Pfizer/BioNTech’s COVID-19 vaccine shows up to 95% efficacy in final analysis, including in over-65s

pharmafile | November 18, 2020 | News story | Research and Development BioNTech, COVID-19, Pfizer, Vaccine 

Pfizer and BioNTech have backed up their promising interim Phase 3 data showing 90% efficacy for their COVID-19 vaccine candidate with a final analysis of the findings, showing an even higher level of efficacy, and in crucial sub-populations.

In global Phase 3 studies of over 43,000 participants, researchers identified 170 confirmed cases of COVID-19 amongst the trial population, with 162 of these infected patients having received the placebo and just eight had received the vaccine. Statistically, this gives the vaccine a projected efficacy rate of 95%.

Furthermore, only one of the eight infected vaccinated patients displayed severe COVID-19, whereas there were nine severe cases in the placebo group.

In participants over the age of 65 who are at considerably increased risk from the virus, the vaccine demonstrated an efficacy rate almost consistent with the broader patient population at more than 94%.

No side effects were reported and the vaccine was consistently effective across age and ethnicity groups.

The developers also stated that the study had now collected at least two months of safety data following the second dose, meeting the FDA’s threshold for the monitoring of side effects, and plan to file for an Emergency Use Authorisation with the regulator “within days”.

Matt Fellows

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