The coronavirus vaccine developed by drug giant American Pfizer and German biotechnology firm BioNTech was more than 90 per cent effective at protecting people from infection as compared to placebo saline shot, according to an analysis.
The analysis was conducted by an independent data monitoring committee that met Sunday.
“I would say it is a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Washington Post quoted Kathrin Jansen, head of vaccine research and development at Pfizer, as saying. “Hearing that at the interim analysis we are over 90 percent effective — it was almost stunning to hear.”
Pfizer has conducted 44,000-person trial. Among them, there have been so far 94 cases of COVID-19 in persons who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine, a strong signal of efficacy.
The vaccine requires two doses, given three weeks apart. Pfizer and BioNTech are working around-the-clock to scale up production, in hopes of having 50 million doses — enough for 25 million people to receive both shots — by the end of the year, and 1.3 billion doses in 2021.
The data is not yet published or peer-reviewed, and the company news release could not be presented to outside experts under the terms of an embargo.
With more people being exposed to the virus amid the coronavirus surge, the trial is rushing toward completion faster than company executives anticipated.
The data community noted no serious safety concerns. Jansen said the side-effect profile of the vaccine was similar to what was reported in an earlier study, which included pain at the injection site and fatigue, chills and fever – that occurred more frequently in younger trial participants than in adults over age 65.
Pfizer and BioNTech said they plan to submit an application for emergency authorisation from the Food and Drug Administration (FDA) after the third week of November, when they will have two months of safety follow-up data on half of the participants in their trial, along with data on their manufacturing process.
The trial will continue until it reaches its endpoint of 164 cases of COVID-19, which Jansen said could take a few weeks. (ANI)