>> Howard Bauchner: Peter, right before we came on, you mentioned that actually there's differences for EUAs for a drug versus an EUA for vaccine. And you're going to face many more of these. I know there's a hearing this Thursday for the Moderna vaccine. I think there's other phas...
The Food and Drug Administration on Thursday said it had advised COVID-19 vaccine companies to produce an updated vaccine for this fall, an aim to give people broader and stronger immunity in an upcoming booster campaign ahead of the winter. It’s the latest step in the FDA’s strategy to...
FDA recommends update to COVID vaccine against latest strain ABC News chief medical correspondent Dr. Jen Ashton explains the recommendations from the FDA to update vaccines against the latest COVID-19 strain, which will likely have mutated by winter. ...
On Wednesday, the U.S. Food and Drug AdministrationapprovedNovavax Inc.'s protein-based vaccine as a first booster dose. Until now, it had only been approved as a two-dose primary series. “The U.S. now has access to the Novavax COVID-19 Vaccine, adjuvanted, the first protein-based...
The Johnson & Johnson COVID-19 vaccine was authorized for emergency use in the United States on Feb. 27, 2021. Through March 18 this year, the FDA and the U.S. Centers for Disease Control and Prevention have identified 60 confirmed TTS cases, including nine fatal cases, according to the...
The FDA's Vaccines and Related Biological Products Advisory Committee will vote on a recommendation of the vaccine later Tuesday. If authorized, it would be the first COVID-19 vaccine for children ages 5 to 11. Once the FDA makes its authorization, the U.S. Centers for Disease Control and...
JNJ Covid vaccine pause after rare blood-clotting — Here’s what experts are saying The Food and Drug Administration asked states on Tuesday to temporarily halt usingJohnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S...
As of October 2021, there are three FDA-approved COVID-19 vaccines in the United States. These are thethree options: The Pfizer vaccine (also called the Pfizer-BioNTech vaccine) was the first COVID 19 vaccine approved by the FDA for emergency use in December 2020. It now has full approva...
This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multipl...
In its analysis of Pfizer's data, the FDA said that rates of hospitalization and death due to COVID-19 among children under 5 were higher than among those aged 5 to 17, "underscoring the benefit of an effective COVID-19 vaccine in this age group." ...