Pfizer’s COVID-19 vaccine recommended for FDA’s authorization in US

Ebangla Bureau 

AHEAD OF Christmas, residents of US  are expected to have a  COVID-19 Vaccine following a committee of leading U.S. vaccine scientists recommending that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans. The endorsement paves the way for a final decision by the FDA and mass vaccinations to begin within days in thousands of front-line heath care workers and nursing home residents. After an eight-hour public hearing, the independent Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention to recommend the vaccine made by Pfizer and its partner BioNTech called BNT162b2. Members found the benefits of the vaccine outweighed the risks for most people 16 years old and older.” It’s a huge milestone,” said Dr. Ofer Levy, a paediatric infectious disease expert and head of the precision vaccine program at Boston Children’s Hospital. Pfizer and its German partner BioNTech previously reported the shots appeared 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study. That’s based on the first 170 infections detected. The U.S. Food and Drug Administration on Tuesday released a 53-page report summarizing data from Pfizer and BioNTech’s COVID-19 candidate vaccine trial. The data supports earlier findings that the vaccine is safe and will prevent 95% of people from becoming sick with COVID-19. The companies are asking the FDA for authorization to use the vaccine in people ages 16 and up. They have also begun testing the vaccine in ages 12-15, but have not yet accumulated enough data to request authorization in that age group. The FDA panel that must review the vaccine before authorization meets all day Thursday, with authorization expected as soon as that evening. Another candidate vaccine, made by Moderna, will be reviewed next week. Health Canada approved the same Pfizer-BioNTech vaccine on Wednesday that the U.S. Food and Drug Administration could authorize for emergency-use here within days or even hours. The vaccine is already being rolled out across Britain, where it encountered its first rough spot – health officials there have decreed that people with a “significant history” of allergic reactions shouldn’t get the vaccine pending further investigation. USA TODAY says ‘’Flying under the global radar is a Chinese vaccine that quietly won approval in the United Arab Emirates on Wednesday, important because that vaccine, likely to be cheaper than Western models, could prove a lifeline for some developing nations. pharmaceutical giant Moderna has a successfully tested vaccine candidate awaiting FDA approval. And data on a candidate vaccine made by AstraZeneca and Oxford University is being presented to regulators in the U.K., Europe and elsewhere around the world, the collaborators said this week’ ’inputs courtesy to USA TODAY.edited by PK Chakravarty