Washington, Feb. 1 (US): US health regulators have given full approval for Moderna’s COVID-19 vaccine, an injection that has already been given to tens of millions of Americans since the emergency declaration more than a year ago.
The FDA’s action means the agency has completed the same rigorous and time-consuming review of Moderna’s episode as dozens of other well-established vaccines, The Associated Press reports.
The decision has been bolstered by real evidence from more than 200 million doses administered in the United States since the Food and Drug Administration launched the vaccine in December 2020. The Food and Drug Administration granted full approval for the Pfizer vaccine last August.
Public health advocates initially hoped that regulatory discrimination would boost public confidence in the footage. But there was no noticeable bump in vaccinations after Pfizer’s approval, which President Joe Biden and other federal officials have promoted. However, regulators said Monday they hope the additional certification will encourage more people to get vaccinated.
More than 211 million Americans, or 63% of the total population, have been vaccinated. About 86 million people received a booster dose. Vaccinations peaked last spring at more than 3 million a day, and now averages less than 750,000 a day. The pace of vaccinations rose briefly after news of the omicron variant in December but has slowed again since then.
The Food and Drug Administration (FDA) reviewed months of additional follow-up data provided by Moderna to confirm the vaccine’s effectiveness against COVID-19. The FDA has also analyzed and monitored serious side effects that have been shown to be very rare. The vaccine includes a warning of a rare type of heart infection that often occurs in young adults after the second dose. Most cases are mild and resolve quickly.
Additionally, the Food and Drug Administration (FDA) has reviewed the company’s manufacturing process and facilities.
“The public can be assured that this vaccine has been approved in line with the strict scientific standards of the US Food and Drug Administration,” Dr. Peter Marks, the FDA’s top vaccine regulator, said in a statement.
With full consent, Moderna will now market the vaccine under the brand name Spikevax. It’s the first FDA-approved product for a Cambridge, Massachusetts company.
In the United States, only adults use Moderna, for the initial vaccination and as a half-dose booster. The company said last fall that the U.S. Food and Drug Administration had delayed a decision on whether to disinfect 12- to 17-year-olds while it was being screened for risk of carditis.
Johnson & Johnson has not yet submitted an application for full approval for its COVID-19 vaccine.
On Monday, Novavax Inc. The FDA has officially authorized a different type of COVID-19 vaccine, with the hope that it will become the fourth US option.