The US authorities have fully approved the Pfizer / BioNTech vaccine. This will change the development of the pandemic, experts agree – ČT24 – Czech Television


According to the AP, the move may help strengthen the American public’s confidence in vaccination at a time when the United States is facing an increase in infections due to a more contagious variant of the delta. The vaccine was approved for emergency use in the United States last December, with more than 204 million people since receiving it. So far, about 51 percent of Americans have received covid-19 vaccination.

According to epidemiologist Leana Wen of George Washington University, this change could lead to a significant increase in vaccination coverage. The expert expects that full approval will not only alleviate hesitant concerns, but will also pave the way for other mandatory vaccines and give physicians more freedom in prescribing booster doses. “It’s a huge milestone,” she told National Geographic.

“There are many concerns about the emergency use of a vaccine, especially because it has been approved so quickly,” said C. Buddy Creech, director of Vanderbilt’s Tennessee Vaccine Research Program. “I think a few people will convince this.”

Persuasion will be easier for Pfizer once fully approved – the company can now use all the power and budget of its marketing apparatus for a vaccine sold under the Comirnaty brand after full approval. In the coming weeks, people can expect an influx of commercials and commercials to persuade people to get vaccinated, Wen said – adding that this will help increase vaccination rates.

Full approval opens the door to duty

In light of the regulatory approval of the vaccine, vaccination will be mandatory for all members of the U.S. military, the Pentagon said shortly after the FDA’s announcement. “Now that Pfizer’s vaccine is approved, the ministry will issue a directive requiring all employees to be vaccinated,” Pentagon spokesman John Kirby said.

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The obligation to vaccinate is already being introduced by other US federal and state agencies. For example, the U.S. Department of Veterans Affairs already requires vaccinations from its front-line health care workers, and California was the first state to require that all teachers and school staff be vaccinated or subjected to weekly covid testing.

Authorities also announced on Monday the obligation to vaccinate all employees in New York education. Proof of at least one vaccination dose must be provided by 27 September.

With full approval, enforcing this obligation will become much easier for government agencies and other organizations or companies, experts agree.

“While millions of people have already received the covid-19 vaccine safely, we understand that FDA approval can give people confidence in vaccination,” said Janet Woodcock, the commission’s commissioner. “The public can be confident that this vaccine meets the high standards of safety, efficacy and quality of production required by the FDA for an approved product,” she said.

More will follow

At the same time, according to Pfizer, the United States is the first country in the world to fully approve this vaccine. Since last December, the preparation has also been approved by the European Medicines Agency (EMA) for emergency use.

Moderna has also applied for full approval of its vaccine in the United States. According to the AP, the manufacturer of the single-dose vaccine Johnson & Johnson hopes to submit the application by the end of this year.

What is needed for full approval

The FDA granted the original emergency approval for Pfizer / BioNTech based on a study that examined 44,000 people over the age of 16 for at least two months. Pfizer then continued the study, and the US authority also relied on evidence from the use of the vaccine outside of clinical trials. The vaccine is now fully approved for people over 16 years of age; for adolescents aged 12 to 15, the vaccine is still for emergency use only.

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According to the FDA, serious side effects of the vaccine – such as chest pain or inflammation of the heart muscle in adolescents and young adults – are still extremely rare. A six-month study shows that Pfizer / BioNTech is 97 percent effective against the severe course of covid-19 disease. Protection against mild progression is highest about two months after the second dose (96 percent) and 84 percent after six months.

The AP recalls that these data are based on the time before the more contagious coronavirus variant delta began to spread around the world. Other data from the US Centers for Disease Control and Prevention (CDC) show that the vaccine is also effective against this variant.

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