The White House has been blocking the release of new guidelines for the emergency authorisation of vaccines, penned by the Food and Drug Administration (FDA) for two weeks now, as several biotech companies are approaching the end of COVID-19 trials, The New York Times reported, citing anonymous sources.
The new set of guidelines, which is a non-binding document outlining recommendations for pharmaceutical companies, reportedly suggests that trial subjects must be observed for two months after the last injection of a drug to ensure its safety and efficiency. The document was submitted by the FDA to the Office of Management and Budget for a review on 21 September, but has since been blocked by White House Chief of Staff Mark Meadows, The New York Times sources claimed.
Meadows reportedly objected to the introduction of the two month-observation period in the trials of the crucial vaccine against the coronavirus. He also suggested that the guidelines were heavily affected by the agency's career scientists, the NYT report said.
Should the reported guidelines be adopted and followed by pharmaceutical companies, authorisation of the COVID-19 vaccine before the 3 November election will be unlikely to happen. This, in turn, will go against the numerous hints that US President Donald Trump has made during speeches, suggesting that a significant breakthrough in developing the vaccine might be made in October. POTUS himself earlier dubbed the FDA's proposed guidelines as "a political move more than anything else".
Biotech companies, however, appear to diagree with the president as the industry's trade association urged the White House to release the guidelines to improve the drugs' reception among Americans.
"The public must have full faith in the scientific process and the rigour of [the] F.D.A.'s regulatory oversight if we are to end the pandemic", trade group BIO said in an official letter to the administration.
At least one company, competing in the development of a COVID-19 vaccine, Johnson & Johnson, has announced that it will be following the FDA's new guidelines regardless of whether they will be authorised for public release or not. This follows recent poll results by the Pew Research Centre, which showed a major drop in support for vaccination against COVID-19 among Americans – from 72% in May down to 51% in September – possibly marking a lack of faith in its safety or efficiency.