Pfizer and BioNTech’s COVID-19 vaccine candidate, if proven to be safe and effective by federal regulators, could reach Americans before 2020-end, according to Pfizer CEO Albert Bourla.
"I cannot say what the United States Food and Drugs Administration (FDA) will do, but I think is a likely scenario and we are preparing for it," Bourla said during American channel CBS’ “Face the Nation” segment.
He said they “will be ready” in case of good indicators from the vaccine study, FDA and advisory committee and have already “started manufacturing and have already manufactured hundreds of thousands of doses” in preparation, Fox Business reported.
According to Bourla, Pfizer’s study will show if there is a “good chance if the product works” by October-end, the distribution would depend on license issuances from regulators such as the FDA.
The vaccine candidate is moving towards Phase 3 trial with 30,000 participant enrolment targeted by next week. Overall Pfizer is aiming for close to 44,000 participants, so as to increase diversity and include more vulnerable populations, adolescents as young as 16 and individuals with chronic conditions such as HIV, Hepatitis C or B, it added.
“I think we should strive to have as more a diverse population as possible, but right now we are not bad. We try of course to increase it, particularly an emphasis on African-Americans and Latinos.” Bourla added.
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Pointing out that Pfizer turned down inclusion in the US government’s $10 billion Operation Warp Speed initiative for accelerated COVID-19 vaccine development, Bourla said this was done in an effort to "liberate our scientists from any bureaucracy” as “money from someone always comes with strings” and would entail providing detailed and continuous progress reports.
“I didn't want to have any of that. I gave them an open chequebook so that they can worry only about scientific challenges, nothing else. I also wanted to keep Pfizer out of politics, by the way,” he said.
Acknowledging that the candidate could fail, Bourla argued that any potential financial hit – despite the $1.5 billion investment, would not break the company.
The US has signed a $1.95 billion agreement with Pfizer and BioNTech for at least 100 million doses of its coronavirus vaccine after it is approved by the FDA, with room for acquisition of another 500 million doses.
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