Fact Check of the LifeSite Article: If you get the Pfizer vax, you're more likely to get COVID Part 2: Details
This is the original mind numbingly long article that I wrote. I realized that it was too much for a first time read so created Part 1 as a summary. P^3
I stopped following LifeSite quite a while ago, but an article popped up and was so counter-intuitive it merited a 'FACT CHECK' (If you get the Pfizer vax, you're more likely to get COVID, link). Meaning, that if their claim was correct, I would have to alter my conclusions about the efficacy of the various vaccines being administered to the populace.
Caveat: I see that they have "UPDATED" stamped on the article so I'll need to see what changed and whether or not I need to withdraw my application for the job of LifeSite News Fact Checker. Just kidding, I am way too busy to do that.
By the way, the first problem I encountered what that their citation didn't lead to the correct document. It led to the briefing presentation and I had to surf for about 20 minutes to find the correct document. I am happy to report that they have updated the document with the correct link.
A more detailed report of the study can be found at this https://www.fda.gov/media/151733/download link.
Issues with the article:
""- The original title of the article was more sensational and was 'UPDATED'
- FROM: ‘If you get the Pfizer vax, you’re more likely to get COVID’: Insider leaks FDA study
- TO: UPDATED. ‘If you get the Pfizer vax, you’re more likely to get COVID’: Industry analyst flags FDA study
- Tradicat: Well I'm glad because it is hard to 'leak' a public document. Second, the person is question was not an insider. Looking further we find she is an 'ex-employee'.
- The subtitle states the premise of the article as follows:
- 'So, when they weren’t injected, their infection rate was 1.3% and when they got injected, it was 4.34%. It went up by over 300%,’ Pfizer ex-employee Karen Kingston stated. ‘They had less infection when they had no protection. So, that’s a problem.’ <Claim A>
- Tradicat: I don't know where she got this information because it isn't in the briefing document. Looking at table 7a and 7b, the infection rate was 4% during the trial.
- Here's my attempt and converting that to incidence:
- Cases: 833 + 854 =
- Populaton: 20118 + 21,210
- Timeframe:
- "A former Pfizer employee, now working as an industry analyst (Tradicat: Probably self-employed), has
provided documentation indicating the pharmaceutical giant—whose
gene-based COVID-19 vaccine has now been reportedly injected almost 225 million times into the arms of Americans—knows these shots cause recipients to become more susceptible to contracting COVID-19. " <Claim B>
- Tradicat: Ah nope. I looked up up to make a conversion here (link).
- Formula: Incidence = (New Cases) / (Population x Timeframe)
- I will add a table below comparing the incidence cases. What Pfizer knows is something that most of us suspected ... immunity wanes over time.
- "Involving over 36K participants, the main study revealed that the group injected with the regimen earlier were more likely to be infected with the virus than those injected later, indicating a possible “waning of immunity” for the shots. The group injected earlier had a 7% chance of infection in the time period, and those injected later, only a 5.16% rate, equating to the former group having a 36% greater chance of infection than the latter. "<Claim C>
- Tradicat: I converted all the numbers to the incidence rates to compare 'apples to apples'. End result - nope the incidence for the placebo group was higher - way higher. See Table.
- "In addition, since both groups were measured for the same time period, the latter involving a significant placebo period prior to injection (5.1 months on average), the placebo group was unusually untouched. As Kingston stated in a telephone interview with LifeSiteNews, “There should have been more people infected in the placebo group because they were going on longer without any protection.” She suggested this would therefore seem to indicate that those injected have an even higher chance of being infected with COVID-19 than the 36% difference indicated by this portion of the study. "<Claim D>
- Tradicat:
- So these claims are pretty far out there as it implies that instead of creating a lasting immune response it actually impedes an immune response making the immunized MORE vulnerable. If true this would indeed be grievous.
- Fortunately, it is not true. Based on my calculations, the placebo groups had incidence levels of ~140. Whereas when immunized the placebo group had an incidence level of ~50. The last time I checked, 140 > 50.
As noted, I searched for and found the document. While I will admit it took some time and effort to read it carefully, I have concluded that LifeSite News should have done what I did - read the report carefully.
What I believe to be the pertinent text from the report is reproduced below. Tables 7a and 7b come from the report indicating the incidence of COVID amongst the immunized vs placebo. The report text is the paragraphs that I believe that LifeSite News believes proves their point. I have highlighted some key sentences.
So what did I conclude. That LifeSite made a gaff in their article. Originally, I thought that they were mixing up the groups - which is still possible. Then I did the math and either way, the data does not support their theory. It simply supports the conclusion reached by Pfizer - the longer the time period after the immunization, the more the vaccine wanes.
| Study / Group | State | Cases | Surveillance Time | Population | Incidence |
| Study A Grp A | Vaccine | 77 | 6.092 | 19711 | 12.6 |
| Placebo | 833 | 5.857 | 19741 | 142.2 | |
| Study A Grp B | Vaccine | 81 | 6.34 | 20533 | 12.8 |
| Placebo | 854 | 6.11 | 20595 | 139.8 | |
| Study B | Vaccine | 70.3 | |||
| Placebo (Vaccinated Later) | 51.6 |
References
Original Study Table
Report Text
6.4.6. COVID-19 cases among C4591001 study participants during the Delta variant surge
Responding to an FDA request, Pfizer performed a post hoc analysis of protocol-specified COVID-19 cases accrued during the period of July 1, 2021 through August 31, 2021 (corresponding to the Delta variant surge) among participants 16 years of age and older who completed the 2-dose primary series. The analysis compared rates of COVID-19 among participants who completed the 2-dose primary series early in the study (i.e., those who were originally randomized to BNT162b2) vs. those who completed the 2-dose primary series later in the study (i.e., those who were originally randomized to placebo and then crossed over to BNT162b2). Study participants included in the analysis were those who remained at risk for first occurrence of COVID-19 following the BNT162b2 primary series (i.e., participants who previously reported COVID-19 or who received additional study vaccinations after the primary series were excluded). The analysis used data extracted on September 2, 2021 from the study’s live database; the datasets were not submitted to FDA.
NB: Red = Group A and A', Green = Group B'
Although not independently verified by FDA, the post hoc analysis appears to indicate that the incidence of SARS-CoV-2 during the analysis period among 18,727 study participants originally randomized to BNT162b2 (mean of 9.8 months post-Dose 2 at the beginning of the analysis period) was 70.3 cases per 1,000 person-years, compared with an incidence of 51.6 cases per 1,000 person-years among 17,748 study participants originally randomized to placebo and crossed over to BNT162b2 (mean of 4.7 months post-Dose 2 at the beginning of the analysis period). An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period. Only 3 severe COVID-19 cases were reported during the analysis period, all of which occurred among study participants originally randomized to BNT162b2.
The reported incidence of COVID-19 among study participants who completed the primary series [Tradicat: ie immunized]<4 months prior to the start of the analysis period was 43.4 cases per 1,000 person-years. In contrast, during the blinded, placebo-controlled follow-up period of the study with data cutoff of March 13, 2021 (prior to the Delta variant surge), the incidence of COVID-19 among BNT162b2 recipients in the Evaluable Efficacy Population (nearly 60% of whom had 4 months or more of blinded follow-up post-Dose 2) was 12.6 cases per 1,000 person-years.1 [Tradicat: This foot note points to the original study data] This observation suggests that while waning immunity is one potential factor that may have contributed to the higher incidence breakthrough cases during the Delta variant surge, it is possible that other factors (e.g., dynamics of Delta variant transmission and potential differences in vaccine effectiveness against the Delta variant vs. strains circulating during the placebo-controlled portion of the trial) may also have contributed.
6.4.7. Summary of booster dose immunogenicity and safety data
The clinical data submitted to this BLA supplement come from an ongoing Phase 1/2/3 study (C4591001), which is also the source of clinical data supporting the original approval of the 2-dose primary series for use in individuals 16 years of age and older. The BNT162b2 30 μg booster dose was initially assessed in a cohort of 23 Phase 1 study participants (11 participants 18-55 years of age and 12 participants 65-85 years of age), and then in 306 Phase 2/3 study participants 18 through 55 years of age. Pfizer is requesting approval of the booster dose for use in individuals 16 years of age and older; therefore, safety and effectiveness of the booster dose in individuals 16 and 17 years of age would be based on extrapolation from safety and effectiveness data in adults. Effectiveness of the booster dose against the reference strain is being inferred based on immunobridging to the 2-dose primary series, as assessed by SARS-CoV-2 neutralizing antibody titers elicited by the vaccine. Immunobridging success criteria for the reference strain were met for both pre-specified co-primary immunogenicity endpoints of GMT ratio and difference in seroresponse rates among study participants with no evidence of SARS-CoV-2 infection prior to 1 month after the booster dose. The submission also includes exploratory descriptive analyses of immunogenicity against the SARS-CoV-2 Delta variant among adults 18 through 55 years of age and 65 through 85 years of age enrolled in the Phase 1 portion of the study. Safety data from 306 Phase 2/3 booster recipients do not show evidence of increased local or systemic reactogenicity relative to Dose 2. While evaluated in only 12 participants in the age cohort of 65 through 85 years, the booster dose was less reactogenic in this age cohort compared to younger adults 18 through 55 years of age. Most reactogenicity events after the booster dose were of mild to moderate severity and self-limited in duration. Lymphadenopathy was observed more frequently following the booster dose than after primary series doses (5.2% compared to 0.4%). No deaths, vaccine-related serious adverse events, or events of myocarditis, pericarditis, anaphylaxis, appendicitis, or Bell’s palsy were reported among study participants who received the BNT162b2 booster dose.
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