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FDA Authorized COVID-19 Vaccine Booster Shots

The booster doses only apply for Pfizer and Moderna vaccines.

FDA Authorized COVID-19 Vaccine Booster Shots
A COVID-19 vaccine shot. Chaz Bharj/ iStock

The United States Food and Drug Administration (FDA) has authorized booster doses for the immunocompromised. The move is expected to offer additional protection to individuals whose immune systems are weakened and may not have produced enough antibodies after the two doses of the COVID-19 vaccine. 

Earlier last month, the Center for Disease Control (CDC) had reported that 16 to 80 percent of individuals who had weak immune systems did not produce enough antibodies to fend off COVID-19 infection, even after two vaccine doses, CNBC reported.

Immune systems can be compromised when individuals are affected by diseases such as AIDS or cancer. Patients who have undergone organ transplants are also given medications that weaken the immune system to improve the success rates of the transplant. Another CDC study showed that with an additional dose of vaccine, antibody levels increased up to 50 percent in such individuals. 

As the more virulent Delta variant is leading to a spike in infections, even in countries that have a high vaccination coverage, the FDA reviewed the data about a third dose for the Pfizer and Moderna vaccines and arrived at the decision to authorize additional doses for added protection. Accordingly, the emergency use authorizations (EUA) of both the vaccines were updated to include a booster dose, after 28 days of completion of the second dose, the press release said. Data for the single-dose Johnson & Johnson vaccine, which also enjoys the EUA in the US was not reviewed and does not qualify for use as a booster dose.

Along with its authorization, the FDA also counseled immunocompromised individuals to maintain physical distancing and use face masks and recommended their close contacts to get fully vaccinated as well. The agency also highlighted its other EUAs for monoclonal antibody treatments in case of SARS-CoV-2 infection or exposure. 

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The CDC's vaccine advisory committee is scheduled to meet, discuss and vote on the booster doses later today. If approved, the administration of booster doses could begin immediately. According to CDC estimates, this accounts for about 2.7 percent of the US population.  

Aside from the U.S., France and Germany are also considering rolling out booster doses but for the elderly population. Israel has already kicked off its campaign to vaccinate its elderly and plans to study how the Delta variant could be combated, Reuters reported.

The Biden administration is expected to lay out next month a strategy for a national rollout of booster doses, even as the World Health Organization (WHO) has called for a moratorium on them to allow poorer nations to improve their vaccination coverage. 

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