It looks like President Donald Trump’s hope that America will have a coronavirus vaccine before the election may not come true.
Pfizer, one of the major pharmaceutical companies working to produce such a vaccine, announced that it will not seek emergency authorization for its vaccine until at least the third week of November.
This information comes by way of a statement that Pfizer recently posted to its website.
“There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use,” Pfizer CEO and Chairman Albert Bourla wrote. “First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.”
Causing the delay appears to be the second prong and the fact that the Food and Drug Administration (FDA) recently altered its Emergency Use Authorization requirements. Bourla writes that the FDA now “is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine.”
According to Bourla, this means that Pfizer would not be able to seek Emergency Use authorization until “the third week of November.”
“Just another political hit job!”
President Trump tweeted in response that the “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day.”
Critics have argued that the goal of having a vaccine before the election is a politically motivated one. This, in turn, has eroded public confidence in a potential vaccine, which appears to be why the FDA and pharmaceutical companies have taken steps to reaffirm that confidence.
The result, though, is no vaccine until at least mid-November. While multiple other pharmaceutical companies are working on vaccines, Pfizer was the last one that still had a chance to be approved pre-election, according to Politico.
It’s not all bad news
The good news is that companies like Pfizer clearly seem to be making enormous strides in their quest for a coronavirus vaccine. The $10 billion that the Trump administration has dedicated to a vaccine-development initiative known as Operation Warp Speed appears to be paying off.
Recently, Pfizer has even released footage of its potential coronavirus vaccine being mass-produced. The company claims to have produced several hundred thousand of the 100 million doses it plans to have available by the end of the year, if it is approved.
The coronavirus’ days appear to be numbered.