The government has now approved the supply of the Pfizer-BioNTech COVID-19 vaccine. The reason they have been able to do this so quickly is because they have taken advantage of the temporary authorisation regime laid out by the Human Medicine Regulations of 2012 and 2020. The 2012 Regulations were updated in 2020 specifically to facilitate the smooth rollout of the COVID-19 vaccine. In the public consultation preceding the introduction of these updated regulations, several respondents raised concerns regarding unlicensed vaccines and immunity from civil liability. In practice, very little is known about these regulations and their application. This article seeks to shed some light on the temporary authorisation regime and suggest a means of alleviating concerns in the context of “vaccine hesitancy”.
At stake at one point last year was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. “There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano,” Mr Etigwe said. “The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer.” Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.
TED (Tenders Electronic Daily) is the online version of the ‘Supplement to the Official Journal’ of the EU, dedicated to European public procurement.
The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed.
None of this, however, explains the 40 years of medical misinformation and suppression of the pharmaceutical truth. To have covered up the knowledge for four decades that viruses could potentially be treated by antimicrobials required extensive effort:
• Censorship. It is likely that some scientists were never published again after authoring one paper on the antiviral benefits of CQ. • Buying silence of news media. This is evident from the blackout across the political news spectrum concerning vaccine adverse effects. Pharmaceutical manufacturers provide the most lucrative advertising for both written and broadcast news programs. • Misdirection. For years, pharmacology professors in medical schools have perpetuated lies of omission. • Lies by drug companies. Merck was caught publishing its own “peer reviewed” journal to promote its drugs.54 • Regulatory capture. “Big Pharma” essentially owns the FDA by being its biggest funder and employing more than 58 percent of the FDA’s upper-level regulators and administrators either before or after their tenure.55,56 • Research funding. Big Pharma is the major funder of nearly all “independent” drug research, and there is no incentive to research cheap/ less profitable solutions.
The COVID-19 pandemic is calling attention to the potential for treating viral diseases with currently available drugs, and exposing long-available but ignored research. The implications of all this are very disturbing. Where have the virologists been, and the CDC “experts” who claim to care about influenza deaths? Has the burgeoning nearly trilliondollar vaccine industry been built at the expense of patients’ lives?
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements, a senior executive told Reuters.
With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations.
“In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest,” he said, adding that Astra and regulators were making safety and tolerability a top priority.
In July Health Secretary Matt Hancock claimed that conspiracy theorists are putting lives at risk
The UK government’s Vaccine Damage Payment scheme is proof that vaccines can be unsafe
Eligibility criteria Vaccine Damage Payment changed in 2015
Update October 2020: AstraZeneca protected from vaccine liability
Update November 2020: MHRA expects high volume of COVID-19 vaccine adverse drug reaction
Update December 2020: Pfizer is given protection from legal action by the UK government
Discussion around vaccinations can be very contentious. There’s great nuance in this area and a short post will not do justice to the complex issues surrounding the usefulness and safety of vaccines. Nevertheless, while vaccines may have their role in protecting target populations from disease, not all have been proven safe to an acceptable level as shown in the resources below.
The UK government’s Vaccine Damage Payment scheme is probably the strongest proof that vaccines can be unsafe. Under the Vaccine Damage Payment scheme, people who have been severely disabled as a result of a vaccination against certain diseases can be eligible for a one-off tax-free payment of £120,000.
Conspiracy theorists are putting lives at risk?
It is an objective fact that a compensation scheme exists for those who have been damaged by vaccines. Nevertheless, Health Secretary Matt Hancock claimed that conspiracy theorists are putting lives at risk:
“Those who promulgate lies about dangers of vaccines that are safe and have been approved–they are threatening lives…”
Clearly, concerns about the safely of vaccines cannot be lies if there is a vaccine damage compensation scheme in place.
Eligibility changed in 2015
Eligibility requirements for vaccines covering certain diseases are listed and change over time. Interestingly, sometime around 2015, damage from vaccines for influenza caused by pandemics are explicitly listed as not eligible.
We do not know how the government compiles is eligibility criteria or why this change was made. However, it would be worthwhile to keep an eye on this list to see if the status of the upcoming COVID-19 vaccines.
AstraZeneca protected from vaccine liability
Update 1 August 2020: On 30 July 2020, Reuters reported that AstraZeneca, the UK government’s partner for developing its COVID-19 vaccine, will be exempt from coronavirus vaccine liability claims in most countries. The countries have not been named but Ruud Dobber, a member of Astra’s senior executive team, commented:
“This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects.
In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest.”
MHRA expects high volume of COVID-19 vaccine adverse drug reaction
Update November 2020: It came to light in mid-November that the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) put out a contract award notice for an Artificial Intelligence (AI) software tool. It appears they expect a high volume of COVID-19 vaccine Adverse Drug Reaction (ADRs) from the upcoming vaccines:
…it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively.
Pfizer given legal indemnity
Update 2 December 2020:According to the Independent, Pfizer now has a legal indemnity from being sued by patients who develop any complications from its new mRNA vaccine that will be rolled out in the UK. NHS staff providing the vaccine will also be protected.
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