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FDA Expected to Approve Third Dose of Covid-19 Vaccine

2021-08-12T02:13:57.762Z


The booster vaccine would be a third dose of Pfizer and Moderna's covid-19 vaccines and would be available only to immunosuppressed patients.


USA evaluates dose booster plan for vaccinated 0:52

(CNN) -

The United States Food and Drug Administration (FDA) is expected to announce within the next 48 hours the authorization of booster doses of covid-19 vaccines for some people immunosuppressed, according to a source familiar with the conversations.

It would be a third dose of the current two-dose vaccines from Pfizer and Moderna.

That announcement could change, the source warned, but it is the chosen moment.

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"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of licensed covid-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN.

"The agency, in conjunction with the CDC, is evaluating possible options on this issue, and will share information in the near future."

NBC News was the first to report on the long-awaited announcement.

The FDA must authorize the use of the vaccines in new forms outside of the existing authorization.

All three COVID-19 vaccines used in the US are administered under emergency use authorization from the FDA, but full approval is pending for the vaccine from Pfizer.

After FDA grants approval or authorization, the Centers for Disease Control and Prevention (CDC) advises on the effective use of a vaccine under FDA clearance.

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CDC vaccine advisers will meet on Friday to discuss booster doses of COVID-19 vaccines and additional doses for some immunosuppressed people, according to the meeting's agenda released by the agency Monday. .

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A recent study by Johns Hopkins researchers revealed that immunocompromised people are 485 times more likely to end up in hospital or die from COVID-19 compared to the general vaccinated population.

According to a CDC estimate, about 9 million Americans are immunosuppressed, either from the diseases they suffer or from the medications they take.

It has been known for months that covid-19 vaccines may not work well in this group.

The hope was that vaccination rates in general were so high that the "herd" would protect them.

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But it hasn't worked out that way, as roughly a third of eligible people in the US haven't received even one dose of the COVID-19 vaccine.

The Biden administration is expected to establish a Covid-19 vaccine booster strategy for all Americans vaccinated in September.

Dr. Vivek Murthy, the US chief health officer, said Wednesday that the administration is studying who will need more backup and when, and information about its efforts to protect immunosuppressed people from COVID-19 is expected. be "very soon".

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"We are concerned about these individuals. We have monitored them closely, and I think most of us believe that we need to do more to protect them," Murthy told CNN's Wolf Blitzer on "The Situation Room."

"The FDA has been working hard to basically do the assessment around safety and make sure that we have everything we need to make these extra doses available to people," he said, adding that the CDC "is also there. studying to ensure that guidance is clear and available for immunocompromised individuals. "

Murthy noted in his interview that immunocompromised people include some cancer patients, those taking drugs that suppress the immune system, and organ transplant recipients.

- CNN's Lauren Mascarenhas and Devan Cole contributed to this report.

covid-19 vaccine

Source: cnnespanol

All news articles on 2021-08-12

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