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COVID-19 – Pfizer to apply for authorization for a third dose of vaccine

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Trials are already underway for a third dose of Covid-19 vaccine, administered six months after the second, to increase the level of neutralizing antibodies. The possibility of a third dose of Covid-19 vaccine is beginning to materialize. The Pfizer/BioNTech alliance plans to apply for authorisation in the coming weeks, in the United States and Europe in particular, the companies announced in a statement. This booster dose is intended to provide enhanced immune protection to those 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, EMA and other regulatory authorities in the coming weeks,” they added in reference to the US and European Medicines Agencies.“Preliminary study data show that a booster dose given six months after the second dose has a consistent tolerance profile, while generating high levels of neutralizing antibodies” against the virus, including the Beta variant, appeared in South Africa. These levels are “five to ten times higher” than those observed after the two initial doses.

Decline in efficiency expected
The two companies also pointed out that their vaccine had shown good laboratory results 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. The results of this study will be published in a scientific journal.

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“Although 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’s why we said, and we continue to believe, that it is likely, based on the totality of the data we have now, that a third dose may be required between 6 and 12 months after vaccination,” he added.

The U.S. drug agency, the FDA, and the lead federal public health agency, the Centers for Disease Prevention and Control, issued a joint statement on Thursday night that said they are studying “the need for a recall or not”.“Americans who have been fully vaccinated do not need a recall at this time,” the two health authorities say. “We are prepared to administer booster doses if and when science has shown that they are needed,” they added.

In France, the Prime Minister has already taken a position on the most vulnerable.On his way to Blois on Thursday, he explained that for these people, “who were vaccinated first both because they are vulnerable and this vaccination was done early,” a “third dose” would be needed.

Source : Le Parisien

       

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