FDA authorizes new guidance on Pfizer vaccines and boosters for children and adults
On Jan. 3, 2022, the Food and Drug Administration (FDA) amended the authorization of emergency use of the Pfizer-BioNTech COVID-19 vaccine guidance in three ways.
Tag: Emergency Use Authorization
FDA, CDC, Western States authorize booster doses of the Pfizer COVID-19 vaccine for 16- and 17-year-olds
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Western States Scientific Safety Review Committee today authorized for emergency use the Pfizer-BioNTech COVID-19 vaccine for 16- and 17-year-olds, at least six months after they received their second shot of that vaccine.
New medication approved for prevention of COVID-19 in certain adults and children
On Dec. 8, 2021, the Food and Drug Administration (FDA) authorized AstraZeneca’s Evusheld under emergency use for prevention of COVID-19 infection in certain adults and children. Evusheld is a long-acting monoclonal antibody therapy.
FDA expands authorization for COVID-19 treatment to pediatric patients, including newborns
On Dec. 3, 2021, the agency expanded emergency use of bamlanivimab/etesevimab to include all patients at risk of severe disease, including newborns. “Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
FDA advisory committee finds that pediatric Pfizer vaccine benefits outweigh risks for children ages 5 to 11
Today, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of medical experts, recommended Emergency Use Authorization (EUA) for administration of the Pfizer COVID-19 vaccine to children ages 5 to 11. The Pfizer vaccine for this age group is a smaller dose (0.2 mL) than the Pfizer vaccine for ages 18+ (0.3 mL).
Oregon prepares for possible federal decisions to authorize COVID-19 booster shots for Moderna and Johnson & Johnson vaccines
Oregon will be ready to make booster shots available to eligible persons who had previously received the Moderna and Johnson & Johnson COVID-19 vaccines, should the U.S. Food and Drug Administration (FDA) amend its Emergency Use Authorizations and the Centers for Disease Control and Prevention (CDC) and the Western States Scientific Safety Review Workgroup recommend their use.
Medical and public health experts determine when to recommend a booster
Medical and public health experts determine when to recommend a booster. This week, the U.S. Food and Drug Administration (FDA) will consider whether to recommend that individuals who were vaccinated with Johnson & Johnson and Moderna COVID-19 vaccines should get booster doses.
How federal decisions on COVID-19 vaccines make their way to Oregon consumers
On Oct. 7, 2021, Pfizer and BioNTech asked the Food and Drug Administration (FDA) to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11. So when can children under age 12 in Oregon be vaccinated? The answer depends on how long it takes for the decision to make its way through the process to authorize vaccinations in Oregon.
OHA releases statement on booster dose recommendation
Today, officials from the Food and Drug Administration (FDA) convened medical experts to discuss whether to recommend that people who’ve previously been fully vaccinated with the Pfizer COVID-19 vaccine should receive a booster shot to help maintain the effectiveness of their vaccinations over time. At today’s hearing, the committee recommended that people age 65 and […]
FDA approves Pfizer COVID-19 vaccine
Today, the U.S. Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech mRNA COVID-19 Vaccine, which will be marketed as “Comirnaty.” Under the newly granted FDA approval, Comirnaty will be available to all people ages 16 and older to prevent COVID-19 disease. Under Emergency Use Authorization, the vaccine will continue to be available […]