Pfizer COVID-19 vaccine is the final hurdle before US decision

Pfizer COVID-19 vaccine is the final hurdle before US decision

Washington: Pfizer’s COVID-19 vaccine faces one final hurdle as it becomes the first shot greenlight in the US: a panel of experts who will examine the company’s data for any red flag.
Thursday’s meeting of the Food and Drug Administration’s Vaccine Advisory Panel is the last step ahead of the US decision to shipping potentially millions of doses of shot, demonstrating strong defenses against coronoviruses.
The FDA panel acts like a science court that will separate data and debate – in public and live-stream – whether the shot is safe and effective, sufficient for emergency use. Non-governmental experts are experts in vaccine development, infectious diseases and medical statistics. The FDA is expected to follow the committee’s advice, although it is not required to do so.
The FDA ruling comes as coronovirus continues worldwide, claiming more than 1.5 million lives, including more than 289,000 in the US
Hanging the meeting is a warning from UK officials that people with a history of severe allergic reactions should not receive the vaccine. Government officials are investigating two reports of reactions that occurred when the country began mass vaccination.
Nevertheless, a positive recommendation and early US approval seems almost certain after FDA scientists released a comprehensive positive initial review of the vaccine earlier this week.
The FDA stated that the results of a large, ongoing study of Pfizer show that it was co-developed with BioNotech of Germany, which was more than 90% effective in people of various ages, races and underlying health conditions, including Diabetes and obesity were included. No major safety issues were highlighted and common vaccine-related side effects such as fever, fatigue, and injection site pain were tolerable.
The head of the International Vaccine Access Center of Johns Hopkins University, Drs. William Moss said, “The figures presented in the briefing report were consistent with what we heard and were really exciting.” “Nothing I’m seeing will delay an Emergency Use Authority.” The meeting gives regulators the opportunity to try to increase public confidence in the breakneck development process that has produced the Pfizer-BioNotech vaccine and a string of other upcoming shots in less than a year. The FDA has faced weeks of verbal abuse from President Donald Trump for not applying a vaccine before Election Day.
FDA Commissioner Stephen Hahn said in an interview, “We have a lot of questions about why it took us so long or ‘Are we tough enough?” “I hope people will see with our transparency that we have taken a very harsh stance on this.” Hahn said the agency had already finished the process of authorizing the vaccine to eliminate all legal paperwork, regardless of the final decision. On Thursday’s agenda:
Rare reactions
The FDA in its review of a 44,000-person study of Pfizer highlighted no major safety issues, with no allergies of the type reported in the UK, but such studies cannot detect rare problems that are only common. Small slices of the population may be affected.
FDA reviewers noted four cases of Bell’s paralysis that occurred between all people receiving the vaccine. They concluded that the cases were likely unrelated to the vaccine because they occurred at rates that would be expected without any medical intervention. But the agency said that cases of nervous disorder should be tracked, noting that other vaccines may cause the problem.
“I think we have to stay ahead without scaring people, that we are not yet aware of any possible, rare, long-term adverse events,” Moss said.
Impact question
The FDA found the vaccine to be highly effective in various demographic groups. But it is unclear how well this vaccine works in people with HIV and other immune system disorders.
Pregnant women are excluded in the study, but experts will tease out the data for any indication in case of vaccination of women before becoming pregnant. Children under 12 are under study.
Effect of emergency automation
Pfizer’s study will need to continue for several months to answer some of these questions.
When the FDA panel met in October, experts warned against allowing trial participants who would switch to placebos and receive the real vaccine soon after the FDA received emergency OK. Doing so that it is impossible to find answers to long-term questions, in which time there is safety.
Pfizer and BioNotech state that they want to allow such participants to receive the vaccine after six months, on request or at the latest request.
The FDA has still not clarified if it would accept that view.
“The FDA is determined that they want to complete these tests,” said Norman Byler, former director of the FDA’s vaccine office.

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