The FDA plans to release data and analysis on Moderna’s Covid-19 vaccine Tuesday in advance of its independent review by an outside panel of scientific experts Thursday, WSJ reports.
Why It Matters: Moderna’s shot is likely to become the second Covid-19 vaccine to be granted emergency-use authorization, following Pfizer and BioNTech’s offering. Supply and distribution of the Pfizer-BioNTech vaccine is limited in the short-term, and bringing another, similarly-effective option to market should only improve the country’s vaccination efforts.
Other Key Details:
- Covid-19 has caused roughly 300,000 deaths in the U.S. and more than 1.6 million globally.
- The same panel that voted 17 to 4 (with one abstention) to approve Pfizer-BioNTech’s shot will review Moderna’s. The FDA doesn’t have to follow their recommendations but usually does.
- Moderna’s vaccine is similar to Pfizer-BioNTech’s in that it also uses mRNA technology and has a comparable, mid-90s efficacy rate.
Production Value: Moderna has previously said it could have 20 million doses available (enough to inoculate 10 million people with its two-shot program) by the end of the year. The company expects to produce between 500 million and 1 billion doses next year for worldwide use.
- Moderna worked closely with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases on vaccine development. The U.S. government “ committed to making nearly $1 billion available to Moderna for its vaccine research and other preparations and has agreed to pay about $3.1 billion to purchase 200 million doses.”
The Final Word: The pandemic has resulted in a faster path to emergency-use approval, but the FDA insists the vaccines still “meet high hurdles in their studies.” As the massive vaccine undertaking begins, which should only benefit from two products instead of one, medical officials are also turning their eyes to whether the treatments can prevent transmission in addition to symptomatic disease.
UPDATE:Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review, according to Bloomberg.