‘Only informed consent should be given to experimental vaccine’

September 8, 2020

SHORT CONSULTATION: Matt Hancock, the Secretary of State for Health, ordered his department to publish the proposed changes to the Human Medicine Regulations to cover a potential roll-out of a vaccine on 28 August. The consultation time frame ends on Sunday 20 September.

RISKY STRATEGY: “I am suspicious of the motives proposing expedited use in the wider human population. Volunteers from these groups should be provided detailed information about risk/benefit, including the sole point I make here. Only informed consent is given should any experimental vaccine be used. I don’t trust you.” – Former vice president of Pfizer and founder of Ziarco Dr Michael Yeadon.

ADVERSE EFFECTS: “Instead, it’s the very principle that politicians seem ready to waive that new medical interventions at this, incomplete state of development, should not be made available to subjects other than explicitly on an experimental basis. That’s my concern. You have literally no data on this and neither does anyone else.”

 

 

 

A MEDICALLY qualified biochemist, toxicologist and former chief executive of a bio-tech company has condemned the Government for misleading potential recipients of a trialled vaccine on safety risks.

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Dr Michael Yeadon founded the company Ziarco, now known as Novartis, and he worked for 32 years in pharmaceutical research and development, mostly in new medicines to treat lung and skin disorders.

Novartis founder writes open letter to Hancock


The former vice-president of Pfizer claims he is very knowledgeable in new medicine research and development and has written an open letter to the Secretary of State Matt Hancock into his consultation document for the roll out of a Covid-19 vaccine.


The document is about changing the Human Medicine Regulations and the department says it will go through the “usual rigorous testing and development process” and will meet the “expected high standards of safety, quality and efficacy before it can be deployed”.


The consultation document was published on 28 August and the date for consultations closes on Monday 20 September, which some critics say is too short a time frame to raise concerns about a mandated vaccine.


In his letter in which he addresses Mr Hancock on Twitter, Dr Yeadon writes: “I have read the consultation document. I’ve rarely been as shocked and upset.

‘I believe recipients are being misled to a criminal extent’


“All vaccines against the SARS-COV-2 are virus by definition novel. No vaccine candidate has been in development for more than a few months.

“If any such vaccine is approved for use under any circumstances that are not explicitly experimental, I believe that recipients are being misled to a criminal extent.

“This is because there are precisely zero human volunteers for whom there could be possibly more than a few months past-dose safety information.

‘You have no data nor does anyone else’

“My concern does not arise because I have negative views about vaccines (I don’t). Instead, it’s the very principle that politicians seem ready to waive that new medical interventions at this, incomplete state of development, should not be made available to subjects other than explicitly on an experimental basis. That’s my concern.

“You have literally no data on this and neither does anyone else.

“It isn’t that I’m saying that unacceptable adverse effects will emerge after longer intervals than dosing.

“No: it is that you have no idea what will happen yet, despite this, you’ll be creating the impression that you do.

‘Don’t develop vaccine without safety data’

“Several of the vaccine candidates use novel technology which have not been previously used to create vaccines.

“There is therefore no long-term safety data which can be pointed to in support of the notion that it’s reasonable to expedite development and to waive absent safety information on this occasion.

“I am suspicious of the motives proposing expedited use in the wider human population. We now understand who is at particularly elevated risk of morbidity and mortality from acquiring this virus.

‘You’ve behaved badly in this crisis and I don’t trust you’

“Volunteers from these groups should be provided detailed information about risk/benefit, including the sole point I make here.

“Only informed consent is given should any experimental vaccine be used. I don’t trust you.

“You’ve not been straight forward and have behaved appallingly throughout this crisis. You’re still doing it now, misleading about infection risk from young children. Why should I believe you in relation to experimental vaccines?”

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