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 The U.S. Food and Drug Administration amended
https://www.fda.gov/news-events/press-announcements/
coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised
its emergency use authorization for both vaccines on Thursday,
paving the way for people who have had an organ transplant, or those
with a similar level of weakened immune system, to get an extra dose
of the same shot they have initially received.
An advisory panel to the U.S. Centers for Disease Control and
Prevention (CDC) voted to recommend the additional shots, and the
agency's director signed off on that recommendation on Friday.
Immunocompromised individuals can begin receving the shots
immediately, according to an agency spokesperson.
Mixing of mRNA vaccines is permitted for the third shot if their
original vaccine is not available.
Patients will not need a prescription or the signoff of a healthcare
provider in order to prove they are immunocompromised and receive
the additional dose, according to officials.
"It will be a patient's attestation, and there will be no
requirement for proof or prescription or a recommendation from an
individual's healthcare provider," CDC official Dr. Amanda Cohn
said, speaking before the advisory panel.
There is growing concern about breakthrough infections in vulnerable
populations in the United Stats as the country sees a huge spike in
new infections from the contagious Delta variant of the coronavirus.
The vulnerable group makes up less than 3% of U.S. adults, Rochelle
Walensky, director of the CDC, had said before the authorization.
"After a thorough review of the available data, the FDA determined
that this small, vulnerable group may benefit from a third dose of
the Pfizer-BioNTech or Moderna vaccines," Janet Woodcock, the FDA's
acting commissioner, wrote in a tweet
https://twitter.com/DrWoodcock
FDA/status/1426019820445868033 on Thursday.
Woodcock said that others who are fully vaccinated do not need an
additional vaccine dose right now.
The FDA's decision does not apply to people who received the
one-dose Johnson & Johnson vaccine, the CDC said, because there is
not enough data to support additional doses yet.
"We think that at least this is a solution for the very large
majority of immunocompromised individuals, and we believe that we'll
probably have a solution for the remainder in the not-too-distant
future," FDA official Peter Marks told the CDC panel.
The FDA and the CDC are working to ensure that immunocompromised
recipients of the J&J vaccine have optimal protection, the CDC said.
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 Dr. David Boulware, an
infectious disease doctor at the University of
Minnesota, backed the FDA decision, noting that
most of the fully vaccinated patients he has
seen in the hospital are immunocompromised.
Boulware said that the plan to let patients
attest to their own status may lead to more
people receiving the shots than intended.
"If it is left up to the honor system, I think
many Americans will suddenly wake up and find
themselves immunocompromised enough to get a 3rd
dose," he said in an email.
BOOSTERS FOR YOUNG, HEALTHY
Scientists are still divided over the broad use
of COVID-19 vaccine boosters among those without
underlying problems as benefits of the boosters
remain undetermined.
Pfizer has previously said the efficacy of the
vaccine it developed with partner BioNTech drops
over time.
Moderna has also said it sees the eventual need
for booster doses, especially since the Delta
variant has caused "breakthrough" infections in
fully vaccinated people.
Reports of infections among vaccinated people
and concerns about diminishing protection have
galvanized wealthy nations to distribute booster
shots, even as many countries struggle to access
first vaccine doses.
The World Health Organization last week called
for a moratorium on COVID-19 vaccine booster
shots until at least the end of September.
 Still, Americans have already started getting
additional shots, even before the FDA has
authorized them. According to the CDC, more than
1.2 million people have already received one or
more additional doses of a COVID-19 vaccine
already.
CDC officials also presented a set of guidelines
to its advisory panel on Friday that it plans to
use to help make its decision about whether
Americans need further COVID-19 doses more
broadly.
The CDC plans to hold another meeting of its
Advisory Committee on Immunization Practices in
the next several weeks where booster shots will
again be discussed.
(Reporting by Manas Mishra in Bengaluru;
Additional reporting by Bhargav Acharya; Editing
by Shinjini Ganguli, Aurora Ellis, Nick
Zieminski and Jonathan Oatis)
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