Coronavirus – A Safe Vaccine ??
Drug manufacturers and regulators have been under intense political pressure from Governments to deliver a safe vaccine. AstraZeneca reported it expected to be able to introduce a coronavirus vaccine with a success rate of 90%-10% before Christmas 2020, but the announcement was premature.
Shortly after the announcement, US (Food and Drug Administration) regulators, (FDA) stopped trials so it could conduct a probe into an adverse event reported in the UK involving a patient on a trial of the vaccine who fell ill with unexplained neurological symptoms, previously believed to be consistent with transverse myelitis.
At that time the regulation of vaccines, which are technically biologics, fell to the remit of the European Medicines Agency (EMA) which supported the American initiative. But Boris Johnson, the UK Prime Minister, announced that the UK would bypass the EMA’s regulatory regime and grant a production and distribution license to AstraZeneca enabling the roll-out of a vaccination programme in the UK, from December 2020. Take a look at the AstraZeneca share price below:
The EMA Rolling Review Procedure
At the beginning of October 2020, the EMA started the first ‘rolling review’ of the COVID-19 vaccine being developed by AstraZeneca in collaboration with the University of Oxford. This meant that the committee had started evaluating the first batch of non-clinical data on the vaccine. It did not mean that a conclusion would be reached on the vaccine’s safety and effectiveness, since much of the evidence had not yet been submitted.
The rolling review programme is a regulatory tool that the EMA used to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine’s effectiveness, safety, and quality, and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorization.
Buy in the case of a rolling review, EMA’s human medicines committee (CHMP) reviewed data as it became available from ongoing studies. When the CHMP decided that sufficient data was available, the formal application would be submitted by the company. In reviewing the data as it became available, the CHMP would reach an opinion sooner on whether or not the medicine or vaccine would be authorized.
There were at least 64 companies worldwide involved in the research and production of a safe vaccine and many are nearing production. So it was expected that a number of vaccines, perhaps safer and more efficacious would be available to the market in the early months of 2021.
Time will be the judge that will decide if the UK Governments’ decision is right.
(https://www.ema.europa.eu/en/news/ema-starts-first-rolling-review-covid-19-vaccine-eu)
2 June 2014: Just let me ask the wife!!! says Civil Servant and UK Tory Government Cabinet Secretary
Sir Jeremy Heywood advised the Prime Minister to prevent a takeover bid from Pfizer for its British rival AstraZeneca.
And just as it happened that Heywood’s wife (who worked for McKinney’s) had only just recently written a report, circulated to Tory politicians, advising pharmaceutical firms to restructure, including mergers with rivals, ‘to navigate turbulent times’. What did she know that other’s didn’t?
The Pfizer bid was subsequently withdrawn. Heywood and his wife’s role’s needed to be independently investigated. But that didn’t happen.
Brexit Uncertainty
AstraZeneca, headquartered in Cambridge UK, is the world’s fifth-largest pharmaceutical company. It is on record as saying that a hard Brexit would mean moving some of its operations away from the UK.
An company spokesman said that moving manufacturing takes several years but the likelihood of the company relocating to the EU is high, in the event of a hard Brexit and the company had taken the first steps in planning for a scenario in which no divorce deal is reached between the UK and the EU by the 31 December 2020 deadline.
caltonjock 
Why are you only concerned about the Astrazeneca “vaccine”? The definition of a vaccine was altered so that the mRNA jabs could be described as such. Not one of them was licensed. They were made available under emergency use authorisation. How many people would have volunteered to be injected with experimental gene therapy drugs with nothing known about the longterm effects they would have?
LikeLiked by 1 person
I raised awareness of the fact that Prime Minister Johnson authorised the universal vaccination of UK citizens using the British AstraZeneca vaccine before it had been approved by the relevant authority. To facilitate his plan he withdrew the UK from the European body responsible for confirming the safety and efficacy of the vaccine then he and the vaccine producers changed the category and terminology of the vaccine enabling it to be approved using a much less stringent procedure. All this to steal a march on other vaccine manufacturers who observed the approval protocols. And what of the incidents that were reported at the start of the trials? Ignorance is bliss and no more was heard about them. And I also referred to the involvement of the UK’s most senior advisor and his wife, Mr and Mrs Sir Jeremy Heywood
LikeLike
I don’t think these details matter nearly as much as raising awareness of the entire scam. The Big Pharma companies in the US are all felons. It’s easy to look up the huge fines they have had to pay in the past for products for which they could be held accountable. Classify something as a vaccine and all accountability is removed. They aren’t going to take more care over products that give them a ‘get out of jail free’ card, are they? What about our right to bodily autonomy? No one was given the information to enable them to make an informed choice before rolling up their sleeves for these injections. Specific details of corruption will always be of interest but won’t do much to open people’s eyes to the way their human rights were ignored during the Covid era and to make sure that they never allow this to happen again. To me that is far more important than raking over all the financial corruption that took place.
LikeLike
I am in agreement with all that you say and concur with your view that the executives of big pharma worldwide needs to be brought to account. Unfortunately many healthy people will die before that happens since shareholders are well accustomed to fantastic financial returns on their investments. The main recipients being Hedge Funds, Pension Schemes, Governments and offshore accounts.
LikeLiked by 2 people