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Updated Covid-19 boosters are expected in September. Will it be ...

CNN —

This fall, Americans could get boosted with a mRNA Covid-19 vaccine unlike any that’s come before.

Both Pfizer and Moderna are working on bivalent boosters: vaccines made up of both the old formula and a new one that targets the Omicron BA.4 and BA.5 subvariants of the coronavirus.

If the shots meet US Food and Drug Administration standards, they will probably be available as early as September, the FDA says.

But cases are high now. There are about 124,000 new cases reported each day – far from the levels reported during the Omicron surge, but nearing peak case rates from the Delta wave – and cases are more undercounted than ever.

Some experts wonder whether the Omicron-specific boosters will come in time to make a difference and if they will actually offer more protection than the current shots.

A prediction game

The current shots are based on the original strain of the virus and offered nearly full protection, even from infection, early on. With new variants in circulation, the vaccines still are good at keeping people out of the hospital, but most scientists think people need a vaccine that offers more protection.

Dr. Michael Chang, a pediatric infectious disease specialist at Memorial Hermann Health System in Houston, thinks vaccines with an Omicron component will be helpful – within limits.

“I just wish that the timing had been sooner so that we could actually be dealing with the kind of BA.5 surge that we have right now,” he said.

With the highly contagious BA.5 subvariant now dominant, the goal of minimizing the number of infections is “kind of lost,” but the new vaccines should help keep hospitalizations and deaths down, Chang said.

“I do think, anytime you can introduce additional strains or variants into a vaccine, the human body’s immune response tends to be a little bit broader and more durable and potentially longer-lasting,” he said.

But it’s impossible to know at this point what variant will be dominant a couple months from now, how different it will be from the currently circulating variants or even how many cases there will be, because it’s hard to predict how humans will behave when cases rise – and cases will most likely rise. Much like with the flu, scientists think the coronavirus transmits more efficiently in colder weather. It also spreads more easily as people spend more time indoors.

Dr. Edward Michelson, chair of the Department of Emergency Medicine at Texas Tech University Health Sciences Center in El Paso, is seeing many patients again, even those who had Omicron earlier in the year.

“Omicron is not protecting people even a few months after they got sick with it. These subvariants are getting them again, much to my surprise,” Michelson said. “The good news is, most of the patients don’t need hospitalization.”

Still, 375 people are dying of Covid-related causes on average every day in the US, according to the CDC.

‘A new vaccine could really pay dividends’

The Covid-19 Scenario Modeling Hub, a group of scientists across the country who create projections for the coming year, predicts an upswing in hospitalizations through early fall. But the model suggests that a booster campaign will make a dent in these numbers, according to Justin Lessler, a University of North Carolina epidemiologist who works with the group.

While scientists are still trying to determine exactly how well the new vaccines will protect people, Lessler said, the model assumes that the reformulated vaccine would have about 80% efficacy against infection with the currently circulating strains. But that depends on how many people actually get an updated booster.

“Absent any real new variants, that kind of efficacy would be enough to really tamp down the current circulation if we have a broad uptake of the vaccines,” Lessler said. “A new vaccine could really pay dividends, particularly if we can get it to a broad swath of the population.”

Ideally, public health campaigns could be built to encourage people to get a flu vaccine and a Covid-19 vaccine at the same time, he said.

Lessler presented an earlier version of the model to the FDA’s independent vaccine advisers, who voted in June to recommend that the vaccine makers include BA.4 and BA.5 in the fall booster. They said that including an Omicron element would offer more protection.

“While it’s impossible for anyone to predict which variants will be circulating at the time, the goal as I see it is to add the subvariants that are most likely to give us that broad spectrum of antibodies that will hopefully prevent serious disease, which is really what we’re trying to do,” said Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Europe’s approach

Some countries may go with vaccines based on the BA.1 Omicron subvariant this fall. It’s not fully understood to what extent the sublineages of Omicron influence vaccine effectiveness, but some scientists who advise the World Health Organization argued that BA.1-based shots would be “more distinct” than other subvariants.

Moderna said it’s developing a booster for the European Union, the UK and Australia that uses the original strain and BA.1. The subvariant is largely extinct, but the company said its studies have shown that this booster candidate still drew “significantly higher neutralizing antibody responses” against BA.4 and BA.5 compared with the currently authorized booster.

Pfizer has said it too will make a vaccine that fits Europe’s needs, as well as the needs in the US.

“Our program continues to focus on all variants of concern and we remain committed to the public health needs as defined by regulators, Europe and elsewhere,” a spokesperson for Pfizer told CNN in an email.

Pfizer submitted its bivalent BA.1-specific vaccine to the European Medicines Agency in mid-July and told CNN it will be ready to distribute this fall, pending authorization.

In the United States, a vaccine updated for BA.4/5 got the go-ahead for fall.

Dr. Larry Corey, a vaccine development expert and professor of medicine and infectious disease division at Fred Hutchinson Cancer Research Center in Seattle, said the data makes a strong case for the addition. Research on infections shows that the BA.4 and BA.5 subvariants seem to induce stronger immune response than BA.1 and BA.2.

“We don’t have the data yet. Certainly, we will know by the end of August,” Corey said.

As with so much during the pandemic, scientists are making educated guesses and figuring things out as they go.

“We’ll start sleeping better in a month, see whether it does well in animals, and we’ll feel we made the right decision when we boost a bunch of people with the BA.4/BA.5 variants,” Corey said.

A virus that breaks all the rules

Even as the virus changes, there is only so much vaccine makers can do, says University of Michigan epidemiologist Arnold Monto, who has served as acting chair of the FDA’s vaccine advisory panel.

“Basically, we can only use those viruses that we know about,” Monto said.

Omicron was a big change from previous variants, he said, and most evolutionary virologists don’t think there will be such a big leap again. Rather, the changes will probably be along the Omicron lines.

But then again, “this has been a tricky virus. It has broken all the rules.”

Regardless, Monto is confident that adding the BA.4/BA.5 element to the new vaccines will help.

“While we know that the latest viruses that we are encountering that will go into the vaccine probably are not going to the be the viruses in the coming fall and winter, the answer is not to chase them but to try and catch up and broaden them,” he said.

In other words, vaccine makers will want to have a wide a distribution of immunity in the population. That’s why they’ll continue to include the original strain as well as Omicron.

It seems possible that we’ll be facing different variants in the fall, but Dr. Eric Rubin, an adjunct professor of immunology and infectious disease at Harvard T.H. Chan School of Public Health, said there is a “very reasonable argument” that having some diversity in the immune response is still a good thing.

“For me, the most important thing we can measure right now is the breadth of immunity and not try to guess which strain is going to be there. That’s probably more important than trying to guess what comes up in the fall,” said Rubin, who is also on the FDA’s vaccine advisory committee but was not a part of the Omicron booster discussion.

Evolution is trying to find its own path, however, and the virus will do whatever works for it as opposed to us. Down the line, he hopes we’ll have even better vaccines that will prevent not just severe disease but infections as well.

“I don’t think a perpetual game of catchup is going to work forever. We need to think about new approaches,” Rubin said.

But he emphasized that more people should get vaccinated and boosted in order to keep cases, hospitalizations and deaths down.

Some people should still get boosted now

The FDA is still encouraging adults 50 and older and those with compromised immune systems to get a second booster now, with the current formula. That would leave enough of an interval for them to get an updated booster in the fall.

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The Biden administration has ended its conversations with the FDA about allowing adults under 50 to get a second booster with the current formula this summer.

Once boosters are updated for the fall, the FDA said, people who get boosted now “may consider getting one.” Scientists say it will be important to get this updated version.

“The current vaccines do a pretty great job at keeping people out of hospitals,” Rubin said. “I don’t really want to dismiss what we’ve got there. Of course, we always want better.”

Coronavirus: As BA.2 subvariant of Omicron rises, lab studies point ...

CNN —

The BA.2 virus – a subvariant of the Omicron coronavirus variant – isn’t just spreading faster than its distant cousin, it may also cause more severe disease and appears capable of thwarting some of the key weapons we have against Covid-19, new research suggests.

New lab experiments from Japan show that BA.2 may have features that make it as capable of causing serious illness as older variants of Covid-19, including Delta.

And like Omicron, it appears to largely escape the immunity created by vaccines. A booster shot restores protection, making illness after infection about 74% less likely.

BA.2 is also resistant to some treatments, including sotrovimab, the monoclonal antibody that’s currently being used against Omicron.

The findings were posted Wednesday as a preprint study on the bioRxiv server, before peer review. Normally, before a study is published in medical journal, it is scrutinized by independent experts. Preprints allow research to be shared more quickly, but they are posted before that additional layer of review.

“It might be, from a human’s perspective, a worse virus than BA.1 and might be able to transmit better and cause worse disease,” says Dr. Daniel Rhoads, section head of microbiology at the Cleveland Clinic in Ohio. Rhoads reviewed the study but was not involved in the research.

The US Centers for Disease Control and Prevention is keeping close watch on BA.2, said its director, Dr. Rochelle Walensky.

“There is no evidence that the BA.2 lineage is more severe than the BA.1 lineage. CDC continues to monitor variants that are circulating both domestically and internationally,” she said Friday. “We will continue to monitor emerging data on disease severity in humans and findings from papers like this conducted in laboratory settings.”

BA.2 is highly mutated compared with the original Covid-causing virus that emerged in Wuhan, China. It also has dozens of gene changes that are different from the original Omicron strain, making it as distinct from the most recent pandemic virus as the Alpha, Beta, Gamma and Delta variants were from each other.

Kei Sato, a researcher at the University of Tokyo who conducted the study, argues that these findings prove that BA.2 should not be considered a type of Omicron and that it needs to be more closely monitored.

“As you may know, BA.2 is called ‘stealth Omicron,’ ” Sato told CNN. That’s because it doesn’t show up on PCR tests as an S-gene target failure, the way Omicron does. Labs therefore have to take an extra step and sequence the virus to find this variant.

“Establishing a method to detect BA.2 specifically would be the first thing” many countries need to do, he says.

“It looks like we might be looking at a new Greek letter here,” agreed Deborah Fuller, a virologist at the University of Washington School of Medicine, who reviewed the study but was not part of the research.

Mixed real-world data on subvariant’s severity

BA.2 has been estimated to be about 30% more contagious than Omicron, according to the World Health Organization. It has been detected in 74 countries and 47 US states.

The US Centers for Disease Control and Prevention estimates that about 4% of Americans with Covid-19 now have infections caused by BA.2, but many other parts of the world have more experience with this variant. It has become dominant in at least 10 other countries: Bangladesh, Brunei, China, Denmark, Guam, India, Montenegro, Nepal, Pakistan and the Philippines, according to World Health Organization’s weekly epidemiological report.

However, there’s mixed evidence on the severity of BA.2 in the real world. Hospitalizations continue to decline in countries where BA.2 has gained a foothold, like South Africa and the UK. But in Denmark, where BA.2 has become the leading cause of infections, hospitalizations and deaths are rising, according to WHO.

Resistant to monoclonal antibody treatments

The new study found that BA.2 can copy itself in cells more quickly than BA.1, the original version of Omicron. It’s also more adept at causing cells to stick together. This allows the virus to create larger clumps of cells, called syncytia, than BA.1. That’s concerning because these clumps then become factories for churning out more copies of the virus. Delta was also good at creating syncytia, which is thought to be one reason it was so destructive to the lungs.

When the researchers infected hamsters with BA.2 and BA.1, the animals infected with BA.2 got sicker and had worse lung function. In tissues samples, the lungs of BA.2-infected hamsters had more damage than those infected by BA.1.

Similar to the original Omicron, BA.2 was capable of breaking through antibodies in the blood of people who’d been vaccinated against Covid-19. It was also resistant to the antibodies of people who’d been infected with Covid-19 early in the pandemic, including Alpha and Delta. And BA.2 was almost completely resistant to some monoclonal antibody treatments.

But there was a bright spot: Antibodies in the blood of people who’d recently had Omicron also seemed to have some protection against BA.2, especially if they’d also been vaccinated.

And that raises an important point, Fuller says. Even though BA.2 seems more contagious and pathogenic than Omicron, it may not wind up causing a more devastating wave of Covid-19 infections.

“One of the caveats that we have to think about as we get new variants that might seem more dangerous is the fact that there’s two sides to the story,” Fuller says.

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The virus matters, she says, but as its would-be hosts, so do we.

“Our immune system is evolving as well. And so that’s pushing back on things,” she said.

Right now, she says, we’re in a race against the virus, and the key question is, who’s in the lead?

“What we will ultimately want is to have the host be ahead of the virus. In other words, our immunity, be a step ahead of the next variant that comes out, and I don’t know that we’re quite there yet,” she said.

For that reason, Fuller says, she feels like it’s not quite time for communities to lift mask mandates.

“Before this thing came out, we were about 10 feet away from the finish line,” she said. “Taking off the masks now is not a good idea. It’s just going to extend it. Let’s get to the finish line.”

Why the Omicron offshoot BA.5 is a big deal | CNN

CNN —

Once again, Covid-19 seems to be everywhere. If you feel caught off-guard, you aren’t alone.

After the Omicron tidal wave washed over the United States in January and the smaller rise in cases in the spring caused by the BA.2 subvariant, it might have seemed like the coronavirus could be ignored for a while. After all, the US Centers for Disease Control and Prevention estimated in December that nearly all Americans had been vaccinated or have antibodies from a past infection. Surely all that immunity bought some breathing room.

But suddenly, many people who had recovered from Covid-19 as recently as March or April found themselves exhausted, coughing and staring at two red lines on a rapid test. How could this be happening again – and so soon?

The culprit this time is yet another Omicron offshoot, BA.5. It has three key mutations in its spike protein that make it both better at infecting our cells and more adept at slipping past our immune defenses.

In just over two months, BA.5 outcompeted its predecessors to become the dominant cause of Covid-19 in the United States. Last week, this subvariant caused almost 2 out of every 3 new Covid-19 infections in this country, according to the latest data from the CDC.

Lab studies of antibodies from the blood of people who’ve been vaccinated or recovered from recent Covid-19 infections have looked at how well they stand up to BA.5, and this subvariant can outmaneuver them. So people who’ve had Covid as recently as winter or even spring may again be vulnerable to the virus.

“We do not know about the clinical severity of BA.4 and BA.5 in comparison to our other Omicron subvariants,” CDC Director Dr. Rochelle Walensky said at a White House Covid-19 Response Team briefing Tuesday. “But we do know it to be more transmissible and more immune-evading. People with prior infection, even with BA.1 and BA.2, are likely still at risk for BA.4 or BA.5.”

A ‘full-on’ wave

The result is that we’re getting sick in droves. As Americans have switched to more rapid at-home tests, official case counts – currently hovering around 110,000 new infections a day – reflect just a fraction of the true disease burden.

“We estimate that for every reported case there are 7 unreported,” Ali Mokdad, professor of health metrics sciences at the University of Washington’s Institute for Health Metrics and Evaluation, wrote in an email.

Other experts think the wave could be as much as 10 times higher than what’s being reported now.

“We’re looking at probably close to a million new cases a day,” Dr. Peter Hotez said on CNN. “This is a full-on BA.5 wave that we’re experiencing this summer. It’s actually looking worse in the Southern states, just like 2020, just like 2021,” said Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston.

That puts us in the range of cases reported during the first Omicron wave, in January. Remember when it seemed like everyone everywhere got sick at the same time? That’s the situation in the United States again.

It may not seem like a very big deal, because vaccines and better treatments have dramatically cut the risk of death from Covid-19. Still, about 300 to 350 people are dying on average each day from Covid-19, enough to fill a large passenger jet.

“That is unacceptable. It’s too high,” Dr. Ashish Jha, coordinator for the White House Covid-19 Response Team, said at Tuesday’s briefing.

Daily hospitalizations are also climbing in the United States. The fraction of patients needing intensive care is up by about 23% over the past two weeks. And other countries are experiencing BA.5 waves, too.

“I am concerned that cases of Covid-19 continue to rise, putting further pressure on stretched health systems and health workers. I am also concerned about the increasing trend of deaths,” said Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, at a news briefing Tuesday after the agency’s decision to maintain its emergency declaration for Covid-19.

The pandemic, he said, is “nowhere near over.”

What’s at stake with continued spread

There are also more insidious health risks to consider. A recent preprint study that compared the health of people who’d been infected one or more times with Covid-19 found that the risk of new and sometimes lasting health problems rose with each subsequent infection, suggesting that reinfections are not necessarily benign.

Although vaccination reduces the risk of getting long Covid, a certain percentage of people have lasting symptoms after a breakthrough infection.

That’s another reason why high numbers of Covid-19 cases are a big deal: Because the virus is still spreading wildly, it has every opportunity to mutate to make even fitter and more infectious versions of itself. It’s doing this faster than we can change our vaccines, leaving us stuck in the Covid-rinse-repeat period of the pandemic.

On Tuesday, Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, pleaded with Americans to use all available tools to stop the spread of the virus, including masking, ventilation and social distancing.

“We need to keep the levels of virus to the lowest possible level, and that is our best defense. If a virus is not very robustly replicating and spreading, it gives it less of a chance of a mutation, which gives it less of a chance of the evolving of another variant,” Fauci said in a news briefing.

In fact, this is already happening.

Meet BA.2.75

Even as the US comes to terms with BA.5, variant hunters around the world are closely watching another Omicron descendant, BA.2.75. It’s been detected in about 10 countries, including the United States, and seems to be growing quickly in India.

BA.2.75 has nine changes in its spike region that distinguish it from BA.2 and about 11 changes compared with BA.5, according to Tom Peacock, a virologist at Imperial College London.

Several of the mutations in BA.2.75 are in a region of the spike protein known to be an important place for antibodies to bind to stop the virus, said Ulrich Elling, a scientist at the Austrian Academy of Sciences who monitors coronavirus variants for that country.

There’s little information to go on: It’s still not known, for example, how BA.2.75 may compete against BA.5 or whether it causes more severe illness. But experts say it has all the hallmarks of a variant that could go global.

“It spread to many different countries already, so we know that it has some sort of staying power,” said Shishi Luo, associate director of bioinformatics and infectious disease for Helix Labs, which decodes virus samples for the CDC and other clients.

Because of that, and because of changes in the region of the virus that our antibodies look for to shut it down, “we sort of know ahead of time that this one will cause some trouble,” Luo said.

Based on what we know now, she expects that this subvariant could drive a fall Covid-19 wave in the United States.

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In the meantime, Jha said, people should get boosters that are available to them to keep their immunity as strong as possible. US health officials emphasized that people who are boosted now will still be able to get an updated shot this fall that includes the BA.4 and BA.5 strains.

Jha specifically urged Americans who are 50 and older, “if you’ve not gotten a vaccine shot this year, go get one now. It could save your life,” he said.

Flu vaccine appears to be a very good match to circulating strains ...

CNN —

This year’s flu shot appears to be “a very good match” to the circulating strains, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said at a news briefing Monday. However, she noted that flu vaccinations are lagging behind the pace of previous years.

Through the end of October, CDC data shows that vaccinations for pregnant women, a group that is more vulnerable to severe illness from influenza, are down about 12% from the same point in 2021.

Vaccination rates for seniors, the age group most likely to be hospitalized with influenza, were down about 3 percentage points from October 2021.

Flu vaccinations for children are down about 5% compared with where they were before the Covid-19 pandemic, Walensky said.

In a typical year, about 60% of American adults get vaccinated against influenza.

Flu hits the US hard

Flu season has gotten off to an early and severe start in the US, with hospitalization rates hitting levels that typically aren’t seen until December or January.

“We, of course, look in real time as to how well we think the influenza match is to what is circulating right now. The good news is that looks like it is a very good match,” Walensky said of the early start to the respiratory virus season.

She noted that the CDC would have more definitive data later in the season but that the data is encouraging.

Walensky said that even when the vaccine doesn’t closely match the circulating flu strains, “We see a 35% decrease in rates of hospitalization … which really just emphasizes, when we do have a good match, how much more effective it will be.”

CDC data shows that nearly 20,000 people in the United States were admitted to the hospital for flu during the week of Thanksgiving, almost double the number of admissions from the week before.

Covid-19 hospitalizations have ticked up as well, rising 27% in the week after Thanksgiving. But Covid-19 is no longer the only virus straining hospitals.

Just 5% of the US population lives in an area considered to have a high Covid-19 community level.

Walensky said Monday that the CDC was “actively looking into” expanding its community levels beyond Covid-19 to include the effects of other viruses, such as the flu.

“In the meantime, what I do want to say is, one need not take wait for CDC action in order to put a mask,” she said.

People who are sick should stay home and away from others, use good hygiene like covering coughs and washing hands frequently, use a high-quality mask and improve the ventilation in indoor spaces, Walensky said.

Treatment is available

If you do get sick, it’s important to get tested, even if you’ve been vaccinated, said Dr. Sandra Fryhofer, board chair of the American Medical Association and an internal medicine physician in Atlanta.

If you have Covid-19 or the flu, there are antiviral medications for both. But flu antivirals don’t work against Covid-19, and vice versa.

“It is going to be a confusing respiratory infections season. Figuring out what’s making people sick is going to be a conundrum,” Fryhofer said.

In response to a question about shortages of key medications during this rough virus season, Walensky said that “CDC is aware of the reports of some of the shortages for both antivirals as well as antibiotics across the country. I know FDA is working…with manufacturers to try and explore what can be done to address this.”

She also urged doctors not to prescribe antibiotics for illnesses caused by viruses.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville, said he and his colleagues have been astonished by the steep increase in flu cases this season. They have also wondered what could be causing it.

He says it’s likely that after two years without much flu activity in the US, we lost some of our immunity against that virus just as the country has returned to more normal travel and activity patterns.

“Some of it has got to do with our behaviors in the past, having avoided flu and now opening up our lives to activities such as travel, religious services, getting together with families, going out to entertainment venues and doing all those things that take us into groups,” he said.

The flu vaccines are good at preventing severe outcomes, he said, but they don’t do much to stop the virus’ spread.

“It keeps you out of the emergency room, the hospital, the intensive care unit and the cemetery. It’s not very good at interrupting transmission, and it is not very good at preventing milder infection,” he said.

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Schaffner says it’s likely that flu hospitalizations are going up because the virus is hitting the elderly, who, on the whole, tend to get less protection from vaccinations.

“The vaccine works least well among the population we most want to protect, namely older people, and that’s because they have immune systems that are much less robust than the immune systems of younger people.”

Schaffner noted that there are high-dose vaccines for seniors, which are preferred for this age group to help increase their protection.

Omicron variant will 'find just about everybody,' Fauci says, but ...

CNN —

As the Omicron variant spreads like wildfire across the United States, it’s likely just about everybody will be exposed to the strain, but vaccinated people will still fare better, the nation’s leading infectious disease expert said Tuesday.

“Omicron, with its extraordinary, unprecedented degree of efficiency of transmissibility, will ultimately find just about everybody,” Dr. Anthony Fauci told J. Stephen Morrison, senior vice president of the Center for Strategic and International Studies. “Those who have been vaccinated … and boosted would get exposed. Some, maybe a lot of them, will get infected but will very likely, with some exceptions, do reasonably well in the sense of not having hospitalization and death.”

In contrast, those who are not vaccinated are “going to get the brunt of the severe aspect of this,” he added.

Across the United States, at least one in five eligible Americans – roughly 65 million people– are not vaccinated against Covid-19. More than 62% of the country has been fully vaccinated, but only 23% are fully vaccinated and boosted, according to data from the US Centers for Disease Control and Prevention.

Fauci’s comments came in response to a question about whether the pandemic has entered a new phase. That will come when there’s enough protection in the community and drugs to easily treat severe Covid-19, he said, adding, “We may be on the threshold of that right now.”

Also Tuesday, US Food and Drug Administration acting commissioner Dr. Janet Woodcock said that while most people could catch the virus, the focus now should be on making sure hospitals and essential services function.

Woodcock was responding to a question from Sen. Mike Braun about whether it’s time for the United States to change its Covid-19 strategy. Her statement was not a new assessment of Covid-19, but rather an attempt to make clear the need to prioritize essential services as the Omicron variant surges.

“I think it’s hard to process what’s actually happening right now, which is: Most people are going to get Covid,” Woodcock said Tuesday at a Senate Health, Education, Labor and Pensions Committee hearing. “And what we need to do is make sure the hospitals can still function, transportation, you know, other essential services are not disrupted while this happens.”

On Tuesday, the number of US patients hospitalized with Covid-19 hit a record high, adding strain to health care networks and pushing states toward emergency staffing and other measures as they struggle to cope.

More than 145,900 people were in US hospitals with Covid-19 as of Tuesday – a number that surpasses the previous peak from mid-January 2021 (142,246), and is almost twice what it was two weeks ago, according to data from the Department of Health and Human Services.

The hospitalization record comes amid a surge in cases fueled by the highly transmissible Omicron variant.

The United States averaged more than 754,200 new Covid-19 cases daily over the past week, according to Johns Hopkins University data. That’s about three times last winter’s peak average (251,987 on January 11, 2021), and 4.5 times the peak from the Delta-driven surge (166,347 on September 1), according to JHU.

The country has averaged 1,646 Covid-19 deaths a day over the past week – 33% higher than a week ago, according to JHU. The peak average was 3,402 daily on January 13, 2021, JHU data shows.

The Omicron variant caused 98.3% of new coronavirus cases in the United States last week, according to estimates posted Tuesday by the US Centers for Disease Control and Prevention.

A technician administers a Covid-19 test Monday at a drive-thru location at Churchill Downs, Kentucky. Jon Cherry/Getty Images

Leaders activate new measures to combat surging numbers

Hospitals are increasingly juggling staffing issues – not just because of the increased demand, but also because their employees, who are at a high risk of infection, have to isolate and recover after testing positive.

In Virginia, Gov. Ralph Northam declared a limited state of emergency Monday after the number of intensive care unit hospitalizations more than doubled since December 1. The order allows hospitals to expand bed capacity and gives more flexibility in staffing, he said, adding that it also expands the use of telehealth as well as expanding which medical professionals can give vaccines.

In Texas, at least 2,700 medical staffers are being hired, trained and deployed to assist with the surge, joining more than 1,300 personnel already sent across the state, the Texas Department of State Health Services said in a statement to CNN.

Kentucky has mobilized the National Guard to provide support, with 445 members sent to 30 health care facilities, the state announced.

“Omicron continues to burn through the commonwealth, growing at levels we have never seen before. Omicron is significantly more contagious than even the Delta variant,” said Kentucky Gov. Andy Beshear, noting the earlier variant that spurred a surge of cases in the summer and fall.

“If it spreads at the rate we are seeing, it is certainly going to fill up our hospitals,” he said, and Kentucky is “down to 134 adult ICU beds available.”

And New Jersey reinstated a public health emergency, Gov. Phil Murphy announced, saying the state needed to “commit every resource available to beating back the wave” caused by Omicron. In the past two weeks alone, the state saw more than 10,000 people requiring hospitalization due to Covid-19, the governor said in a video announcement.

Mitigation measures such as mandatory masking are also being revived in some areas.

Delaware Gov. John Carney signed a universal indoor mask mandate Monday because of hospitalization increases, with some hospitals “over 100% inpatient bed capacity amid crippling staffing shortages,” he said. Churches and places of worship are exempt, while businesses should provide masks to customers and have signage about indoor mask requirements.

“It’s time for everyone to pitch in and do what works. Wear your mask indoors. Avoid gatherings or expect to get and spread Covid. Get your vaccine and, if eligible, get boosted. That’s how we’ll get through this surge without endangering more lives,” Carney said.

Share of hospitalizations from breakthrough infections is growing, but risks for unvaccinated are higher

The HHS data on Covid-19 hospitalizations includes both those patients who are hospitalized because of Covid-19 complications and those who may have been admitted for something else but test positive for Covid-19. This has been true throughout the pandemic, though the share of patients who fall into each category may have changed over time.

Fully vaccinated people are accounting for a growing share of people hospitalized with Covid-19 – but hospitalizations among people who received a booster shot are still rare, and the gap in risk by vaccination status has been wide.

Between April and July 2021, before the emergence of the Omicron variant, more than 90% of Covid-19 hospitalizations were among people who were either unvaccinated or partially vaccinated, according to a study published by the CDC.

But a sampling of data collected by CNN suggests that figure has dropped to somewhere between 60% and 75% in recent days and months:

• In Pennsylvania, about 75% of Covid-19 hospitalizations between September and early December 2021 were among people who were not fully vaccinated, according to data from the state health department.

• In New York, about 61% of Covid-19 hospitalizations during the week ending January 2, 2022 were among people who were not fully vaccinated, according to data from the state health department.

• Beaumont Health, the largest health care system in Michigan, reported on Thursday that 62% of Covid-19 patients in its eight hospitals were unvaccinated.

In some hospitals, up to 40% of patients with Covid-19 “are coming in not because they’re sick with Covid, but because they’re coming in with something else and have had Covid or the Omicron variant detected,” CDC Director Dr. Rochelle Walensky told Fox News on Sunday.

But Covid-19 cases in hospitals strain resources, regardless of whether a patient was hospitalized because of Covid-19, CNN chief medical correspondent Dr. Sanjay Gupta said.

“If they get (incidentally) diagnosed with Covid in the hospital, they still need to go into infection protocol – personal protective equipment, all of that still needs to be utilized. So it’s a huge drain on the system overall,” Gupta said Tuesday.

While fully vaccinated people are accounting for a larger share of Covid-19 hospitalizations, multiple accounts suggest that those who are fully vaccinated and boosted account for a small share.

In the University of Maryland Medical System, less than 5% of hospitalized patients were fully vaccinated and boosted, President and CEO Dr. Mohan Suntha said Thursday. Beaumont Health reported Thursday that only 8% of Covid-19 patients were fully vaccinated and boosted.

The CDC did not respond to CNN’s multiple requests for data on the share of Covid-19 hospitalizations by vaccination status.

The agency publishes data on its website regarding the relative risk by vaccination status. Cumulatively, the risk of hospitalization has been eight times higher for unvaccinated people than for fully vaccinated people. But in the last week of November, CDC data showed that hospitalization rates were about 17 times higher for unvaccinated people than for fully vaccinated people.

Schools and industries face Omicron issues

The debate over safety in schools from Covid-19 continues to play out as only about one in six children ages 5 to 11 is fully vaccinated, according to data from the CDC.

As Los Angeles prepared to return to school on Tuesday, approximately 62,000 students and staff had tested positive for Covid-19 and will have to stay home, data from the Los Angeles Unified School District showed Monday, equating to a 14.99% positivity rate. The positivity rate of Los Angeles County at large, by comparison, has spiked to 22%.

In Chicago, educators returned to school Tuesday and students are expected to resume in-person learning Wednesday following a nearly weeklong dispute. The Chicago Teachers Union had voted to teach remotely last week, and the school district responded by canceling classes for four days.

The agreement, announced late Monday, included metrics for when a classroom would need to go remote due to Covid-19 levels.

In areas where schools have returned to in-person learning after the holiday break, the time needed for those with Covid-19 to recover has impacted some essential services.

Other sectors also are struggling due to high infection rates.

Some municipalities have seen nearly a quarter of their trash collection workforce call in sick in recent weeks due to Covid-19, leading to delays, according to the Solid Waste Association of North America.

“This coincided, unfortunately, with increased trash and recycling volumes associated with the holidays. However, we hope that as volumes decline and sanitation workers return to work, these delays will prove temporary,” executive director and CEO David Biderman said in a statement Monday.

In travel, US airlines canceled thousands of additional flights over the weekend due to Covid-19 callouts and winter storms, and cruise line Royal Caribbean International announced it has canceled voyages on four ships because of “ongoing Covid-related circumstances around the world.” Last week, Norwegian Cruise Line canceled the voyages of eight ships.

Public transit systems in major metropolitan areas such as New York City and Washington, DC, have had to scale back service with employees ill from Covid-19. In Detroit, 20-25% of SMART bus service is canceled or delayed, the agency said in a statement Saturday.

Travis Caldwell Jason Hanna Deidre Mcphillips Christina Maxouris

What is the rare Monkey B virus that killed vet in China? | The Week ...

A man has died after contracting a rare infectious disease known as the Monkey B virus that is carried by primates, Chinese officials have revealed.

The victim, a 53-year-old veterinarian, is the first reported human case of the virus in China and worked at a Beijing research institute specialising in primate breeding, according to the Chinese Center for Disease Control and Prevention (CCDC). Two of his close contacts, a male doctor and a female nurse, were isolated following his death but tested negative for the virus.

What is Monkey B virus?

The virus “is prevalent among macaque monkeys, but extremely rare - and often deadly - when it spreads to humans”, The Washington Post reports. Also known as “herpes B virus”, it “tends to attack the central nervous system and cause inflammation to the brain, leading to a loss of consciousness”, the paper adds, and has around an “80% fatality rate” if untreated.

India Today reports that the virus is “found in saliva, faeces, urine, brain or spinal cord tissue of macaques”, and can “survive for hours on surfaces, particularly when moist”.

“While the risk of common people getting infected by the virus is low, it is high among laboratory workers, veterinarians, and others who may be exposed to monkeys or their specimens,” according to the news site.

Despite that risk, however, the US Centre for Disease Control (CDC) says that Monkey B infections in humans have been “rare” since the virus was first identified, in 1932. Only 50 cases have been recorded in humans, of whom 21 died.

Most of the infected people were diagnosed with the virus after being “bitten or scratched by a monkey, or when tissue or fluids from a monkey got on their broken skin, such as by needle stick or cut”, says the public health agency. In one case, in 1997, “a researcher died from B virus infection after bodily fluid from an infected monkey splashed into her eye”.

The vet who died in China is believed to have been infected while dissecting two dead monkeys.

The symptoms

The CDC lists the earliest symptoms of the Monkey B virus as:

fever and chills

muscle ache

fatigue

headache

Patients may later develop other symptoms including:

Shortness of breath

Nausea and vomiting

Abdominal pain

Hiccups

The agency say that as the disease progresses, it can cause pain, numbness, itching near the wound site; problems with muscle coordination; brain damage and severe damage to the nervous system; and in the most serious cases, death.

Chinese case

The unnamed vet “experienced nausea and vomiting followed by fever with neurological symptoms” a month after dissecting the monkeys in March, the CCDC reports.

Following his death, on 27 May, his blood and saliva samples were sent to the Beijing-based health centre, “where researchers found evidence” of the virus, says The Washington Post.

Like coronavirus, the Monkey B virus is “the consequence of species jumps”, Nikolaus Osterrieder, dean of the Jockey Club College of Veterinary Medicine and Life Sciences in Hong Kong, told the paper.

“But the important difference is that in the case from herpes B, it’s a dead end. It’s not jumping from one human to another human,” he continued. “SARS-CoV-2, on the other hand, acquired the ability to spread to a new host.”

The CCDC reports that the Chinese vet sought treatment “in several hospitals” prior to his death from the virus. But the state-owned Global Times says that his “close contacts are safe from it for now”.

Nearly 1 million children in London offered polio boosters after virus ...

CNN —

Children living in London will be offered an extra dose of the polio vaccine following the discovery of poliovirus in sewage in the British capital, health authorities announced Wednesday.

The UK Joint Committee on Vaccination and Immunisation said a targeted inactivated polio vaccine booster dose should be offered to all children between the ages of 1 and 9 in all London boroughs.

“This will ensure a high level of protection from paralysis and help reduce further spread of the virus,” the UK Health Security Agency (UKHSA) said in a statement announcing the move.

Around 1 million children of that age live in the London region, according to the most recent data from the UK Office for National Statistics.

The UKHSA said a total of 116 virus isolates were identified in 19 sewage samples collected in London between February and July.

While most of the samples contained vaccine-like virus, some showed “sufficient mutations to be classified as vaccine derived poliovirus.” The UKHSA said this was more concerning as such virus behaves more similarly to “wild polio and may, on rare occasions, lead to cases of paralysis in unvaccinated individuals.”

The authorities stressed the vaccination drive is a precautionary measure.

“No cases of polio have been reported and for the majority of the population, who are fully vaccinated, the risk is low. But we know the areas in London where the poliovirus is being transmitted have some of the lowest vaccination rates,” Dr. Vanessa Saliba, a consultant epidemiologist at UKHSA said.

Vaccines are key as there’s no cure for polio

Polio is caused by an enterovirus called the poliovirus. It was one of the world’s most feared diseases until Dr. Jonas Salk invented the polio vaccine and tested its safety in 1954.

By 1988, reported cases of polio worldwide reached a peak of 350,000, according to the World Health Organization.

About 1 in 4 infected people have flu-like symptoms including sore throat, fever, tiredness, nausea, headache and stomach pain. As many as 1 in 200 will develop more serious symptoms that include tingling and numbness in the legs, an infection of the brain or spinal cord and paralysis, according to the US Centers for the Disease Control and Prevention.

There is no cure for polio. Treatment to address symptoms may include medication to relax muscles and heat and physical therapy to stimulate muscles. However, any paralysis caused by polio is permanent.

The last case of polio in the UK was in 1984, according to the UKHSA statement.

“Decades ago before we introduced the polio vaccination programme around 8,000 people would develop paralysis every year,” Saliba added.

There are three strains of the virus, two of which have been eliminated in the world, according to the Global Polio Eradication Initiative, a WHO program. One type of wild polio virus still circulates in Pakistan and Afghanistan. Transmission can also occur when not enough children are vaccinated in an area.

Last month, a person from Rockland County, New York, was been diagnosed with polio, the first case identified in the United States in nearly a decade. The unvaccinated young adult began experiencing weakness and paralysis, county Health Commissioner Dr. Patricia Schnabel Ruppert said at the time.

This story has been updated with additional information.

BA.5: The 'worst variant' is here | CNN

This is the weekly edition of CNN’s coronavirus newsletter. Look out for your roundup every Wednesday. If you haven’t subscribed yet, sign up here.

CNN —

In the meantime, vaccine makers Pfizer, Moderna and Novavax have already been testing updated versions of their vaccines, including some bivalent vaccines that target Omicron variants.

Repeated Covid-19 waves have left millions of people dead, with only vaccines helping to blunt the toll. Now the virus is spreading again — evolving, escaping immunity and driving an uptick in cases and hospitalizations. The latest version of its shape-shifting, BA.5, is a clear sign that the pandemic is far from over.

The newest offshoot of Omicron, along with a closely related variant, BA.4, are fueling a global surge in cases — 30% over the past fortnight, according to the World Health Organization (WHO).

In Europe, the Omicron subvariants are powering a spike in cases of about 25%, though Dr. Michael Ryan, the executive director of WHO’s Health Emergencies Program, has said that number may actually be higher, given the “almost collapse in testing.” BA.5 is on the march in China, ratcheting anxieties that major cities there may soon re-enforce strict lockdown measures that were only recently lifted. And the same variant has become the dominant strain in the United States, where it accounted for 65% of new infections last week, according to the Centers for Disease Control and Prevention (CDC).

Video Ad Feedback Dr. Fauci explains why new BA.5 subvariant is concerning 04:58 - Source: CNN

“We have been watching this virus evolve rapidly. We’ve been planning and preparing for this moment. And the message that I want to get across to the American people is this: BA.5 is something we’re closely monitoring, and most importantly, we know how to manage it,” said Dr. Ashish Jha, the White House’s Covid-19 response coordinator, in a news briefing on Tuesday.

On the same day, WHO’s Emergency Committee said Covid-19 remained a Public Health Emergency of International Concern — its highest level of alert, first declared on January 20, 2020 — amid rising cases, ongoing viral mutation and increasing pressure on already overstretched health systems. In a statement, the committee, which is made up of independent experts, highlighted challenges to the ongoing global Covid-19 response, including a drop-off in testing and spotty genome sequencing, raising the question of just how accurately any nation might reasonably be able to monitor BA.5.

Official data dramatically undercount the true number of infections in the US, epidemiologists say, leaving the nation with a critical blind spot as the most transmissible coronavirus variant yet takes hold. Some experts think there could be as many as 1 million new infections every day in the broader US population — 10 times higher than the official count.

As for how to manage the new wave, Jha urged Americans aged 50 and older to get second booster shots. Adults who are up to date with vaccinations are less likely to be hospitalized than those who are unvaccinated. But only about one in four adults in the US over 50 have gotten their recommended second boosters, data collected by the CDC show.

US health officials are urgently working on a plan to allow second Covid-19 boosters for all adults, a senior White House official confirmed to CNN on Monday, amid fears that younger adults’ immunity may be waning as Covid-19 cases rise with the dominance of BA.5.

What makes BA.5 different? Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research, has called BA.5 “the worst version of the virus we’ve seen.” He explained in a recent newsletter: “It takes immune escape, already extensive, to the next level, and, as a function of that, enhanced transmissibility,” well beyond earlier versions of Omicron.

In other words, BA.5 can easily evade immunity from previous infections and vaccines, increasing the risk of reinfection. Though the variant does not appear to lead to more severe illness, in an interview with CNN on Monday, Topol said that given the extent of BA.5’s immune evasion, he expects to see an escalation in hospitalizations, as we’ve seen in Europe and elsewhere that the variant has taken root. “One good thing is it doesn’t appear to be accompanied by the ICU admissions and the deaths as previous variants, but this is definitely concerning,” he added.

Public health experts in the US may take some solace from the trajectory of the variant in Europe. WHO’s Ryan said last week that while many European countries are experiencing a jump in hospitalizations, “what we’re not seeing is an increase in intensive care unit admissions, so the vaccines are very much still working and it is those gaps in immunity that are causing the problem.”

But still, steep reductions in Covid-19 surveillance worldwide are hindering epidemiologists’ efforts as they race to trace the virus’ evolution.

“Sub-variants of Omicron, like BA.4 and BA.5, continue to drive waves of cases, hospitalization and death around the world,” WHO Director-General Tedros Adhanom Ghebreyesus said in a media briefing on Tuesday. “Surveillance has reduced significantly – including testing and sequencing – making it increasingly difficult to assess the impact of variants on transmission, disease characteristics, and the effectiveness of counter-measures.”

“New waves of the virus demonstrate again that the Covid-19 [pandemic] is nowhere near over,” he added.

YOU ASKED. WE ANSWERED.

Q: Will we ever know how the pandemic began?

A: A team of international scientists tasked with understanding the origins of the coronavirus pandemic released its first report on Thursday, saying that all hypotheses remain on the table, including a possible laboratory incident.

“I don’t think that most people should have to change their daily activities, but I do think people need to be aware of their risk of contracting Covid-19 if they don’t take additional precautions,” Wen said. The question to ask yourself, she added, is this: How much do I want to continue to avoid infection?

For individuals who want to reduce their risk, Wen advises that they stay up to date with their boosters (in the US, everyone age 5 and older can receive a first booster, and those 50 and older can receive a second booster for a total of four shots). She also recommends wearing a high-quality N95 mask or equivalent in indoor, crowded settings, and staying outside for large gatherings as much as possible — something easier to do in the summertime.

“For those who find masks uncomfortable, I’d encourage mask-wearing in the highest-risk settings — for example, mask while in a crowded security line at the airport and during boarding and deplaning,” she said.

Send your questions here. Are you a health care worker fighting Covid-19? Message us on WhatsApp about the challenges you’re facing: +1 347-322-0415.

READS OF THE WEEK

Earlier this year, an 11-year-old snow leopard at Miller Park Zoo in Bloomington, Illinois died after contracting the virus. The leopard, Rilu, also developed pneumonia before death, zoo officials said.

Beijing last week announced a Covid-19 vaccine mandate for residents wanting to enter public venues, becoming the first city in mainland China to do so as it attempts to contain the spread of BA.5, Nectar Gan writes. Those who are “not suitable” for vaccination will be exempt from the requirement, a city official said, without clarifying how they can provide the proof needed for exemption.

The vaccine mandate comes as Beijing reported three cases of the highly contagious Omicron subvariant. Several Chinese cities have imposed new curbs after detecting BA.5. Shanghai, which only recently emerged from a two-month lockdown, identified its first case on Friday and will perform two rounds of Covid tests this week. An outbreak of BA.5 has already shut down the northwestern city of Xi’an, home to 13 million people, where entertainment, sports and religious venues have been closed, and restaurants limited to takeaway and delivery services.

Casinos in the gambling hub of Macao were ordered to shut for the first time since February 2020 because of a Covid outbreak, sending shares of their operating companies plunging, and fears of new lockdowns in Shanghai undermined the broader China market. Chinese stocks remained under pressure after Monday’s sell-off fueled by the threat of new Covid restrictions, especially the tech sector, Laura He reports.

People stand in line at a coronavirus testing site in Beijing on July 4. Andy Wong/AP

Drug-resistant infections and deaths have risen among hospital patients

The US had made significant progress in fighting drug-resistant infections in recent years. But those gains were largely erased during the Covid-19 pandemic, with hospital-acquired infections and resulting deaths rising 15% in 2020, according to new data, Deidre McPhillips reports.

A special report released Tuesday by the CDC found that more than 29,400 people died from antimicrobial-resistant infections in the first year of the pandemic — nearly 40% of those deaths were among people who got the infection while in the hospital. The full number is probably even higher, given that data for half of the 18 pathogens identified as threats are unavailable or delayed.

WHO has called antimicrobial resistance a “silent pandemic,” and drug-resistant infections were linked to nearly 5 million deaths globally in 2019. The Covid-19 pandemic probably contributed to the increased risk in the US, particularly because many people delayed care or left infections untreated — either because of closed clinics or fear of exposing themselves to Covid-19 — which can increase the risk of developing drug resistance.

Pulse oximeters don’t work as well for people of color

Often when Dr. Thomas Valley sees a new patient in the intensive care unit at Michigan Medicine in Ann Arbor, he clamps a pulse oximeter on their finger — one of the many devices he uses to gauge their health and what course of care they require, whether they are a child having seizures, a teenage car accident victim or an older person with Covid-19.

But recently, Valley, an assistant professor in the University of Michigan’s Division of Pulmonary and Critical Care, realized that the small device may yield less accurate oxygen readings in patients with dark skin. If the device isn’t calibrated correctly, the darker pigmentation can affect how the light is absorbed by the sensor, leading to flawed oxygen readings and patients being discharged when they shouldn’t.

The findings of Valley and his colleagues add to a growing body of research – dating back to the 1980s – that suggests flawed pulse oximeter readings among Black and brown patients can be a real and life-threatening issue in medical care. But the public has only recently been made more aware of this health disparity, and US health officials have announced plans to investigate the accuracy of pulse oximeters, Jacqueline Howard reports.

TOP TIP

The man began taking more than 20 over-the-counter supplements every day, including 50,000 international units (IU) of vitamin D three times a day, after a visit with a private nutritionist. That’s a dose “375 times the recommended amount” in the UK, said the report’s coauthor and endocrinologist at William Harvey Hospital, Dr. Alamin Alkundi. Within a month, the man began suffering from nausea, abdominal pain, diarrhea and repeated bouts of vomiting, along with cramping in the legs and ringing in the ears.

Edith Bracho-Sanchez, director of pediatric telemedicine and assistant professor of pediatrics at Columbia University Irving Medical Center, didn’t think she’d be an anxious mom. But that changed when she had her son. “I stress over every decision I make for William. I make long pro and con lists, I discuss everything with my partner, sleep on things and ultimately, I pray,” she wrote in a recent column for CNN.

Knowing how difficult it is to make decisions — big and small — she said she understood why some parents might struggle with the choice to vaccinate their children against Covid-19. This is why she says she did it, and her advice to anxious new moms like her:

First, Covid-19 is an unpredictable illness. While most children have minor symptoms and recover well, many have landed in hospitals and emergency rooms, and to date, more than 400 children under the age of 5 have died from the illness in the US alone, according to the CDC. We also don’t yet fully understand the long-term effects of the disease.

Second, I know the vaccine is in the body for a short period of time and with a specific mission. It instructs the body to make protective antibodies against Covid-19, and the body’s own cellular mechanisms quickly break it down soon after. Because of this, there really is no plausible way it will interfere with my little William’s development, something about which I am constantly thinking.

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When will the US have a Covid-19 vaccine for the youngest children ...

CNN —

It’s been more than a year since adults first got Covid-19 vaccines, but about 18 million children under 5 in the US are still waiting – and will probably have to wait until the summer, despite some predictions that shots would be available in the first part of 2022.

While Moderna has shared some data on two doses of Covid-19 vaccine for younger children, Pfizer and BioNTech’s data on three doses for younger children is not yet available.

The US Food and Drug Administration is weighing whether to consider emergency use authorization for both the Pfizer/BioNTech and Moderna Covid-19 vaccines for young children at the same time, rather than considering them separately, Dr. Anthony Fauci, chief medical adviser to President Biden, said Thursday.

“Two products that are similar but not identical, particularly with regard to the dose, and what the FDA wants to do is to get it so that we don’t confuse people to say ‘this is the dose. This is the dose regimen for children within that age group of 6 months to 5 years,’ ” Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Kasie Hunt.

The Pfizer vaccine was made to protect against the original strain of the coronavirus, and the initial series of two 3-milligram doses tested in kids under 5 wasn’t powerful enough to keep them safe from the more infectious Omicron variant.

“It didn’t meet the criteria for efficacy,” Fauci said. “There was never a safety issue, but it didn’t meet the criteria, which then had them go back and do a study with a third dose as a part of the primary regimen.”

Pfizer CEO Albert Bourla said the goal is to have its Covid-19 vaccine available for kids 4 and younger by summer.

“I hope, we will aim to make it in June,” Bourla said on the “In the Bubble with Andy Slavitt” podcast, posted Monday. He said the FDA has been extremely collaborative and flexible during this testing and authorization process.

In a statement, the FDA said it couldn’t comment on any particular company’s Covid-19 vaccine EUA request but noted “that at this time, we do not have a complete EUA request in house to consider for children under 5 years of age.”

“We continue to engage with companies to discuss their data, but we cannot adjudicate a decision on any vaccine without a complete EUA request, in order to allow us to do our thorough review. Any timeline on these actions is driven by when the data are provided to FDA and fully support a regulatory action,” FDA spokesperson Abby Capobianco said.

Pfizer studying third doses

When Pfizer and BioNTech were testing their vaccine for younger children with two doses, the FDA asked the companies to submit a request for emergency use authorization of that regimen; they said would continue to test a third dose as the two-dose regimen moved through the regulatory process.

In mid-February, the plan changed again. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency needed to see data on the third vaccine dose in these younger children in order to move forward with emergency use authorization.

Scientists working on clinical trials for the youngest children have the benefit of observing what happens with other age groups. After seeing breakthrough infections in 2021, especially with the rise of the highly contagious Omicron variant, researchers learned quickly that adults and adolescents needed additional doses of Covid-19 vaccine.

“When we started comparing not only against Delta, that was the previous one, but against Omicron, we realized the same thing as we realized in adults,” Bourla said. “In adults, two doses, they provide very little protection against Delta. The third dose makes very strong. So we realized that this is the case also for pediatric, so we extended the trials to go to the third dose.

“We will provide you pretty soon data on the third dose, which we think will provide dramatically higher results,” Bourla told Slavitt.

‘Safety is of paramount importance’

Moderna has said its vaccine for younger children had a favorable safety profile, and for the Pfizer vaccine, Bourla said “so far, that the safety looks very, very good.”

“My expectation is that we will have zero issues with safety. We’re waiting to see the efficacy, and my expectation is that it will be very good,” Bourla said.

“Safety is of paramount importance,” Bourla said, which is why the company went with a lower dose of vaccine for young children than what’s used in adults.

The biggest questions that remain for the Pfizer vaccines are exactly how protective the vaccines are, what the right vaccine schedule and dose is. The trials should answer these questions.

If the vaccine is authorized, little kids could get it on a different schedule than adults and adolescents. Rather than waiting four or five months before a third dose like older ages, the youngest age group could get a third shot as quickly as two months after the second.

Children are less likely than adults to be hospitalized or to die from Covid-19, but at least 463 children 4 and younger have died from the disease, according to the US Centers for Disease Control and Prevention.

“We need [the vaccines],” said Dr. Paul Offit, the director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee. “This virus is going to be with us until I’m dead. I can promise you that.

“We still vaccinate children against polio in this country, and we haven’t had polio in this country for almost 50 years. Why? Because it still exists in this world. This virus is going to exist in the world and continue to do harm.”

Offit said the world is going to need a population that’s highly immune to the coronavirus for a “very long time.”

“Every year, 3½ to 4 million children are born in this country who are unprotected. They are going to need to be protected for some time,” he said. “And the sooner the better, the sooner you can do it safely.”

Moderna moves ahead with two doses

Moderna has also been working on a vaccine for younger children. Dr. Paul Burton, the company’s chief medical officer, said at the end of March that a vaccine for this age group is a “huge priority.” The company plans to submit its application to the FDA and other regulators around the world “just as soon as we can.”

Moderna said its Covid-19 vaccine performs as well in children as it does in adults.

Two 25-microgram doses provided a similar immune response for children 6 months through 5 years as two 100-microgram doses for adults 18 to 25, the company said, indicating that the benefit conferred to young adults is also conferred to young children.

The data showed it was safe and had “a robust neutralizing antibody response.” The two doses are given to children 28 days apart.

Moderna said it was preparing to evaluate the potential of a booster shot for all children 6 months and older that would target the original strain of the virus as well as the Omicron variant.

Burton told Yahoo Finance last month that he wanted to be “realistic for the parents waiting.”

“We’re still talking a couple of months to the availability of the vaccine. This is not a couple of weeks,” he said.

Steps parents can take now

While parents are waiting to vaccinate their little ones, there is something they can do to protect the children.

All adults who interact with the children should be vaccinated, the experts say, and ideally boosted. Adults are also advised to use masks around unvaccinated children, even as many mandates have fallen away.

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Dr. Doran Fink, who oversees the FDA’s clinical and toxicological review of investigational and US-licensed vaccines, told the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices on Wednesday that he understood parents’ concerns. He also promised that the FDA would work “diligently” to verify any data submitted.

“We know that many parents and caregivers and health care providers are anxious to have Covid vaccines available for this age group,” Fink said. “I do want to reassure the committee and the public that we understand this concern, and we want to have available safe and effective vaccines for all age groups who will benefit from them.”