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Reports: FDA expected to authorize COVID-19 vaccine booster shots for immunocompromised within days

Reports: FDA expected to authorize COVID-19 vaccine booster shots for immunocompromised within days
according to the Wall Street Journal, the Food and Drug Administration is expected to recommend a vaccine booster strategy for immuno compromised americans. As soon as september, the strategy is projected to lay out when and which individuals should get the follow up shots eagerly targeting those who received their first immunization. In the initial rollout back in december or january, the site reports, research shows that the authorized vaccines offer effective protection for at least six months, but the protection does reduce over time. Therefore, a swift release of a booster strategy is desired by the biden administration. Despite abc news reporting, the FDA NcDc maintain there is not enough data to show that immunity has waned enough among vaccinated individuals to warrant a third shot. Yet. However, Stephen hope authorized vaccine Moderna's president says we believe a booster dose is likely to be necessary this fall, particularly in the face of the delta variant. Irrespective. The booster strategy will remain under a magnifying glass as the U. S. Government will need to address declining protection for certain individuals at a time when vaccines remain restricted within the developing world
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Reports: FDA expected to authorize COVID-19 vaccine booster shots for immunocompromised within days
The U.S. Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing COVID-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing."The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."NBC News was first to report on the expected announcement.The FDA must give authorization for the vaccines to be used in new ways outside the existing authorization. All three COVID-19 vaccines being used in the U.S. are given under emergency use authorization by the FDA, but full approval is pending for Pfizer's vaccine. After FDA grants approval or authorization, the U.S. Centers for Disease Control and Prevention then advises on whether to actually use a vaccine as authorized by the FDA.Vaccine advisers for the CDC will meet on Friday to discuss booster doses of COVID-19 vaccines and additional doses for some immunocompromised people, according to a meeting agenda posted by the agency on Monday.A recent study by Johns Hopkins researchers found that vaccinated immunocompromised people are 485 times more likely to end up in the hospital or die from COVID-19 compared to the general population that is vaccinated.Based on an estimate by the CDC, about 9 million Americans are immunocompromised, either because of diseases they have or medications they take.It has been known for months that COVID-19 vaccines might not work well for this group. The hope was that vaccination rates overall would be so high so that the "herd" would protect them.But it didn't work out that way, because about a third of eligible people in the U.S. have not received even one dose of a COVID-19 vaccine.The Biden administration is expected to lay out a COVID-19 vaccine booster strategy for all vaccinated Americans in September.U.S. Surgeon General Dr. Vivek Murthy said Wednesday the administration is now considering who will need boosters most and when, and information on its efforts to protect immunocompromised people from COVID-19 is expected "very soon.""We've been concerned about these individuals. We've been following them closely, and I think most of us believe that we've got to do more to protect these individuals," Murthy told CNN's Wolf Blitzer on "The Situation Room.""The FDA has been working hard to basically do the evaluation around safety and make sure that we have everything we need to make these additional doses available to people," he said, adding that the CDC "is also looking into making sure the guidance is clear and available for immunocompromised individuals."Murthy noted in his interview that immunocompromised people include some cancer patients, those taking medication that suppresses the immune system and organ transplant recipients.

The U.S. Food and Drug Administration is expected to announce booster shots for some people who are immunocompromised, according to a source familiar with the discussions.

This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.

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"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

on the expected announcement.

The FDA must give authorization for the vaccines to be used in new ways outside the existing authorization. All three COVID-19 vaccines being used in the U.S. are given under emergency use authorization by the FDA, but full approval is pending for Pfizer's vaccine. After FDA grants approval or authorization, the U.S. Centers for Disease Control and Prevention then advises on whether to actually use a vaccine as authorized by the FDA.

Vaccine advisers for the CDC will meet on Friday to discuss booster doses of COVID-19 vaccines and additional doses for some immunocompromised people, according to a meeting agenda posted by the agency on Monday.

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

Based on an estimate by the about 9 million Americans are immunocompromised, either because of diseases they have or medications they take.

It has been known for months that COVID-19 vaccines might not work well for this group. The hope was that vaccination rates overall would be so high so that the "herd" would protect them.

But it didn't work out that way, because about a third of eligible people in the U.S. have not received even one dose of a COVID-19 vaccine.

The Biden administration is expected to lay out a COVID-19 vaccine booster strategy for all vaccinated Americans in September.

U.S. Surgeon General Dr. Vivek Murthy said Wednesday the administration is now considering who will need boosters most and when, and information on its efforts to protect immunocompromised people from COVID-19 is expected "very soon."

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

"The FDA has been working hard to basically do the evaluation around safety and make sure that we have everything we need to make these additional doses available to people," he said, adding that the CDC "is also looking into making sure the guidance is clear and available for immunocompromised individuals."

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