Pfizer CEO Albert Bourla said on Sunday that it is a “likely scenario” that the company’s coronavirus vaccine could be distributed to Americans before the new year if it’s proven by federal regulators to be safe and effective.
“I cannot say what the FDA will do, but I think is a likely scenario and we are preparing for it,” Bourla said in an interview on CBS’ “Face the Nation.” “We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA, plus the advisory committee feels comfortable, that we will be ready.”
Though Bourla said Pfizer’s studies show that there’s “a good chance that we will know if the product works by the end of October,” he noted that distribution before the end of the year ultimately comes down to if and when regulators like the Food and Drug Administration issue a license.
Pfizer’s vaccine candidate, which is being developed in partnership with BioNTech, is moving to its Phase 3 trial and is expected to reach its initial enrollment target of 30,000 participants by next week.
The pharmaceutical giant has announced plans to expand its trial to approximately 44,000 participants to increase the diversity of those involved in the study and to include more vulnerable populations, like adolescents as young as 16 years old and people with chronic stable conditions like HIV, Hepatitis C, or Hepatitis B infection.
“I think we should strive to have as more a diverse population as possible, but right now we are not bad, actually. We have a population that globally, only 60% are Caucasians, 40% approximately minorities,” Bourla said. “Also, 44% are older people. We try of course to increase it, particularly an emphasis on African-Americans and Latinos.”…Read more>>