https://www.fda.gov/media/144245/download
If the mRNA (messenger RiboNucleic Acid) vaccines really work, how is it possible for someone to get COVID-19 after receiving both the first and second shot of the Pfizer/BioNTech vaccine?
The results of the research submitted to the FDA (Food and Drug Administration) for an EUA (Emergency Use Authorization) show that the vaccine is much more effective than was expected. Originally, the efficacy goal for a vaccine was to prevent at least 50% of disease. The Pfizer/BioNTech vaccine research shows that it prevents 95%.
For participants without evidence of SARS-CoV-2 infection prior to 7 days after Dose 2, VE [Vaccine Efficacy] against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0%. The case split was 8 COVID-19 cases in the BNT162b2 group compared to 162 COVID-19 cases in the placebo group (Table 6).
Link to research – Efficacy Results – Primary Endpoint (Evaluable Efficacy Population)
95.0% is more precise than anyone should be using, even if it is mathematically correct to calculate it that way. The paper does admit this: “The 95% credible interval for the vaccine efficacy was 90.3% to 97.6%, . . .” As more people are vaccinated, the numbers reported will more accurately represent the true protection from disease.
Here is where things start to get complicated. Protection from “disease”, in the case of vaccine approval, means not developing symptoms. Symptoms are what the person experiences – cough, shortness of breath, weakness, aches, et cetera. Signs are things that the person might not feel, such as an elevated heart rate or hypoxia (hypoxia is a low oxygen saturation). Hypoxia is a particular problem with COVID-19, since many patients have been hypoxic, but have not experienced any difficulty breathing or other respiratory symptoms. It is easy to miss hypoxia in COVID-19 patients, if we are not measuring oxygen saturation.
If the person does not have any symptoms, does that mean that the person is not infected? No.
Is that a problem? Probably not. It would be best, if the vaccines provide sterilizing immunity – immunity that prevents the transmission of infection. Often an infection is asymptomatic, so the person is not aware of being infected. Measuring the rate of infection requires frequently testing everyone, but that was not the goal of this research. The goal was for the vaccine to decrease the spread of disease (an infection that is causing symptoms), when compared with placebo. We do not yet know if any COVID-19 vaccines prevent transmission of infection. The Pfizer/BioNTech vaccines, which is what US Rep. Stephen Lynch received two doses of, prevents development of symptoms 95% better than placebo (not receiving any active vaccine doses). That also means that a small percentage (5%) of the people who are vaccinated will be expected to become symptomatic.
A statement from the South Boson congressman’s office says Lynch isn’t displaying any symptoms of COVID-19.
Since he is not reported to be experiencing any symptoms, Rep. Lynch is still considered to be asymptomatic, therefore probably in the 95% protected from disease (symptoms). It is possible that Rep. Lynch would have developed an asymptomatic infection, if he were not vaccinated, but we do not know. At 65 years old, Rep. Lynch is not expected to develop an asymptomatic infection. That is much more likely to occur in much younger people, but there are no guarantees.
Why did the researchers only look at symptoms? Because it would be a lot more work, and money, and could discourage people from volunteering for the study, since participants would have to get tested for COVID-19 every few days to determine if they had infection, rather than only getting tested after developing symptoms. Is it possible that more people became infected in the vaccine group, than in the placebo group? Yes, but it is unlikely and more infections in the vaccine group, with 95% less disease, would not indicate that vaccination is a problem. Why?
In the final analysis of the evaluable efficacy population (7 days), four participants had severe COVID-19 disease at least 7 days after Dose 2 (one subject who received BNT162b2 and three participants who received placebo). The vaccine recipient who had severe COVID-19 disease met the severe case definition because oxygen saturation at the COVID-19 illness visit was 93% on room air. The subject was not hospitalized, did not seek further medical care, and did not have risk factors for severe disease. The three placebo recipients who had severe COVID19 disease met the severe case definition for the following reasons: one subject had an oxygen saturation of 92% on room air without other severe disease criteria, one subject was hospitalized for noninvasive positive pressure ventilation with bilateral pneumonia, and one subject had an oxygen saturation of 92% and ICU admission for heart block. One of these placebo recipients with severe disease also had a body mass index > 30 kg/m2 as a risk factor, while the other two participants did not have any risk factors for severe disease. The vaccine efficacy of this secondary efficacy endpoint is shown in Table 11.
The worst outcome, among those vaccinated, was an oxygen saturation that dropped to 93%. It does not describe if symptoms resulted in testing, or if it was due to an exposure, or something else, but the reason this person is categorized as severe disease is an oxygen saturation of 93%. One of the three patients in the placebo group was also considered to have severe disease is for a similar oxygen saturation (92%), which is essentially the same as 93% for treatment purposes.
Has the protection provided by vaccine decreased since the EUA approval for the vaccine? No. There have not been any reports of decreasing efficacy of either mRNA vaccine. Any reasonable person, who does not have a medical reason for not getting vaccinated (severe allergies seems to be the only consideration), should receive both shots of vaccine.
You can develop immunity naturally, with about a 1% chance of death and about a 15% chance of severe disease (depending on age, co-morbidities, …), or you can obtain immunity by vaccination, with the possibility of some side effects, which are reported to be less severe for older people.
The only reason Rep. Lynch found out that he was infected was testing after a member of his staff tested positive for COVID-19. He is not reporting any symptoms. A vaccine that prevents symptoms, even if it allows infection, is still a successful vaccine. Preventing disease and preventing death are both very important benefits of vaccines.
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