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“He has an excellent profile and I consider this vaccine … almost perfect, and that he has a near perfect profile,” Sahin said in an exclusive interview with CNN.
US pharmaceutical giant Pfizer and German company 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.
In July, the US Department of Health and Human Services and the Department of Defense announced a $ 1.95 billion agreement with Pfizer to produce 100 million doses of a Covid-19 vaccine. The agreement also allows the United States government to purchase an additional 500 million doses.
Sahin told CNN that he believes approval for emergency use will be granted quickly by regulatory authorities, adding that the “understanding of the company’s mode of action, in combination with safety data from the running test “means they have” a lot of confidence “in him.
“Yes, we believe that we have a safe product and we believe that we will be able to demonstrate efficacy,” he said.
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. Therefore, only a small proportion of the participants in this trial have a fever,” Sahin said. “We also see much lower symptoms like a headache or feeling tired. And the symptoms that you see with such vaccines are temporary, usually seen for a day or two and then disappear.”
“I do not know of any scientist involved in this effort who thinks we will be getting gun shots at any time before Election Day,” an official who is familiar with Operation Warp Speed, the federal government effort, previously told CNN. to develop vaccines against the 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 Food and Drug Administration. US drugs before the end. October.
President Trump, however, has responded for a faster schedule, saying in August that he was “optimistic” that a vaccine would be ready by November 3.
“[It’s] it will be done in a very short period of time, it could even do it during the month of October, “the president said at a press conference on Monday. We will have the vaccine soon, perhaps before a special date. You know what date I’m talking about. “
Sahin told CNN that he believes regulatory authorities will quickly grant approval for emergency use.
Still, BioNTech and Pfizer were two of nine biopharmaceutical companies that signed an unusual pledge to maintain “high ethical standards,” suggesting that they will not seek premature government approval for the Covid-19 vaccine.
This pledge, released Tuesday, states: “We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”
Sahin told CNN that companies will quickly obtain regulatory approval for their vaccine once the candidate is submitted, adding: “I believe, given that we have addressed the full package that is required for vaccine development, including scientific studies, Preclinical studies, safety tolerability “. trials and evidence of efficacy, there shouldn’t be too much time between authorization for emergency use and full approval. “
Elizabeth Cohen and Wesley Bruer contributed reporting.
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