Information regarding Viral Spike Protein of SARS-CoV-2

Response to this request is delayed. By law, Medicines and Healthcare Products Regulatory Agency should normally have responded promptly and by (details)

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

It is my understanding that the COVID-19 vaccines that have been granted temporary Authorisation under Regulation 174, namely, Vaccine BNT162b2 from Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca from AstraZeneca, or a national conditional Marketing Authorisation, namely COVID-19 Vaccine Moderna from Moderna (collectively known as "COVID-19 vaccines") all introduce, or are at least intended to introduce, the viral spike (S) protein of SARS-CoV-2 ("S protein") within the recipient of the vaccine(s).

During the assessment of the above-mentioned COVID-19 vaccines and subsequent to the granting of authorisations, what data do the MHRA rely upon to be certain that the S proteins produced via the vaccines do not themselves lead to damage to the recipient?

To give context, it is now hypothesised that the spike protein “plays [an] additional key role in [COVID-19]” and “alone [is] enough to cause disease” [1].

Yours faithfully,

Nicholas Wells

[1] https://www.salk.edu/news-release/the-no...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Nicholas Wells,

 

Regarding your email of 11 May 2021, MHRA have previously sent you links
to the Public Assessment Reports (PARs) and Information for Healthcare
Professionals/Summaries of Product Characteristics for each of the
authorised vaccines. These documents explain how MHRA authorised the
vaccines, including information on the efficacy and safety of these
vaccines.

 

To give you some context, you have referred to the spike protein playing a
role in COVID-19 such that alone it is enough to cause disease. However,
this interpretation of the spike protein is not what has been observed in
the clinical trials of any of the authorised vaccines, please see the PARs
published by MHRA.

 

Kind Regards,

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

 

 

 

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Dear MHRA Customer Services,

Thank you for your response dated 3 June 2021. I do not feel that you have fully understood and therefore responded appropriately to the original request, within which I ask:

"During the assessment of the above-mentioned COVID-19 vaccines and subsequent to the granting of authorisations, what data do the MHRA rely upon to be certain that the S proteins produced via the vaccines do not themselves lead to damage to the recipient?"

As you can see the request refers to "during the assessment" and "subsequent to the granting of authorisations." I appreciate that MHRA reviewed the submitted (pre)clinical data submitted by the applicants, however, that is a mere snapshot in time, hence the "subsequent to the granting of authorisations" part of the request.

You also seem to misunderstand the main thrust of the request, that being the publication of NEW evidence, including the study I referenced in the request, suggesting that the spike protein itself may have the potential to lead to damage within the body. The spike protein I refer to, as is clear in the request, is the one introduced by or created as a result of the COVID-19 vaccines.

If the answer is that the MHRA relies solely upon the (pre)clinical trial data submitted at the time of application by the various applicants, please state this and please clarify where the clinical trial designs specifically assess the potential for damage from the spike protein introduced or created by the COVID-19 vaccines. Please note, in a separate response to a FOI Request (FOI 21/479) you have already admitted that the MHRA have not assessed the content of the clinical trial for the Pfizer/BioNTech pivotal trial, which does not fill me with confidence that a full assessment has been carried out.

Notwithstanding the response to the above, and assuming it is the case, please also state for the record that the MHRA has not considered and does not rely upon any additional data or findings with regards to the potential for damage to COVID-19 vaccine recipients from the spike protein created and/or introduced via any of the COVID-19 vaccines.

Yours sincerely,

Nicholas Wells

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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• is illegible
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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,
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The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

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Dear MHRA Customer Services,

In addition to my earlier email today (04 June 2021) in response to this FOI request, the below links may be useful in better understanding and responding to my request, particularly where I refer to more recent (post-authorisation) data and information:

1) Vaccine researcher admits ‘big mistake,’ says spike protein is dangerous ‘toxin’ - https://www.lifesitenews.com/news/vaccin...

2) Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients - https://academic.oup.com/cid/advance-art...

Yours sincerely,

Nicholas Wells

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

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. Our [1]guidance and information can be accessed here. 

References

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

 

Our Reference: CSC 49661

 

Dear Nicholas Wells,

 

Thank you for your email.

 

We have reviewed your enquiry and this has been passed on for
consideration.  

 

Should you have any other questions or requests please feel free to call
us on 0203 080 6000 or email at [1][MHRA request email]

 

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Kind Regards

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

 

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Read our guidance on coronavirus (COVID19)

[2]https://www.gov.uk/government/collection...

 

 

 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Wells,

Thank you for your email.

We have already provided with all of the currently available published information and as such we are unable to provide you with anything further.

Kind regards

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
gov.uk/mhra
Stay connected

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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 'Information regarding Viral Spike Protein of SARS-CoV-2'.

In your response to the FOI request referred to above and with the link below, with your reference CSC 49661, you have provided a link to PARs and SmPCs, however this only relates to information submitted to the MHRA by the applicants in support of their COVID-19 vaccines. As I explained, I want to know "what data do the MHRA rely upon to be certain that the S proteins produced via the vaccines do not themselves lead to damage to the recipient" both received from the applicants and subsequent to any approval, from ANY source.

If the MHRA, as it is presumed now, have not considered and do not rely upon any further data in relation to whether the spike proteins produced as a result of the vaccines could lead to damage (harm) to the recipient, and are not willing to investigate further, including the information I have provided in a follow up to this original request, please confirm in writing.

Otherwise, I request the MHRA to provide information, including but not limited to internal discussions, meeting minutes, email communications, literature that refers to the potential harm to the recipient of COVID-19 vaccines as a result of the spike proteins produced by or from the vaccines.

If this information has been previously withheld as part of this response please investigate as part of this internal review and confirm why.

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

Yours faithfully,

Nicholas Wells

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

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. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...