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Covid-19 vaccine candidate is 90% effective, says manufacturer - mass roll out will take a while but if 90% holds this certainly makes a huge difference https://www.theguardian.com/world/2020/nov/09/covid-19-vaccine-candidate-effective-pfizer-biontech
Washington Post has more detail - 90% is actually against infection not justseverity "In Pfizer’s 44,000-person trial, there have.. been 94 cases of covid19, t... Fewer than nine of those cases were among people who received 2 shots of the vaccine, a strong signal of efficacy"
Pfizer plan to submit an application for emergency authorization from FDA after 3rd week of Nov when they will have 2 months of safety .. data on 1/2 of participants ..along with data on manufacturing. Trial will continue until it reaches its endpoint of 164 cases of covid-19
"vaccine requires 2 doses, given 3 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."
If all the above holds true I think this would be effective enough to end the pandemic providing enough people get vaccinated to provide actual herd immunity. /4
AFAIK the other vaccine candidates also due to announce soon use broadly similar technology so may show similar results. If so that means that available doses next year of one of these vaccines should run into billions /5
NYT - "1st analysis was based on 94 volunteers who developed Covid-19. Dr. Jansen said the outside board did not say how many of those cases came from participants who had been vaccinated. But with a rate over 90 percent effectiveness, most had to have been in placebo group /6
NYT - 11 vaccines are in late-stage trials, including 4 in the United States. Pfizer’s progress could bode well for Moderna’s vaccine, which uses similar technology. Moderna has said it could have early results later this month. /7
NYT - The data released by Pfizer Monday was 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 more than 90 percent efficacy could change as the trial goes on /8
NYT - "The first interim analysis was supposed to have taken place after 32 people in the study developed Covid-19, but the company said that, after discussing the matter with the F.D.A., it decided to wait until the second analysis — at 62 cases" https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html
Wide distribution of Pfizer’s vaccine will be a logistical challenge. Because it is made with mRNA, the doses will need to be kept at ultra cold temperatures. Pfizer has developed a special cooler to transport the vaccine, equipped with GPS-enabled thermal sensors /10
This thread explains the technical side of efficacy calculations & the difference between protection against severity and/or infection. The minimum goal here was the first at only 50% but they appear to have got the 2nd at 90% https://twitter.com/nataliexdean/status/1310613702476017666
It shouldn't need to be said but this announcement makes any strategy other that minimising infections until enough vaccine is deployed to give herd immunity full on criminal. We don't have to 'I've with the virus' for an indefinite period, we have to minimise sickness & death
"Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected"
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against
Pfizer’s estimate to file for authorization by 3rd week November was based on assumption FDA would be willing to accept 1-month safety data on half volunteers in study as initially planned, when it was to include 30k volunteers, not more than 44k as now https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/
Another good thread on how to interpret this (still good news) https://twitter.com/nataliexdean/status/1325820512946302977?s=20
And this one defends the science that allowed today’s release of information via press statement https://twitter.com/gbrumfiel/status/1325817117191655425
Another excellent what this means thread https://twitter.com/florian_krammer/status/1325887332428505090
On cost - this article from August says the Pfizer vaccine will cost $19.50 - existing treatments got Covid can cost 1000s of dollars ( Remdesivir costs 3100) & monoclonal antibody bodies 10s of 1000s. So while Big Pharma is a thing vaccine is cheap https://gulfnews.com/world/revealed-prices-of-some-leading-covid-19-vaccine-candidates-1.1598192772387
This is a very useful overview of the hopes & limitations https://coronavirus.medium.com/an-epidemiologist-on-what-to-expect-from-a-covid-19-vaccine-c727f4bf32dc
One difficulty the first successful vaccination be created is that other vaccines in progress may then have issues with ethical testing - this thread looks at that https://twitter.com/rvenkayya/status/1326876432665022465
And now we have two, Modena press releases an even higher effectiveness (94%) and without the need for an ultra low temperature chain https://twitter.com/andrewflood/status/1328310126843998210?s=20
Pfizer says it has now achieved its FDA safety data requirements for an Emergency use authorisation & with 170 confirmed cases effectiveness has risen to 95%. "170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group"
Very importantly "observed efficacy in adults over 65 years of age was over 94%" and "Efficacy was consistent across age, gender, race and ethnicity demographics"
Submission & data sharing expected within days with intention to "produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021" https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
"There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group." The Phase 3 clinical trial .. has enrolled 43,661 participants to date, 41,135 of whom have received a second dose
This is an excellent thread on why vaccine development normally takes 10 years but hasn't this time https://twitter.com/mark_toshner/status/1328837111869566976
