Species and strains used for safety testing of the Pfizer-BioNTech COVID-19 “vaccine".

Public Health England did not have the information requested.

Dear Public Health England,

Elliot Colburn MP in a recent parliamentary debate has said that the current COVID-19 vaccine is safe because of the safety testing including “in vivo testing often using mice".

What preclinical species and the strain of each species (e.g. C57BL/6 mouse, BALB/c mouse, Sprague Dawley rat and cynomolgus monkey) have been recorded as being used for safety studies (i.e. all safety studies including “Antibody Dependent Enhancement” (ADE) and effects on female fertility) that the Pfizer-BioNTech COVID-19 vaccine has been tested in?

Yours faithfully,

J Grove

FOI, Public Health England

OFFICIAL
Dear J Grove,

We acknowledge receipt of your email and request for information, which will be treated as a request for information under statutory access legislation.

Please note that requests under the Freedom of Information Act and the Environmental Information Regulations (EIRs) will receive a response within 20 working days from the day following the date of receipt of your request.

If the request is for your personal data, your request has been handled as a data subject access request (SAR) under Article 15 of the General Data Protection Regulation (GDPR), then we will respond within one month of the receipt of the request.

Public Health England (PHE) is responsible for providing guidance and advice to government and front-line services for all aspects of public health. It is a designated Category 1 responder organisation under the Civil Contingency Act and this specifically includes the COVID-19 response, providing clinical expertise and wider public health advice and guidance across national and local government, the NHS and third sector. As such, you may experience delays when making statutory information access requests during the pandemic.

We will aim to address all requests promptly and within the required response timeframes. However when we are unable to meet the response timeframe we will keep requesters updated on a revised expected timescale for a response to their request. The Information Commissioner recognises this position in its recent guidance, see link: https://ico.org.uk/global/data-protectio...

Public Accountability Unit
Public Health England
[Public Health England request email]
Tel: 020 8327 6920
www.gov.uk/phe Follow us on Twitter @PHE uk

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FOI, Public Health England

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    2165 FOI Animals safety studies of Pfizer BioNTech COVID 19 vaccine.pdf

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OFFICIAL
Dear J Grove,

Please find attached Public Health England's response to your request.

FOI Team
Public Accountability Unit
Public Health England
[Public Health England request email]
Tel: 020 8327 6920
www.gov.uk/phe Follow us on Twitter @PHE uk

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Dear Public Health England,

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

I am writing to request an internal review of Public Health England's handling of my FOI request 'Species and strains used for safety testing of the Pfizer-BioNTech COVID-19 “vaccine".'.

The provision of the information on the MHRA website is appreciated but if PHE provides "advice to government" who indemnify "vaccine" manufacturers then it would be reasonably be expected that a full record of the preclinical species used and tests performed would be recorded and retained by PHE.

The information on the MHRA website relating to safety testing states:

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on a conventional study of repeat dose toxicity.

Reproductive toxicity

Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered with the COVID-19 mRNA Vaccine BNT162b2 prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to body weight differences, spanning between pre-mating day 21 and gestational day 20). SARS-CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No data on the COVID-19 mRNA Vaccine BNT162b2 are available on vaccine placental transfer or excretion in milk.

Even a relatively ignorant member of the public will have heard of the thalidomide disaster and will know that a large battery of sensitive reproductory safety tests across a number of pre-clinical species are required for drugs/products prior to authorisation and release to women of reproductory age such that there is no "black box" warning.

The safety data reported by the MHRA does not detail the antibody dependent enhancement (ADE) studies that should have been performed in ferrets and cats, given the earlier reported deaths in these species when exposed to live coronaviruses after being given vaccines then it would be reasonably expected that PHE would keep a recorded list of safety studies, so that appropriate advice could be given to the UK Government.

Please look back at your records system and identify if the species associated with the appropriate safety studies have been recorded.

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

Yours faithfully,

J Grove

FOI, Public Health England

OFFICIAL
Dear J Grove,

We acknowledge receipt of your email, which will be treated as a request for an internal review, following your request for information under the Freedom of Information Act 2000.

Please note we aim to complete your internal review within 20 working days from the day following the date of receipt of your request. We will notify you if we anticipate the internal review taking longer than 20 working days.

FOI Team
Public Accountability Unit
Public Health England
[Public Health England request email]
Tel: 020 8327 6920
www.gov.uk/phe Follow us on Twitter @PHE uk

show quoted sections

FOI, Public Health England

1 Attachment

OFFICIAL
Dear J Grove,

Please find attached Public Health England's response to your request for an internal review.

FOI Team
Public Accountability Unit
Public Health England
[Public Health England request email]
Tel: 020 8327 6920
www.gov.uk/phe Follow us on Twitter @PHE uk

show quoted sections