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Moderna Stock Climbs; FDA Seeks Rapid Review of Omicron Vaccines

Moderna climbs on reports U.S. health officials are looking to fast-track omicron-targeted vaccines and drugs.

Moderna  (MRNA) - Get Moderna, Inc. Report shares climbed Friday following a report that the U.S. Food and Drug Administration is laying the groundwork for the rapid review of omicron-targeted vaccines and drugs if they are needed.

Shares of the Cambridge, MA biotech were climbing 5.7% to $319 at last check. Pfizer PFE shares ticked up 0.4% to $53.24 and partner BioNTech added 2.2% to $340.71.

The FDA has been meeting with drugmakers and setting guidelines for the studies and data needed to swiftly evaluate products targeting the omicron Covid-19 variant, The Wall Street Journal said, citing people familiar with the matter.

The agency is building on rules established earlier this year to assess shots and treatments.

Under the rules that the FDA is putting into place, drugmakers working on new vaccines would be expected to meet standards similar to those required for authorization of boosters.

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For vaccines, companies wouldn’t have to conduct large, lengthy trials enrolling thousands of subjects that wait for a certain number to catch symptomatic Covid-19. 

Instead, they could study the immune responses in a few hundred subjects.

Drugmakers would need about three months to develop and test the new vaccines. After that they would seek authorization of the shots through an expedited review process, and it would take the FDA one to two weeks to decide.

Moderna has said that it can advance new candidates to clinical testing in 60 to 90 days. Pfizer Chief Executive Albert Bourla said that company and its partner BioNTech could have vaccines ready in 100 days.

The FDA did not immediately respond to a request comment.

An FDA advisory panel this week recommended the emergency authorization of Merck's  (MRK) - Get Merck & Co., Inc. Report Covid antiviral treatment.