The Food and Drug Administration has taken the necessary action to ensure that Moderna’s shot was reviewed thoroughly and in a timely manner. This is similar to the review of dozens of long-established vaccines.
Real-world evidence was used to support the decision. The FDA approved the shot in December 2020. Pfizer’s vaccine was approved by the FDA in August.
Initial hopes of public health advocates were that the regulatory distinction would increase public confidence in the shots. The Pfizer approval was heavily promoted by President Joe Biden, as well as other federal officials. However, there was not a noticeable increase in vaccinations. However, regulators stated Monday that they hoped that the additional endorsement would encourage more people who are vaccinated.
Sixty-three percent of Americans are fully vaccinated, which is more than 211 million. Around 86 million people have received a booster dose. The average daily vaccination rate is now less than 750,000. After December’s announcement of the omicron variant, vaccinations slowed down briefly.
Moderna submitted additional follow-up data for months to the FDA. This was used to confirm that the vaccine is effective against COVID-19. The FDA monitored side effects and analyzed them carefully. A warning is included in the vaccine about rare heart inflammation, which usually occurs in young men after receiving the second dose. Most cases are mild and resolve quickly.
FDA also reviewed the manufacturing process and facilities of the company.
“The FDA’s top vaccine regulator Dr. Peter Marks stated that the vaccine was approved according to strict scientific standards.
Moderna has received approval to market the vaccine under Spikevax. This is the first FDA-approved product that Moderna, based in Cambridge, Massachusetts, has produced.
Moderna is only used in the U.S. by adults for first vaccinations and boosters. Last fall, the company stated that FDA delayed deciding whether to give shots to 12- to 17-year olds because it was examining the risk of heart inflammation.
Johnson & Johnson is yet to apply for full approval for its COVID-19 vaccine.
