# U.S. FDA authorizes COVID-19 vaccine boosters for the immunocompromised
Author:  Pal Sinha, Barnali 
Author URL: https://financedigest.com/author/pal-sinha-barnali
Published: 2021-08-13
Category: NEWS
Category URL: https://financedigest.com/category/news
Meta Title: FDA authorizes COVID-19 vaccine booster doses for
Meta Description: FDA approves third dose of Pfizer and Moderna vaccines for organ transplant patients and others with weakened immune systems for added protection.
URL: https://financedigest.com/u-s-fda-authorizes-covid-19-vaccine-boosters-for-the-immunocompromisedhtml

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By Manas Mishra and Michael Erman

(Reuters) -The U.S. Food and [Drug Administration has authorized a third dose of COVID-19 vaccines by Pfizer](https://www.financedigest.com/bristol-myers-pfizer-abbvie-drugs-likely-to-face-u-s-price-negotiation.html "Bristol Myers, Pfizer, AbbVie drugs likely to face U.S. price negotiation") Inc-BioNTech and Moderna Inc for people with compromised immune systems.

The amended https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised emergency use authorization on Thursday [paves the way](https://www.financedigest.com/soft-lending-and-inflation-data-pave-way-for-smaller-ecb-hike.html "Soft lending and inflation data pave way for smaller ECB hike") 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.

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,”](https://www.financedigest.com/u-s-cdc-signs-off-on-moderna-jj-covid-19-vaccine-boosters-mix-and-match-shots.html "U.S. CDC signs off on Moderna, J&J COVID-19 vaccine boosters, mix-and-match shots") Janet Woodcock, U.S. FDA’s acting commissioner, said in a tweet https://twitter.com/DrWoodcockFDA/status/1426019820445868033 on Thursday.

Others who are fully vaccinated are adequately protected & do not [need an additional dose of COVID-19](https://www.financedigest.com/the-financial-services-industry-needs-to-get-serious-about-cyber-security-in-the-covid-19-era.html "The financial services industry needs to get serious about cyber security in the Covid-19 era") 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.

Supporting the move to approve an additional shot, Paul Offit, director of the [Vaccine Education Center at Children’s](https://www.financedigest.com/germanys-vaccine-panel-says-one-covid-shot-enough-for-children.html "Germany’s vaccine panel says one COVID shot enough for children") 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… hopefully the CDC will be more specific about that… (and) whether or not therapies can be manipulated so you can give your patient an optimal chance of having an immune response.”

A panel of advisers to the CDC will [meet on Friday to discuss](https://www.financedigest.com/new-zealand-pm-meets-biden-to-discuss-u-s-indo-pacific-strategy.html "New Zealand PM meets Biden to discuss U.S. Indo-Pacific strategy") booster doses, and a vote later by the committee will help decide on the rollout of the extra shots.

BOOSTERS FOR YOUNG, HEALTHY

Scientists are still divided over the broad use of [COVID-19 vaccine](https://www.financedigest.com/factbox-countries-making-covid-19-vaccines-mandatory-2.html "Factbox-Countries making COVID-19 vaccines mandatory") 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](https://www.financedigest.com/inflation-in-key-german-states-eases-for-second-month.html "Inflation in key German states eases for second month") dose.

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](https://www.financedigest.com/israels-covid-19-vaccine-boosters-show-signs-of-taming-delta.html "Israel’s COVID-19 vaccine boosters show signs of taming Delta") 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](https://www.financedigest.com/fda-advisers-back-the-same-covid-vaccine-for-initial-shots-boosters.html "FDA advisers back the same COVID vaccine for initial shots, boosters") until at least the end of September.

We think other countries might also follow suite, despite WHO’s concerns for vaccine equity, due to the [rising health risks](https://www.financedigest.com/ecb-governors-see-rising-risk-of-rate-hitting-2-to-curb-inflation-sources.html "ECB governors see rising risk of rate hitting 2% to curb inflation – sources") posed by the Delta variant and diminishing protection of the vaccine over time,” CFRA Research analyst Sel Hardy said.

[Wall Street](https://www.financedigest.com/asian-stocks-edge-up-before-u-s-jobs-data-defying-wall-street-selloff.html "Asian stocks edge up before U.S. jobs data, defying Wall Street selloff") 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 and Shinjini Ganguli)


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