President Donald Trump, shown walking to Marine One at the White House on Thursday, promised that a coronavirus vaccine would be ready before Nov. 3, but Pfizer said Friday its candidate will not be ready until mid-November at the earliest. Photo by Ken Cedeno/UPI | License Photo
Oct. 16 (UPI) -- The chairman of Pfizer said Friday the drugmaker will not have a coronavirus vaccine ready until mid-November at the earliest, despite President Donald Trump's prediction that a vaccine would be ready before the Nov. 3 election.
Pfizer chairman and CEO Albert Bourla issued a public letter he said was meant to clear up confusion about its effort to produce an effective vaccine for COVID-19. His company is one of the leaders in the work of making a vaccine that could protect people from the virus.
"We are operating at the speed of science," Bourlas said in the letter.
He said that while the company may know whether its vaccine works by the end of October, it also must prove that the vaccine meets safety requirements and that quality and consistency will be maintained in manufacturing.
"Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November," he said. "Safety is, and will remain our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years."
The Food and Drug Administration said this month it would not review coronavirus vaccine applications unless safety data is available that reaches past a median of two months.
For that to occur for Pfizer, it would need to wait for half of its volunteers in the trial to have been followed for two months before the drugmaker could make its application to the FDA.
President Donald Trump has clashed with health officials, calling the FDA politically motivated in its plans to tighten study requirements to ensure a vaccine is safe and effective and threatening to overrule the agency.