Sept. 13 (UPI) — Pfizer CEO Albert Bourla on Sunday said there is a good chance the company will know whether its COVID-19 vaccine candidate will work by the end of October, but was unsure how long it would take to receive approval.
Appearing on CBS News’ Face the Nation, Bourla said that the study of the effectiveness of its vaccine candidate has “recruited very quickly” as it increases from 30,000 participants to 44,000 participants, adding Pfizer feels “quite comfortable” with the safety of the product.
“In our base case, we have quite the good — it’s more than 60% that we will know if the product works or not by the end of October. But of course, that doesn’t mean that it works. It means we will know if it works,” he said.
Last month Pfizer said its vaccine candidate was on track for regulatory review as early as October, as the novel coronavirus has sickened 6,496,159 people in the United States and resulted in 193,787 deaths, according to data collected by John’s Hopkins University.
Bourla said on Sunday he could not say whether the American people will have to wait until 2021 to receive the vaccine, but said Pfizer is preparing for the “likely scenario” that the Food and Drug Administration will approve it for distribution before the end of this year.
“We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA plus the advisory committee feels comfortable that we will be ready,” he said.
FDA Commissioner Stephen Hahn said last month that the FDA would be willing to grant an emergency use authorization — which is short of full approval — to COVID-19 vaccine candidates, as it did with convalescent plasma treatments following criticism by President Donald Trump.
California leads the United States in COVID-19 cases with 754,923 cases, including 4,625 new cases reported Sunday. The state also reported 78 new deaths for the third highest total in the nation at 14,329.
Florida reported 2,243 new cases for the second highest total in the nation at 663,994 and eight new deaths — its lowest total since June 15 — for a death toll of 12,764, fifth in the nation.
Texas has reported the third highest case total in the nation at 657,589 as of Saturday, in addition to the fourth highest death toll with 14,143.
New York reported 725 new cases for the fourth highest total in the United States at 44,365, along with six new deaths, adding to its nation-leading death toll of 25,390, after having been the U.S. epicenter for the virus.
Georgia tallied the fifth highest case total in the nation at 292,905 along with 6,287 deaths , 10th in the country as of Saturday.