Moderna announced Monday that U.S. regulators gave full approval for its Covid-19 vaccine. This shot has been administered to tens and millions of Americans since it was approved as an emergency authorization more than a year ago.
The action of the Food and Drug Administration signifies that the agency completed the same thorough, time-consuming review as many other long-established vaccines.
Real-world evidence was used to support the decision. The FDA approved the shot in December 2020. The FDA approved Pfizer’s vaccine in full last August.
Public health advocates originally hoped that the regulatory distinction would increase public confidence about the shots. The Pfizer approval was heavily promoted by President Joe Biden, and other federal officials. However, there was no noticeable increase in vaccinations.
Over 211 million Americans are fully vaccinated, which is 63 percent of total population. Around 86 million people have received a booster dose. The average daily rate of vaccinations is now less than 750,000. After December’s announcement of the micron variant, vaccinations accelerated briefly but have since fallen back.
Like regulators in Europe, the FDA initially approved emergency use of Moderna’s vaccine. This was based on a study that followed 44,000 adults over at least 2 months. That is the period during which serious side effects are most common. Moderna extended the study because it was shorter than the required six months of safety data for full approval. The FDA monitored for side effects, which have been very rare.
Moderna can only be used by adults in the United States. Last fall, the FDA delayed deciding whether to clear shots for 12- and 17-year-olds. This was because it looked at a rare risk of developing heart disease in young men.
