Moderna Asks For Full FDA Authorization Of Covid Vaccine
Both Moderna and Pfizer have now applied to the Food and Drug Administration to move beyond the emergency use authorization that their respective vaccines are currently administered under. Full approval would allow the companies to market directly to consumers and make it easier for schools and employers to mandate covid shots.
Politico:
Moderna Seeks Full FDA Approval Of Its Covid-19 Vaccine
Moderna has asked the Food and Drug Administration for full approval of its coronavirus vaccine in people 18 and older. The company is the second vaccine maker to seek full approval from U.S. regulators, which would allow it to market the shot directly to consumers. Full approval also makes it easier for schools, employers and the military to require inoculation against Covid-19. (Morello, 6/1)
CNBC:
Moderna applies for full FDA approval of its Covid vaccine
The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of data. Over 100 million of the shots have already been administered, according to data compiled by the Centers for Disease Control and Prevention. (Lovelace Jr., 6/1)
In other news about vaccine developers —
Politico:
Moderna To Double EU Vaccine Manufacturing With New Dutch Site
Moderna will start producing a retooled version of its coronavirus vaccine in the Netherlands, doubling the company's expected EU production, the company announced today. The new contract, inked with the subcontractor Lonza, will allow Moderna to make approximately 300 million doses a year starting at the end of 2021. The Dutch site, in addition to a drug-substance site run by Rovi in Spain, will allow Moderna to make 600 million doses a year in the EU. (Deutsch, 6/2)
The Wall Street Journal:
Vaccine Makers Face Challenge In Sustaining Winning Streak
Covid-19 vaccine-makers’ shares have soared since the beginning of 2020. Moderna Inc. is up about 850%, BioNTech SE has risen 510% and Novavax Inc. is up nearly 3,620%. Each of these companies has produced vaccines that have won regulatory authorization or are expected to win that backing. Some of the vaccine makers are racking up huge revenues. Their valuations assume more big gains, which depend on the next stages of the pandemic and whether the companies’ vaccine technology can be used to treat other diseases. (Zuckerman, 6/1)
