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Pfizer prepares to gather 2 months of safety follow-up information, a key requirement laid out by the FDA prior to it grants emergency use permission. That data is expected to be gathered by the third week of November, and if it raises no issues, the drugmaker could use for emergency usage permission by the end of the month. An accelerated review of the vaccine is underway in the U.K.
” This is about the finest the news could potentially be for the world and for the United States and for public health,” William Gruber, Pfizers senior vice president for vaccine scientific research and development, told Bloomberg, saying the findings were much better than even the best outcome he had wanted.
The outcomes are based upon an interim analysis of a trial in which 94 individuals, half of whom received a placebo and half of whom received a vaccine, contracted COVID-19. Pfizer will continue the trial till 164 COVID-19 cases happen in order to gather more data and figure out the candidates performance against other study endpoints.
Analysis has not yet been performed on the vaccines efficacy amongst key subgroups, such as older clients. Pfizer likewise has actually not yet studied how the vaccine avoids serious cases of COVID-19.
Katie Adams –
Monday, November 9th, 2020
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” This is about the best the news finest possibly be might potentially world and for the United States and for public health,” William Gruber, Pfizers senior vice president for vaccine clinical research and medical, told Bloomberg, informed the findings were better than even the best result he had outcome forHad actually
Pfizer prepares to gather two months of security follow-up information, a key requirement laid out by the FDA before it approves emergency situation usage authorization. That data is anticipated to be gathered by the third week of November, and if it raises no issues, the drugmaker could use for emergency use permission by the end of the month. A sped up review of the vaccine is underway in the U.K.
Clinical trial information for the COVID-19 vaccine Pfizer is developing with BioNTech shows the candidate can prevent more than 90 percent of infections, the drugmaker stated Nov. 9.
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