WASHINGTON (AP), Moderna announced Monday that U.S. regulators gave full approval for its COVID-19 vaccination. This shot has been administered to tens to millions of Americans since it was approved as an emergency authorization more than a year ago.

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. Despite the Pfizer approval being heavily promoted by President Joe Biden, and other federal officials, there was not a noticeable increase in vaccinations.


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 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 approve shots for 12- and 17-year-olds because it was examining a rare risk associated with heart inflammation that is mostly seen in young men and teenage boys.


Johnson & Johnson is yet to apply for full approval of the COVID-19 vaccine.