After much anticipation, the MHRA have released an important bulletin on COVID-19 Vaccination Adverse Reactions 👇🏼
❗️This is an important aspect of the UK Vaccination campaign – to provide ongoing transparency on the safety profile of the administered vaccines.
On 5th Feb (last Friday), MHRA released the first public insight into the Yellow Card scheme for the experimental Pfizer and AstraZeneca COVID-19 vaccines.
The insight is thorough, which I expect many people will be grateful for, but more (ongoing) insight is needed to answer all the questions people have.
👇🏼The below graphic pulls together the headline figures for both vaccine types, as well as offering summarised events and associated fatalities per disorder category.
🟩 THE GOOD NEWS:
🔹 Detailed visibility into each sub category of adverse event recorded
🔹 Details on number of reports, reactions and post-vaccine deaths per vaccine product
🔹No meaningful signal when compared to expected background rates of disorder/death, according to MHRA analysis
🔹Yellow Card reported post-vaccine deaths are very low (1: 50,000)
🔹 The majority of adverse reactions are acute and tolerable – injection-site reactions, ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat.
🟨 THE UNCLEAR:
🔸 Yellow Card language suggests death outcomes are tracked up to 7 days after an ADR is reported. If so, this is woefully inadequate. Surely ~30 days post vaccine dose would be more thorough?
🔸 It is unclear how may of the ADR’s manifest into worse reactions – such as a heavy sustained flu-like illness, before recovering. Especially important for the elderly and/or infirm.
🔸 This data is not intended to provide any insight into the vaccines effectiveness in stopping a SARS CoV2 infection. There is no signal thus far that could spell success for COVID vaccines rollout. Time will tell, but honest science would need to consider the other 6-10 variables that will be driving down deaths and infections.
🔸 Much more insight is needed into the Coronavirus infections and deaths to understand if these are a function of (a) vaccines not working, (b) infection occurring before vaccine could take hold, (c) false positive or (d) very poor health of the patient.
🟥 THINGS TO CONSIDER:
🔻 As expected, there are double standards at play here. COVID reporting is fast and loose, with no effort to interrogate and minimise the alarmist nature of this data. Whereas (and rightly so), MHRA are going to long lengths to both set expectations that old/frail people will have coincidental deaths/reactions as well as deeply scrutinise the data to identify true causality.
🔻 With only 20 days of AstraZeneca data (a replication-defective modified adenovirus vaccine), indicators suggest an increase in negative outcomes when compared to Pfizer Vaccine. However, timing, seasonality, health of vaccinated cohort etc must be factored into this analysis.
🔻 A failure of time-limited self-reporting surveillance, is it does not follow the patient with proactive medical assessments. It does not take a reading of health markers before, and does not systematically re-take those biomarkers for a period thereafter. As such any loss of health or function (e.g auto immune condition, gut issue, neurological issue or reproductive issue) is near on impossible to detect and link back to the vaccination.
🔻 For several reasons, the number of self-reports will only ever be a fraction of the total events. Motivation, awareness, other illnesses, lack of technical skills, old age etc will effect the accuracy of this surveillance strategy.
Big step forward
👍🏼Net-net, this is a big step forward.
Some would argue it’s too late, there is too much hand-waving, and the data should be updated in real time like COVID stats and VAERS.
Others would argue that there is a strong correlation in Total Mortality and Vaccination Uptake, and more data would be needed to satisfy that there is no direct link in those particular deaths.
👁 But all that said, this should help bring some context and calm to the current short-term safety profile of these 1ST DOSE VACCINATIONS of Pfizer and AZ vaccines.
🤞🏼Hopefully we will see increasing data transparency and depth from the UK Govt and their subsidiaries – occurring as a minimum on a weekly basis.
MHRA Vaccine ADR Bulletin 5th Feb 2021. Link to the assets page below 👇🏼
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