The vaccine will now be sold as Comirnaty, manufactured by Pfizer and its partner BioNTech, and now has the strongest support from the U.S. Food and Drug Administration, which has never had so much evidence to judge the safety of injections before. Since its emergency use in December last year, Pfizer has used more than 200 million doses of the drug in the United States-hundreds of millions of doses have been used worldwide.
“The public can be very confident that this vaccine meets the FDA’s high standards for the safety, effectiveness, and manufacturing quality of approved products,” said FDA Acting Commissioner Janet Woodcock. “Today’s milestone brings us one step closer to changing the course of this epidemic in the United States”
Pfizer stated that the United States became the first country to fully approve vaccines, and CEO Albert Burla said in a statement that he hopes that this decision “will help increase confidence in our vaccines because of vaccination. It is still our best tool to help protect lives.”
Vaccinations in the United States bottomed out in July. With the delta hospital bed overcrowded, the number of injections has increased again-1 million times a day on Thursday, Friday and Saturday. More than half of the American population has been vaccinated with one of the three vaccines in the United States, namely Pfizer, Moderna or Johnson & Johnson.
The FDA’s actions may also stimulate mandatory requirements for vaccines by companies, universities, and local governments. This month, New York City, New Orleans and San Francisco have implemented vaccination certification requirements for restaurants, bars and other indoor venues. At the federal level, President Joe Biden requires government workers to sign forms certifying that they have been vaccinated, or submit regular tests and other requirements.
There are more and more anxious Americans: According to a recent poll by the Associated Press-NORC Public Affairs Research Center, nearly six in ten people agree to require people to be vaccinated when traveling on airplanes or attending crowded public events .
Dr. Carlos del Rio of Emory University said: “When you get full approval, authorization becomes much easier.” “I think many companies have been waiting for it.”
Like regulatory agencies in Europe and most parts of the world, the FDA initially allowed emergency use of Pfizer’s vaccines based on a study that followed 44,000 people aged 16 and over for at least two months-which is usually a serious side effect. period.
This is shorter than the six months of safety data usually required for full approval. Therefore, Pfizer continued to conduct this research, and the FDA also reviewed the real-world safety evidence and decided to provide a full license for people 16 years and older (the group with the longest study period). Pfizer’s injections still have emergency authorization for children between 12 and 15 years of age.
The FDA says that even after hundreds of millions of injections, serious side effects—such as chest pain and heart inflammation in teenagers and young adults—are still very rare.
As for effectiveness, a six-month follow-up of Pfizer’s original research showed that the vaccine still has 97% protection against severe COVID-19. The protection against mild infections weakened slightly, from a peak of 96% two months after the second vaccination to 84% six months later.
These data appeared before the extra infectious delta variant began to spread, but other data from the Centers for Disease Control and Prevention showed that the vaccine is still good at preventing serious diseases caused by the mutant.
As for all discussions on booster doses, the FDA’s approval does not cover these. The agency will decide separately.
The FDA has allowed the emergency use of a third dose of Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients who do not respond as strongly to the usual two injections. For others who have been vaccinated with these vaccines, the Biden administration is planning to increase the vaccination starting in the fall if the FDA and CDC agree.
What remains to be decided is the vaccination of children under 12 years of age. Both Pfizer and Moderna are studying adolescents and are expected to provide data in the fall.
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