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FDA authorises Moderna and Pfizer’s COVID vaccine boosters for all US adults

Moderna and Pfizer both announced that regulators had broadened the authorization for their booster shots.

FDA authorises Moderna and Pfizer's COVID vaccine boosters for all US adults-dnm
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Washington D.C., First Published Nov 19, 2021, 8:00 PM IST
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The US Food and Drug Administration (FDA) on Friday authorized booster shots of both the Pfizer-BioNTech and Moderna vaccines for all adults, a move that will make boosters available to everyone ages 18 and up. This announcement belatedly fulfils a critical part of the Biden administration’s plan to administer extra doses to the general public as growing data demonstrates the efficacy of vaccines wanes over time.

Moderna and Pfizer both announced that regulators had broadened the authorization for their booster shots. The approval comes about two months late — after scientists advising the FDA rejected the administration’s original plans to start distributing boosters to all adults the week of September 20, citing a lack of data supporting the third doses, CNBC reported.

Fearful that waning protection and the onset of winter will set off a wave of breakthrough infections, a growing number of governors had already offered boosters to everyone 18 and older ahead of the holidays.

Also read: Pfizer to seek EU authorisation of its COVID pill on Friday

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a statement.

Pfizer requested authorization last week, citing results from a Phase 3 clinical trial with more than 10,000 participants that found that the third dose was safe and effective. Moderna requested authorization Wednesday.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech Covid-19 vaccines to individuals 18 years of age and older,” Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement Friday.

Broadly distributing booster shots is controversial among public health authorities. The World Health Organization has criticized wealthy nations for rolling out third shots when people in poorer countries have very limited access to Covid vaccines.

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