Government advisers debated Tuesday if Americans should get a modified COVID-19 booster shot this fall — and exactly how best to update it to fight a virus that surely will change even more by then.
“That’s the problem — we’re being asked to more or less have a crystal ball today,” said Dr. Arnold Monto of the University of Michigan, who heads the Food and Drug Administration’s vaccine advisory committee.
Current COVID-19 vaccines have saved millions of lives globally and those used in the U.S. still offer strong protection against hospitalization and death — especially after a booster dose. But their ability to block infection markedly dropped when the super-contagious omicron mutant emerged.
Pfizer and Moderna tested shots updated to better match the omicron that surged over the winter, but that first mutant has disappeared — replaced by its genetically distinct relatives. The two newest omicron cousins, called BA.4 and BA.5, now make up about half of U.S. cases, according to the Centers for Disease Control and Prevention.
That makes for a tough decision on how to tweak the shot recipe, and “our goal is to have the best possible match” to blunt an expected COVID-19 surge this fall and winter, FDA vaccine chief Dr. Peter Marks said Tuesday.
While people vaccinated and boosted have good protection against COVID-19’s worst outcomes, it has slipped some, said CDC epidemiologist Heather Scobie, describing an increase in omicron-sparked hospitalizations among older adults.
Only about half of vaccinated Americans ever got that all-important booster. And while a second booster that’s recommended for people 50 and older again restores protection, only a quarter of those eligible have gotten one. Authorities hope an updated booster for fall might entice more interest.
So what’s the evidence for a recipe change? Among the evidence Tuesday:
— Both Moderna and Pfizer found what scientists call “bivalent” shots — a combination of the original vaccine plus omicron protection — substantially boosted levels of antibodies capable of fighting that variant, more than simply giving another regular dose. Many scientists favor the combination approach because it preserves the original vaccines’ proven benefits, which include some cross-protection against other mutants that have cropped up during the pandemic.
Both companies found the tweaked shots also boosted antibodies against BA.4 and BA.5 but not nearly as many.
— Pfizer and its partner BioNTech also are offering up an omicron-only shot. Also in animal testing is vaccine further tweaked to match BA.4 and BA.5.
— A third company, Novavax, is awaiting FDA authorization of a more traditional kind of COVID-19 vaccine, protein-based shots. It argued that a booster of its regular vaccine promises a good immune response against the new omicron mutants.
Another issue: Advisers to the World Health Organization recently said that omicron-tweaked shots may be beneficial as a booster rather than a replacement for first vaccinations — because they should increase the breadth of people’s protection against multiple variants.
“We don’t want the world to lose confidence in vaccines that are currently available,” said Dr. Kanta Subbarao, a virologist who chairs that WHO committee.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
A Paris court ruled on Tuesday that the French government failed to sufficiently stock up on surgical masks at the outset of the coronavirus pandemic in 2020 and prevent the virus from spreading.
The ruling came as the number of registered infections with coronavirus variants rises sharply. It wasn’t immediately clear if the decision will lead to any specific sanctions for the government.
Officials across France are contemplating new measures, including an indoor mask mandate in some cities, to curb the spread of the virus but keep the economy open amid the summer tourism season.
“The government is at fault for failing to ensure a sufficient stock of masks to fight against a pandemic linked to a highly pathogenic respiratory agent,” the court’s ruling said.
The administrative court in Paris also ruled that the government was wrong by suggesting at the start of the COVID-19 crisis that masks don’t protect people from contracting the virus.
But the court said that neither of the government’s wrongs have been the source of specific cases of infection with the virus.
The French government is unlikely to introduce any new regulations until a new governing coalition is formed following France’s parliamentary election earlier this month. The results have shifted the balance of power from President Emmanuel Macron and away from the center as voters opted for parties on the far-right and far-left. A new government is expected at the start of next month.
France lifted most COVID-19 restrictions in March, including abolishing the need to wear face masks in most settings and allowing people who aren’t vaccinated back into restaurants, sports arenas and other venues. By the end of May, mask wearing was recommended on public transportation in some cities, but not mandatory.
U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match recent changes of the shape-shifting coronavirus.
Moderna and Pfizer have tested updated shots against the super-contagious omicron variant, and advisers to the Food and Drug Administration will debate Tuesday if it’s time to make a switch — setting the stage for similar moves by other countries.
“This is science at its toughest,” FDA vaccine chief Dr. Peter Marks told The Associated Press, adding that a final decision is expected within days of the advisory panel’s recommendation.
Current COVID-19 vaccines saved millions of lives around the world in just their first year of use. And the Moderna and Pfizer shots still offer strong protection against the worst outcomes — severe illness and death — especially after a booster dose.
But those vaccines target the original coronavirus strain and between waning immunity and a relentless barrage of variants, protection against infections has dropped markedly. The challenge is deciding if tweaked boosters offer a good chance of blunting another surge when there’s no way to predict which mutant will be the main threat.
In an analysis prepared for Tuesday’s meeting, FDA officials acknowledged targeting last winter’s version of omicron is “somewhat outdated” since it already has been replaced by its even more contagious relatives.
“We would obviously like to get it right enough,” Marks said, so that with one more shot “we get a full season of protection.”
Many experts say updated boosters promise at least a little more benefit.
“It is more likely to be helpful” than simply giving additional doses of today’s vaccine, said epidemiologist William Hanage of the Harvard T.H. Chan School of Public Health.
That’s assuming the virus doesn’t throw another curve ball.
“We’re following rather than getting ahead which is so vexing — that we haven’t come up with a better variant-proof vaccine,” said Dr. Eric Topol, head of the Scripps Research Translational Institute, who has urged a major government push for next-generation immunizations.
Adding to concern about a winter COVID-19 wave is that about half of Americans eligible for that all-important first booster dose never got it. An updated version might entice some of them.
But “we do need to change our expectations,” said Dr. William Moss of the Johns Hopkins Bloomberg School of Public Health, who noted that studies early in the pandemic raised unrealistic hopes of blocking even the mildest infections. “Our strategy can’t be booster doses every couple of months, even every six months, to prevent infections.”
The top candidates are what scientists call “bivalent” shots — a combination of the original vaccine plus omicron protection.
That’s because the original vaccines do spur production of at least some virus-fighting antibodies strong enough to cross-react with newer mutants — in addition to their proven benefits against severe disease, said University of Pennsylvania immunologist E. John Wherry.
“Being able to push the boost response a little bit in one direction or the other without losing the core is really important,” he said.
Moderna and Pfizer found their combo shots substantially boosted levels of omicron-fighting antibodies in adults who’d already had three vaccinations, more than simply giving another regular dose.
Recipients also developed antibodies that could fight omicron’s newest relatives named BA.4 and BA.5, although not nearly as many. It’s not clear how much protection that will translate into, and for how long.
Antibodies are a key first layer of defense that form after vaccination or a prior infection. They can prevent infection by recognizing the outer coating of the coronavirus — the spike protein — and blocking it from entering your cells.
But antibodies naturally wane and each new variant comes with a different-looking spike protein, giving it a better chance of evading detection by remaining antibodies. Separate studies published this month in Nature and the New England Journal of Medicine show the newest omicron relatives are even better at dodging antibodies — both in the vaccinated and in people who recovered from the original omicron.
That first booster people were supposed to get strengthened immune memory, helping explain why protection against hospitalization and death is proving more durable. If the virus sneaks past antibodies, different defenders called T cells spring into action, attacking infected cells to curb illness.
“T cells recognize the virus in a fundamentally different way,” not hunting for disguised spike protein but for parts of the virus that so far haven’t been altered as much, said Penn’s Wherry.
Still, as people get older, all parts of their immune system gradually weaken. There’s little data on how long T cell protection against COVID-19 lasts or how it varies with different mutations or vaccines.
Wherry and dozens of other scientists recently petitioned the FDA to quit focusing solely on antibodies and start measuring T cells as it decides vaccination strategy.
The Biden administration has made clear that it needs Congress to provide more money so that if the FDA clears updated boosters, the government can buy enough for every American who wants one. And Dr. Anthony Fauci, the government’s top infectious disease expert, told Congress last week more research funding also is critical to create better next-generation vaccines, such as nasal versions that might better block infection in the nose or more variant-proof shots.
“The virus is changing and we need to keep up with it,” Fauci, said.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Pfizer announced Saturday that tweaking its COVID-19 vaccine to better target the omicron variant is safe and works — just days before regulators debate whether to offer Americans updated booster shots this fall.
The vaccines currently used in the U.S. still offer strong protection against severe COVID-19 disease and death — especially if people have gotten a booster dose. But those vaccines target the original coronavirus strain and their effectiveness against any infection dropped markedly when the super-contagious omicron mutant emerged.
Now with omicron’s even more transmissible relatives spreading widely, the Food and Drug Administration is considering ordering a recipe change for the vaccines made by both Pfizer and rival Moderna in hopes that modified boosters could better protect against another COVID-19 surge expected this fall and winter.
Pfizer and its partner BioNTech studied two different ways of updating their shots — targeting just omicron, or a combination booster that adds omicron protection to the original vaccine. They also tested whether to keep today’s standard dosage — 30 micrograms — or to double the shots’ strength.
In a study of more than 1,200 middle-aged and older adults who’d already had three vaccine doses, Pfizer said both booster approaches spurred a substantial jump in omicron-fighting antibodies.
“Based on these data, we believe we have two very strong omicron-adapted candidates,” Pfizer CEO Albert Bourla said in a statement.
Pfizer’s omicron-only booster sparked the strongest immune response against that variant.
But many experts say combination shots may be the best approach because they would retain the proven benefits of the original COVID-19 vaccine while adding new protection against omicron. And Pfizer said a month after people received its combo shot, they had a 9 to 11-fold increase in omicron-fighting antibodies. That’s more than 1.5 times better than another dose of the original vaccine.
And importantly, preliminary lab studies show the tweaked shots also produce antibodies capable of fighting omicron’s genetically distinct relatives named BA.4 and BA.5, although those levels weren’t nearly as high.
Moderna recently announced similar results from tests of its combination shot, what scientists call a “bivalent” vaccine.
The studies weren’t designed to track how well updated boosters prevented COVID-19 cases. Nor is it clear how long any added protection would last.
But the FDA’s scientific advisers will publicly debate the data on Tuesday, as they grapple with whether to recommend a change to the vaccines’ recipes — ahead of similar decisions by other countries.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Up to 40,000 Army National Guard soldiers across the country — or about 13% of the force — have not yet gotten the mandated COVID-19 vaccine, and as the deadline for shots looms, at least 14,000 of them have flatly refused and could be forced out of the service.
Guard soldiers have until Thursday to get the vaccine. And according to data obtained by The Associated Press, between 20% to 30% of the Guard soldiers in six states are not vaccinated, and more than 10% in 43 other states still need shots.
Guard leaders say states are doing all they can to encourage soldiers to get vaccinated by the time limit. And they said they will work with the roughly 7,000 who have sought exemptions, which are almost all for religious reasons.
“We’re going to give every soldier every opportunity to get vaccinated and continue their military career. Every soldier that is pending an exemption, we will continue to support them through their process,” said Lt. Gen. Jon Jensen, director of the Army National Guard, in an Associated Press interview. “We’re not giving up on anybody until the separation paperwork is signed and completed. There’s still time.”
The Army Guard’s vaccine percentage is the lowest among the U.S. military — with all the active duty Army, Navy, Air Force and Marine Corps at 97% or greater and the Air Guard at about 94%. The Army reported Friday that 90% of Army Reserve forces were partially or completely vaccinated.
The Pentagon has said that after June 30, Guard members won’t be paid by the federal government when they are activated on federal status, which includes their monthly drill weekends and their two-week annual training period. Guard troops mobilized on federal status and assigned to the southern border or on COVID-19 missions in various states also would have to be vaccinated or they would not be allowed to participate or be paid.
To make it more complicated, however, Guard soldiers on state activate duty may not have to be vaccinated — based on the requirements in their states. As long as they remain in state duty status, they can be paid by the state and used for state missions.
At least seven governors formally asked Austin to reconsider or not enforce the vaccine mandate for National Guard members, and some filed or signed on to lawsuits. In letters to the governors, Austin declined, and said that the coronavirus “takes our service members out of the fight, temporarily or permanently, and jeopardizes our ability to meet mission requirements.” He said Guard troops must either get the vaccine or lose their Guard status.
Jensen and Maj. Gen. Jill Faris, director of the Guard’s office of the Joint Surgeon General, said they are working with states adjutants general to get progress updates, including on the nearly 20,000 troops who are not flat refusals and haven’t submitted any type of exemption request. Some, they said, may just be a lag in self-reporting, while others may still be undecided.
“Part of those undefined are our soldiers who say, well, I have until 30 June and so I’ll take till 30 June,” said Jensen.
Others may have promised to bring in vaccine paperwork, and haven’t done it yet. Still others are on the books, but haven’t yet reported to basic training, so don’t have to be vaccinated until they get there. It’s not clear how many are in each category.
Jensen acknowledged that if the current numbers hold, there are concerns about possible impact on Guard readiness in the states, including whether it will affect any Guard units preparing to deploy.
“When you’re looking at, 40,000 soldiers that potentially are in that unvaccinated category, absolutely there’s readiness implications on that and concerns associated with that,” said Jensen. “That’s a significant chunk.”
Overall, according to the data obtained by the AP, about 85% of all Army Guard soldiers are fully vaccinated. Officials said that if those with one shot are counted, 87% are at least partially vaccinated.
Across the country, in all but one case, Guard soldiers are vaccinated at a higher rate that the general population in their state. Only in New Jersey is the percentage of vaccinated Guard solders very slightly lower than the state’s overall population, as of earlier this month when the data was collected.
The three U.S. territories — Virgin Islands, Guam and Puerto Rico — and the District of Columbia, all have more than 90% of their soldiers fully vaccinated. The highest percentage is in Hawaii, with nearly 97%, while the lowest is Oklahoma, at just under 70%.
Guard leaders in the states have run special shot programs, and provided as much information as possible to their forces in order to keep them on the job.
In Tennessee, they set up small teams in the east, west and central regions and did monthly events providing vaccines to troops who wanted them. And every Wednesday, Guard members could make appointments for shots in the middle Tennessee region, in Smyrna. In addition, in early June they called in all soldiers who have so far refused the vaccine.
“We held a big, mass event,” said Army Guard Col. Keith Evans. “We had all of our medical providers here. So if there were any questions to clear up, any misconceptions, any misinformation, we had all of our our data and were able to provide them all the information.”
Evans, who is commander of his Army Guard’s medical readiness command, said they also had recruiting and other leaders there who could explain what would happen if soldiers chose to not get the shot and ended up leaving the Guard.
“We wanted to let them know what benefits they had earned because these are soldiers that had had done their time, served their country,” said Evans.
Officials say they believe the information campaign has been working. Jensen said that about 1,500 soldiers a week around the country are moving into the vaccinated category. “We expect, as we approach the deadline, that we’ll see some some larger growth.”
There is now a second COVID-19 option for kids ages 6 to 17 in the U.S.
The Centers for Disease Control and Prevention on Friday announced it is recommending Moderna shots as an option for school-age kids and teens. This group has been able to get shots made by Pfizer since last year.
CDC sets the federal government’s vaccine guidance for U.S. doctors and their patients.
Last week, the Food and Drug Administration authorized the shots — full-strength doses for children ages 12 to 17 and half-strength for those 6 to 11. The doses are to be given about a month apart. An expert advisory panel this week voted unanimously to recommend that CDC endorse the Moderna shots, too.
Moderna officials have said they expect to later offer a booster to all kids ages 6 to 17.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
