A vial of Moderna COVID Vaccine is displayed over a counter at a pharmacy in Portland, Ore.
Highlight
- Moderna’s Kovid Vaccine Gets Full Approval from the US Food and Drug Administration
- The vaccine, called Spikevax, is approved for use in people 18 years of age and older.
- Spikewax meets FDA’s rigorous standards for safety, effectiveness required for approval
US health regulators on Monday gave full approval to Moderna’s COVID-19 vaccine, a shot that has been given to millions of Americans since its emergency authorization a year ago.
The Food and Drug Administration’s action means the agency has completed the same rigorous, time-consuming review of Moderna’s shot as dozens of other long-established vaccines.
The decision was bolstered by real-world evidence from more than 200 million doses administered in the US since the FDA approved the shot in December 2020. The FDA gave full approval for Pfizer’s vaccine last August.
Public health advocates initially hoped that the regulatory distinction would increase public confidence in the shots. But there has been no significant jump in vaccination after Pfizer’s approval, which was heavily promoted by President Joe Biden and other federal officials. Still, regulators said on Monday they hope the additional support will encourage more people to get vaccinated.
More than 211 million Americans, or 63% of the total population, have been fully vaccinated. About 86 million people have received a booster dose. Vaccinations exceeded 3 million per day last spring, and now averages less than 750,000 per day. The pace of vaccination accelerated briefly after news of the Omicron edition in December, but has since slowed again.
The FDA reviewed months of additional follow-up data submitted by Moderna to confirm the vaccine’s effectiveness against COVID-19. The FDA also analyzed and monitored serious side effects that have proven to be very rare. The vaccine includes warnings about a rare type of heart inflammation that occurs mostly in young men after the second dose. Most cases are mild and resolve quickly.
Additionally, the FDA reviewed the company’s manufacturing process and facilities.
“The public can rest assured that the vaccine was approved in accordance with the FDA’s rigorous scientific standards,” the FDA’s top vaccine regulator, Dr. Peter Marks, said in a statement.
Moderna will now market the vaccine under the brand name Spikevax with full approval. It is the first FDA-approved product for the Cambridge, Massachusetts-based company.
In the US, Moderna is used only by adults, for initial vaccination and as a half-dose booster. The company said last fall the FDA had delayed deciding whether to clear shots for children ages 12 to 17 because it investigated the risk of heart inflammation.
Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.
Also on Monday, Novavax Inc. formally requested FDA authorization of a different type of COVID-19 vaccine, in hopes of becoming the fourth US alternative.
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