The United
States will begin widely distributing Covid-19 booster shots next month as new
data shows that vaccine protection wanes over time, top U.S. health officials
announced Wednesday.
It’s now “very
clear” that immunity starts to fall after the initial two doses, and with the
dominance of the delta variant, “we are starting to see evidence of reduced
protection against mild and moderate disease,” according to the statement
signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet
Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S.
health leaders.
“Based on our
latest assessment, the current protection against severe disease,
hospitalization, and death could diminish in the months ahead, especially among
those who are at higher risk or were vaccinated during the earlier phases of
the vaccination rollout.”
As a result,
U.S. agencies are preparing to offer booster shots to all eligible Americans
beginning the week of Sept. 20, starting eight months after their second dose
of Pfizer or Moderna’s vaccines, officials said. While they said recipients
of Johnson & Johnson’s single-shot vaccine
will likely need boosters, they are awaiting more data in the next few weeks
before making a formal recommendation.
“With those
data in hand, we will keep the public informed with a timely plan for J&J
booster shots as well,” the officials said.
In a statement
late Wednesday, J&J said: “We are engaging with the U.S. FDA, CDC and other
health authorities and will share new data shortly regarding boosting with the
Johnson & Johnson COVID-19 vaccine.”
The statement
added: “In July, Johnson
& Johnson shared data demonstrating that our single-shot COVID-19 vaccine
generated strong, persistent immune activity against the rapidly spreading
Delta variant and other highly prevalent SARS-CoV-2 viral variants. Interim results from
a Phase 1/2a study published in the New England Journal of Medicine also showed
that the durability of the immune response was strong, with no waning for at
least eight months, the length of time that had been evaluated to date.”
Ensuring
long-term and durable protection against hospitalization and death are critical
in curbing the COVID-19 pandemic.
The plan is
subject to a formal recommendation from a CDC vaccine advisory committee and
approval from the FDA, also a formality.
The
announcement came ahead of a White House Covid press briefing Wednesday, where
federal health officials further outlined their plan for boosters.
The booster
shot “will boost your immune response,” President Joe Biden said later
Wednesday in a speech at the White House. “It will increase your protection
from Covid-19.”
Biden also
addressed criticism from some health advocates who say the U.S. should focus on
sending vaccine doses to countries facing shortages, rather than prioritizing
booster shots for Americans.
“I disagree,”
Biden said. “We can take care of America and help the world at he same time.”
The decision to
recommend booster shots comes as the public becomes increasingly concerned
about the delta variant and a rise in breakthrough cases — infections in fully
vaccinated individuals. It marks a shift from previous comments made by U.S.
health officials, who said in recent months that fully vaccinated Americans did
not need booster shots at this time. ose
U.S. officials
changed their message on boosters in recent days as cases continued to rise.
Fauci said Thursday that everybody will “likely” need a booster shot at
some point. On Friday, federal officials approved administering booster shots
to Americans with weakened immune systems, which includes cancer and HIV
patients and people who have had organ transplants.
National
Institutes of Health Director Dr. Francis Collins, who also signed the
statement, said Tuesday that new Covid data, including from Israeli health
officials, caused U.S. health leaders to rethink their
position on vaccine boosters. Israel released new data Monday showing a
reduction in the effectiveness of Pfizer’s Covid vaccine against severe illness
among people 65 and older who were fully vaccinated in January or February.
The U.S. is
beginning to see similar trends in vaccine effectiveness as well, Collins said.
He said the rise in breakthrough cases may be due to a combination of the
fast-spreading delta variant and Covid vaccine protection waning over time.
The
effectiveness of Pfizer’s Covid vaccine steadily declines over time, dropping to about 84% for vaccinated
people about four to six months after getting their second dose, according to
CEO Albert Bourla. Moderna said its vaccine remained 93% effective in the first six months after
the second dose but expects that protection to fall and boosters will be
necessary.
During a press
briefing Wednesday, Walensky said officials based their decision on studies
that showed immunity from Pfizer and Moderna’s vaccines diminished over several
months. One study in New York from May 3 through July 25 showed that the
vaccine’s effectiveness in protection against infection dropped from around 92%
to 80%. Another study by the Mayo Clinic showed that Pfizer’s vaccine efficacy
fell from around 76% to 42% while Moderna’s declined from 86% to 76%.
“Right now,
it’s still as if our vaccine protection is working really well,” Collins said.
“But we don’t want to wait until it’s like oh, too late.”
The move to
recommend boosters is likely to spark criticism, especially as a large portion
of the global population has yet to receive even one dose of a Covid vaccine.
Earlier this
month, the World Health Organization asked wealthy nations to stop the
distribution of booster shots until at least the end of September to give
poorer countries the chance to vaccinate their populations with the first
rounds of shots. The request is part of WHO Director-General Tedros Adhanom
Ghebreyesus’ plan to vaccinate 40% of the world by December.
The U.S.
released the statement minutes after the WHO condemned wealthy nations that
support boosters for the general public.
“We believe
clearly that the data to date does not indicate that boosters are needed,” Dr.
Soumya Swaminathan, the WHO’s chief scientist, said during a press briefing.
“And we need to know which groups at what period after the vaccination and
which particular vaccines people have received in their primary course.”
Lawrence
Gostin, director of the WHO’s Collaborating Center on National and Global
Health Law, called the U.S. booster shot plan “a slap in the face” to the
international health agency.
“There’s a
better way to create a win-win,” he said in a phone interview. “We should boost
only our health workers and vulnerable people. At the same time, Biden should pledge
a bold campaign to vaccinate the world, including vastly increased donations
and a surge in vaccine production.”
“That way we do
good to America and do good for the world. It’s in our national interests to
stop the development of even more dangerous variants,” he added.
During a White
House briefing Tuesday, press secretary Jen Psaki said the administration
believes it can boost the American population while ensuring the rest of the
world gets vaccinated.
“We believe
that is a false choice. We can do both,” Psaki said. “The United States is far
and away the biggest contributor to the global fight against Covid. We will
continue to be the arsenal for vaccines around the world. We also have enough
supply and had long planned enough supply should a booster be needed for the eligible
population.”
Administering
third shots appears to be safe. Early data from small studies of the
effects of booster doses in immunocompromised patients didn’t show any severe
adverse effects from a third shot of an mRNA vaccine, nor did recipients
develop side effects beyond those already identified after the initial two-dose
regimen.
Once booster
shots are approved, nursing home residents, health-care providers and the
elderly — the first groups to get vaccinated in December and January — are
likely to be prioritized to get extra shots, Collins said Tuesday. He said
“ideally” people should stick with the same manufacturer they got their first
two doses from.
“But if for
some reason you don’t have access to it, well, then get the other one,” he
said. “Again, I’d feel more comfortable as a scientist fixing our plans on real
data, and that means sticking to the same kind of vaccine that you got to begin
with.”
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