than what are administered now. The current vaccines are based on the coronavirus that emerged in late 2019, but the experts will discuss Tuesday if vaccines should also target the Omicron variant.

In their meeting, VRBPAC members will vote on the question: “Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”

This is a moment of transition for the approach to the coronavirus vaccines. Anticipation is mounting that vaccinations could be needed annually – similar to how seasonal flu shots are administered each year.

“There’s anticipation that we would need a fall booster and what that framework would look like and if a vaccine is needed due to a different variant,” Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, told CNN.

“This becomes challenging, because is it really a booster if it’s not the same formulation? And should we be talking about it in that way or is it simply a new vaccination?” Freeman added. “We don’t discuss that we have received boosters of flu shots over the years. It’s just part of getting your flu shot every year. So this transition is an important one.”

In May, a trio of top FDA officials wrote in the medical journal JAMA that the United States might need to update its Covid-19 vaccines each year and “a new normal” may include an annual Covid-19 vaccine alongside a seasonal flu shot.

“By summer, decisions will need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters and regarding vaccine composition,” wrote Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research; Principal Deputy Commissioner Dr. Janet Woodcock; and FDA Commissioner Dr. Robert Califf.

“Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration,” they wrote.

‘This is going to be … a transitional year’

The FDA’s vaccine advisers previously met in April to discuss how the composition of Covid-19 vaccines could change to target any new and emerging coronavirus variants. The committee agreed that there needs to be a framework for how and when such changes take place.

FDA’s Marks has called this year a “transitional” one in how we view the evolving Covid-19 vaccine schedule.

“The hypothesis now is that this is going to look somewhat like influenza. In this 2022-23 season, instead of just getting vaccinated against influenza, you’ll also get your booster for Covid-19. And we’ll see how that goes,” Marks told Bloomberg in an opinion article earlier this month.

“If people who get that boost do well and we seem to have avoided another big wave from October to March-April of next year, we will have gotten people used to that,” he said.

People age 5 and older are already eligible for booster doses, and certain immunocompromised people and adults 50 and older are eligible for additional doses of Covid-19 vaccine.

“We have to start thinking about vaccines that we can adjust strains of once a year and make it more of a flu model rather than saying, OK, every five months or four months, you’ll get another booster,” Marks told Bloomberg. “The idea here is that next year we have one campaign, and we don’t have to follow it up with another booster campaign. Ultimately, next-generation vaccines would ideally help hold us for that full year.”

Currently, the original versions of the Pfizer/BioNTech, Moderna and Johnson & Johnson coronavirus vaccines are used in the United States – but vaccine makers have been working on updated versions of their vaccines.

Moderna has developed a bivalent Covid-19 vaccine booster, named mRNA-1273.214, which the company announced this month has been shown to elicit “potent” immune responses against the Omicron subvariants BA.4 and BA.5. This bivalent booster vaccine candidate contains components of both Moderna’s original Covid-19 vaccine and a vaccine that targets the Omicron variant. T

On Saturday, Pfizer and BioNTech said their two Covid-19 vaccine boosters targeting Omicron showed a substantially higher immune response than its current Covid-19 vaccine, and preliminary lab studies suggest the vaccines could neutralize the Omicron BA.4 and BA.5.

Another vaccine maker, Novavax, has received VRBPAC’s support for emergency use authorization in the United States, but has not not yet been authorized by the FDA. Novavax scientists also have been developing variant-specific updated versions of their Covid-19 vaccine as well as a Covid-19 and flu combination vaccine.

‘Booster uptake so far isn’t that great’

Public health experts worry that there might be a sluggish uptake of any modified Covid-19 vaccines in the future.

“Our booster uptake so far isn’t that great, and so another booster is not going to necessarily cause people to run out and get the boosters they’ve already missed,” Freeman said.

About two-thirds of the US population – 67% – is fully vaccinated against Covid-19 with at least their initial series of vaccine, but less than a third – 32% – have received their booster, according to data from the CDC, as of Friday.

Vaccination rates for children still lag far behind other age groups – just 30% of children ages 5 to 11 and 60% of those ages 12 to 17 are fully vaccinated, compared with nearly 77% of adults. National data on vaccination rates for children under 5, who became eligible this month, will likely not be available for a few weeks.

The CDC still considers receiving two doses of the Pfizer/BioNTech or Moderna vaccines or a single dose of the Johnson & Johnson vaccine as being fully vaccinated. Any additional doses are called “boosters,” and completing all recommended boosters of vaccine is considered being “up to date.”

But that language and messaging around completing booster doses – and considering them as being up to date instead of as part of being fully vaccinated – “is not working,” said Dr. Peter Hotez, vaccine scientist and dean of the National School of Tropical Medicine at Baylor College of Medicine, told CNN. That is evident in the slow uptake of additional doses.

“Since the beginning of January 2021, I’ve said this was always a three-dose vaccine,” he said.

Now, people who have not yet completed their booster doses are becoming more vulnerable to Covid-19 infections, hospitalizations and deaths.

“There’s heavy consequences because we’re starting to see not only breakthrough hospitalizations, but even breakthrough deaths in people getting only two doses of the vaccine and not getting the booster – especially those over the age of 65 – so this is more than a theoretical discussion. Lives are being lost because of the messaging,” Hotez said.

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At the moment, vaccine-induced protection against Covid-19 seems to not stay durable for as long as vaccine experts would hope, but it is not so clear why. Waning protection could be due to the vaccines themselves or due to the emergence of coronavirus variants evading the vaccines.

Hotez said that he thinks the White House should convene a panel of vaccine experts – outside of FDA’s VRBPAC – in a special meeting to determine whether the Covid-19 vaccine technology has a weakness when it comes to durability and what that means for future vaccine strategies.

“There’s two things happening at once. There could be waning immunity,” Hotez said, but at the same time, there have been variants like Delta and Omicron arriving on the scene.

“If all we had to worry about was Delta, would we be having a problem? Or would things have held up? And so I don’t know the answer to that,” Hotez said. “That’s why you want to convene the experts.”