A week after the first COVID-19 vaccine was approved for Americans, the Food and Drug Administration issued a second emergency approval for Moderna Inc.'s COVID-19 vaccine on Friday.
Moderna announced it would ship the vaccine to the U.S. government immediately and expects to dispose of 20 million doses by the end of December and up to 125 million doses by the first quarter of 2021. The vaccine is expected to reach patients as early as Monday.
“Through the FDA's open and transparent scientific review process, two COVID-19 vaccines were approved within an expedited timeframe, while meeting the rigorous standards of safety, efficacy, and manufacturing quality required to support the emergency approval of the American people from the FDA expect, "said FDA Commissioner Stephen Hahn in a statement Friday. “These standards and our review process, which are the same that we used in the review of the first COVID-19 vaccine and that we plan to use for all other COVID-19 vaccines, included input from independent science and public health experts as well as one thorough analysis of the data by the agency's career staff. "
The regulator's announcement follows the support of an independent advisory committee that voted 20-0 with one abstention on Thursday that the benefits of the vaccine outweigh the risks. The vote was not final, but the FDA often follows the committee's advice.
A similar process took place last week when the same committee voted for BioNTech SE with one abstention 17-4
and Pfizer Inc.
Covid19 vaccination. The FDA approved the vaccine a day later, and it is already being given to a number of healthcare workers and nursing home residents in the United States.
The stock rose more than 2% in after-hours trading after the announcement.
Moderna's vaccine is approved for use in adults aged 18 and over. This is a slightly different indication than BioNTech and Pfizer's, which is approved for use by people who are 16 years or older. However, giving the vaccine to adolescents in this age group was one reason four committee members voted “no” on whether the benefits outweighed the risks during that consultation.
"Overall, both AdComs were more of a formality than a hard query of the data (although we believe the FDA has fully reviewed both vaccines)," Bank of America analysts told investors this week. "Rather, the panel seems to have been intended to give the FDA and its experts the opportunity to review the results (publicly) and to justify the approval."
The US government has bought 200 million doses of the Moderna vaccine, which would be used to vaccinate 100 million people in the US. (The company's vaccine, mRNA-1273, consists of two doses one month apart.)
This is the first FDA approval or approval Moderna has ever received for any of its products. The biotech company plans to apply for a full license in the new year.
"We were able to manufacture and manufacture the Moderna COVID-19 vaccine from sequence to approval in 11 months and at the same time advance clinical development with a phase 1, phase 2 and central phase 3 study with 30,000 participants" , reported Stéphane Bancel on Friday's announcement. "It's been a 10 year science, business, and medical journey and I'm grateful to everyone who helped us get here today."
There are several other COVID-19 vaccines that are still in late development, including candidates from the University of Oxford and AstraZeneca
and Johnson & Johnson
"The bigger picture, the possibility of several future COVID-19 vaccines (some at potentially much cheaper prices) and the uncertain duration of the pandemic make us relatively cautious about the significant value that the market is already ascribing to mRNA-1273," JP Morgans Cory Kasimov wrote in a note to investors on Thursday.
Moderna's shares are up 617% so far this year, while the S&P 500
has increased by 15.2%.