FDA Releases New COVID-19 Vaccine Guidelines Opposed by White House

By Mary Anne R. Oct 07 2020, 04:34 AM EDT

The Food and Drug Administration (FDA) has posted its updated COVID-19 vaccine standards on Tuesday for vaccine makers. This even after the White House blocked their formal release.

It marked the latest tug-of-war between the government's public health scientists and the Trump administration.

In its new posting, the FDA said that vaccine makers must follow trial participants for at least two months to rule out safety issues.

It should be done for at least two months before seeking an emergency approval to ensure that the COVID-19 vaccine is safe. That requirement would mean that a vaccine will not be cleared until after the presidential elections on Nov. 3.

Vaccine Makers

Moderna CEO Stéphane Bancel said that the company does not expect its vaccines to be ready to file for emergency use authorization until late November.

Bancel said the earliest would be Nov. 25 before the company can seek the emergency use approval. Under the company's phase three trial, a total of 15,000 participants received the second dose on Sept. 25.

President Donald Trump earlier said that a vaccine is on its way before Election Day. Top government scientists said that Trump's timeline is unlikely.

Recent reports noted that Moderna slowed enrollment on its late-stage trial as the company failed to enroll enough Black, Latino, and Native American participants. Enrolling enough number of minorities in the vaccine trials determine how the vaccine works in the populations.

COVID-19 Vaccine Being Politicized

FDA officials have warned that a public perception of a COVID-19 vaccine being rushed due to political pressure could affect efforts to vaccinate millions of Americans.

Pfizer CEO Albert Bourla said their company is moving at the speed of science and not political pressure.

"The only pressure we feel - and it weighs heavy - are the billions of people, millions of businesses and hundreds of government officials that are depending on us," Bourla said in a report.

The pharmaceutical giant's CEO added that Pfizer's priority is developing a safe and effective vaccine as he is a scientist. With nine other pharmaceutical companies, Pfizer signed a pledged in early September, promising to uphold the scientific process.

In a letter to colleagues, Bourla vowed to continue working together to build trust in the science as this is what they are doing in Pfizer. He added that it is a tragedy to have a safe and effective vaccine, but many people did not trust it.

"That is a risk none of us should accept," Bourla noted.

White House Blocking New FDA Guidelines

Top White House officials are blocking strict new federal guidelines for the emergency release of a COVID-19 vaccine.

Mark Meadows, the White House chief of staff, raised concern for the need for two-month follow-up data. Meadows said that stricter recommendations would change the rules in the middle of clinical trials.

FDA officials later justified the new addition to the guidelines, saying that the two-month follow-up was needed to note possible side effects. Aside from that, it was being required to ensure that the vaccine's protection is not short-lived.