Vaccine Safety Update

This is the third of the weekly round-ups of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate (find the second one here). By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from getting inoculated. It should be read in conjunction with Lockdown Sceptics‘ other posts on vaccines, which include both encouraging and not so encouraging developments. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not take them. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against a particular policy. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers reach their own conclusions about what is best for them, based on the available data.

The U.S. CDC is investigating reports of heart problems following vaccination with the mRNA vaccines (Pfizer and Moderna), particularly in young adults aged between 18 and 30, according to the Mail. It is estimated that around 1 in 100,000 vaccine recipients suffer myocarditis – an inflammation of the heart muscle – as an adverse event. The Israeli Health Ministry has announced further investigation into the issue while the Pentagon is reportedly monitoring it in the U.S. after 14 cases were reported following military vaccination. A study in the Lancet suggests a possible mechanism by which the virus itself could trigger such a condition.
The European Medicines Agency has approved the Pfizer vaccine for children of 12 years and above, the Metro reports. In Israel, 93 Doctors have signed an open letter calling for vaccines not to be offered to children on account of the low risks to them of the disease and the unknown risks of the vaccines. America’s Frontline Doctors have filed for a temporary restraining order against the use of COVID-19 vaccines in children in the Northern District of Alabama. In the U.K., the JCVI has not made a recommendation on the vaccination of children, and it will reportedly be left to Prime Minister Boris Johnson to make a decision in the coming weeks. If true, this seems a very unsatisfactory state of affairs – in the absence of a clear medical and scientific recommendation to authorise the use of a medicine on children, the default position should surely be not to authorise it?
A comment piece in the Lancet has raised the issue of the missing consideration of Absolute Risk Reduction (ARR) in the vaccine trials and studies. The authors, including Professor Piero Olliaro of the Centre for Tropical Medicine and Global Health at the University of Oxford, calculate an ARR of 1.3% for AstraZeneca, 1.2% for Moderna, 1.2% for Janssen and 0.84% for Pfizer.
A letter in the Journal of Neurology, Neurosurgery and Psychiatry (BMJ) (also reported by the Mail and ITV) highlights the risk of stroke following receipt of the AstraZeneca vaccination, linking it to the newly identified condition of Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) (blood clots).
The U.K. Government has released two reports on the hospitalisation rates of vaccinated people with COVID-19 over the winter and spring. One, from PHE, suggests 57% of patients admitted with Covid over the period had received at least one vaccine dose. The other, from the ISARIC4C consortium, suggested just 7.3% of Covid hospital admissions over the period had received at least one vaccine dose. This large discrepancy has not been acknowledged or explained.
The Johnson & Johnson vaccine has received conditional marketing authorisation in the UK.
EudraVigilance – the equivalent of the Yellow Card reporting system in the EU – has logged reports claiming 12,184 people have died and 1,196,190 have suffered injuries following receipt of the Covid vaccines in the EU.
Suspected adverse events in the U.K. as reported in the media: Stephanie Dubois (39); Lisa Shaw (44); Kirsty Hext (25).

Summary of Adverse Events UK

According to an updated report published on May 27th (covering the period up to May 19th), the MHRA Yellow Card reporting system has recorded a total of 859,481 events, based on 246,970 reports. The total number of fatalities reported is 1,213.

Pfizer (12.7 million first doses, 10.5 million second doses) now has one Yellow Card in 380 doses, 2.9 adverse reactions (i.e., symptoms) per card, one fatal reaction in 61,000 doses.
AstraZeneca (24.2 million first doses, 10.7 million second doses) has one Yellow Card in 190 doses, 3.7 adverse reactions per card, one fatal reaction in 43,000 doses.
Moderna (0.3 million first doses) has one Yellow Card in 152 doses, 2.8 adverse reactions per card, one fatal reaction in 75,000 doses.

Note that these rates have dropped slightly from last week.