The White House finally bowed to pressure and agreed to the FDA’s guidelines for vetting COVID-19 vaccines. This means that COVID-19 vaccines are not likely to be ready before the November 3 presidential election. This would have served as a powerful campaign tool by the Trump campaign organization if the vaccines had been available.
The FDA had on Tuesday released the guidelines, saying it would help the public put things into perspective on the manner the agency uses only science-based decisions to approve or authorize any vaccine designed for the public. It said its processes assure the public of quality, safety, and efficacy of any vaccine that will be approved.
A senior official of the drug agency had said the White House was withholding the guidelines for review, and when it was eventually approved, it was without changes.
Senior Trump officials were vocal on disapproving the guideline because of the length of time needed for its observation (a two-month observation period is required in order to evaluate how people responded to the vaccine, especially its adverse side effects).
The two-month observation period does nothing but close any hopes that vaccines will be ready before the country goes for the presidential election. This is a target analysts said President Trump was trying to meet in order to add it to his retinue of achievements during campaigns that will be rounding off in a few weeks.
Trump had earlier tweeted and tagged the official handle of the head of the Drug Regulatory Agency, Stephen Hahn. In his tweet, President Trump said, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”
It is reported in some media that White House officials, particularly Chief of Staff to the President, Mark Meadows, and the Office of Management and Budget (OMB), had refused to sign the guidelines during discussions with FDA officials.
A spokesperson for the OMB responded to these allegations by saying that the OMB had never opposed the FDA guidelines. Meadow, a social official of the Trump administration, was only trying to be certain that the FDA was not acting out of political considerations. He had wanted to know why the FDA would suddenly change the protocols that it had used in approving vaccines in the past – for decades now.
The FDA is, however, ready to go ahead with its stated guidelines even if the president would not sign it – this it had indicated in its plans to policymakers.