Despite there still not being any vaccine trial data, safety or technical analysis published by Pfizer, or by the MHRA, the media was full of assurances about the vaccine’s safety from Government press releases and appearances on TV of the CEO of MHRA June Raine telling a Downing Street press conference that the public could be confident there had been an “extremely thorough and scientifically rigorous review”.
The Pfizer/BioNTech vaccine was authorised by the Medicines and Healthcare products Regulatory Agency on Tuesday under regulation 174 of the Human Medicine Regulations 2012 which allows an unlicensed medication to be used in an emergency such as a pandemic.
Yet despite this, it emerged in the media today that the Government has given the pharmaceutical giant Pfizer a legal indemnity protecting it from being sued, enabling its Covid-19 vaccine to be rolled out across the country as early as next week.
Ministers have had to change the law following a short three-week consultation in September to give new protections to companies such as Pfizer, giving them immunity from being sued by patients in the event of any complications.
This now sets a precedent because this is the first time those regulations include a legal indemnity protecting them from civil liability in the event of any complications as a result of their vaccine being used.
This was confirmed also by the Department of Health and Social Care along with the fact that NHS staff giving the vaccine, as well as manufacturers of the drug, are also protected.
The Independent newspaper reports today that:
‘In a press conference with journalists on Wednesday, Ben Osborn, Pfizer’s UK managing director, refused to explain why the company needed an indemnity.
He said: “We're not actually disclosing any of the details around any of the aspects of that agreement and specifically around the liability clauses."
Asked about when the full data on the vaccine’s clinical trial would be published, the company said this was still being worked on.
Dr Berkeley Phillips, medical director for Pfizer UK, said: “The publication is in progress. The priority, absolutely, had to be the regulatory submissions to MHRA, EMA and the FDA. That was the most important thing we needed to do. The full protocol is published and available for everyone to see and the team are working on the publication of the manuscript in parallel to the regulatory submissions.”
The news item concludes:
'The Department of Health and Social Care confirmed an indemnity was in place for Pfizer and added that the government would be adding the coronavirus vaccine to the list of vaccinations covered by the Vaccine Damages Payments Act. This pays out a one-off £120,000 payment to people who are permanently disabled or harmed as a result of a listed vaccination.’
Yet all we know about the safety or otherwise of this vaccine is that which comes from the manufacturer themselves, with no independent scientific analysis having taken place.
Most importantly none of the associated safety data for the vaccine has been published.
Pfizer used around 43,000 people in its trials. Over 20,000 volunteers were given the vaccine, with only mild side-effects being reported. The results of the testing showed that it was 95% effective in stopping the disease.
However, whilst this may suggest that dangerous side effects can be ruled out, it won’t be until after the vaccine has been used in a great number, involving hundreds of thousands, of the population; before any serious side effects which only affect a small group of people will emerge, if at all. A small clinical trial can never cover that number of people, and certainly not within such a small time frame in which this vaccine ahs been developed.
As previously reported by Unionsafety, the Yellow Card reporting system that allows anyone to report side effects they believe were caused by the vaccine; will be used by the MHRA to monitor the roll out of the vaccine.
With all of the above being said, and despite what some anti vaccination campaigners are claiming; vaccines in general are safe and save millions of lives a year.
But history tells us that very rarely; complications do happen for some people which can be devastating in their long-term health problems and often changing the lives of those affected and that of their loved ones.
Cases such as that of the thalidomide drug which caused birth defects and more recently the GlaxoSmithKline bird flu vaccination which caused narcolepsy in some patients.
Whilst the Government via the Vaccine Damages Payments Act 1979 will pay a one-off payment of £120,000, this when a life is permanently damaged as a result of a vaccine side-effect; is but a mere drop in the ocean of the life-time costs many encounter.
Source: The Independent / Gov.UK website / unionsafety
See also: UK Medicines Regulator Gives Approval For First UK COVID-19 Vaccine
See Covid Vaccine Information for Healthcare Professionals, and Information for UK recipients available now from the Unionsafety E-Library here and here
