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The Committee was asked to respond whether “based on all available scientific evidence, the benefits of Pfizer-BioNTech COVID-19 outweigh the risks for people 16 years of age and older.”
The result of this vote is not binding, but the FDA is expected to follow the recommendation and make an appropriate decision in the next few days.
The recommendation of the expert committee was published in the United States, the country most affected by a pandemic in the world, some 6,000 people died in the 48 hours after a coronavirus infection. people. The total number of COVID-19 victims in the country is close to 300,000.
As Northern Hemisphere countries faced a new wave of pandemics in the winter, the UK this week became the first Western country to launch a mass vaccination against COVID-19 with a vaccine developed by Pfizer and BioNTech.
Canada, Bahrain and Saudi Arabia have also already approved the product.
At that time, the countries of the European Union eagerly await the bloc’s pharmaceutical supervision service to give the green light to vaccines. The hackers staged a two-week cyber attack against the European Medicines Agency (EMA) that sought to steal data related to COVID-19, but said the incident would not affect the vaccine’s approval schedule.
Detailed clinical trials of the Pfizer and BioNTech vaccines, involving nearly 44,000 people, were published in the New England Journal of Medicine on Thursday. volunteers, results. They show that the vaccine is 95% effective. and it does not cause serious side effects.
“The test results are impressive enough to be taken as an example of any analysis imaginable. It’s a triumph, “said the New England Journal of Medicine.
However, voting members of the Vaccines and Related Biologicals Advisory Committee (VRBPAC) discussed a number of outstanding issues in depth during a live meeting.
Among other things, it was considered when people who received placebo in clinical trials should be vaccinated. There was also a delicate debate on the need to have better controlled data and, on the other hand, to reward volunteers for their services.
More complex questions have also been raised, such as whether there will be any yet unidentified safety concerns when millions or perhaps billions of people are vaccinated with the vaccine.
It is also not known whether there will be more long-term side effects, how long the vaccine will remain effective, whether it will control the spread of the infection, and how it will affect children, pregnant women, and immunosuppressed patients.
The FDA announced that it would issue an allergy warning when two vaccinated healthcare workers in the UK needed medical help for an allergic reaction.
Since the new coronavirus was first detected in China last year, the infection has claimed at least 1,570,398 lives worldwide, according to data from the AFP news agency.
The United States expects to vaccinate 20 million this month. people. Nursing home residents and healthcare workers will be vaccinated first.
President-elect Joe Biden called the FDA experts’ decision “bright light in unnecessarily dark times.”
However, he pointed out the enormous challenges involved in vaccine distribution. The president-elect has asked Congress and the Donald Trump administration to provide funding for the purchase of vaccine doses agreed to with Pfizer and Moderna, and to work quickly to begin mass production of vaccines.
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