Pfizer's analysis of Adverse Events

Some missing entries in later documents

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As part of its Biological License Application (BLA) to the US Federal Drug Administration (FDA), Pfizer submitted an analysis of adverse event reports from 1 December 2020, through 28 February 2021 from 63 countries. Most reports came from the United States and the United Kingdom. The data was collected from surveillance systems like the US government’s Vaccine Adverse Event Reporting System (VAERS), or the UK’s Yellow Card Scheme as well as ‘cases published in the medical literature, cases from Pfizer-sponsored marketing programs, non-interventional studies and cases of serious ARs reported from clinical studies regardless of causality assessment’ .

You can read the whole '“Cumulative Analysis of Post-Authorization Adverse Event Reports” here. You may have done so already as others have already looked at some of the numbers.

Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,378 medically confirmed and 16,707 non-medically confirmed). 13,404 of those cases were from the UK which had delivered approximately 21 million injections by that point. So for the UK, there was approximately 1 case per 1,500 injections.

They had already noticed a lot of adverse events by that point including 1,972 blood and lymphatic system disorders, 1,098 cardiac disorders and 1,223 fatalities.

Anaphylaxis was already an important identified risk with 2,341 serious events and 9 deaths. So was VAED, as I have discussed previously, with 138 serious cases and 38 deaths.

Now any lay person would assume that with so many serious and fatal adverse events, the vaccine programme would be halted and an investigation started. We know however, that didn’t happen, so if we are ever allowed to see the updated version of this document, it will probably come as a shock to most people.

However, what I wanted to comment on in this article, is the similarity between this document (up to February 2021) and the Cominarty Risk Management Plan (up to June 2021) produced for the European Medical Agency (EMA) and the information that is missing in the latter.

Compare the safety concerns in February (table 3) with those in June (table 58).

So similar safety issues but with some added concerns (e.g. myocarditis and pericarditis). However, why did the concern for paediatric individuals <12 years of age and vaccine effectiveness suddenly disappear?

Moreover, in the first report, the rows with missing information (use in pregnancy, paediatric individuals and vaccine effectiveness) are looked at in further detail but in the most recent report they are either missing or replaced with just a short paragraph.

For example, in the first report, with pregnancies and lactation, there were 413 cases, including 75 serious pregnancy cases (25 spontaneous abortions). In paediatric individuals there were 24 serious cases and with vaccine effectiveness there were 1665 cases, including 65 fatalities.

The cases during this earlier report occurred during a time when very few pregnant women or children were injected, so I would imagine a lot more occurred once these groups were vaccinated in bigger numbers.

Playing devil’s advocate, you could argue that the women and children vaccinated in the earlier report were more likely to be in a vulnerable category and so consequentially more likely to suffer an adverse event. However, even if this were the case, you would think the numbers would be included to allay any concerns from the initial report. Furthermore, you could equally argue that due to the vulnerable categorisation of these early cases, a lot more may have been missed and put down to their age or co-morbidity.

Instead, the data for children and vaccine effectiveness is missing and for pregnancy there is one paragraph which reads:

The safety profile of the vaccine is not known in pregnant or breastfeeding women due to their initial exclusion from the pivotal clinical study. There may be pregnant women who choose to be vaccinated despite the lack of safety data. It will be important to follow these women for pregnancy and birth outcomes. The timing of vaccination in a pregnant woman and the subsequent immune response may have varying favourable or unfavourable impacts on the embryo/foetus. The clinical consequences of SARS-CoV-2 infection to the woman and foetus during pregnancy is not yet fully understood and the pregnant woman’s baseline health status may affect both the clinical course of her pregnancy and the severity of COVID-19. These factors and the extent to which the pregnant woman may be at risk of exposure to SARS-CoV-2 will influence the benefit risk considerations for use of the vaccine.

I find some of the wording in that paragraph concerning. “There may be pregnant women who choose to be vaccinated despite the lack of safety data”. By the time this report was compiled, women (in the UK at least) were actively encouraged to get vaccinated. Secondly, “The timing of vaccination in a pregnant woman and the subsequent immune response may have varying favourable or unfavourable impacts on the embryo/foetus”. This sounds quite a significant piece of information to determine before actively telling women to get vaccinated.

Again, for balance, the UK Health Surveillance Agency reports regularly on vaccines in pregnant women and concludes that it prevents severe disease in the mother and barely any difference in babies that are born, compared to those born from unvaccinated mothers. However, it doesn’t record the number of pregnant women who were vaccinated or number of spontaneous abortions, only numbers of vaccinated women who gave birth. With a huge drop in numbers of babies born in 2021 (in the data to date, continuing decreasing fertility trends and probably exacerbated by Covid), I would want to see this information.

Why did the EMA not ask for this missing information before approval?