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Pfizer-BioNTech Vaccine May Be Ready for Approval in October, But There Are Still 'Questions'

2020-09-08T17:33:26.318Z


Pfizer and BioNTech are confident they may have a novel coronavirus vaccine ready for regulatory approval in mid-October, Bio's CEO and co-founder told CNN ...


Pfizer-Biontech: Vaccine "could be approved in October" 0:43

(CNN) -

Pfizer and BioNTech are confident they may have a new coronavirus vaccine ready for regulatory approval by mid-October, BioNTech CEO and co-founder Ugur Sahin told CNN.


"He has an excellent profile and I consider this vaccine ... almost perfect, and he has a near perfect profile," Sahin said in an exclusive interview with CNN.

He added that the "understanding of the company's mode of action, combined with the security data from the running test" meant that they had "a lot of confidence" in it.

"Yes, we believe that we have a safe product and we believe that we will be able to demonstrate efficacy," he said.

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Sahin told CNN that he believes regulatory authorities will quickly grant approval for emergency use.

US pharmaceutical giant Pfizer and German firm BioNTech say they plan to provide 100 million doses of their candidate vaccine, BNT162, by the end of the year, and up to 1.3 billion doses in 2021.

Sahin states that antibody responses in both young and elderly adults have been shown to be strong so far, with minimal side effects.

"We don't see frequent fever," Sahin said.

“We also see much milder symptoms such as a headache or feeling tired.

And the symptoms seen with such vaccines are temporary, usually seen for a day or two and then disappear.

But while BioNTech and Pfizer say approval could happen in mid-October, federal officials have told CNN they think this is an optimistic timeline.

"I don't know of any scientist involved in this effort who thinks that we will inject our arms at any time before Election Day," an official who is familiar with Operation Warp Speed, the federal government's effort to develop vaccines against coronavirus.

Meanwhile, Moncef Slaoui, the senior advisor for Operation Warp Speed, told NPR last week that it is "extremely unlikely, but not impossible" that a COVID-19 vaccine could be licensed for emergency use by the Administration. US Food and Drug Administration before the end.

October.

President Trump, however, has opted for a faster schedule, saying in August that he was "optimistic" that a vaccine could be ready by November 3.

USA and Pfizer agree to mass distribution of vaccine 1:26

Source: cnnespanol

All news articles on 2020-09-08

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