Pfizer and BioNTech say final analysis shows coronavirus vaccine is 95% effective
Source: CNN
(CNN)A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday. The company counted 170 cases of coronavirus infection among volunteers who took part in the trial. It said 162 infections were in people who got placebo, or plain saline shots, while eight cases were in participants who got the actual vaccine. That works out to an efficacy of 95%, Pfizer said.
The data show Pfizer's initial claim of a better than 90% efficacy -- a claim that stunned and pleased health officials and vaccine developers last week -- holds up. "Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%," Pfizer and its German partner BioNTech said in a joint statement. "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." BNT162b2 is the experimental name for the vaccine.
An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said. "The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2," the companies said. Older adults tended to have fewer adverse events and those they had were milder. Pfizer said it will seek US Food and Drug Administration emergency use authorization "within days." "These data also will be submitted to other regulatory agencies around the world," Pfizer said. They plan to publish the data in a peer-reviewed scientific journal, as well.
"The rapid protection this vaccine provides -- combined with its tolerability profile in all age groups studied so far -- should help make this vaccine an important tool to address the current pandemic," said Dr. Ugur Sahin, CEO and co-founder of BioNTech. Pfizer said on November 9 that interim data provided initial evidence the vaccine had an efficacy of more than 90%. That data was based on the first 94 cases of coronavirus infection among volunteers. The company said at the time it would need to count more cases of infection in the trial before it could consider the Phase 3 part of the trial finished and seek FDA authorization.
Read more: https://www.cnn.com/2020/11/18/health/pfizer-coronavirus-vaccine-safety/index.html
Full headline: Pfizer and BioNTech say final analysis shows coronavirus vaccine is 95% effective with no safety concerns
underpants
(182,721 posts)BumRushDaShow
(128,710 posts)needed to do something to counter Moderna's "95% effective" claim vs Pfizer's earlier "90% effective" claim. It's just that simple.
LisaL
(44,972 posts)NT
BumRushDaShow
(128,710 posts)Moderna's announcement yesterday of "95% effectiveness" vs Pfizer " (only) 90% effectiveness", coupled with Moderna's emphasis that THEIR vaccine didn't require a -100F freezer like Pfizer's, meant that Pfizer needed to get their asses in gear to be competitive.
RobertDevereaux
(1,853 posts)BumRushDaShow
(128,710 posts)They are not a non-profit research hospital.
Over the past 20 or so years, they bought 5 big well-known pharmaceutical companies including biggies like Warner-Lambert and Wyeth, so they are mindful of whatever debt load they have from all of that and maximizing their product offerings and market share.
Moderna is a smaller, more-targeted "newbie" in the marketplace - I suppose what they might call "agile". But in this case, they were around at the right place and at the right time if their product is successful. I expect someone much larger will gobble them up at some point.
Happy Hoosier
(7,251 posts)We either trust him, or we don't. I trust him.
BumRushDaShow
(128,710 posts)let alone anything to do with Fauci.
But they ARE a company that must show value to their stock holders and they do jockey for market share with their marketing and product announcements - particularly when they are competing against a smaller newer "start up" like Moderna (among others who are out there working on a vaccine).
Happy Hoosier
(7,251 posts)If that is in error, my apologies.
BumRushDaShow
(128,710 posts)Just chuckling at the fact that they probably knew what their final numbers would be but went "conservative" with their initial announcement until a smaller, "narrow-focused" ("young, scrappy, and hungry" ) company jumped out with theirs that for all intents and purposes, served to "look better" than the giant (at least to investors). So then the big wigs at Pfizer probably told them to go head and put their final numbers out PLUS up it a bit by including their being ready to go for the final approval.
They are all businesses and Pfizer has become a huge conglomerate that gobbled up many large well-known, now-defunct pharmaceutical companies over the years, so they have been there done that. But this pandemic is extra challenging but also lucrative, so they probably feel they need to "do it right" for the long term.
They already do vaccines like Prevnar 13, which is one of the popular pneumonia vaccines.
Happy Hoosier
(7,251 posts)BumRushDaShow
(128,710 posts)LisaL
(44,972 posts)can conclude much faster.
DeminPennswoods
(15,273 posts)Lost in all the red vs blue and acrimony is the absolutely stunning speed with which the medical, biotech, pharmaceutical, scientific and research communities and government entities worked together to develop more than 1 effective vaccine. Less than a year after the first discovery of SARS2, there are at least 2 vaccines ready for production with more on the way.
For comparison, it took decades of work to develop the Salk and Sabin polio vaccines.
A salute to the clinical trial volunteers as well. IIRC, there were several DU'ers who had planned to participate.
Sherman A1
(38,958 posts)moreland01
(736 posts)How long will it be effective? Will everyone need two shots yearly?
BumRushDaShow
(128,710 posts)Both vaccines require two doses. Pfizers booster shot will be given three weeks after the first one; Modernas is spaced four weeks later.
https://www.washingtonpost.com/health/2020/11/17/covid-vaccines-what-you-need-to-know/?arc404=true
LisaL
(44,972 posts)I'd want to get the vaccine and not wait 3-4 weeks for another dose before I am "immune."
Happy Hoosier
(7,251 posts)Maybe a later vaccine will do that. In the mean time we have an effective vaccine.
TheRickles
(2,047 posts)in the placebo arm of 20,000 subjects, only nine people developed serious symptoms of Covid, with no deaths reported. This makes for a morbidity rate of less than 0.05% in the normal population, and a fatality rate of 0.00%. A deadly pandemic would have much, much higher numbers. What am I missing?
LisaL
(44,972 posts)conditions.
Presumably this group is less represented in a clinical trial than in general population. It's also a fair guess that clinical trial participants are more carefully monitored for signs of covid than general population, resulting in faster testing and treatment.
TheRickles
(2,047 posts)"...41% of global and 45% of U.S. participants are 56-85 years of age." Their clinical status isn't mentioned, and it's quite possible that they were generally healthy. So this reinforces part of your point, regarding low representation in the study of elders with serious pre-existing conditions. But if the many presumably healthy elders in the study had such a low morbidity rate, then perhaps our public health measures should be aimed at protecting frail elders, not the general population as a whole.
LisaL
(44,972 posts)Elders are not living in a vacuum. They have younger relatives.
TheRickles
(2,047 posts)or nursing home employees and etc. are the ones we should be most vigilant about. But for the rest of the country that isn't in contact with frail elders, there should be some shades of gray in our public health measures.
LisaL
(44,972 posts)Which is why our covid cases are going through the roof.
TheRickles
(2,047 posts)But I haven't been able to find stats about what % of those folks who test positive are also symptomatic. Or about how effective the asymptomatic positive testers are at spreading the virus, compared to symptomatic people. These seem to be big gaps in the prevailing narrative, so if you have some links, that'd be greatly appreciated. Thanks.