FDA fully approves BioNTech/Pfizer Covid vaccine


Covid-19 vaccine update

The US Food and Drug Administration has fully approved the BioNTech/Pfizer Covid-19 vaccine, which may encourage unwilling people to get the vaccine.

Since December, in view of the urgent need for a vaccine to fight the pandemic, two doses of BioNTech / Pfizer injections have been under emergency use authorization.

Monday’s decision fully approved the mRNA vaccine for people over 16 years of age. This is the first Covid-19 vaccine to receive this name. According to the emergency authorization, it continues to be used in children aged 12-15 and as a booster injection for people with weakened immune systems.

“As the first Covid-19 vaccine approved by the FDA, 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,” FDA Acting Director Janet Woodco K, said in a statement on Monday.

“Although millions of people have been safely vaccinated against Covid-19, we recognize that for some people, the FDA-approved vaccine may now inject additional confidence in vaccination.”

As employers increasingly seek proof of full vaccination from employees and customers, approval is obtained.

Lately in some states, delayed vaccination rates have risen. In these states, the highly transmitted Delta variant has led to a surge in infections and hospitalizations, mainly for those who have not been vaccinated.

The FDA stated that its assessment of vaccine effectiveness involves data from 20,000 vaccine recipients and 20,000 placebo recipients, while its safety is analyzed from the data of 22,000 people in the two groups.


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