U.S. FDA authorizes COVID-19 vaccine boosters for the immunocompromised

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(Reuters) – The U.S. Food and Drug Administration has authorized a third dose of COVID-19 vaccines by Pfizer Inc (PFE.N)-BioNTech and Moderna Inc (MRNA.O) for people with compromised immune systems.

The amended emergency use authorization on Thursday paves 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. The patients may consult with their doctor to see if they are eligible, FDA spokesperson Abby Capobianco said.

Patients will not need a prescription or the sign off of a health care provider in order to prove they are immunocompromised and receive the additional dose, according to an official with the Centers for Disease Control and Prevention (CDC) speaking before a panel of advisers that will vote on the extra doses later on Friday. Patients can attest to their status themselves.

“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, U.S. FDA’s acting commissioner, said in a tweet on Thursday.

“Others who are fully vaccinated are adequately protected & do not need an additional dose of COVID-19 vaccine at this time.”

The vulnerable group makes up less than 3% of U.S. adults, Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), had said before the authorization.

The FDA’s decision does not apply to people who received the one-dose Johnson & Johnson (JNJ.N) 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.

Supporting the move to approve an additional shot, Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said it would be important for the CDC to provide clear recommendations about who should receive it.

“Most clinicians are not going to know what an equivalent level of compromise is for solid organ transplant patients,” Offit said. “Hopefully the CDC will be more specific about that.”

One of the boxes containing the Moderna COVID-19 vaccine is prepared to be shipped at the McKesson distribution center in Olive Branch, Mississippi, U.S. December 20, 2020. Paul Sancya/Pool via REUTERS


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 said the efficacy of the vaccine it developed with partner BioNTech drops over time, citing a study that showed 84% effectiveness from a peak of 96% four months after a second dose. read more

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. read more

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.

Wall Street analysts expect the authorization of a booster dose for a broad population to bolster profits of COVID-19 vaccine makers.

Shares of Pfizer, Moderna and U.S.-listed shares of BioNTech rose between 1% and 2% in early trading.

Reporting by Manas Mishra in Bengaluru; Additional reporting by Bhargav Acharya; Editing by Shounak Dasgupta, Shinjini Ganguli and Aurora Ellis

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