Match Day 2026: The countdown ends, the journey begins
//
The Biden administration is reportedly planning to give Americans ages 50 and up the choice to receive a second COVID-19 booster dose of the Pfizer-BioNTech or Moderna vaccines.
The New York Times said Friday that the move would be made without "recommending outright" that the group get one, citing "several people familiar with the plan."
FAUCI SAYS HE DOES NOT ANTICIPATE MAJOR COVID-19 SURGE IN US
However, the publication noted that "major uncertainties have complicated the decision," including how long the protection from the second booster would last, as well as how to present the White House's overall goal to the public.
Politico reported Wednesday that the booster could be recommended for adults 65 and older and that health officials have reviewed recent data showing vaccine effectiveness waning.
Additionally, there's the question of timing and whether to wait until a potential new variant-fueled wave threatens the U.S. – especially as pandemic relief funds dwindle.
In an interview last Monday on "In the Bubble with Andy Slavitt," White House COVID-19 response coordinator Jeff Zients said there is currently no funding for fourth doses.
"Right now, we don't have enough money for fourth doses, if they're called for – booster shots, additional booster shots for all Americans. We don't have the funding, if we were to need a variant-specific vaccine in the future. Immediately, we don't have money to order more of the very effective monoclonal treatments," he said.
CDC SAYS OMICRON SUB-VARIANT BA.2 ACCOUNTS FOR AROUND 35% OF COVID-19 VARIANTS IN US
"Already, we've had to cut back allocations to our state partners by 30%, so we preserve the inventory that we do have," Zients added, calling on Congress to take action.
That said, The Times reported that people familiar with the deliberations said the Food and Drug Administration (FDA) could authorize a second booster as soon as early next week.
Although studies have found that COVID-19 vaccines are less effective against the omicron variant of concern, they still provide strong protection against severe disease and early research indicates they appear just as effective against the BA.2 sub-variant spreading across the globe.
And, while Moderna, Pfizer and BioNTech have requested emergency authorization of second booster shots – Moderna's for all adults – The Times wrote that no meetings of FDA or Centers for Disease Control and Prevention (CDC) advisory committees are scheduled ahead of the purported decision.
CLICK HERE TO GET THE FOX NEWS APP
The FDA's advisory committee will meet in April to discuss what the overall vaccine strategy for the Biden administration should be during the third year of the pandemic.
CDC data shows that 217.3 million Americans are fully vaccinated and 97.1 million have received a booster.
For most Americans, the coronavirus has become a tolerable threat, on par with the flu, and requires minimal precautions, if any. But for older people and the immunocompromised, the virus still poses a formidable risk.
Roughly 300 people in the United States are still dying from Covid-related causes each day, a vast majority of them adults over 70 and people who are medically frail or have impaired immune systems. So should they get another booster shot now?
That's the thorny question facing federal health officials.
About 53 million adults 65 and older live in the United States, accounting for about 16 percent of the population, according to the Census Bureau. And seven million Americans have weak immune systems because of an illness or a medication.
While infection with the coronavirus can be a matter of inconvenience or a mild illness for a relatively young and healthy adult, Covid can spell severe disease, hospitalization and death for older adults and immunocompromised people, said Dr. Céline Gounder, an infectious disease physician and senior fellow at the Kaiser Family Foundation.
"I think it's reasonable to boost immunocompromised people and people in nursing homes every six months," Dr. Gounder said. "I do not think that annual boosters for everyone makes sense."
Some Americans who got their latest boosters in the fall are asking their doctors when they should get the next dose. Britain and Canada have already recommended additional shots for older adults and immunocompromised people starting this spring.
It's unclear whether the Food and Drug Administration will follow suit. In a bid to simplify what had become a bewildering array of guidelines on vaccination, the agency said in January that it would move to a single shot offered each fall to all Americans, as is the case for flu.
"We hope that simplifying the Covid-19 vaccine regimen in the not-too-distant future will lead to the vaccination of more individuals in the coming years," the agency said in a statement.
A one-size-fits-all approach may not work. Americans are "diverse in our age, we're diverse in our risk, we're diverse in our perceptions of risk," said Dr. Ofer Levy, director of the precision vaccines program at Boston Children's Hospital and an adviser to the F.D.A.
Ideally, Dr. Levy said, a high-risk person would be able to consult with a health care provider and decide whether an additional dose of the vaccine was needed.
Immunity against infection declines after just a few months in nearly everyone who is vaccinated. But in people with weak immune systems, protection from a booster shot in the fall "wanes fast enough that by the spring or summer they are no longer distinguishable from people who didn't get boosted," said Dr. Jeremy Faust, an emergency medicine physician and health policy expert at Brigham and Women's Hospital in Boston.
"Immunocompromised people have a very, very short period of benefit from the booster," Dr. Faust said. "And so you have to re-up it."
Dr. Faust cited data on the first round of boosters, which were offered in the fall of 2021 and which targeted the original version of the virus. There is much less research on the effectiveness of the bivalent boosters that were released last fall, and there is no data on the ideal timing for the next round of additional vaccines.
The dearth of information leaves some experts hesitant to recommend another shot for any group of people, even the most vulnerable.
"Given the lack of data, I don't think it's fair to say to people, 'Inject yourself with a biological agent,'" said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and an adviser to the F.D.A.
"It's incumbent upon them when they make recommendations to show the data on which that recommendation is based," Dr. Offit said of federal health officials. "Otherwise, they're just saying, 'Trust us.'"
The F.D.A. Did not comment on plans to consider offering boosters more frequently than once a year.
"We continue to closely monitor the emerging data in the United States and globally, and we will base any decision on additional updated boosters upon those data," the agency said in a statement.
Even if the F.D.A. Were to authorize another booster shot this spring, it's unclear how many people would choose to get it. Just over 16 percent of Americans, and only 42 percent of adults over 65, have opted for the bivalent shots.
"If boosters work, they'll only work if people get them," said Dr. Eric Rubin, editor in chief of The New England Journal of Medicine and an adviser to the F.D.A. "That's a much larger issue than an additional booster."
Dr. Camille Kotton, who treats immunocompromised patients at Massachusetts General Hospital in Boston, said a majority of them were not up to date with their vaccines. She cited many possible reasons: They are not aware of the recommendations, they find the information too confusing or they are simply ready to move on from the pandemic.
"It's nice to focus on another dose of bivalent vaccine, but I do worry that we haven't even given the bivalent vaccine to the majority of immunocompromised and elderly," she said. "Maybe we should focus on those populations."
Another round of COVID-19 booster shots could be coming this spring, for at least some Americans.
The U.S. Food and Drug Administration is expected to decide within a few weeks whether to allow a second updated booster shot for those who are older or otherwise considered at high risk for COVID-19, The Wall Street Journal reported.
Officials "are moving toward authorizing" the shots but have not yet reached a final decision and could still change their minds, the newspaper said, citing one of several unnamed people familiar with the deliberations.
RelatedThe Centers for Disease Control and Prevention would also have to sign off on the additional doses of what's known as a bivalent vaccine, targeted at both the original strain of COVID-19 as well as versions of the omicron variant that wreaked havoc last winter.
The Wall Street Journal said the FDA is looking specifically at the need for an additional booster dose among Americans who are at least 65 years old or who have weakened immune systems.
Reuters news service said the FDA "continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters," citing a statement from the federal agency.
The bivalent doses became available last fall, leading to concerns that the protection they provide against infection may be waning. Since the vaccine was updated, newer versions of the virus have become dominant.
Immunization authorities in both the United Kingdom and Canada already have recommended that high-risk individuals should be offered the chance to get the COVID-19 booster shot this spring, according to STAT, a Boston-based medical journalism publication.
STAT reported earlier this month "radio silence" from the FDA about booster shots this spring, "creating frustration among a small but determined group of people who are keen not to have to wait until the autumn to get another dose of COVID vaccine."
But many Americans appear to be losing interest in following the advice of public health authorities to stay up to date on COVID-19 vaccinations, leading to talk about ways to streamline the process.
Less than 17% of Americans — and fewer than 15% of Utahns — have gotten the current updated booster shot, available to everyone 5 and older as well as some children as young as 6 months old.
Federal authorities have suggested offering an annual COVID-19 shot, updated to reflect current virus strains and rolled out at the same time people are used to getting a flu shot. An additional dose would likely be available to older and medically vulnerable Americans.
RelatedWhile that plan is still being debated, some experts say there's no reason to wait on a second dose of the current booster.
"For those who want it and have risks, they should be able to get it," Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told The Wall Street Journal.
Dr. Leana Wen, a health policy professor at George Washington University, noted last month in her column for The Washington Post that whether some people should get a second updated COVID-19 booster shot "is by far the most-asked question."
Wen told The Wall Street Journal she wants federal authorities to permit the shots for those at high risk.
"People have been doing this anyway by going to pharmacies and saying this is their first booster," Wen said. "It would be reasonable to say that most people can wait until fall to get an annual shot, but those at highest risk who wish to have additional protection can get them more often."
But other experts disagree.
"I got zero data to tell you that getting yet another booster is actually going to decrease your risk," Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, said, according to The Wall Street Journal.
RelatedSTAT pointed out that a top FDA official acknowledged in an interview last fall that another updated booster dose might be needed for older adults and people who are immunocompromised.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told STAT in October 2022 that he was worried about the speed at which the COVID-19 virus was mutating.
"I would be lying to you if (I said) it doesn't keep me up at night worrying that there is a certain chance that we may have to deploy another booster — at least for a portion of the population, perhaps older individuals — before next September, October," Marks said then.
"I'm not saying that's what's going to happen, but it's what keeps me up at night, because we see how fast this virus is evolving."
Comments
Post a Comment