News | January 03, 2022
U.S. FDA grants EUA for Pfizer-BioNTech booster for 12 years and older
First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age
First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age
Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid
EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation
If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2
In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
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