Trump Promises COVID-19 Vaccine Will Arrive by End of 2020

President Trump vowed during his acceptance speech at the Republican National Convention that a coronavirus vaccine will be ready by the end of the year even as many experts continue to express skepticism about such an expedited timeline.

Speaking at the White House Thursday night, the president said that a COVID-19 vaccine will happen “before the end of the year or maybe even sooner.”

“We will defeat the virus, end the pandemic and emerge stronger than ever before,” Trump said.

The president has previously expressed hopes that a vaccine would be ready by the end of the year, but his acceptance speech marked the first time he has pledged one would arrive before the end of the year. The administration’s ambitious Operation Warp Speed initiative, which was announced in May, has a goal of delivering 300 million vaccine doses by January 2021 (DID, May 18).

Trump’s promise is raising additional accusations and concerns over mounting pressure by the administration on the FDA, an agency that some lawmakers and healthcare experts fear could bend to meet the president’s demands for approving COVID-19 treatments and vaccines before they’re adequately evaluated. The president previously accused agency officials of being politically biased and intentionally slowing research to delay a decision on vaccines or therapeutics until after the presidential election (DID, Aug. 26).

Former FDA Commissioner Scott Gottlieb said he believes it’s possible that a COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) by the end of the year, arguing that the data needed to justify the clearance is expected to arrive soon.

“I think that we’re going to have the data on the vaccines probably sometime in October is the most likely scenario,” he said. “And if they’re effective in those trials, if they demonstrate they’re safe and effective, you could have a vaccine available I believe under EUA for select populations before the end of the year.”

Approval for general use, which would make the COVID-19 vaccine widely available, will probably come a little bit later than Trump’s timeline, Gottlieb said, predicting that it wouldn’t occur until early next year.

“It is probably the case, if they are safe and effective in these large trials, you could potentially get them licensed for general use at some point in the first quarter of 2021,” he said.

NIH Director Francis Collins, however, has expressed doubts that phase 3 data would be ready for review by October unless everything goes perfectly, predicting that it is more likely to be available in November or December.

The FDA announced last week that it has set a date of Oct. 22 for a public meeting of the Vaccines and Related Biological Products Advisory Committee to discuss COVID-19 vaccine development, authorization and licensure in a general sense. The agency made clear that no specific vaccine applications would be discussed at the meeting although the agenda could change.

“We will be as open and transparent as possible about our review of a COVID-19 vaccine,” the agency said. “Science alone drives the agency’s regulatory decision-making.” — James Miessler