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F.D.A. Approves New Covid Shots

A nationwide rollout of the vaccines by Pfizer and Moderna
should begin later this week, after the C.D.C. considers guidelines
to prepare Americans for this season when infections usually tick
upward.

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A vaccine drive in Lynwood, Calif., last autumn. This year’s campaign will be the first
since the end of the public health emergency, which expired in May. Mark J.
Terrill/Associated Press

By Christina Jewett and Noah Weiland

Sept. 11, 2023 Updated 2:25 p.m. ET

The Food and Drug Administration approved a new round of Covid

boosters on Monday, that will arrive alongside the seasonal flu
vaccine and shots to protect infants and older adults from R.S.V., a
potentially lethal respiratory virus.

The Centers for Disease Control and Prevention is expected to

follow up on Tuesday with an advisory meeting to discuss who
should get the new shots, by Pfizer-BioNTech and Moderna. After a
final decision by the C.D.C.’s director, millions of doses will be
shipped to pharmacies, clinics and health systems nationwide
within days.

As Covid cases creep up, the trifecta of prevention measures could

portend the first winter of the decade without a crush of patients
overwhelming some hospitals. But a healthy winter is far from a
lock: In the last year, the updated Covid vaccine made it into the
arms of only 20 percent of adults in the United States.

Some experts view that statistic with little alarm because the
number of Covid deaths slowed considerably over the last year,
thanks to an increasingly immune population and higher vaccine
rates among older Americans. Others see this year as an
opportunity to protect more vulnerable people from severe illness
or death.

“Vaccination remains critical to public health and continued

protection against serious consequences of Covid-19, including
hospitalization and death,” said Dr. Peter Marks, the F.D.A’s top
vaccine expert.

The F.D.A. granted full approval for the new formulas for people
who are 12 and older and authorized them to protect infants six
months and older through age 11. The Pfizer shot was authorized in
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the European Union for ages 6 months and older on Aug. 31.
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Some Old-
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Federal officials have been retreating from labeling the new Worth Revisiting

formulation as boosters to previous shots, preferring to recast

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them as an annual immunization effort akin to the flu vaccine. That Recipes for Right
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shift may reflect concern over the fatigue that some Americans
have expressed about yet another round of shots against the virus.

The vaccine campaign will also be the first since the end of the
public health emergency, which expired in May. In previous years,
the U.S. government bought hundreds of millions of vaccine doses
and distributed them for free. This year, private insurance and
government payers like Medicare that cover the vast majority of
Americans are expected to provide the vaccines to people for free.

But the question remains whether the private market of hospitals,

clinics and pharmacies will be able to calibrate their vaccine orders
to stock a realistic supply. Experts are uncertain how much
demand there will be for the latest shots.

More on Covid-19

New Booster Shots: The F.D.A. has approved a new round of Covid
boosters A nationwide rollout of the shots by Pfizer and Moderna will
.

begin after the C.D.C. considers guidelines on the vaccine campaign.

A Steady Uptick: A rise in cases has fueled concern that the virus is
poised to make a comeback . But experts say that the United States will
not see a return to the nightmarish scenarios of previous years.
Stoking Fears: The late-summer rise in Covid infections is bringing with it
a wave of unsubstantiated claims from right-wing influencers and
conspiracy theorists.
Covid’s Origins: More than three years into the coronavirus pandemic and
untold millions of people dead, we still don’t know how it started. Here's
what we do know — and why it matters

“There could be a period in here where things are a little bit

chaotic, and that’s never a good situation,” said Dr. Marcus Plescia,
chief medical officer of the Association of State and Territorial
Health Officials, a public health group.

Packing the Moderna vaccine at a distribution center in Mississippi in 2020. This year,
vaccine makers are expected to donate doses for the uninsured. Paul Sancya/Agence
France-Presse — Getty Images

Also of concern in the handoff to the private market: the nation’s 23

million adults with no health insurance. The Biden administration
has made plans to cover costs and offer the Covid vaccine through
local clinics and major pharmacies, but some experts are worried
about whether people who lack insurance will be aware of the new
shots — or where to get them.

“They don’t have an insurer sending them leaflets — they may not
have a usual source of care,” said Anthony Wright, executive
director of Health Access, a California advocacy group. “And so the
trusted messenger of their health plan, their doctor, their clinic, is
not there saying, ‘It’s no cost. It’s really easy.’”

Vaccine manufacturers are expected to donate doses for the

uninsured. Kelly Cunningham, a spokeswoman for Moderna, said
the company had no cap on the number.

The latest shots are becoming available as Covid hospitalizations

and deaths are rising slightly, albeit not to the levels of past years.
In the week ending Aug. 26, there were 17,400 people admitted to
the hospital — more than about 6,000 at a low point this summer.
Deaths were also up to about 600 a week last month, though far
lower than the weekly average of 14,000 deaths of 2021.

Once the C.D.C. signs off, the Biden administration plans to urge
the public to get their Covid and flu shots at the same time, a
practice that has been studied and considered by some experts to
be safe. It’s a messaging effort they expect to share with major
vaccine makers, which will be marketing the Covid doses
commercially for the first time.

Walgreens and CVS said they both already have the updated flu
and R.S.V. shots available in stores. Dr. Kevin Ban, Walgreens’ chief
medical officer, said the chain would have the new Covid shots on
hand “as soon as possible.” A CVS spokesperson said doses could
be arriving later this week. Representatives of both chains said the
Covid shot would be available at no cost to all who are eligible
under the C.D.C. guidelines expected Tuesday.

Targeted populations most certainly will include people 65 and

older as well as those who are immunocompromised or have
serious underlying medical conditions that leave them more
susceptible to severe illness from the virus.

Nursing homes, which inoculated nearly all of their residents in the

first waves of the pandemic, have fallen behind on booster rates:
Recent Medicare data show that about 62 percent of residents are
up-to-date on their shots even though older adults are among the
most vulnerable to severe disease and death from the virus.

The new Covid vaccines target the XBB.1.5 variant, which was
dominant when vaccine makers began to formulate and test a new
version. They are monovalent because, unlike the earlier boosters,
they do not include protection against the original virus that
caused widespread infections in China more than three years ago.
Though the virus has had a rotating cast of variants, experts say
the new Covid jab should fortify protections against severe
infection.

Recent fears that one newer, highly mutated variant would escape
the vaccine proved unfounded by reputable independent labs, said
Fikadu Tafesse, an associate professor of molecular microbiology
and immunology at Oregon Health & Science University. The
C.D.C. also reviewed studies on the matter and confirmed Friday
that the vaccine was holding strong.

“We were really getting ready for no response at all, but the data is
very, very promising,” Dr. Tafesse said.

A production line of Pfizer’s Covid vaccine in Michigan. As with previous shots, the
latest vaccine won’t eliminate the chances of getting the disease, but is expected to
reduce the chances of severe illness, hospitalization or death. Pfizer, via Associated Press

As with earlier shots, the updated ones are not expected to

eliminate the chances of contracting a mild case of Covid. Instead,
they are expected to reduce the chances of severe illness,
hospitalization or death.

As the first vaccine’s potency waned with newer Omicron variants,

a bivalent booster was approved in August 2022 that targeted the
initial virus and BA.5, which was dominant at the time. That shot
led to fewer people with Covid being hospitalized, dropping over
several months to 25 percent from 60 percent.

Pfizer and Moderna reported that their vaccines had a potent

response to the newest circulating variants, though only Moderna
posted its initial data on Thursday.

But researchers continue to discuss how well it will stand up to

new variants. The F.D.A. has mainly reviewed results submitted by
the companies of animal or smaller human studies of immune
response.

Jerica Pitts, a spokeswoman for Pfizer, said the data submitted by

the company to the F.D.A. in June involved tests in animals. Trials
following people who received the shot are continuing, she said.

Moderna submitted data to the F.D.A. on the immune response of

100 people to the new shots, which the company said in June
“robustly elicit neutralizing antibodies” against XBB variants.

John Moore, a professor of virology and immunology at Weill

Cornell Medicine, said he was not impressed with the latest results.
He said the new shot showed an immune response similar to last
fall’s booster. That means that although the new shot will be worth
getting, “it’s nothing remotely like a game changer.”

Federal officials would also need to consider whether to

recommend the shot to healthy young Americans, said Dr. Walid
Gellad, a drug safety expert at the University of Pittsburgh.

Young males have experienced higher rates of myocarditis , or

inflammation of the heart muscle, after getting vaccinated,
although many recovered after a few months.

“The benefits are just getting lower and lower for young healthy
people who’ve had Covid before,” he said. “You have to think about
how any risk can change that balance.”

Regulators are also considering whether to authorize a booster

dose from Novavax, which employs a different but widely used
technology for its coronavirus vaccine.

Dr. Daniel Griffin, an infectious disease physician at Columbia

University in New York, said getting the Covid shot would help
stop the virus’s spread to the most vulnerable, including older
adults, pregnant people and those with compromised immune
systems.

And while many might be weary of the social-protection argument,

he said they could lessen their own odds of a more serious
outcome.

“So a younger individual may say, ‘I’m not going to get a booster
for the public health,’” Dr. Griffin said, “‘but I am going to get a
booster because if I can reduce my chance of getting Covid, I can
reduce my chance of long Covid.’”
Carl Zimmer and Apoorva Mandavilli contributed to this report.

Christina Jewett covers the Food and Drug Administration. She is an award-winning
investigative journalist and has a strong interest in how the work of the F.D.A. affects the
people who use regulated products. More about Christina Jewett
Noah Weiland is a health reporter in the Washington bureau. He was part of a team that
won a Pulitzer Prize for its coverage of Covid-19 in 2020. More about Noah Weiland

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Covid-19 Guidance
Boosters: The reformulated Covid shots can better help fight off the latest set of
subvariants. Here’s what to know .

New Variants: Concern is rising about the Covid variants EG.5 and BA.2.86, so
how worried should people be? This is what experts say .

Tests: At-home tests are critical to keeping yourself and others safe. Here are
answers to a few common questions .

Masks: Is it time to wear a mask again? Experts offer a refresher on where, when
and how to use them .

Fall Vaccines: This year, Americans will be asked to roll up their sleeves not just
for Covid shots, but also for inoculations against the flu and R.S.V.
Reinfections: Covid reinfections are becoming more common. But experts are
still unsure about how damaging they can be .

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