Pfizer could secure first US approval of COVID-19 vaccine: Trump
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* Trump told Fox News in an interview: “Pfizer’s doing really well,” adding “Johnson & Johnson … they’ll probably be a little later.” He also cited efforts by Moderna Inc and AstraZeneca
WASHINGTON: US President Donald Trump on Monday suggested Pfizer could secure the first US approval of a COVID-19 vaccine in coming weeks, saying a contender by Johnson & Johnson could come later.
Asked which drugmaker could be approved, Trump told Fox News in an interview: “Pfizer’s doing really well,” adding “Johnson & Johnson … they’ll probably be a little later.” He also cited efforts by Moderna Inc and AstraZeneca.
Pfizer too is betting that its coronavirus vaccine candidate will show clear evidence of effectiveness early in its clinical trial, according to the company and internal documents reviewed by Reuters.
Pfizer’s vaccine would need to be at least 76.9% effective to show it works based on 32 infections, according to its protocol. That would mean that no more than six of those coronavirus cases would have occurred among people who received the vaccine, the documents showed.
If the drugmaker’s vaccine does not meet the 76.9% efficacy target at this first interim analysis, it would face tougher statistical significance thresholds during subsequent interim assessments, biostatisticians who reviewed the protocol said.
Pfizer said its interim analyses were designed to show conclusive evidence “as quickly as possible amid the devastating pandemic if our vaccine meets the stringent standards set by FDA.
Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that, using a range of technology platforms, aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines produced by multiple manufacturers across the world.
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