FDA Authorizes Updated Novavax COVID-19 Vaccine Â
The FDA has granted emergency use authorization for an updated Novavax COVID-19 vaccine targeting current variants.Â
Tag: FDA emergency use authorization
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FDA Issues EUA for Injection to Treat COVID-19
The drug is approved under the EUA for the use in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.
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FDA Authorizes Opti Medical COVID-19/Flu Test
The US FDA granted Emergency Use Authorization for the Opti SARS-CoV-2/Influenza A/B RT-PCR Test from OPTI Medical Systems.
FDA Authorizes Pfizer Booster for Children Age 12-15
The Pfizer and BioNTech COVID-19 vaccine is the first to be FDA-authorized as a booster for adolescents 12 through 15 years of age in the US.
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FDA Authorizes Merck Molnupiravir Antiviral COVID Pill
The FDA issued emergency authorization for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults age 18 and older with positive results of direct SARS-CoV-2 viral testing.
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Pfizer Paxlovid COVID Antiviral Pill Authorized by FDA
The US FDA has authorized the emergency use of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients age 12 and older.
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AstraZeneca Long-Acting Monoclonal Antibodies Authorized
The FDA has issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab and cilgavimab) to prevent COVID-19 in certain adults and children.
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FDA Expands Authorization of Pfizer Booster to 16-17 Year Olds
The FDA expanded emergency use for the Pfizer-BioNTech COVID-19 Vaccine single booster dose to teens 16 and 17 years of age.
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Moderna, Pfizer Boosters Authorized for All Americans 18+
The FDA expanded emergency use for both the Moderna and Pfizer-BioNTech COVID-19 vaccine boosters for all individuals 18 years of age and older.
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FDA Authorizes Pfizer COVID-19 Vaccine in Children Ages 5-11
For children 5-11, the Pfizer-BioNTech COVID-19 vaccine is administered as a two-dose primary series, 3 weeks apart, but in a lower dose (10 μg).
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FDA Authorizes Moderna and Janssen Boosters
The FDA authorized single booster doses for the Moderna Inc and Janssen COVID-19 vaccines for certain adults age 18 and older, as well as the use of “mix and match” boosters of differing vaccines.
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FDA Advisory Committee Unanimously Supports Moderna Booster Dose for Seniors, at-risk Adults
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend emergency use authorization for a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level.
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Pfizer Requests COVID-19 Vaccine Authorization for Kids Age 5-11
Pfizer and BioNTech have requested emergency use authorization from the FDA to administer their COVID-19 vaccine (Comirnaty) to children ages 5 to 11 years old, according to a Pfizer tweet.
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AstraZeneca Requests Emergency Use for COVID-19 Antibody
AstraZeneca has submitted a request to the FDA for an emergency use authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
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Pfizer Booster Dose Authorized for Americans 65+ and Those at High Risk of Severe COVID-19
A single booster dose of the Pfizer-BioNTech COVID-19 vaccine was authorized by the FDA for Americans 65+ and others 18 and older at high risk of severe COVID-19, including those with risk of occupational exposure.
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