Story at a glance
- The vaccine candidate created by Pfizer and BioNTech is reportedly revealing positive results with limited side effects.
- Officials caution that October is a very optimistic timeline.
In the race to develop a coronavirus vaccine, frontrunners Pfizer and BioNTech have announced that its vaccine will be ready for regulatory approval by mid-October or early November, BioNTech CEO and co-founder Ugur Sahin told CNN Tuesday.
“It has an excellent profile and I consider this vaccine … near perfect, and which has a near perfect profile,” Sahin told reporters.
Pfizer, a U.S. company, and BioNTech, a German company, intend to provide 100 million doses of their vaccine, called BNT162, by the end of 2020. The joint venture aims to supply an additional 1.3 billion doses in 2021.
Pfizer is one of the companies chosen to receive federal funding as part of President Trump’s Operation Warp Speed, an initiative to expedite the development of an effective coronavirus vaccine.
In July, the U.S. Department of Health and Human Services announced the signing of an agreement worth $1.95 billion with Pfizer to produce 100 million doses of its vaccine candidate.
Sahin told reporters that he believes the U.S. Food and Drug Administration (FDA) will grant BNT162 an emergency use authorization to be given to ill patients. He added that the company has high confidence in its drug primarily due to the safety data coming out of clinical trials. So far, the drug has produced favorable antibody results in a diverse set of patients.
“We believe that we have a safe product and we believe that we will be able to show efficacy,” Sahin said.
Side effects have been minimal, with only slight fevers, drowsiness and headaches.
Despite Sahin’s optimism, other officials are cautioning against this extremely hopeful timeline. Anthony Fauci of the White House Coronavirus Task Force has repeatedly estimated that a successful candidate will emerge toward the end of 2020 or beginning of 2021.
Similarly, Moncef Slaoui, the chief adviser to Operation Warp Speed, reportedly told NPR that it is “extremely unlikely, but not impossible” that an effective COVID-19 vaccine will be ready by October.
This announcement follows a rare joint statement issued by the leading drug companies involved in Operation Warp Speed, including Moderna, AstraZeneca, as well as Pfizer, all of which pledged that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
The statement attempts to assuage concerns of political influence in the approval of a vaccine candidate, with reports of President Trump exerting presidential pressure on the FDA to approve various treatments, including convalescent plasma, which has mixed data regarding effectiveness.