Prospective SARS-CoV-2/COVID-19 vaccine.

P Newton made this Rhyddid Gwybodaeth request to Medicines and Healthcare Products Regulatory Agency

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Roedd y cais yn llwyddiannus.

Dear Medicines and Healthcare products Regulatory Agency,

This is a request for information pursuant Freedom Of Information (FOI) Act 2000.

In light of the referenced contract as per:
https://ted.europa.eu/udl?uri=TED:NOTICE...

Please provide the following information:

1. The contract awarded to Genpact (UK) Ltd for procurement of an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) to ensure that no details from the ADRs’ reaction text are missed.

2. The information determining the anticipation of a “[high volume] of COVID-19 vaccine Adverse Drug Reaction’s (ADR’s) and details of the anticipated ADR’s.

3. A list of active and inactive ingredients so far known to be contained within the overtly bleated Pfizer and other manufacturer COVID-19 vaccine.

Should MHRA seek not to produce the above requested information, which is evidently within the scope of the Public Accountability and Public Interest doctrines, it will be held that MHRA and it’s paid up decision makers are liable to a Criminal Prosecution in accordance with Judicial precedents raised within the UNITED KINGDOM and on the principles of Public and Private International Law. Judicial options may also seek prohibitory injunction (injunctive relief) against the rollout of a COVID-19 vaccine against any man, male and female.

Yours faithfully,

P Newton

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 20/442

       
Dear P Newton,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 12 November 2020. 
     
I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt. 

If you need to contact us again about this request, please quote the reference number above.
        
Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

dangos adrannau a ddyfynnir

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

4 Atodiad

Dear P Newton,

Please find attached the response to your FOI request.

Kind regards,

Pharmacovigilance Service Team

Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Stay connected: mhra.gov.uk/stayconnected

dangos adrannau a ddyfynnir

Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Prospective SARS-CoV-2/COVID-19 vaccine.'.

Part 1 - The Genpact contract is heavily redacted without reasonable justification. Such redaction is declined as is considered concealment of Information amounting to a Public Interest.

Part 2 - Has not been receptive and the information remains to be disclosed.

Part 3 - Has not been receptive and the information remains to be disclosed.

We acknowledge a response and are grateful, though the response is not compliant with the Public Accountability doctrine.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/p...

Yours faithfully,

P Newton

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency


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Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Click here to find out more.

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

4 Atodiad

Dear P Newton,

Thank you for your email.

We confirm that an internal review is being carried out on FOI 20/442.

Please note the deadline for reply for Internal Reviews is 20 working days and for this Internal Review the deadline will be 18 January 2021.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

dangos adrannau a ddyfynnir

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Atodiad

Dear Mr Newton,

Please find attached the response to your internal review request.

Kind regards,
Pharmacovigilance Service Team
 
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Email: [email address]
Stay connected: mhra.gov.uk/stayconnected
 

dangos adrannau a ddyfynnir

Gadawodd Bartholomeus Lakeman (Ataliwyd y cyfrif) anodiad ()

For Pfizer to disclose their true data only after 24 months. it will have some reasons. COVID-19 mRNA vaccine BNT162 list of ingredients and study results disclosed for the Public are unlikely the same as that on Pfizer raw data, idem with the vaccine ADRs occurring after the 2 months disclosed study reports.
As a rationale for the anticipated ADRs to the Covid vaccine, MHRA should take note of that the VEARS (US CDC Vaccine ADRs report system) is reporting more than 1 yellow card per 1000 doses; which includes some deaths. Similar it occurs in Norway and Germany: which raised voices to put a halt to the Pfizer vaccination program.
Yet, MHRA anticipates only 1 Yellow Card report per 1,000 doses administered, and as MHRA has so far not reported covid vaccine Deaths: It indicates that it has failed to develops a proactive vigilance strategy, or that MHRA’ Risk Management Plan (RMP) obscures vaccine ADRs and deaths: them/PHE recording these as a result of covid19 infection.
The above issues are the reasons for MHRA to redact their documents so much that these no longer disclose any information to the public; and indicate that MHRA prioritises the potential commercial harm above that of the public:
Moreover, MHRA response is not compliant with the Public Accountability doctrine.