White House Blocks FDA Guidelines on COVID-19 Vaccine

By Mary Anne R. First Posted: Oct 06, 2020 05:38 AM EDT

The White House has blocked a new Food and Drug Administration (FDA) guidelines on approving a potential COVID-19 vaccine to the market.

The said guidelines would almost certainly prevent a potential COVID-19 vaccine approval before the Nov. 3 election.

The issue was the FDA's planned requirement that participants in the ongoing clinical trials for nearly a half-dozen vaccine candidates be followed for two months to make sure there are no side effects and that the vaccines will provide lasting protection from the virus to receive an emergency approval.

A senior administration official confirmed the move on Monday evening, saying that the White House believed there was "no clinical or medical reason" to add other screening protocols.

FDA Commissioner Stephen Hahn noted that career scientists would decide whether any COVID-19 vaccine meets the requirements. He said it would be the scientists who will determine if it is safe and effective, not the politicians.

Vaccine development typically takes years, but scientists have been racing to deliver in a shorter time. Hahn said that science will guide their decisions and the FDA will not allow any pressure from anyone to change that.

"I will put the interest of the American people above anything else," Hahn said in a report.

The FDA has received backlash for allowing emergency use of some COVID-19 treatments with little evidence. Hahn said if vaccine makers want a faster path to market, they would face additional standards.

Unlike therapies, vaccines are given to healthy people and usually require more proof.

President Donald Trump made clear last month that he was skeptical of any regulatory changes that might delay authorization. Even if these changes in authorizations would increase public trust.

Trump suggested that the effort of FDA to consider stricter guidelines for emergency approval was politically motivated.

"I think that was a political move more than anything else," Trump noted. He added that they have tremendous trust in these massive companies.

The senior administration official said the White House was determined on getting a safe vaccine to market and wanted to make sure there are no additional loopholes that would slow down the process.

Meanwhile, three patients taking part in Moderna and Pfizer's clinical trials reported having serious side effects, according to a report. These side effects include high fever, pounding headaches, intense chills, and exhaustion.

One participant in the Moderna study, named Luke Hutchinson, said he awoke late at night with chills and a fever after being given the second of two COVID-19 vaccine shots during the trial.

One participant in Pfizer said to experience similar side effects after being given a second dose of the company's two-dose candidate.

Moderna CEO Stéphane Bancel said he thinks his company's vaccine will be ready for use in late March or early 2021.

Bancel went on to say that Moderna will not be ready to submit the vaccine to the FDA for a Biologics License Application (BLA) until at least late January 2021.

A BLA is a request for permission to full license a drug to the general population. According to Bancel's timeline, March would be the earliest time the drug can be approved.