It is reported that on Monday, August 23 local time, the U.S. Food and Drug Administration (FDA) fully approved the use of Pfizer biotechnology’s coronavirus vaccine for people aged 16 and over, which is the first approved vaccine that has been authorized for use in a state of emergency (EUA).
So far, Pfizer vaccine has appeared in the U.S. market according to the emergency use authorization approved by FDA in December last year. Since then, Pfizer has injected more than 204 million vaccines, according to data collected by the Centers for Disease Control and prevention. Doctors and epidemiologists say full approval may convince some Americans that vaccination is safe.
The approval came at a time when the United States once again stepped up its fight against the new crown pandemic. The highly infectious delta variant virus has greatly slowed down the progress made in the country in the first half of this year. The Biden administration hopes that this development will encourage at least some of the 85 million Americans who have not yet been vaccinated to be vaccinated as soon as possible.
On the same day, President Biden said on his twitter, “FDA has officially approved the coronavirus disease vaccine. Although all three new coronavirus vaccines meet the stringent standards for emergency use of FDA, the approval of FDA should make people more believe that the vaccine is safe and effective. If you haven’t been vaccinated, it’s time. ”
In a statement, Dr. Janet Woodcock, acting director of the U.S. Food and drug administration, called the approval a “milestone”. “For some people, full FDA approval of Pfizer vaccine may give them confidence in vaccination,” she said“ Today’s milestone brings us one step closer to changing the process of the new crown pandemic in the United States. ”
Dr. Peter max, the FDA’s top vaccine regulator, said Pfizer’s vaccine license was issued after a rigorous review of hundreds of thousands of pages of data, including inspection of vaccine production plants“ The public and the medical community can believe that although we quickly approved the vaccine, it fully meets the high standards of existing vaccines in the United States, “he said.
Pfizer said it submitted data to the FDA on 44000 clinical trial participants from the United States, the European Union, Turkey, South Africa and South America. The company said the data showed that the vaccine was 91% effective in preventing infection – slightly lower than the 95% effective rate shown when the FDA decided to approve the emergency use of the vaccine last December.
Pfizer said that the United States became the first country to fully approve vaccination. CEO Albert bourla said in a statement that he hoped that this decision “will help enhance people’s confidence in our vaccine, because vaccination is still the best tool for us to help protect life.”
Pfizer biontech vaccine will continue to be authorized for emergency use in children aged 12 to 15, and the necessary data will be collected to obtain full approval. So far, more than 92 million Americans – 54% of whom have been vaccinated by Pfizer. Most of the rest were vaccinated against Modena.
Health experts and state officials welcomed the approval. At the same time, private companies and some institutions are increasingly forcing their personnel to be vaccinated. United Airlines recently announced that its employees would be required to produce vaccination certificates within five weeks of regulatory approval. Oregon has similar requirements for staff in all States.
The same is true of many universities from Louisiana to Minnesota. More than 400 universities require students to be vaccinated. The Pentagon announced that it would require 1.4 million US servicemen to be vaccinated by mid September. President Biden announced that all federal civilian employees must be vaccinated or subject to regular testing, social distance, mask requirements and travel restrictions.
The next major issue facing regulators is whether to approve the vaccination of enhancers. The Biden administration said last week that it would provide a third injection to adults eight months after the second injection of Pfizer and Modena vaccines from September 20 before the agency’s approval. The third injection has been authorized to some immunodeficient people.
The United States ranks first in the world in coronavirus diseases and deaths. More than 625000 Americans died, including an average of more than 600 a day in recent weeks. Although more than 60% of the total U.S. population has received at least one dose of vaccine, many Americans say they are still hesitant to get vaccinated even if the highly infectious delta variant virus is spreading.