Moderna seeks full FDA approval for its COVID-19 vaccine
Moderna Inc. said it had completed the application process for full approval of its COVID-19 vaccine in the U.S., putting the company on course to obtain the second such clearance from federal regulators.
The company said in a statement on Wednesday that it had finished the rolling submission process for an approval from the Food and Drug Administration. Moderna first launched the process in June with the beginnings of a so-called Biologics License Application. Since then, the company has been supplying data to regulators on its shot’s safety and effectiveness as it became available in clinical testing.
Moderna’s two-shot regimen currently holds an emergency-use authorization for those 18 and older. The designation that can be revoked at any time and only lasts for the duration of the pandemic. If regulators grant the approval, it would follow the full clearance earlier this week granted to the vaccine made by the partnership of Pfizer Inc. and BioNTech SE.
Moderna’s shares jumped 2.5% to $404.61 at 10:50 a.m. in New York trading on Wednesday.
Both the Moderna and Pfizer vaccines use messenger RNA technology to protect recipients from COVID-19. Together, the two shots have accounted for the vast majority of immunizations in the U.S., according to data from the Centers for Disease Control and Prevention.
Though the typical review of a Biologics License Application can span eight months, the FDA has turned to “sprint teams” to expedite the process for COVID-19 vaccines. The U.S. health agency conducted its review of the Pfizer-BioNTech vaccine in less than half the standard amount of time.
Now, the FDA is expected to do the same for Moderna. Regulators will evaluate a significant amount of safety, efficacy and manufacturing data. They will also inspect Moderna’s facilities.
The FDA couldn’t immediately be reached for comment.
The U.S. government hopes that a swift approval could bolster confidence in the shots, and encourage still-hesitant Americans to seek out vaccination. About 3 in 10 eligible U.S. residents haven’t yet gotten a single dose of any vaccine.
The decision will also make it easier for companies, universities and state and local governments to mandate vaccination. In the wake of the Pfizer-BioNTech vaccine approval, financial-services and consulting firms have put new vaccine requirements in place, and Delta Air Lines Inc. said that it would impose a $200 monthly surcharge on employees who aren’t vaccinated.
More health care and Big Pharma coverage from Fortune:
- The most common COVID Delta variant symptoms in adults and kids
- Pfizer wants you to call its COVID vaccine Comirnaty. How the name came about
- Singapore is trying to do what no other country has done: pivot away from COVID-zero. Will it work?
- What Pfizer’s FDA approval means for Americans and businesses
- Vietnam had a near-perfect record of fending off COVID-19. Then came the Delta variant
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