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17Nov21
Moderna requests emergency authorization for booster dose for all adults
Moderna has submitted a request to the Food and Drug Administration (FDA) to authorize booster doses of its coronavirus vaccine for all adults, seeking to expand the number of people eligible for a third shot.
The vaccine manufacturer announced that it asked the FDA to allow the 71 million adults initially vaccinated with Moderna’s shots to get a third dose, as emerging data shows boosters offer better protection.
The 50 microgram dosage in Moderna’s booster is half of the 100 micrograms used for the first two shots for adults.
We filed for Emergency Use Authorization of our COVID-19 booster vaccine at the 50 µg dose level for all adults ages 18 and older with the @US_FDA. https://t.co/xFZ3XsflpV pic.twitter.com/w9iSj6IAXu
— Moderna (@moderna_tx) November 17, 2021
The FDA previously granted authorization last month for Moderna’s booster dose to be given six months after the second dose to people ages 65 and older and adults at high risk for severe COVID-19 due to underlying conditions or their living or work environments.
The request comes as the FDA is poised to authorize the Pfizer vaccine booster for all adults ahead of a Centers for Disease Control and Prevention (CDC) advisory meeting on Friday.
CDC Director Rochelle Walensky will have the final say on whether all adult Pfizer recipients can get a third dose.
Like Moderna, only certain at-risk populations who received the Pfizer vaccine six months earlier can get a booster. The two companies requested emergency authorization for their booster to be available to all adult recipients last week.
The debate over who should get boosters has been active for months, as the initial vaccine series is still considered effective against hospitalization and deaths. But recent research suggests boosters improve protection against infection.
The administration has faced criticism from the World Health Organization for prioritizing getting more shots to people who are already vaccinated while other countries struggle to get initial doses for their at-risk populations.
Officials have said they can donate doses and provide boosters at the same time.
Experts have said the U.S. won't "boost" its way out of the pandemic while 47 million adults remain unvaccinated, leaving room for the virus to spread.
The CDC first granted permission for immunocompromised people to get an additional dose in August, before expanding to allow at-risk Pfizer recipients to get a booster six months after their last shot.
Last month, Walensky approved Johnson & Johnson recipients getting a booster two months after their first shot. Booster seekers are also allowed to select any authorized vaccine for their dose.
Moderately and severely immunocompromised people who received an initial series of an mRNA vaccine and an additional dose can get a fourth shot after the most recent shot.
[Source: By Justine Coleman, The Hill, Washington, 17Nov21]
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