“We were never part of Warp Speed,” she said. “We haven’t taken any money from the US government or anyone.”
She said she heard about the results from the external expert group shortly after 1 p.m. on Sunday, and that the timing was not affected by the election. “We have always said that science drives our behavior – not politics,” she said.
The data released by Pfizer Monday was published in a press release, not an peer-reviewed medical journal. There is no conclusive evidence that the vaccine is safe and effective, and the initial finding of greater than 90 percent effectiveness could change as the study progresses. “We need to see the real data and we will need longer-term results,” said Jesse Goodman, professor of medicine and infectious diseases at Georgetown University.
Yet so far, the scientists have been baffled by the data.
“That’s a spectacular number, really,” said Akiko Iwasaki, an immunologist at Yale University. “I didn’t expect it to be that high. I prepared for about 55 percent.”
If the final vaccine achieved that effectiveness it would “be higher than your regular flu vaccine, and that vaccine could have a serious impact on the curve of this outbreak’s curve,” said Dr. Saad B. Omer, the director of the Yale Institute for Global Health.
Dr. Jansen said an independent board of directors reviewing the data had not given her or other company executives any additional details, such as how many of the people developed mild or severe forms of Covid-19 – crucial information the FDA said said that every coronavirus vaccine needs to be evaluated. The agency has also requested other detailed data that could take weeks to review, including how the company plans to make millions of cans and ensure the product is consistent and safe.
The study is expected to continue until 164 people in the 44,000-person study develop Covid-19. It also assesses how well it protects against developing severe forms of the disease and how well the vaccine protects people who are already infected with the coronavirus.