The Food and Drug Administration called the shots on Monday when it expanded the emergency use authorization of Pfizer-BioNTech’s booster shot of the COVID-19 vaccine.
With the FDA’s authorization, people who are vaccinated and are at least 12-years-old can receive Pfizer-BioNTech’s booster shot against COVID-19. The booster dose contains the same dosage strength (30-µg) as the dose approved in the primary series and comes a month after the FDA approved it for fully vaccinated 16-year-olds.
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“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” Chairman and Chief Executive Officer of Pfizer, Albert Bourla, said. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”
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The wait time on getting a booster for COVID-19 is also reduced from at least six months to at least five months for those fully vaccinated and aged 12 years and older.
The FDA also expanded the current emergency use authorization to give a third dose of the COVID-19 vaccine for children ages 5-11 with a compromised immune system. The third dose can be administered 28 days after receiving the second dose. Fully vaccinated children with compromised immune systems were previously allowed to get a third COVID-19 vaccine dose in August if they were at least 12-years-old.
Pfizer and BioNTech said as of Dec. 29, 2021, they have delivered 1 billion doses of their COVID-19 vaccine to low- and middle-income countries and expect to deliver another 1 billion doses in 2022. The companies said they do not expect Monday’s news will impact the existing supply agreements in place with governments and international health organizations around the world.
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The expansion on the availability of Pfizer-BioNTech’s booster shot comes after Israel became the first country to begin limited distribution of the fourth dose of the COVID-19 vaccine. It is available to the elderly and immuno-compromised, as well as those who work with them.
