New York: US Food and Drug Administration Commissioner Stephen Hahn described Thursday’s landmark meeting of his agency’s vaccine advisory panel to decide on emergency use authorisation for Pfizer’s Covid-19 vaccine as “an important day for all of America”.
“I have 100 per cent confidence, and I think the American public should as well, with respect to our review of the safety and efficacy of the vaccine,” Hahn told multiple TV networks. He spoke to ABC, CBS and NBC on Thursday.
The FDA’s historic ascience court’ opened at 9 am EST on Thursday as a high powered team of US regulators and independent experts who make up the Vaccines and Related Biological Products Advisory Committee (VRBPAC) kicked off an all-day debate on Pfizer’s Covid-19 vaccine.
The US FDA is expected to go along with the advice of the VRBPAC and there is no deadline for a decision. “We want people to see this discussion, to see the issues that are brought up, and have a vigorous discussion of the data elements by the outside experts,” Hahn said.
When vaccinations do begin, healthcare workers and nursing home residents will be first in line.
Pfizer and its German partner BioNTech have reported their shots are 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study. The efficacy results are based on 170 infections. Only eight of the infections were among volunteers who got the vaccine; the rest were among those who got dummy shots.
New revelations this week show that the Trump administration this summer passed up a chance to buy millions of additional doses of the Pfizer vaccine and this could significantly delay the second batch of doses early next year. Under its contract with Pfizer, the Trump administration committed to buy an initial 100 million doses and opted not to lock in an additional 100 million doses for delivery in the second quarter of 2021.
By Nikhila Natarajan