Tuesday, October 26, 2021
HomeCOVID-19How can we check vaccine safety under this shambolic system?

How can we check vaccine safety under this shambolic system?

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THE Medicines Healthcare products Regulatory Agency (MHRA) is the government body that decided which Covid-19 vaccines we could access. They reviewed the safety studies provided by Pfizer, AstraZeneca and Moderna before granting the three drug companies emergency use licences.

Under the licences these products are subject to additional monitoring. All adverse drug reactions (ADRs) should be reported to the MHRA but they say they receive information on only 10 per cent of ADRs.

Post-administration follow-up is vital to allow us to feel confident that these experimental vaccines are as safe as the manufacturers claim they are. With this in mind, you would expect a robust system to be in place. The snag is that it’s up to the vaccine recipient to decide whether to report or not.

The MHRA’s Yellow Card Scheme for members of the public, doctors and pharmacists to report adverse events is not overtly advertised. There is a word-of-mouth system within hospitals and GPs’ surgeries, instructing staff what to do if a patient thinks they have suffered a bad reaction to a Covid jab. The public are mostly unaware and are rarely given the information by health professionals.

A senior NHS board member contacted UK Column News to voice her concerns about the lack of reporting of adverse reactions by the medical profession. She said: ‘I know that the Yellow Card reporting system is not reflective of the amount of adverse events that are actually happening. I know of a patient who reported their extreme adverse event side-effect to a nurse, and that nurse did not report it to the Yellow Card reporting system. People are told that their adverse events are normal. It is not normal to have to stay in bed for two days after a vaccine.’

Scottish nurse Kirsty Miller, who was based in Tayside, recently resigned from her NHS post as staff nurse. As far back as February she wrote to Rebekah Carton, a subgroup member of the Scottish Government Covid-19 Advisory Group, asking for her advice on Yellow Card reporting.

Mrs Miller said in her email: ‘We have a duty to alert the Yellow Card Scheme and inform patients and families of this process, but we have nowhere to clinically document this in the hospital structure.’ She received no response and resigned a month later, distressed by the numbers of old people who appeared in A&E post-vaccination suffering serious ADRs including delirium, severe headache, eye problems, total collapse and hypothermia.

Mrs Miller said to Ms Carton: ‘These patients are scared and confused. It’s our duty to ensure we do right by them. As a nurse, I took an oath to do no harm. I feel I need to speak out for my patients and my concern that it’s happening throughout Scotland, England and worldwide.’

Mrs Miller also asked her supervisors whether she should be reporting these events to the Yellow Card Scheme, but says some doctors were unaware of it while others were unsure what to do. None had been given clear advice.

Freedom of information requests to hospital trusts in England show that although they are recording Covid deaths, they are not recording reactions to Covid vaccinations. University Hospitals Bristol and Weston NHS Foundation Trust said: ‘We do not hold this information.’ So did Kettering General Hospital NHS Foundation Trust.

Drug trials cannot pick up rare reactions, or reactions that occur after years such as autoimmune disease, so this is a vital service, one you would imagine the MHRA would push hard. After all, the ‘rare’ blood clots identified after the AstraZeneca vaccine rollout did not show up in AZ’s laboratory trials but to date there have been 2,232 reports of thrombosis and blocked arteries associated with their vaccine [or 22,320 multiplying up for the 10 per cent].

In March, eighteen European countries, including France, Germany and Sweden, suspended the AZ jab before the MHRA took any action here. Three weeks later, on April 7, the MHRA and the Joint Committee on Vaccination (JCVI), decided that blood disorders caused by the vaccine affect younger people so recommended that no one under 30 should have the AZ jab. The JCVI revised that advice today to include under-40s.

Denmark has now suspended it permanently, saying it is relying on other vaccines. (Incidentally, Pfizer’s jab caused the same problems but not in the same numbers – 363 [or 3,630 multiplying up] reports to date in the UK – but the figures are not considered high enough to cause the MHRA undue concern.)

Last week, the British regulator reported 41 new cases and 9 more deaths as a result of the rare side effect. In total, there have been 41 deaths caused by blood-clotting side-effects in the UK, giving an incidence rate of just over nine per million doses, 90 per cent higher than the predicted one in a million rare adverse events we are told occur.

In February, when we were being told that all the recorded reactions were ‘coincidental’ and not vaccine damage, I sent a list of questions to the MHRA asking how they encouraged medical professionals and the public to report to the Yellow Card Scheme – social media and mainstream media campaigns as well as information in the vaccination leaflet.

I asked how they investigated the reports they received, how they determined whether a vaccine was responsible for an ADR and under what circumstances they would mount an in-depth investigation.

An MHRA spokesperson said: ‘Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or event in the days and weeks after vaccination. A high proportion of people vaccinated so far are very elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated.

‘Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions* of doses of vaccines administered so far, mostly in the elderly.

‘Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the deaths reported to the scheme.’

At the time I’d spoken to three families who had lost elderly relatives after vaccination and they all said they felt vaccination had played a big part in ending their relatives’ lives. One man in his 80s who had Parkinson’s and diabetes, received his second Pfizer vaccination and ten hours later was in a life-threatening situation. He later died. He received the jab early January, began vomiting and developed diarrhoea as a side-effect. He also had a duodenal ulcer which was aggravated by the vomiting and he began throwing up blood. He’d been prescribed blood thinners, medication contraindicated for vaccination, but the nurse had not picked this up. Because of the vomiting and diarrhoea, he became weak and then suffered a pulmonary embolism – a blockage of an artery in the lungs – which killed him.

The family filled out a Yellow Card report but never got any straight answers from the MHRA and did not feel the death was taken seriously. The man’s daughter said: ‘The MHRA sent us a list of questions back in February and we’ve heard nothing since.’

I put the case to the MHRA who said: ‘As with any serious suspected ADR, reports with a fatal outcome are fully evaluated, including an assessment of post-mortem details if available, to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness.’

Although the vaccination was contraindicated, the MHRA said that they would not apply any sanctions or prosecute any offenders. They simply said they would ‘consider the need to further communicate the risks to prescribers in liaison with the relevant healthcare organisations’.

If a patient dies within 28 days of receiving a Covid vaccine, regardless of whether or not they had underlying health conditions – remember that anyone with comorbidities who tested positive for Covid and died was said to have died with Covid – you would expect a major investigation, but it is passive. The MHRA said: ‘We actively follow up all fatalities where permission has been provided to do so for further information including post-mortem details if available.’

Most families do not know they should fill in a Yellow Card, like Dave Ward, whose former partner Trisha, aged 43 died of a cardiac arrest hours after receiving the Pfizer vaccine. ‘I had to search online to find the information. I wasn’t told by any of the paramedics or professionals involved.’

Having found it he said: ‘The Yellow Card Scheme is quite a hard site to navigate, and I can imagine some people would give up.’ Dave’s father has since died, three weeks after he got his covid vaccine.

The most compelling information comes from the World Health Organisation who in their Global Manual on Surveillance of Adverse Events Following Immunization (AEFI) say that a full investigation should be mounted if two or more cases of the same adverse event are related in time, place or vaccine administration as well as AEFI occurring in similar age groups and populations.

I asked the MHRA about this several times and they have yet to respond, possibly because there are inundated or probably because they have not been following the WHO guidelines. Until April 22, the agency had received reports of 973 fatalities, a number you would think worthy of a major investigation.

*35 million have received 1 dose, 16 million have received 2 doses.

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Sally Beck
Sally Beck is a freelance journalist with 30 years of experience in writing for national newspapers and magazines. She has reported on vaccines since the controversy began with the MMR in 1998.

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