All seniors, health care workers, first responders and vulnerable individuals could be vaccinated against COVID-19 by the end of January, the U.S. Department of Health and Human Services (HHS) Secretary Alex Azar told reporters Wednesday (Oct. 21) during a news briefing.
But this ambitious timeline rests on a critical factor: enough data to know that the vaccine is safe and effective. Not even the drug companies conducting late-stage phase 3 clinical trials know yet if their candidate vaccines meet those standards.
The question of “when” we will know whether those vaccines are safe and effective “will really be dependent on events in the trial. That’s outside of anyone’s control,” Azar said. In order to understand whether or not a potential vaccine is protective against COVID-19, enough people enrolled in the trial need to be exposed naturally to the virus.
Pharmaceutical giant Pfizer, which is testing one of the leading vaccine candidates in the U.S., expects to have enough safety and efficacy data by the third week of November. Assuming the results are positive, the company will at that point apply for emergency use authorization (EUA) in the U.S., according to a statement published online Oct. 16 by the company’s Chief Executive Officer Albert Bourla.
But even if vaccines are approved, it’s not clear how long it will take to manufacture and distribute them to everyone in the U.S. As part of the government’s Operation Warp Speed, many of the leading vaccine candidates are already being manufactured prior to trial results. These vaccines will be ready to be distributed before they are given approval, Azar said.
By the end of the year, officials expect that there will be enough FDA-authorized vaccine to be able to vaccinate the most vulnerable individuals, Azar said. “Then by the end of January, we expect we’ll have enough to vaccinate all seniors as well as our health care workers and first responders. And by the end of March to early April, enough vaccine for all Americans who would want to take a vaccine.” However, he did not mention children, an age group on which the leading vaccines have not yet been tested and who will thus likely receive a vaccine much later.
“Having a vaccine ready is one thing, being able to deliver it is yet another,” said Dr. William Schaffner, an infectious-diseases specialist at Vanderbilt University in Tennessee. “I think that process will take much longer than this timeline.”
One of the reasons for that is public skepticism on the safety and efficacy of COVID-19 vaccines, which runs high especially in African American and ethnic communities that have been disproportionately affected by the virus, Schaffner told Live Science. Surveys have shown that as many as half of Americans do not trust these vaccines, he said. That’s because “this whole process is so politicized, unfortunately.”
When a vaccine is approved, assuming that it meets the standards of efficacy and safety and has been thoroughly vetted by