White House Blocks New Coronavirus Vaccine Guidelines
The White House is blocking new coronavirus vaccine guidelines from the Food and Drug Administration over concerns they will push emergency authorization past the November election, according to The New York Times.
- At issue is the recommendation that authorization not be granted until volunteers who participated in the vaccine clinical trials have been followed for a median of two months after receiving their final dose.
- The FDA submitted the guidelines to the Office of Management and Budget over two weeks ago, but they are hung up in the office of White House chief of staff Mark Meadows over political concerns.
- FDA officials later explained further to the White House “that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19…was not short-lived," The Times reported.
- The White House blockade has not yet budged, so the FDA is seeking other avenues to make sure the vaccines meet new guidelines. This includes sharing the standards with an outside advisory committee of experts.
- FDA officials hope the committee, which is supposed to meet publicly prior to the emergency authorization of any vaccine, will enforce the guidelines no matter the White House’s reaction.
By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.
A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.
- Per the NYT, “Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.”
- The most likely candidates for receiving any vaccine that achieves emergency authorization are high-risk populations like health care workers, The Times noted.
In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.
The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.
- The Washington Post noted that "President Trump has repeatedly said a vaccine would be ready by Nov. 3, and many scientists fear he might attempt to intervene in a review process designed to boost public trust in a vaccine."