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BREAKING: Great news! @Pfizer says an early analysis of its #coronavirus vaccine trial by independent experts found the vaccine to be >90% effective in preventing #COVID19 in previously uninfected healthy people. No serious safety concerns were observed. https://www.bloomberg.com/news/articles/2020-11-09/pfizer-s-covid-vaccine-prevents-90-of-infections-in-large-study
Pfizer plans to ask the @US_FDA for emergency authorization of its 2-dose #coronavirus vaccine later this month, after it has collected the recommended 2 months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people.
The vaccine relies on messenger RNA (mRNA) technology never before used in an approved vaccine. The #mRNA is genetic material that encodes a #coronavirus protein, turning the body’s cells into #vaccine factories, allowing it to be developed much faster than a traditional vaccine.
IMPORTANT: Pfizer has not yet released the data (they will soon), and longer-term safety and efficacy data are needed to confirm:
Is it safe longer term?How long does immunity last? Is a booster needed?Is it effective in the elderly?Does it prevent severe #COVID19?
Although questions remain, these initial results are very encouraging. The first vaccines were expected to be 60% to 70% effective, per Fauci. >90% is a level of protection that puts it on par with highly effective childhood vaccines for diseases such as measles. https://twitter.com/drdenagrayson/status/1325785219413184512
Pfizer’s encouraging results bode well for other experimental vaccines, including Moderna’s that also uses #mRNA. Its trial could generate efficacy and safety results in weeks. If that study succeeds, there could be 2 vaccines available in the U.S. by around year-end.
Pfizer should get 2 months of safety follow-up—required by FDA before emergency authorization is granted—in the 3rd week in November. If no issues arise, Pfizer could apply for FDA authorization this month. The data monitoring committee has identified no serious safety concerns.
Operation Warp Speed, the US effort to accelerate a #vaccine, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans FREE of charge. Pfizer did not take any federal money to help pay for research and development.
IMPORTANT: The data released by Pfizer were delivered in a news release, not a peer-reviewed medical journal. It is NOT conclusive evidence that the vaccine is safe and effective, and the initial finding of >90% efficacy could change as the trial continues.
The trial will continue until 164 people in the ~44,000 person trial have developed #COVID19, and will evaluate how well it protects against developing severe forms of the disease, and how well the #vaccine protects people who have already been infected with the #coronavirus.
Bottom line: this interim analysis by an INDEPENDENT data monitoring committee of Pfizer’s #coronavirus vaccine is extremely encouraging, but early.
If all goes well, and this/other vaccines prove safe and effective, we could have vaccines widely available in the US by mid-2021. https://twitter.com/drdenagrayson/status/1325782553295527943
If all goes well, and this/other vaccines prove safe and effective, we could have vaccines widely available in the US by mid-2021. https://twitter.com/drdenagrayson/status/1325782553295527943
