The pandemic is over (POTUS)
Emergency use authorizations
August 31, 2022
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine,
and the Pfizer-BioNTech COVID-19 Vaccine,
to authorize bivalent formulations,
for use as a single booster dose
Original strain + BA.4 and BA.5 lineages
For each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence,
including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines,
safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1 lineage
that is similar to each of the vaccines being authorized,
Has already placed an order for 170 million doses
Data collected by the companies
Human data, only available BA.1 booster
BA.1 trails did not look for protection against severe disease, (People trials are very expensive)
For the BA.4/BA.5 boosters, the companies have submitted animal data.
(not released publicly)
Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose, (for EMA)
Showed an increased antibody response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.
Clinical trials for the BA.4/BA.5 vaccines will begin this month
August 19, 2022
Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine,
in individuals 12 through 17 years of age.
This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA.
July 13, 2022
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine,
in individuals 18 years of age and older.
June 17, 2022
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine,
in children down to 6 months of age.
December 22, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid