While President Donald Trump has focused on a vaccine as a major component of his administration’s COVID-19 response, he received some disappointing news on that front this week.
Pfizer, a major pharmaceutical firm working on the massive undertaking, announced that it will not seek emergency authorization for its vaccine trial prior to the general election, as reported by National Review.
“Three key areas”
The company announced its update in a statement 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,” wrote Pfizer CEO and Chairman Albert Bourla. “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.
The delay in testing appears to be related to the second requirement, as Bourla explained, noting that the Food and Drug Administration “is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine.”
Current projections indicate that the trial will “reach this milestone in the third week of November.”
While Trump has repeatedly stated his desire to see a vaccine available by the end of this month, detractors have described the pursuit as a politically motivated tactic tied to the upcoming election.
“Just another political hit job!”
As a result of the push for preventative care against the ongoing pandemic, the FDA has released new guidelines regarding how it would evaluate a vaccine for emergency-use authorization.
Those new regulations have led to Pfizer and other firms to take additional steps to reassure the public that such vaccines would be safe and effective.
According to the president, FDA officials are the ones motivated by partisanship, not him.
“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day,” he tweeted on Oct. 6. “Just another political hit job!”
Regardless of what his critics might say, it is clear by the $10 billion that the Trump administration has dedicated to a vaccine-development initiative known as Operation Warp Speed that he is committed to tackling this virus as completely and quickly as possible.