The FDA’s decision paved the way for legal requirements for the wider distribution of jabs and vaccines in the United States.
The US Food and Drug Administration (FDA) has granted full safety approval for Pfizer and BioNTech’s COVID-19 vaccine in a landmark decision that will allow leading US employers and universities to enforce injections.
According to data from Johns Hopkins University, the FDA’s decision enabled the U.S. government to obtain a license for the coronavirus vaccine that causes COVID-19 for the first time. Since the beginning of the pandemic, the vaccine has caused more than 628,500 deaths in the United States.
The Pfizer vaccine, which was previously approved urgently, has been widely distributed in the United States and shipped to Other countries.
FDA Acting Commissioner Janet Woodcock said: “Although millions of people have been safely vaccinated against COVID-19, we recognize that for some people, the FDA approved vaccine may now inject more confidence in vaccination. .”
The decision is for a vaccine for people 16 years and older. The FDA is still reviewing data for the 12 to 15-year-old population and has not yet allowed the vaccination of younger children.
Woodcock said in a statement: “Today’s milestone brings us one step closer to changing the course of this epidemic in the United States.”
The FDA’s approval is based on the latest data from the company’s clinical trials.
“Based on the long-term follow-up data we submitted, today’s approval for people aged 16 and over confirms the effectiveness and safety of our vaccines when they are urgently needed,” said Pfizer CEO Albert Bourla. In a statement.
The FDA stated that the Pfizer-BioNTech vaccine will now be sold under the name Comirnaty.
The vaccine contains genetic material, messenger RNA, which allows the body to produce an immune response by mimicking a virus, which has not been found in humans before.
Some US cities, including New York and San Francisco, have implemented regulations requiring vaccinations during activities such as dining in restaurants or working in government offices.
The FDA’s decision provides a legal basis for the U.S. military to require all service personnel to obtain a vaccine, which will become a model for other states and large public organizations.
Although the first round of vaccines is still being distributed, U.S. health officials now recommend that all Americans get vaccinated Booster jab Strengthen their protection in the evidence that Delta variants are proliferating and vaccine effectiveness is declining.
“Recent data clearly shows that over time, protection against mild and moderate diseases has declined,” U.S. surgeon Dr. Vivek Murthy said on Wednesday.
Some Americans have Boycott the vaccine, Leading to large-scale outbreaks of Delta variants among unvaccinated people in some states such as Texas and Florida.