“A front-runner coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90 percent effective at protecting people compared with a placebo saline shot, according to an interim analysis by an independent data monitoring committee that met Sunday. [ANCOR note: the vaccine still needs to be reviewed and receive approval from the Food and Drug Administration, so it could be months before it is available to the public.]
The early look at the ongoing trial provides a decisive initial glimpse of the real-world performance of one of the four coronavirus vaccines in the last stages of testing in the United States. It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.
In Pfizer’s 44,000-person trial, there have so far been 94 cases of covid-19, the illness caused by the coronavirus, in people 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 company’s shares soared more than 13 percent in premarket trading. The data is not yet published or peer-reviewed.
‘The results are really quite good, I mean extraordinary,’ said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, adding that the results might bode well for a vaccine being developed by biotech firm Moderna and his institute that uses a similar technology, ‘which gives you hope we might even have two vaccines.’
Fauci said he had spoken with Pfizer chief executive Albert Bourla about the results, but had not yet reviewed the individual data.
The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. With more people being exposed to the virus amid the surge, testing the vaccine becomes easier — and faster.
Pfizer and BioNTech said they plan to submit an application for emergency authorization from the Food and Drug Administration 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.
Outside experts said crucial details of the data need to be examined: How did the vaccine perform in high-risk populations, such as elderly people? Were the cases of disease mostly mild, or did the vaccine also prevent severe disease? Will the effectiveness hold up at this high level as the trial moves toward completion? How long will protection last? What do detailed safety data show?
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.”
We encourage members wishing to learn more on this issue to visit the full article, linked to above, as it is a developing story still being updated by the Washington Post.
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