U.S. health regulators on Monday fully approved Moderna’s COVID-19 vaccine, a vaccine that has already been given to tens of millions of Americans since its emergency authorization more than a year ago.
The FDA’s actions mean the agency has completed the same rigorous and lengthy review of Moderna’s vaccine as dozens of other long-established vaccines.
This decision was backed by real-life data from more than 200 million doses administered in the US since the FDA approved the vaccine in December 2020. The FDA fully approved Pfizer’s vaccine last August.
Public health advocates initially hoped that regulatory differences would increase public confidence in vaccinations. But since Pfizer’s approval, there has been no notable jump in vaccination, which has been heavily promoted by President Joe Biden and other federal officials. However, regulators said on Monday they hope the additional approval will encourage more people to get vaccinated.
More than 211 million Americans, or 63% of the total population, are fully vaccinated. About 86 million people received a booster dose. Vaccinations peaked last spring at more than 3 million a day and now average less than 750,000 a day. Vaccination rates briefly jumped after the news of the omicron variant in December, but have since slowed down again.
The Food and Drug Administration (FDA) has reviewed additional surveillance data submitted by Moderna over several months to confirm the effectiveness of the COVID-19 vaccine. The FDA also analyzed and monitored serious side effects, which turned out to be very rare. The vaccine warns of a rare type of heart inflammation that mostly occurs in young men after a second dose. Most cases are mild and resolve quickly.
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In addition, the FDA has inspected the company’s manufacturing process and equipment.
“The public can rest assured that this vaccine has been approved to the FDA’s rigorous scientific standards,” Dr. Peter Marks, the FDA’s chief regulator, said in a statement.
With full approval, Moderna will now market the vaccine under the brand name Spikevax. This is the first FDA-approved product for the Cambridge, Massachusetts company.
In the US, Moderna is only used by adults for initial vaccination and as a half-dose booster. The company said last fall that the FDA was delaying a decision to stop vaccinating children aged 12 to 17 as it looked into the risk of heart inflammation.
Johnson & Johnson has not yet applied for full approval of its COVID-19 vaccine.