Safe and Effective Semantics – assurances and risk

“I’m well aware of the global crimes against humanity being perpetrated against a large proportion of the world’s population.” said Dr Mike Yeadon, former Vice President and Chief Science Officer at Pfizer, in an interview with America’s Frontline Doctors.

Dr Yeadon went on to say that even if these pharmaceutical agents were legitimate, protection is needed only by those at notably elevated risk of death from the virus. For others it’s wholly unethical to administer something novel and for which the potential for unwanted effects after a few months is completely unknown. ‘It is also intended that minor children and eventually babies are to be included in the net, and that’s what I interpret to be an evil act … there is no medical rationale for it’ he said .

UK Government’s Yellow Card Reporting Scheme

‘Dr. Wolfgang Wodarg and I petitioned the EMA Dec 1, 2020 on the genetic vaccines. They ignored us. Recently, we wrote privately to them, warning of blood clots, they ignored us. When we went public with our letter, we were completely censored. Days later, more than ten countries paused use of a vaccine citing blood clots.’

An Oxford-AstraZeneca vaccine trial on children was paused while the UK MHRA investigated a possible link between the injections and blood clotting disorders, specifically cases of blood clots in veins within the brain. The vaccine companies and their regulators are emphasising that the experimental biological agents are safe and effective, and that adverse reactions are rare.

CNBC reported on 7th April that Europe’s medicines regulator, the European Medicine Authority, is investigating a possible link between the coronavirus vaccine developed by AstraZeneca and rare blood clotting issues, though it said the benefits of getting the injection outweigh the risks. The EMA press conference also noted other possible side effects and said that it was important that health-care professionals, and people receiving the Oxford-AstraZeneca vaccine, were aware of the risks and watch for possible symptoms that typically occur in the first two weeks after inoculation.

Dr. Sabine Straus, chair of EMA’s safety committee, said at the press conference that these symptoms might include, ‘for example, shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms including severe or persistent headache or blurred vision, and skin bruising beyond the site of injection.’ In an interview with Italian newspaper Il Messaggero, Marco Cavaleri, chair of the EMA’s vaccine evaluation team, said: “In my opinion we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction.”

The EMA says that its investigation continues and will report soon.

On the same day, according to MSN, the US National Institute of Health said it had begun investigating why some people have suffered from severe allergic reactions shortly after receiving the Pfizer-BioNTech and Moderna Covid-19 vaccines.

‘The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,’ Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement, ‘The information gathered during this trial will help doctors advise people who are highly allergic … about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the risks.’

On 1st April 2021 the total number of adverse reactions reported on the UK Government’s Yellow Card Reporting Scheme was 566,608 with 786 fatalities in the UK. Health Impact News reports that the American CDC  has recorded 56,869 injuries and 2794 deaths. This fatality figure already exceeds the 2588 US deaths recorded over the previous eleven years. Eudravigilance, the European database of suspected adverse drug reactions, reports 5365 fatalities and 238,949 injuries.

It is still not known whether any of these agents are safe and effective, and it will be some time before the truth of the matter, whatever it turns out to be, becomes apparent. The distribution of unapproved medicines that have not previously been fully tested is, effectively, a clinical trial ‘in the wild’.

To date, people who are under fifty-five with no co-morbities and living healthily in a healthy environment are at very little risk from the epidemic pathogen. A substantial body of evidence is building to suggest that gene therapies may pose multiple substantive and as yet poorly defined risks. As children are at vanishingly small risk of serious harm from the current epidemic it seems to be, as Dr Yeadon says, ‘madness’ that they should be exposed to unknown risks from untested interventions. The UK Government’s High Consequence Infectious Disease group has acknowledged that the disease itself is characterised by a low mortality rate save for particular limited demographics.

At this early stage of distribution more than half a million adverse reactions have been reported in the UK, many hundreds of people have died, and it is widely acknowledged that the voluntary Yellow Card Reporting Scheme attracts only a small proportion of the events that occur.

In his interview Dr Yeadon states that those who survived the SARS-Cov-1 outbreak have proven to have strong T-cell driven immunity to its cousin, SARS-Cov-2, and he says that ‘the best data that exists suggests that immunity should be robust for at least 17 years and it’s entirely possible that it is lifelong.’

‘No variant differs from the original sequence by more than 0.3% … As a general rule, variants form very often, routinely, and tend to become less dangerous & more infectious over time, as they come into equilibrium with the human host. Variants generally don’t become more dangerous. This degree of similarity of variants means there is zero chance that an immune person (whether from natural infection or from vaccination) will be made ill by a variant.’

With so much uncertainty regarding the disease, its variants, and the long term effects of novel technologies and untried interventions, surely it is time to pause human testing of experimental biological agents until the potential long term risks of the millions of doses already distributed can be identified and assessed.

DR 12 April 2021