Pfizer’s COVID-19 vaccine was approved by the United States on Monday. This may boost public confidence as the country battles the most contagious coronavirus mutation yet.
Pfizer and BioNTech have now received the strongest endorsements from the Food and Drug Administration. This agency has never had as much evidence to determine if a shot is safe. Since December’s emergency use, more than 200 million Pfizer vaccines have been used in the United States.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said acting FDA Commissioner Janet Woodcock. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
According to Pfizer the U.S. is now the first country to approve the shot. CEO Albert Bourla stated that he hopes the decision will “help increase confidence in our vaccine” as it remains the best tool to protect lives.
In July, the U.S. vaccines dropped to their lowest level. The number of shots is on the rise as delta fills hospitals beds. One million shots are given each day on Thursday, Friday, and Saturday. Only half of the U.S. population has been fully vaccinated using one of three options: Moderna, Pfizer or Johnson & Johnson.
Companies, universities, and local governments may also be encouraged to mandate vaccines through the FDA’s actions. New York City, New Orleans, and San Francisco all enforced proof-of-vaccination requirements for indoor restaurants, bars, and other venues this month. Federally, President Joe Biden requires government workers to sign forms attesting to their vaccinations or submit to regular testing.
According to a poll conducted by The Associated Press-NORC Center for Public Affairs Research, more Americans are anxious to board planes. Nearly 6 in 10 Americans support requiring full vaccinations to fly on airplanes and attend crowded public events.
“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”
Like regulators in Europe, the FDA initially approved emergency use of Pfizer’s vaccine. This was based on a study that followed 44,000 adults 16 years and older for at most two months. That is the time when side effects are most common.
This is shorter than the normal six months of safety data required to approve full approval. Pfizer continued the study, and FDA reviewed real-world safety evidence before deciding to fully license vaccines for adults 16 years and older. These were the longest studies. Pfizer still has an emergency authorization for children aged 12-15 years old.
The FDA stated that serious side effects such as heart inflammation and chest pain in teenagers and young adults, despite hundreds of millions of shots taken, are still extremely rare.
Pfizer’s original study found that the vaccine was 97% effective against severe COVID-19. Six-month monitoring of this data showed that the vaccine was still 97% effective. The protection against milder infections decreased slightly from 96% at the peak two months after the second dose to 84% six months later.
These data samples were collected before the spread of the extra-contagious Delta variant. However, other data from the Centers for Disease Control and Prevention show that the vaccine is still effective in preventing severe diseases caused by this mutant.
The FDA doesn’t license booster doses. That will be decided by the agency separately.
For people who have severely compromised immune systems or organ transplant recipients, the FDA allows emergency use of the Moderna or Pfizer vaccines. Everyone else who received those vaccines has been vaccinated by the Biden administration. If the FDA and CDC are in agreement, they will be starting a booster in the fall.
The vaccination of children younger than 12 years old is still a matter of debate. Moderna and Pfizer are currently studying children, with data expected to be available in the fall.
