Pfizer and BioNTech to seek authorization for third dose

The Pfizer / BioNTech alliance plans to request “in the coming weeks” authorization for a third dose of its vaccine against Covid-19, in the United States and in Europe in particular, the companies announced in a press release. This booster dose aims to provide enhanced immune protection to people already vaccinated with the first two doses. “Pfizer and BioNTech have seen encouraging results from ongoing trials for a third dose of the current vaccine,” they explained. They “plan to submit this data to the FDA, the EMA and other regulatory authorities in the coming weeks,” they added with reference to the American and European drug agencies.

“Preliminary study data shows that a booster dose given 6 months after the second dose has a consistent safety profile, while eliciting high levels of neutralizing antibodies” against the virus, including against the Beta variant , appeared in South Africa. These levels are “5 to 10 times higher” than those seen after the initial two doses. The results of this study will be published in a scientific journal, said Pfizer / BioNTech.

Good results against the Delta variant too

The two companies also pointed out that their vaccine had shown good results in the laboratory against the Delta variant, and that a third dose would therefore be able to boost immunity against it as well. Tests are underway to “confirm this hypothesis”, they said. “Even if the protection against severe cases of the disease remains high for six months, a decline in its effectiveness against symptomatic cases over time and the emergence of variants is expected,” the statement said.

“That is why we said, and we continue to believe that it is likely, based on all of the data we have now, that a third dose might be needed between six and twelve months. after vaccination ”, he added. The U.S. drug agency, the FDA, and the leading federal public health agency, Centers for Disease Prevention and Control (CDC), released a joint statement Thursday evening in which they say they are studying “the need or not to ‘a reminder “.

“Americans who have been fully vaccinated do not need a booster at this time,” say the two health authorities. “We are ready to give booster doses if and when science shows they are necessary,” they added.

Source

Pfizer BioNTech seek authorization dose

 
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