Nation faces delays in program to ensure free COVID-19 shots this fall

The Biden administration is rushing to finalize a $1.1 billion bridge program to provide free COVID-19 vaccines for uninsured and underinsured people in time for the release of new boosters, report Adam Cancryn and David Lim at Politico. 

Since the public emergency ended in May, the government will no longer cover the costs of COVID-19 prevention, testing and treatment for everyone. Private and public insurance plans are, for the most part, expected to cover the vaccine costs, which would otherwise be up to $130 out of pocket.

But as many as 30 million people don’t have coverage. That includes millions of people who lost Medicaid after expansive COVID-19-era benefits expired. Many of these people remain eligible but fell off the rolls due to bureaucratic hurdles. 

The bridge program is supposed to make the shots free for anyone whose insurance doesn’t fully cover the costs. 

The free vaccines will be available immediately at federally qualified clinics and individual providers. But pharmacies are the most convenient place for many to get the shots, and the pharmacy contracts are yet to be in place.

Nearly nine out of 10 Americans live within five miles of a pharmacy, but other health facilities are often farther away, reports Roll Call.

If officials fail to get the pharmacy plan in place by late September, when the new shots are expected to be released, it could complicate the rollout. 

“You’re going to have people showing up at the pharmacy looking to get vaccinated … and being told we’re not yet prepared to give it to you,” Georges Benjamin, executive director of the American Public Health Association, told Politico recently. “Some of those people will come back and get vaccinated and some of those people will just get frustrated and not show up again.”

Lack of awareness about eligibility or vaccine availability were key reasons that people didn’t get a booster last fall, when the shots were still free to all.

Pfizer and Moderna also plan to offer assistance programs for people who can’t otherwise afford their vaccines, reports Julie Appleby at KFF Health News.

Women of color report widespread mistreatment in maternity care

More than one in four Black, Hispanic and multiracial women report being mistreated during maternity care, according to a new CDC report. For women of all races combined, the figure was one in five.

Women who lacked health insurance or were on public insurance also reported more mistreatment than those with private insurance.

“These data show that we must do better to support moms,” said Dr. Debra Houry, the CDC’s chief medical officer.

Women reported a variety of problems, such as receiving threats to withhold treatment, being forced to accept undesired treatment, or not getting responses to their requests for help.

Discrimination, often based on age, weight or income, was reported by 29% of women overall, but by more than 35% of women of color.

The results covered 2,402 mothers surveyed in April 2023.

The report comes amid a growing crisis in U.S. maternal mortality rates, which have risen from 17.4 deaths per 100,000 live births in 2018 to 32.9 deaths per 100,000 live births in 2021, notes Eduardo Cuevas at USA Today. 

Black women die during pregnancy, childbirth or soon after at 2.6 times the rate of white women, notes Mary Kekatos at ABC News. 

Systemic racism leads to health consequences, including death, for Black mothers as well as their infants, writes Sandy West at KFF Health News. 

“Medical providers often dismiss Black women’s questions and concerns,” writes West. The gap in mortality rates between Black and white newborns was halved for Black babies when Black physicians cared for them, she adds.

Maternal mortality rates for Hispanic women overtook those for white women in 2021.

Native Hawaiian, Pacific Islander, American Indian and Alaska Native populations also have higher maternal death rates than white women, writes Shannon Firth at MedPage Today.

Maternity care “deserts” — about 2 million women of childbearing age live 25 miles or more away from the nearest labor and delivery unit — also create disparities for women of color, reports Nada Hassanein at USA Today.

More than 80% of maternal deaths are preventable, according to the CDC.

While the new survey results don’t directly explain maternal deaths, “We know that racism and discrimination can lead to delays in treatment and sometimes tragic and preventable deaths,” Wanda Barfield, director of the CDC’s division of reproductive health care, said in a media release.

Training health care providers in unconscious bias and how to provide care that is “culturally appropriate” could be a first step to repair the situation, Barfield suggested. The CDC also recommends health care systems hire diverse workforces and communicate better with patients.

“There is no single solution” to the maternal mortality crisis, writes the Editorial Board of The Washington Post. “Still, it’s time for federal, state and local institutions to start thinking creatively.” 

Paying attention to health equity and learning from other nations with lower maternal mortality rates should be part of the solution, the editors wrote.

They also note that American women need better postpartum care. Most pregnancy-related deaths occur not during childbirth but in the days and months that follow, but many women don’t receive any care.

Women, people of color and elders face extra-long waits for stroke treatment

Speedy treatment is essential to preserve brain cells after a stroke, but according to a new JAMA study, many people wait too long to be transferred to a hospital that can care for them.

The delays were longer for people older than 80, women and Black and Hispanic individuals.

“Every additional second that passes without blood flow increases the chance that the brain suffers irreparable damage,” writes Bree Iskandar at STAT. “These minutes could have profound impacts on patient outcomes.”

Medical guidelines recommend that stroke patients who arrive in the emergency room but require transfer to a better-equipped facility depart within two hours. The average delay in the study was closer to three hours.

Patients who arrived at the first hospital by ambulance got transferred faster, probably because the emergency medical technicians notified the first emergency department that they were coming, so physicians were prepared. 

But ambulance transfer is not covered by some insurance policies, disadvantaging low-income people of color.

And millions of rural residents live in “ambulance deserts,” more than 25 minutes from the nearest ambulance station, Taylor Sisk reports at KFF Health News.

Iskandar adds that medical training for stroke diagnosis has focused on the presentation in white males, but others may have variations in symptoms that slow the diagnosis.

The problem is also compounded by the higher stroke risk faced by Black Americans.

“These delays put older, Black and Hispanic patients with stroke at risk of not receiving effective treatments,” Dr. Deborah Levine of the University of Michigan, who was not involved in the study, told STAT. “It is critical we understand and reduce these inequities.”

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Americans who got the updated COVID-19 booster shots are better protected against symptomatic infection than those who haven’t — at least for now, U.S. health officials said Tuesday.

Updated boosters rolled out by Pfizer and rival Moderna in September have been a hard sell for vaccine-weary Americans. Only about 13% of U.S. adults so far have gotten a “bivalent” shot that targets the omicron strain and the original coronavirus. On Tuesday, White House officials announced a renewed push for more Americans to get the latest shots.

The first look at the new shots’ real-world effectiveness shows they work, said Dr. Anthony Fauci, the nation’s top infectious disease expert.

Speaking at a White House briefing expected to be his last before he retires from the government at the end of year, Fauci said what “may be the final message I give you from this podium is that please, for your own safety, for that of your family, get your updated COVID-19 shot as soon as you’re eligible.”

The Centers for Disease Control and Prevention analyzed about 360,000 COVID-19 tests given to people with coronavirus-like symptoms at drugstores around the country between September, when the new boosters rolled out, and early November. Researchers compared the vaccination status of those who wound up having COVID-19 with those who didn’t.

The new omicron-targeting booster added 30% to 56% protection against symptomatic infection, depending on how many prior vaccinations someone had, how long ago and their age, the CDC concluded.

People getting the greatest benefit are those who’d never had a prior booster, just two doses of the original COVID-19 vaccine at least eight months earlier, said CDC’s Dr. Ruth Link-Gelles, who led the study.

But even people who got a summertime booster of the original vaccine before seeking the new fall formula were 30% to 40% more protected than if they’d skipped this latest shot, she said.

“We think about it as the additional benefit or incremental benefit of getting one more dose, and in this case that one more dose is a bivalent,” Link-Gelles said.

The updated boosters target the BA.5 omicron strain that until recently was the most common type, an effort to build on the original COVID-19 vaccines’ protection as the virus continues to mutate.

The original shots have offered strong protection against severe disease and death no matter the variant, but protection against mild infection wanes. CDC’s analysis tracked only the first few months of the new boosters’ use so it’s too early to know how long added protection against symptomatic infection lasts.

But “certainly as we enter the holiday season, personally I would want the most possible protection if I’m seeing my parents and grandparents,” Link-Gelles said. “Protection against infection there is going to be really helpful, because you potentially would stop yourself from getting a grandparent or other loved one sick.”

Even protection against severe illness slipped some when BA.5 surged, the reason health authorities have strongly urged older adults and others at high risk not to skip the new booster.

To that end, the Biden administration announced a six-week campaign urging people — especially seniors — to get the boosters, saying the shots could save lives as Americans gather for the holidays.

The campaign echoes a call earlier this week from the American Medical Association and nearly a dozen other health groups for people to hurry up and get both the COVID-19 booster and their yearly flu vaccination. The flu has hit unusually strong and early this year. Combined with COVID-19 cases and other problematic respiratory viruses, hospitals and doctors’ offices are packed.

Some people may be reluctant to get vaccinated or boosted because of a torrent of misinformation about the shots despite evidence that they’re safe and have saved millions of lives.

“You can decide to trust America’s physicians or you can trust some random dude on Twitter,” said Dr. Ashish Jha, the White House COVID-19 coordinator.

Fauci said “as a physician it pains me” that the country’s harsh political division has some people refusing vaccination for non-health reasons.

And he noted that while it’s important to for people to get the new booster, those most at risk if there’s another winter surge will be people who never got the primary vaccine series.

Adding to the uncertainty, relatives of BA.5 are now the the most common coronavirus subtypes. Lab testing from Pfizer and Moderna show the updated booster revs up people’s levels of virus-fighting antibodies, particularly against BA.5. The companies point to preliminary antibody evidence that the new shots also may offer at least some protection against the even newer omicron subtypes, despite not being an exact match.

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The U.S. on Wednesday authorized updated COVID-19 boosters for children as young as 5, seeking to expand protection ahead of an expected winter wave.

Tweaked boosters rolled out for Americans 12 and older last month, doses modified to target today’s most common and contagious omicron relative. While there wasn’t a big rush, federal health officials are urging that people seek the extra protection ahead of holiday gatherings.

Now the Food and Drug Administration has given a green light for elementary school-age kids to get the updated booster doses, too — one made by Pfizer for 5- to 11-year-olds, and a version from rival Moderna for those as young as 6.

The Centers for Disease Control and Prevention, which recommends how vaccines are used, also signed off.

Americans may be tired of repeated calls to get boosted against COVID-19 but experts say the updated shots have an advantage: They contain half the recipe that targeted the original coronavirus strain and half protection against the dominant BA.4 and BA.5 omicron versions.

These combination or “bivalent” boosters are designed to broaden immune defenses so that people are better protected against serious illness whether they encounter an omicron relative in the coming months — or a different mutant that’s more like the original virus.

“We want to have the best of both worlds,” Pfizer’s Dr. Bill Gruber, a pediatrician, told The Associated Press. He hopes the updated shots will “re-energize interest in protecting children for the winter.”

The updated boosters are “extremely important” for keeping kids healthy and in school, said Dr. Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis.

Parents should know “there is no concern from the safety perspective with the bivalent vaccines, whether Moderna or Pfizer,” Newland added.

Only people who’ve gotten their initial vaccinations — with any of the original-formula versions — qualify for an updated booster. That means about three-fourths of Americans 12 and older are eligible. As of last weekend, only at least 13 million had gotten an updated booster, White House COVID-19 coordinator Dr. Ashish Jha estimated Tuesday.

To pediatricians’ chagrin, getting children their first vaccinations has been tougher. Less than a third of 5- to 11-year-olds have had their two primary doses and thus would qualify for the new booster.

This age group will get kid-size doses of the new omicron-targeting booster — and they can receive it at least two months after their last dose, whether that was their primary vaccination series or an earlier booster, the FDA said.

“Vaccination remains the most effective measure to prevent the severe consequences of COVID-19,” Dr. Peter Marks, FDA’s vaccine chief, said in a statement.

While children tend to get less seriously ill than adults, “as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized,” Marks said.

For the updated booster made by Pfizer and its partner BioNTech, 5- to 11-year-olds would get a third of the dose that anyone 12 and older already receives. Pfizer said it could ship up to 6 million kid-sized doses within a week of authorization, in addition to ongoing shipments of adult-sized doses.

Until now, Moderna’s updated booster was cleared only for adults. FDA just expanded that adult bivalent dosage to 12- to 17-year-olds, and authorized half the dose for kids ages 6 to 11.

As for even younger tots, first vaccinations didn’t open for the under-5 age group until mid-June — and it will be several more months before regulators decide if they’ll also need a booster using the updated recipe.

Exactly how much protection does an updated COVID-19 booster shot offer? That’s hard to know. Pfizer and Moderna are starting studies in young children.

But the FDA cleared the COVID-19 booster tweaks without requiring human test results — just like it approves yearly changes to flu vaccines. That’s partly because both companies already had studied experimental shots tweaked to target prior COVID-19 variants, including an earlier omicron version, and found they safely revved up virus-fighting antibodies.

“It’s clearly a better vaccine, an important upgrade from what we had before,” Jha said earlier this week.

Jha urged adults to get their updated shot in October — like they get flu vaccinations — or at least well before holiday gatherings with high-risk family and friends. People who’ve recently had COVID-19 still need the booster but can wait about three months, he added.

___

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.

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WASHINGTON (AP) — The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common omicron strain. Shots could begin within days.

The move by the Food and Drug Administration tweaks the recipe of shots made by Pfizer and rival Moderna that already have saved millions of lives. The hope is that the modified boosters will blunt yet another winter surge — and help tamp down the BA.5 omicron relative that continues to spread widely.

“These updated boosters present us with an opportunity to get ahead” of the next COVID-19 wave, said FDA Commissioner Dr. Robert Califf.

Until now, COVID-19 vaccines have targeted the original coronavirus strain, even as wildly different mutants emerged. The new U.S. boosters are combination, or “bivalent,” shots. They contain half that original vaccine recipe and half protection against the newest omicron versions, BA.4 and BA.5, that are considered the most contagious yet.

The combination aims to increase cross-protection against multiple variants.

“It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told The Associated Press.

The updated boosters are only for people who have already had their primary vaccinations, using the original vaccines. Doses made by Pfizer and its partner BioNTech are for anyone 12 and older while Moderna’s updated shots are for adults — if it has been at least two months since their last primary vaccination or their latest booster. They’re not to be used for initial vaccinations.

There’s one more step before a fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should get the additional shot. An influential CDC advisory panel will debate the evidence Thursday — including whether people at high risk from COVID-19 should go first.

The U.S. has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week. Moderna didn’t immediately say how many doses are ready to ship but that some will be available “in the coming days.”

The big question is whether people weary of vaccinations will roll up their sleeves again. Just half of vaccinated Americans got the first recommended booster dose, and only a third of those 50 and older who were urged to get a second booster did so.

Here’s the rub: The original vaccines still offer strong protection against severe disease and death from COVID-19 for generally healthy people, especially if they got that important first booster dose. It’s not clear just how much more benefit an updated booster will bring — beyond a temporary jump in antibodies capable of fending off an omicron infection.

Still, “people have to realize this is a different kind of booster than was previously available. It will work better at protecting against omicron,” said virologist Andrew Pekosz of the Johns Hopkins Bloomberg School of Public Health.

Even people who had an earlier omicron version still can get reinfected so “you should definitely go for the booster even if you’ve been infected in the last year,” added Pekosz. He thinks “if we can get good buy-in to use this, we might really be able to make a dent” in COVID-19 cases.

The FDA cleared the modifications ahead of studies in people, a step toward eventually handling COVID-19 vaccine updates more like yearly changes to flu shots.

FDA vaccine chief Dr. Peter Marks stressed the agency considered “the totality” of evidence. Pfizer and Moderna have previously brewed vaccine doses updated to match earlier mutants — including the omicron strain named BA.1 that struck last winter — and tested them in people. Those earlier recipe changes were safe, and the BA.1 version substantially boosted virus-fighting antibodies — more than another dose of the original vaccine — although fewer that recognized today’s genetically distinct BA.4 and BA.5 strains.

But instead of using those BA.1 shots, FDA ordered the companies to brew even more up-to-date doses that target those newest omicron mutants, sparking a race to roll them out. Rather than waiting a few more months for additional human studies of that very similar recipe tweak, Marks said animal tests showed the latest update spurs “a very good immune response.”

“One needs to refresh the immune system with what is actually circulating,” Marks said. That’s why FDA also is no longer authorizing boosters made with the original recipe for those 12 and older.

The hope, Marks said, is that a vaccine matched to currently spreading variants might do a better job fighting infection, not just serious illness, at least for a while.

What’s next? Even as modified shots roll out, Moderna and Pfizer are conducting human studies to help assess their value, including how they hold up if a new mutant comes along.

And for children, Pfizer plans to ask FDA to allow updated boosters for 5- to 11-year-olds in early October.

It’s the first U.S. update to the COVID-19 vaccine recipe, an important but expected next step — like how flu vaccines get updated every year.

And the U.S. isn’t alone. Britain recently decided to offer adults over 50 a different booster option from Moderna, a combo shot targeting that initial BA.1 omicron strain. European regulators are considering whether to authorize one or both of the updated formulas.

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COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but still up in the air is how much benefit the booster shots will offer, who should get one — and how soon.

Pfizer and rival Moderna both asked U.S. regulators this week to authorize modified versions of their booster vaccine — shots that are half the original recipe and half protection against BA.4 and BA.5, the newest versions of omicron.

The Food and Drug Administration ordered that recipe and now is evaluating what scientists call a “bivalent vaccine,” with a decision expected soon.

Dr. Peter Marks, the FDA’s vaccine chief, said Thursday that once authorized, the tweaked boosters could help right away — while BA.5 infections still are too high — as well as hopefully blunt yet another winter surge.

Marks told the Associated Press that the new boosters could rev up the immune system to prevent not just serious illness but maybe milder infections, too, like the original vaccines did earlier in the pandemic, before super-contagious mutants emerged.

“The hope here is that by better matching things, not only will we get that benefit or even more, but we’ll also have that last for a longer period of time,” he said.

WHY DID FDA ORDER A RECIPE CHANGE?

BA.5 currently is causing nearly all COVID-19 infections in the U.S. and much of the world. Current COVID-19 vaccines match the coronavirus strain that circulated in early 2020. And while those vaccinations still offer strong protection against serious illness or death from COVID-19, there’s little effectiveness against infection from the wildly mutated omicron family.

The first update to the recipe is an an important but expected next step — like how flu vaccines get updated every year. True next-generation vaccines are still in development.

“We need to give a clear, forward-looking set of expectations,” said University of Pennsylvania immunologist E. John Wherry, who compares vaccine tweaks to periodically updating your computer software.

The gamble is that BA.5, or something similar, still will be circulating through the winter. (Vaccines target the spike protein that coat the coronavirus, and the BA.4 and BA.5 spikes are identical although those strains vary in other ways.)

HOW WERE THE MODIFIED SHOTS TESTED?

Pfizer and Moderna both studied an earlier tweak to their vaccines that targets the original omicron, called BA.1, that hit last winter, as well as even earlier variants.

To evaluate the combo shots, FDA is using data from human testing of the BA.1-tweaked doses plus mice tests of the BA.5-targeted version that Marks said show “a very good immune response.”

Human data on the newest tweak will come later in the year, to help assess the value of modified shots — especially whether they offer cross-protection if a new mutant comes along, Marks said. Moderna has started a clinical trial of its BA.5 combo shot; Pfizer and its partner BioNTech expect to open a similar study soon.

WILL THEY WORK BETTER?

No one knows. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and an FDA vaccine adviser, said the antibody jump from that earlier BA.1-tweaked candidate was “underwhelming.”

“What the administration is asking us to do is to accept this bivalent vaccine as significantly better” than another dose of today’s vaccine, he said. “It would be nice if there were data to support that.”

But while FDA hasn’t made a final decision, Marks said there’s evidence that the updated boosters are safe and that waiting for more study of their effectiveness would risk another mutant appearing before they could roll out.

They “essentially refresh the immune response,” he said. “Granted, it’s still a bit of a guess how long it will last but, this is doing our best.”

Given how outdated the current shots are, an update makes sense, said Dr. Walter Orenstein of Emory University, a former vaccine director at the Centers for Disease Control and Prevention. While he’d like to see more data, he plans to get the new booster.

WHO SHOULD GET AN UPDATED SHOT?

That’s up to the CDC, which called a meeting of its influential vaccine advisers next Thursday and Friday to help decide.

Pfizer wants to open its updated boosters to everyone 12 and older who’s already had a primary series of today’s vaccine, while Moderna has applied only for adult use. CDC will determine if people at highest risk should go first. Studies of doses for younger children are expected later in the year.

A government rollout plan anticipates that people who’ve already gotten their initial vaccinations would qualify for one of the new combination shots, regardless of how many boosters they’ve already had.

WHEN SHOULD THOSE ELIGIBLE GET THE NEW BOOSTER?

Marks is aiming for a very simple message: “It’s probably going to be everyone who has not had a booster within the past X number of months should go out and get the booster in a timely manner,” he said. Officials still have to decide just how many months, though.

How long to wait after your last vaccine dose or an infection is a critical decision, immunologists agree. That’s because if you still have a lot of antibodies in your bloodstream, they’ll counteract the brand new antibodies that the vaccine dose is supposed to produce.

So if you already got a booster in July or August and then seek the new combo shot in September, “you’ll receive very little additional boosting from that,” Penn’s Wherry said. He recommends waiting four to six months.

The CDC also will weigh in after after considering how many doses will be available in early September versus later in the fall. The Biden administration has purchased more than 170 million doses.

WILL PEOPLE ROLL UP THEIR SLEEVES AGAIN?

Americans have been reluctant to keep up with COVID-19 vaccinations. While three-quarters of Americans 12 and older have gotten their initial vaccinations, only half got a first booster shot — deemed crucial for the best protection against variants. And just a third of people 50 and older who were advised to get a second booster when omicron arrived did so.

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Americans 50 and older can get a second COVID-19 booster if it’s been at least four months since their last vaccination, a chance at extra protection for the most vulnerable in case the coronavirus rebounds.

The Food and Drug Administration on Tuesday authorized an extra dose of the Pfizer or Moderna vaccine for that age group and for certain younger people with severely weakened immune systems.

The Centers for Disease Control and Prevention later recommended the extra shot as an option but stopped short of urging that those eligible rush out and get it right away. That decision expands the additional booster to millions more Americans.

Dr. Rochelle Walensky, CDC’s director, said it was especially important for older Americans — those 65 and older — and the 50-somethings with chronic illnesses such as heart disease or diabetes to consider another shot.

“They are the most likely to benefit from receiving an additional booster dose at this time,” Walensky said.

There’s evidence protection can wane particularly in higher-risk groups, and for them another booster “will help save lives,” FDA vaccine chief Dr. Peter Marks said.

For all the attention on who should get a fourth dose of the Pfizer and Moderna vaccines, only about half of Americans eligible for a third shot have gotten one — and the government urged them to get up to date. Two shots plus a booster still offer strong protection against severe illness and death, even during the winter surge of the super-contagious omicron variant.

The move toward additional boosters comes at a time of great uncertainty, with limited evidence to tell how much benefit an extra dose right now could offer. COVID-19 cases have dropped to low levels in the U.S., but all vaccines are less powerful against newer mutants than earlier versions of the virus — and health officials are warily watching an omicron sibling that’s causing worrisome jumps in infections in other countries.

Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults “to provide flexibility” for the government to decide who really needs one.

FDA’s Marks said regulators set the age at 50 because that’s when chronic conditions that increase the risks from COVID-19 become more common.

Until now, the FDA had allowed a fourth vaccine dose only for the immune-compromised as young as 12. Vaccines have a harder time revving up severely weak immune systems, and Marks said their protection also tends to wane sooner. Tuesday’s decision allows them another booster, too — a fifth dose. Only the Pfizer vaccine can be used in those as young as 12; Moderna’s is for adults.

What about people who got Johnson & Johnson’s single-dose shot? They already were eligible for one booster of any kind. Of the 1.3 million who got a second J&J shot, the CDC said now they may choose a third dose — either Moderna or Pfizer. For the more than 4 million who got Moderna or Pfizer as their second shot, the CDC says an additional booster is only necessary if they meet the newest criteria — a severely weakened immune system or are 50 or older.

That’s because a CDC study that tracked which boosters J&J recipients initially chose concluded a Moderna or Pfizer second shot was superior to a second J&J dose.

If the new recommendations sound confusing, outside experts say it makes sense to consider extra protection for the most vulnerable.

“There might be a reason to top off the tanks a little bit” for older people and those with other health conditions, said University of Pennsylvania immunologist E. John Wherry, who wasn’t involved in the government’s decision.

But while he encourages older friends and relatives to follow the advice, the 50-year-old Wherry — who is healthy, vaccinated and boosted — doesn’t plan on getting a fourth shot right away. With protection against severe illness still strong, “I’m going to wait until it seems like there’s a need.”

While protection against milder infections naturally wanes over time, the immune system builds multiple layers of defense and the type that prevents severe illness and death is holding up.

During the U.S. omicron wave, two doses were nearly 80% effective against needing a ventilator or death — and a booster pushed that protection to 94%, the CDC recently reported. Vaccine effectiveness was lowest — 74% — in immune-compromised people, the vast majority of whom hadn’t gotten a third dose.

To evaluate an extra booster, U.S. officials looked to Israel, which opened a fourth dose to people 60 and older during the omicron surge. The FDA said no new safety concerns emerged in a review of 700,000 fourth doses administered.

Preliminary data posted online last week suggested some benefit: Israeli researchers counted 92 deaths among more than 328,000 people who got the extra shot, compared to 232 deaths among 234,000 people who skipped the fourth dose.

What’s far from clear is how long any extra benefit from another booster would last, and thus when to get it.

“The ‘when’ is a really difficult part. Ideally we would time booster doses right before surges but we don’t always know when that’s going to be,” said Dr. William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health.

Plus, a longer interval between shots helps the immune system mount a stronger, more cross-reactive defense.

“If you get a booster too close together, it’s not doing any harm — you’re just not going to get much benefit from it,” said Wherry.

The newest booster expansion may not be the last: Next week, the government will hold a public meeting to debate if everyone eventually needs a fourth dose, possibly in the fall, of the original vaccine or an updated shot.

Even if higher-risk Americans get boosted now, Marks said they may need yet another dose in the fall if regulators decide to tweak the vaccine.

For that effort, studies in people — of omicron-targeted shots alone or in combination with the original vaccine — are underway. The National Institutes of Health recently tested monkeys and found “no significant advantage” to using a booster that targets just omicron.

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The U.S. is urging that everyone 12 and older get a COVID-19 booster as soon as they’re eligible, to help fight back the hugely contagious omicron mutant that’s ripping through the country.

Boosters already were encouraged for all Americans 16 and older, but Wednesday the Centers for Disease Control and Prevention endorsed an extra Pfizer shot for younger teens — those 12 to 15 — and strengthened its recommendation that 16- and 17-year-olds get it, too.

“It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease,” Dr. Rochelle Walensky, the CDC’s director, said in a statement Wednesday night.

“This booster dose will provide optimized protection against COVID-19 and the Omicron variant. I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations,” she said.

Vaccines still offer strong protection against serious illness from any type of COVID-19, including omicron — what experts say is their most important benefit. But the newest mutant can slip past a layer of the vaccines’ protection to cause milder infections. Studies show a booster dose at least temporarily revs up virus-fighting antibodies to levels that offer the best chance at avoiding symptomatic infection, even from omicron.

Earlier Wednesday, the CDC’s independent scientific advisers wrestled with whether a booster should be an option for younger teens, who tend not to get as sick from COVID-19 as adults, or more strongly recommended.

Giving teens a booster for a temporary jump in protection against infections is like playing whack-a-mole, cautioned CDC adviser Dr. Sarah Long of Drexel University. But she said the extra shot was worth it to help push back the omicron mutant and shield kids from the missed school and other problems that come with even a very mild case of COVID-19.

More important, if a child with a mild infection spreads it to a more vulnerable parent or grandparent who then dies, the impact “is absolutely crushing,” said panelist Dr. Camille Kotton of Massachusetts General Hospital.

“Let’s whack this one down,” agreed Dr. Jamie Loehr of Cayuga Family Medicine in Ithaca, New York.

The vaccine made by Pfizer and its partner BioNTech is the only option for American children of any age. The CDC says about 13.5 million children ages 12 to 17 — slightly more than half of that age group — have received two Pfizer shots. Boosters were opened to the 16- and 17-year-olds last month.

Wednesday’s decision means about 5 million of the younger teens who had their last shot in the spring are eligible for a booster right away. New U.S. guidelines say anyone who received two Pfizer vaccinations and is eligible for a booster can get it five months after their last shot, rather than the six months previously recommended.

But one committee member, Dr. Helen Keipp Talbot of Vanderbilt University, worried that such a strong recommendation for teen boosters would distract from getting shots into the arms of kids who have not been vaccinated at all.

The advisers saw U.S. data making clear that symptomatic COVID-19 cases and hospitalizations are between seven and 11 times higher in unvaccinated adolescents than vaccinated ones.

While children do tend to suffer less serious illness from COVID-19 than adults, child hospitalizations are rising during the omicron wave — the vast majority of them unvaccinated.

During the public comment part of Wednesday’s meeting, Dr. Julie Boom of Texas Children’s Hospital said a booster recommendation for younger teens “cannot come soon enough.”

The chief safety question for adolescents is a rare side effect called myocarditis, a type of heart inflammation seen mostly in younger men and teen boys who get either the Pfizer or Moderna vaccines. The vast majority of cases are mild — far milder than the heart inflammation COVID-19 can cause — and they seem to peak in older teens, those 16 and 17.

The FDA decided a booster dose was as safe for the younger teens as the older ones based largely on data from 6,300 12- to 15-year-olds in Israel who got a Pfizer booster five months after their second dose. Israeli officials said Wednesday that they’ve seen two cases of mild myocarditis in this age group after giving more boosters, 40,000.

Earlier this week, FDA vaccine chief Dr. Peter Marks said the side effect occurs in about 1 in 10,000 men and boys ages 16 to 30 after their second shot. But he said a third dose appears less risky, by about a third, probably because more time has passed before the booster than between the first two shots.

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More COVID-19 booster shots may be on the way — but when it’s your turn, you’ll get an extra dose of the original vaccine, not one updated to better match the extra-contagious delta variant.

And that has some experts wondering if the booster campaign is a bit of a missed opportunity to target delta and its likely descendants.

“Don’t we want to match the new strains that are most likely to circulate as closely as possible?” Dr. Cody Meissner of Tufts Medical Center, an adviser to the Food and Drug Administration, challenged Pfizer scientists recently.

“I don’t quite understand why this is not delta because that’s what we’re facing right now,” fellow adviser Dr. Patrick Moore of the University of Pittsburgh said last week as government experts debated whether it’s time for Moderna boosters. He wondered if such a switch would be particularly useful to block mild infection.

The simple answer: The FDA last month OK’d extra doses of Pfizer’s original recipe after studies showed it still works well enough against delta — and those doses could be rolled out right away. Now the FDA is weighing evidence for boosters of the original Moderna and Johnson & Johnson vaccines.

“It’s less churn and burn on the manufacturing” to only switch formulas when it’s really necessary, said FDA vaccine chief Dr. Peter Marks.

But Pfizer and Moderna are hedging their bets. They’re already testing experimental doses customized to delta and another variant, learning how to rapidly tweak the formula in case a change eventually is needed — for today’s mutants or a brand new one. The tougher question for regulators is how they’d decide if and when to ever order such a switch.

What we know so far:

CURRENT VACCINES ARE WORKING EVEN AGAINST DELTA

Vaccines used in the U.S. remain strongly effective against hospitalization and death from COVID-19, even after the delta variant took over, but authorities hope to shore up waning protection against less severe infection and for high-risk populations. Studies show an extra dose of the original formulas revs up virus-fighting antibodies that fend off infection, including antibodies that target delta.

MIGHT A DELTA-SPECIFIC BOOSTER WORK EVEN BETTER?

Vaccines target the spike protein that coats the coronavirus. Mutations in that protein made delta more contagious but to the immune system, it doesn’t look all that different, said virus expert Richard Webby of St. Jude Children’s Research Hospital.

That means there’s no guarantee a delta-specific booster would protect any better, said University of Pennsylvania immunologist John Wherry. Waiting for studies to settle that question — and if necessary, brewing updated doses — would have delayed rolling out boosters to people deemed to need them now.

Still, because delta is now the dominant version of the virus worldwide it almost certainly will be a common ancestor for whatever evolves next in a mostly unvaccinated world, said Trevor Bedford, a biologist and genetics expert at the Fred Hutchinson Cancer Research Center.

A delta-updated vaccine would “help to provide a buffer against those additional mutations,” he said. Bedford is paid by the Howard Hughes Medical Institute, which also supports The Associated Press Health and Science Department.

TWEAKING THE RECIPE

The Pfizer and Moderna vaccines are made with a piece of genetic code called messenger RNA that tells the body to make harmless copies of the spike protein so it’s trained to recognize the virus. Updating the formula merely requires swapping out the original genetic code with mRNA for a mutated spike protein.

Both companies first experimented with tweaked doses against a mutant that emerged in South Africa, the beta variant, that has been the most vaccine-resistant to date, more so than the delta variant. Lab tests showed the updated shots produced potent antibodies. But the beta variant didn’t spread widely.

Now the companies have studies underway of fully vaccinated people who agreed to test a booster dose tweaked to match delta. Moderna’s studies also include some shots that combine protection against more than one version of the coronavirus — much like today’s flu vaccines work against multiple influenza strains.

The mRNA vaccines are considered the easiest kind to tweak but some other vaccine makers also are exploring how to change their recipes if necessary.

WHY STUDY UPDATED SHOTS IF THEY’RE NOT YET NEEDED?

Moderna’s Dr. Jacqueline Miller told an FDA advisory panel last week the company is studying variant-specific boosters now to learn if they offer advantages, and to be ready if they’re needed.

And Penn’s Wherry said it is critical to carefully analyze how the body reacts to updated shots because the immune system tends to “imprint” a stronger memory of the first virus strain it encounters. That raises questions about whether a subtly different booster would prompt a temporary jump in antibodies the body’s made before — or the bigger goal, a broader and more durable response that might even be better positioned for the next mutations to come along.

NO RULES YET FOR MAKING A SWITCH

“What is the tripping point?” asked Webby, who is part of a World Health Organization network that tracks influenza evolution. “A lot of what is going to need to go into that decision making is just going to be learned by experience, unfortunately.”

Bedford said now is the time to decide what drop in vaccine effectiveness would trigger a formula change, just as is done with flu vaccines every year.

That’s important not just if a dramatically worse variant suddenly develops. Like many scientists, Bedford expects the coronavirus to eventually evolve from a global crisis into a regular threat every winter — which might mean more regular boosters, maybe even yearly in combination with the flu shot.

Timing between shots matters, too, Wherry noted.

“Your boostability may actually improve with longer intervals between stimulation,” he said. While scientists have learned a lot about the coronavirus, “the story’s not finished yet and we don’t know what the last chapters say.”

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