Pfizer-BioNTech to request authorization for a 3rd Covid shot: press release
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Washington (AFP)
Pfizer and BioNTech announced Thursday that they will seek regulatory approval for a third dose of their Covid-19 vaccine.
It comes after initial data from an ongoing trial showed that a third hit pushed antibody levels five to 10 times higher against the original coronavirus strain and the beta variant, first found. times in South Africa, compared to the first two doses alone, according to a statement.
“The companies plan to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the Food and Drug Administration (FDA), EMA (European Medicines Agency) and others. regulatory authorities in the coming weeks, “the statement said.
In addition, the companies expect a third dose to be equally effective against the highly transmissible strain Delta, which is rapidly becoming dominant globally.
To be on the safe side, the companies are also developing a vaccine specific to Delta, the first batch of which was manufactured at BioNTech’s plant in Mainz, Germany.
The companies expect clinical studies to begin in August, subject to regulatory approvals.
The companies added that, based on the drops in efficacy seen in Israel after six months, they believe a third dose may be needed within six to 12 months of the full vaccination.
“While protection against serious illness has remained high for the full 6 months, a decline in efficacy against symptomatic illnesses over time and the continued emergence of variants are expected,” the statement said.
© 2021 AFP