Pfizer recently announced that its covid vaccine is over 90% “effective” in preventing covid-19.
Shortly after this announcement, Moderna announced that its covid vaccine was 94.5% “effective” in preventing covid-19. Unlike the flu shot, which is a vaccine, the two covid vaccines require two injections given three to four weeks apart. Hidden near the end of both announcements were the definitions of “effective”.
Both trials have a treatment group that received the vaccine and a control group that did not. All of the trial subjects were covid negative before the trial began. Analysis of both trials was performed when a target number of “cases” was reached. “Cases” were defined by positive polymerase chain reaction (PCR) tests. There was no information on the cycle number of the PCR tests. There was no information on whether the “cases” were showing symptoms or not. There was no information on hospitalizations or deaths. The Pfizer study had 43,538 participants and was analyzed after 164 cases. Thus, about 150 participants out of 21,750 (less than 0.7%) became PCR positive in the control group and about one tenth of that number in the vaccinated group became PCR positive. The Moderna trial had 30,000 participants. There were 95 “cases” in the 15,000 control participants (about 0.6 percent) and 5 “cases” in the 15,000 vaccine participants (about one-twentieth of 0.6 percent). The “efficiency” figures cited in these announcements are odds ratios.
There is no evidence yet that the vaccine prevented hospitalizations or deaths. Moderna’s announcement claimed that eleven cases in the control group were “severe” disease, but “severe” was not defined. If there were any hospitalizations or deaths in either group, the public was not informed. When the risks of an event are low, odds ratios can be misleading about the absolute risk. A more significant measure of effectiveness would be the number to be vaccinated to avoid hospitalization or death. These figures are not available. An estimate of how many of the Moderna trial would need to be treated to avoid a single “case” would be fifteen thousand vaccines to avoid ninety “cases” or 167 vaccinations per “case” avoided, which doesn’t look as good as 94.5 percent efficiency. Publicists working for pharmaceutical companies are very intelligent people. If there was a reduction in mortality from these vaccines, that information would appear in the first paragraph of the ad.
There is no information on how long a protective benefit from the vaccine would persist. The antibody response after covid-19 appears to be short-lived. From what we know, the covid vaccine may require two injections every three to six months to be protective. The more shots it takes, the greater the risk of side effects from vaccine awareness.
There is no security information. No. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers. I am employed by an academic medical center which is a referral center for the West Texas area. My colleagues include resident physicians and faculty physicians who work with patients with covid on a daily basis. I asked several of my colleagues if they would be the first to receive the new vaccine. I have yet to hear any of my colleagues say yes. The reasons for the reluctance are that the uncertainties about security exceed what they perceive to be a small advantage. In other words, my colleagues would rather try their luck with covid rather than testing the vaccine in beta. Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.
These announcements from Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harms of covid-19. I certainly hope these vaccines are safe. If these two conditions are met, no one should be forced to take the vaccine. However, you should pay even more attention to what is left out in an ad than what is stated. Pharmaceutical companies are more than happy that patients misunderstand what is meant by efficacy. Caveat emptor (Attention the buyer)!
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