The U.S. Food and Drug Administration released a 54-page document outlining Moderna’s (MRNA) request for an emergency use authorization (EUA) Tuesday, bringing the biotech one step closer to the finish line.
Though it is widely anticipated that an EUA is issued by the weekend, based on the precedent set by Pfizer (PFE) and BioNTech (BNTX) last week, the exact timeline still remains unclear. The FDA’s vaccine advisory committee is slated to meet December 17 to vote on recommending authorization of the vaccine in adults 18 and older.
Last week, Pfizer’s vaccine received an EUA late Friday, more than 24 hours after the vaccine advisory committee’s vote, leading to the first shots in the arm this week among health care workers.
Moderna’s vaccine, while it uses a similar technology to Pfizer’s, does not require the ultra-low refrigeration that continues to be watched as more Pfizer shipments reach their destination this week.
Moderna’s COVID-19 vaccine candidate showed 95% efficacy against the virus, and was especially effective in preventing severe symptoms. Unlike Pfizer, Moderna’s trial was more robust with data for minorities and the elderly, providing greater hope for broad distribution.
On an Operation Warp Speed call Monday, officials said that since Moderna’s authorization will come at a later date, it has had more time to build up its stock of the vaccine and therefore more will be allocated in the first shipments.
Pfizer is shipping 6.4 million in the first round, with half the doses in reserve for the second shot. Both Pfizer and Moderna are two-shot vaccines, and a combined 40 million doses are expected to be administered to frontline health workers and nursing home residents by the end of the year.
Today’s authorization for the first fully at-home OTC diagnostic test follows last month’s authorization of the first prescription #COVID19 test for home use & last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample.
— Dr. Stephen M. Hahn (@SteveFDA) December 15, 2020
Meanwhile, the FDA is moving ahead with more authorizations for testing that is more easily accessible at home, a move already adopted by other countries.
The agency approved an at-home, rapid antigen test that can be bought over the counter, making it the second OTC test available.
Health experts like Harvard’s Dr. Michael Mina have belabored the fact that other countries are able to test their populations more broadly and cheaply, because the are not as intent on getting perfect accuracy. To-date, only LabCorp’s (LH) swab collection kit was authorized for over-the-counter use.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn in a statement.
The test by Australia-based Ellume has high accuracy, according to the company, and will be available in stores and online for around $30. By comparison, antigen tests available in Europe go for as low as five Euros.