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- Pfizer has said it will not charge other developed countries a lower price for the vaccine than what the United States will pay.
Pfizer and BioNTech announced today that the initial interim analysis of data from the phase 3 study of the companies' experimental COVID-19 vaccine shows that it is more than 90% effective.
However, additional key data will be needed to fully understand the effectiveness of Pfizer and BioNTech's vaccine, including whether it prevents severe cases of COVID-19.
The companies are continuing to accumulate safety data and now estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate - the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization - will be available by the third week of November.
However, this analysis was not performed for 'operational reasons, ' and after discussion with the FDA, was reset for a minimum of 62 cases. However, with the Phase 3 study still ongoing, the vaccine efficacy percentage is still open to change.
Clemson-Florida State Postponed Due to COVID-19 Concern
Both teams are continuing to adhere to the minimum outlined protocols within the ACC Medical Advisory Group report, the ACC said. Wake Forest's matchup against Duke was originally postponed but the league announced Saturday it will be not be played.
Pfizer and BioNTech began testing the COVID-19 vaccine (BNT162b2) with 43,538 participants on July 27, reporting that no serious safety concerns have been observed.
Considering that the USFDA as well as several global regulators and health organisations have suggested that a Covid-19 vaccine has to be able to protect at least 50 per cent of those receiving it, the findings in Pfizer and BioNTech's case seem promising. The data will be discussed with regulatory authorities worldwide.
"The first interim analysis of our global Phase III study provides evidence that a vaccine may effectively prevent COVID-19".
".While we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality", Professor Ugur Sahin, BioNTech co-founder and CEO, said.
The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo.
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