DENVER (CBS4) – President Donald Trump continues to insist a COVID-19 vaccine could be approved before the presidential election, but Health and Human Services Secretary Alex Azar is not committing to a Nov. 3 deadline. Azar said the “timing will be what the timing is” and it will be up to the Food and Drug Administration.
“At the end of the day it’s going to be the FDA making the call on whether a vaccine is safe and effective for the American people,” Azar told CBS4’s Political Specialist Shaun Boyd.
Azar insists politics will play no role in the approval of a vaccine despite a New York Times article that said the White House tried to block release of new FDA guidelines that would delay a vaccine until after the election.
Azar wouldn’t comment on the article but said, “The FDA has communicated with the manufacturers already what it would expect to and want to see in terms of emergency use authorization.”
The White House reportedly dropped its objection to the guideline, which recommends trial participants be followed for two months after the last dose before the vaccine is approved. Azar said the approval process is multi-layered.
“We don’t even get data out of clinical trials until an independent data and safety monitoring board concludes that the data standard has been met,” said Azar. “Second, the drug company has to determine the data meets their independent ethical standards to submit an application for approval. Third, the FDA has published the standards and the data that it expects to see and will hold the manufacturers to. And fourth, there will be an independent advisory committee process that’s public to review that information and give FDA advice. And fifth, it will be the career officials at FDA who will make the decision on approving a vaccine.”
Pharmaceutical companies aren’t waiting for approval to begin manufacturing. Azar said they are producing millions of doses as they test their vaccines and, he says, everyone who wants a vaccine will be able to get one by late March or early April of next year.
“Vaccines will start being distributed within 24 hours of an FDA authorization,” said Azar.
While we don’t have a COVID-19 vaccine, we do have a flu vaccine and Azar strongly recommended getting that. He also said Trump has also ordered the distribution of 150 million rapid tests, most of which, he says, will likely go to schools.