FOOD AND DRUG ADMINISTRATION
FDA advisory panel to meet on Moderna, Johnson & Johnson COVID vaccine booster shots
The Food and Drug Administration’s vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, and we are getting our first look at the data the panel will be using to make its recommendation on booster shots for Moderna and Johnson & Johnson.
FDA advisory panelist in Michigan explains voting in favor of Moderna COVID-19 vaccine
ANN ARBOR, Mich. – The U.S. Food and Drug Administration granted an emergency use authorization for the Moderna COVID-19 vaccine Friday evening, the second vaccine to be authorized in the country. Prior to the authorization, the FDA advisory panel voted 20-0 with one abstention on Thursday to recommend the vaccine. UPDATE: US clears Moderna vaccine for COVID-19, 2nd shot in arsenalDr. A Oveta Fuller, a virologist and viral pathogen researcher at the University of Michigan, voted “No” to recommend the Pfizer vaccine. However, she said she voted “Yes” this time for Moderna. It seemed like their study was set up to meet that at the minimum but it wasn’t set up to do a whole lot else,” Fuller said.
Here’s a look at FDA’s COVID-19 vaccine review process
Scientists with the U.S. Food and Drug Administration (FDA) are working to review two COVID-19 vaccines submitted by drug companies Pfizer and Moderna. Pfizer submitted its application on Nov. 20 for an emergency use authorization to the FDA Center for Biologics Evaluation and Research (CBER). “The safety profile of a vaccine that’s going to be deployed in millions of people has to be incredibly clean,” said Dr. Peter Marks, who directs CBER. “We, as an agency, are one of the last agencies in the world that we still actually get the primary data. We don’t get summary data.”CBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.
FDA authorizes rapid at-home COVID-19 test
When it comes to COVID testing, we’ve been hearing about growing lines and delayed results. But the Food and Drug Administration (FDA) issued a new emergency use authorization for an at-home test. The new test by California-based Lucira is a nasal swab test that can provide a result within 30 minutes and is for use by anyone ages 14 and older if their healthcare provider thinks they may have COVID-19. The nasal swab test involves swirling a patient’s self-collected sample swab in a vial, which is then placed in the test unit. The FDA did not talk about the price of the test but the company’s website indicated that the test is intended to cost less than $50.