US President Donald Trump has expressed his anger as the US Food and Drug Administration posted new guidance on Tuesday for companies hoping to get emergency use authorisation for coronavirus vaccines, stating they will have to include at least two months of follow-up after volunteers get their second dose of the vaccine.
The US Food and Drug Administration’s decision means no company could seek an emergency use authorisation for a COVID-19 vaccine before mid-November, because the vaccines furthest along in clinical trials – those made by Pfizer and Moderna – both require waiting either 21 or 28 days between doses.
The decision dashed any hope the US President had of announcing a vaccine to treat COVID-19, which has killed almost 212,000 people in the US, before the election on November 3.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA
— Donald J. Trump (@realDonaldTrump) October 7, 2020
“Being open and clear about the circumstances under which the issuance of an emergency use authorisation for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Dr Peter Marks, who directs the US Food and Drug Administration’s Center for Biologics Evaluation and Research.
“The FDA’s new guidance on emergency use authorisation of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorisation decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorised or approved.”
Dr Francis Collins, director of the country’s National Institutes of Health, said he is optimistic that the US will have a vaccine by the end of this year or the beginning of 2021.
“I’m one of those who’s optimistic we will have one or more vaccines that turn out to be safe and effective by sometime around the end of this year, maybe a little bit into January,” he said.
The politicisation of the vaccine development process has been a distraction, one that has polarised many people, Collins said during a Johns Hopkins University and University of Washington virtual symposium on vaccine development.
“Putting all that aside and dealing with the fact that we have this huge problem of vaccine hesitancy that needs to be dealt with, I am still guardedly optimistic that come 2021, we’re going to be on a path – over many months, let’s not talk about this being a quick solution, but on a path – where we can eventually put COVID-19 in the rear view mirror, although we will be changed by it, and I think he will be around us globally for quite a long time to come,” said Collins.
Moderna CEO Stephane Bancel told the Financial Times it would have sufficient safety data to put in an emergency use authorisation submission to the US Food and Drug Administration on November 25. With the US Food and Drug Administration’s new guidelines it would not be approved until the late first quarter of 2021 or even the early second quarter of 2021, he forecasted.