Coronavirus Pfizer-BioNTech vaccine update: Pfizer-BioNTech's BNT162b2 Covid-19 vaccine was found to be well tolerated as more than 43,000 participants enrolled for a human trial.
With the coronavirus surging around the US and the world, the pressure is on for regulators to make a speedy decision.
Coronavirus Pfizer-BioNTech vaccine update: In the much-awaited announcement, Pfizer has unveiled Phase 3 human trial final efficacy analysis of BNT162b2 Covid-19 vaccine. It has said the mRNA-based Coronavirus vaccine, jointly developed by US drugmaker Pfizer and German pharma giant BioNTech, has met all “primary efficacy endpoints” and showed an efficacy rate of 95 per cent.
Apart from the efficacy data, Pfizer has revealed key details pertaining to instances of severe cases. Pfizer has said that during the trial, 10 severe cases of Covid-19 came to the notice. Out of the 10, one case occurred in the two-dose mRNA vaccine group and nine cases were detected in the placebo group.
Here are key highlights of Pfizer-BioNTech vaccine phase 3 study
Pfizer-BioNTech’s BNT162b2 has proven to be 95 per cent effective against Coronavirus commencing 28 days after the first dose. A total of 170 Coronavirus confirmed cases were monitored — 162 were in the placebo group and eight in the vaccine group.
Pfizer-BioNTech’s BNT162b2 Covid-19 vaccine showed consistent efficacy across gender, age, ethnicity demographics and race. In a positive sign, Pfizer-BioNTech’s Coronavirus vaccine had an efficacy of 94 per cent in the age group of 65 years and more.
Regarding the side-effects, Pfizer-BioNTech has also released data regarding reactogenicity. Reactogenicity denotes the ability to produce common adverse reactions on participants during phase 3 human trials. The data shows that severe adverse effect like fatigue was noticeable in 2 per cent, fatigue was visible at 3.8 per cent and headache at 2.0 per cent.
Pfizer-BioNTech’s BNT162b2 Covid-19 vaccine was found to be well tolerated as more than 43,000 participants enrolled for a human trial.
Pfizer Chairman and CEO Dr. Albert Bourla termed efficacy results as a pivotal step in the company’s historic eight-month journey of developing the elusive Coronavirus vaccine. He said that Pfizer-BioNTech’s BNT162b2 Covid-19 vaccine has the capacity to end the prevalent Coronavirus pandemic.
Pfizer-BioNTech started the Phase 3 clinical trial of BNT162b2 on July 27. As many as 43,661 participants were enrolled. Out of the total, 41,135 have received a second dose of BNT162b2 Covid-19 vaccine candidate as of November 13, 2020.