Five months after U.S. health regulators granted full approval to another COVID jab, Moderna has announced on Monday that they received full approval for its COVID vaccine. This is the same COVID vaccine that has been given to millions of Americans since December 2020, since the Food and Drug Administration (FDA) gave it emergency use authorization. The decision from the FDA indicates that the agency has completed its same review of Moderna's COVID vaccine as dozens of other vaccines that have long been used to inoculate Americans.
According to CBN News, the FDA's most recent decision is backed by real-world evidence coming from over 200 million doses given in the U.S. since the Moderna vaccine's emergency use authorization in December 2020. Back in August 2021, the FDA had granted full approval to Pfizer's COVID vaccine.
Authorities and advocates of public health are hopeful that the regulatory distinction will help encourage the public to get vaccinated. However, there was no observable increase in vaccination following the full approval of the Pfizer vaccine, which was heavily promoted by President Joe Biden and other federal officials.
Over 211 million Americans or 63% of the total American population are now fully vaccinated against COVID. AN estimated 86 million have received a booster dose. Back in Spring of 2021, vaccinations peaked with more than 3 million getting a COVID vaccine per day. Now, that number is down to 750,000 per day. Vaccinations briefly increased again amidst the spread of the Omicron variant of COVID, but decreased when the spread slowed down.
As part of the full approval process, the FDA reviews months worth of additional follow-up data submitted by Moderna to confirm its efficacy against COVID. NBC News reported that the FDA, as with health regulators in Europe, had allowed the emergency use of Moderna's COVID jab following a study that tracked 44,000 people 18 and older for at least two months, which is shorter than the usual six months of safety data normally required for full approval. Moderna then continued that study.
The FDA said it also monitored and analyzed serious side effects, which they claimed to be very rare. The Moderna shot now includes a warning about a rare type of heart inflammation that occurs in young men after the second dose. Most cases were found to be mild and resolved swiftly.
"The public can be assured that this vaccine was approved in keeping with the FDA's rigorous scientific standards," FDA's top vaccine regulator Dr. Peter Marks said in a statement. Following the full approval of the Moderna COVID vaccine, the company will now market the jab under the brand name Spikevax.
Moderna CEO Stéphane Bancel said in a statement that the real-world data submitted to the FDA "reaffirms the importance of vaccination against this virus," creating a "momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," USA Today reported.
