From https://www.businesswire.com/news/home/20201210005703/en/
-Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19. “These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated."
Questions?
1. How many participants who received the vaccine had serious side effects?
To date, an independent, external data monitoring committee has not observed any serious safety concerns, and the data from our Phase 3 study has demonstrated that our COVID-19 candidate vaccine has been well tolerated.
So, no serious side effects among the participants. That's good.
2. What do you mean "preventing COVID-19"? Do you mean they don't show symptoms? Or that they can't be infected by someone who is known to have Covid? And/or that they are not infectious and won't spread the disease to someone else who is not infected and isn't vaccinated?
They don't answer this. They do say that 162 case of Covid were in the placebo group and 8 in the vaccinated group. So, if you don't get vaccinated, there is a 99.25% chance you won't get Covid. If you do get vaccinated, there is a 99.96% chance you won't get Covid. I don't see how the 95% efficacy rate is calculated.
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.
This is the real test. Who cares about a mild case of Covid - the concern is a severe case of Covid. So, recalculate. If you don't get vaccinated, there is a 99.96% (21719/21728) chance that you won't get a severe case of Covid. If you do get vaccinated, there is a 99.995% (21719/21720) that you won't get a severe case of Covid.
So I don't see the harm in taking the Pfizer vaccine, and it will increase your odds of not getting a serious case by a very tiny amount. It may have a placebo effect - you can believe that you are immune and you can feel superior to people who haven't been vaccinated. But I don't think it passes the cost/benefit analysis. These vaccines have to be stored at -70 degrees celsius. But the government is paying for it, so who cares.
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Update: COVID-19: Four Pfizer vaccine volunteers develop Bell's palsy
As the United Kingdom started inoculating people with the coronavirus vaccine developed by Pfizer-BioNTech, four volunteers who were administered the vaccine in the trial stage developed Bell's palsy, according to US Food and Drug Administration (FDA) regulators. Bell's palsy is a form of temporary facial paralysis.
Earlier, the medicine regulator in the UK has advised that people with a history of significant allergic reactions should avoid getting shot of Pfizer vaccine after two people reported adverse effects.
Hmm. This wasn't mentioned in the press release. That's because this occurred in the UK not in the US. Is it the same model of vaccine?
Yes, the same model - BNT162b2.
Among non-serious unsolicited adverse events, there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group, though the four cases in the vaccine group do not represent a frequency above that expected in the general population. https://www.fda.gov/media/144245/download
So Bell's palsy isn't considered a serious adverse event? I'll pass on the BNT162b2.
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Update: The 95% efficacy rate is calculated as (162-8)/162. In the control group of about 15,000, there were 162 cases. So they would have expected 162 cases in the vaccinated group but there were only 8 cases.
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