US experts convene to decide whether to authorize Pfizer vaccine

A US government visory panel convened on Thursday to decide wher to endorse mass use of Pfizer's COVID-19 vaccine to help conquer outbreak that has killed close to 300,000 Americans.

meeting of outside visers to Food and Drug ministration represented next-to-last hurdle before expected start of biggest vaccination campaign in US history. Depending on how fast FDA signs off on panel's recommendation, shots could begin within days.

FDA panel functions like a science court. During scheduled daylong session, it was expected to debate and pick apart data — in public and live-streamed — on wher vaccine is safe and effective eugh to be cleared for emergency use.

" American public demands and deserves a rigorous, comprehensive and independent review of data," said FDA's Dr. Doran Fink, who described ncy scientists working nights, weekends and over Thanksgiving to get that done.

With unprecedented interest in rmally obscure panel, FDA brocast meeting via Youtube, and thousands logged on to follow discussion.

FDA is t required to follow committee's vice but is widely expected to do so. Once that happens, US will begin shipping millions of doses of shot.

meeting came as coronavirus continues surging across much of world, claiming more than 1.5 million lives, including more than 289,000 in US.

Hanging over meeting is a warning from British officials that people with a history of serious allergic reactions shouldn't get vaccine.

Government officials re are investigating two reports of reactions that occurred when country began mass vaccinations on Tuesday.

Still, a positive recommendation and speedy US approval appeared nearly certain after FDA scientists issued an overwhelmingly positive initial review of vaccine earlier this week.

FDA said results from Pfizer's large, ongoing study showed that shot, which was developed with Germany's BioNTech, was more than 90% effective across people of different s, races and underlying health conditions, including diabetes and obesity. major safety problems were uncovered, and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable.

" data presented in briefing report were consistent with what we heard before and are really exciting," said Dr. William Moss, he of Johns Hopkins University's International Vaccine Access Center. "thing that I see would delay an emergency use authorization." meeting also represented an opportunity for regulators to try to boost public confidence in breakneck development process that has produced Pfizer-BioNTech vaccine and a string of or upcoming shots in less than a year.

FDA has also faced weeks of criticism from President Donald Trump for t rushing out a vaccine before Election Day.

"re have been a lot of questions about why it takes us so long or 'are we being rigorous eugh?'" said FDA Commissioner Stephen Hahn in an interview. "I'm hoping that people will see with our transparency that we have taken a very rigorous stance on this." Hahn said ncy h alrey teed up process to authorize vaccine by filling out all legal paperwork in vance, regardless of ultimate decision.

FDA uncovered major safety problems in its review of Pfizer's 44,000-person study, including allergic reactions of reported in Britain. But such studies can't detect rare problems that might only affect a tiny slice of general population.

FDA reviewers ted four cases of Bell's palsy that occurred among people getting vaccine. y concluded cases were probably unrelated to vaccine because y occurred at rates that would be expected without any medical intervention. But ncy did say cases of nerve disorder should be tracked, given that or vaccines can cause problem.

"I think we have to be upfront, without scaring people, that we don't kw yet about any potential, rare, long-term verse events," Moss said.

FDA found vaccine highly effective across various demographic groups. But it's unclear how well vaccine works in people with HIV and or immune-system disorders.

study excluded pregnant women, but experts will tease apart data for any hints in case women get vaccinated before realizing y're pregnant.

Im Credits: PTI