Pfizer Inc. (PFE) CEO Albert Bourla said an update could be provided on the late-stage trial of their vaccine candidate for coronavirus (COVID-19) as early as October 2020.
“We are in a very advanced stage” and have already enrolled 23,000 out of the required 30,000 volunteer patients for the ‘big pivotal’ Phase 3 trial that began in late July,” he said.
Bourla was speaking at the Global Biopharma CEO / Top Execs virtual press briefing-COVID-19 Therapeutics conducted by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) on Thursday. IFPMA represents the research-based pharmaceutical companies and associations across the globe.
IFPMA organized a virtual press briefing with CEOs and top executives who are at the forefront of biopharmaceutical R&D. They included Eli Lilly Chairman and CEO David Ricks, Gilead Chairman and CEO Daniel O’Day, MSD Chairman and CEO Kenneth Frazier, Roche CEO Severin Schwan, apart from Bourla.
In the face of an unprecedented public health and economic crisis, the world’s leading innovative vaccine companies are working in partnership with international organizations, governments, academia and many others across the world in answering the call to develop novel vaccines against SARS-CoV-2.
Pfizer is co-developing the potential vaccine candidate BNT 162 with German drug maker BioNTech SE (BNTX). BNT162 is an mRNA-based vaccine candidate against SARS-CoV2.
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.
Bourla said he expects to know if the vaccine works, by the end of October, and is planning to submit it for authorization or approval to the U.S. Food and Drug Administration at the same time, assuming clinical success.
However, Bourla confirmed that they “will not cut corners” in fast-tracking the vaccine and phase 3 study results will be the basis for the submission for authorization or approvals. He assured that, “we will never ourselves submit for authorization or approval any vaccine before we feel that it is safe and effective.”
Bourla said this amid political pressure on the FDA to issue at least an emergency use authorization (EUA) for a vaccine candidate before the upcoming presidential elections on November 3. President Donald Trump has said a vaccine will be available by the end of 2020.
Pfizer recently announced its plans to supply up to 100 million doses worldwide by the end of 2020, and approximately 1.3 billion doses by the end of 2021.
Source: Read Full Article