SARS-CoV-2 virus spike proteins damage the lungs and arteries of an animal model.

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Dear Mr Gilmore
 
Regarding your email, dated 02 May 2021, non-clinical animal studies were
submitted to MHRA. MHRA's assessment of these studies are available in the
Information for Healthcare Professionals and the Public Assessment Report
(PAR) for each vaccine, links to which have been provided to you
previously.
 
Best regards
 
Ella
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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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.
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Please note that we may not respond if your query: 

• contains offensive language
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London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
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The UK has left the EU, and the transition period ends on 31 December
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Our Reference: CSC 49802

Dear Roland Gilmore,

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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
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• is illegible
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• 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
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Thank you for your email.  This auto-response is to inform you that your
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We will respond to you as soon as possible. 

Please note that we may not respond if your query: 

• contains offensive language
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• 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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Dear Mr Gilmore,

RE: CSC 49802 & 48472 Freedom of Information request - SARS-CoV-2 virus
spike proteins damage the lungs and arteries of an animal model. Ref:
GENQ-00147125

Thank you for your recent emails, dated 2^nd May 2021 and 12^th May 2021.
It was noted that you initially raised with us your concerns over the
authorisation of the COVID-19 vaccines for the emergency National
vaccination programme and questioned the use of animal trials by vaccine
producers. This was then followed by your subsequent concerns that the
MHRA gave authorisation in the knowledge that injuries, including
thrombosis, would occur as a result of vaccination and asked what
investigations of victims reported as suffering such injuries on the
MHRA's Yellow Card system is the MHRA undertaking and when will the MHRA
publish an interim report on these injuries. Firstly, I would like to take
this opportunity to thank you for taking the time to get in touch with us
regarding your concerns, as it is communication like yours that allow us
to improve the accessibility of the information we routinely publish
during the National rollout of this vaccination programme.

It was noted in your follow up reply that you were concerned that the MHRA
gave authorisation in the knowledge that injuries, including thrombosis,
would occur as a result of vaccination. Whilst the Public Assessment
Reports (PAR) for [1]Pfizer and [2]AstraZeneca and Information for
Healthcare Professionals have already been provided to you previously, I
would like to take this opportunity to reiterate the contents of these
reports. These reports contain details about why the vaccines were
approved and the ongoing measures being taken to ensure the safe and
effective use of the vaccines following their conditional authorisation.
It should be noted, as detailed within the report, whilst an acceptable
level of information has been received to provide assurance that
appropriate standards of quality, safety and efficacy have been met for
authorisation, that COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine
Pfizer remain under review as MHRA continues to receive data from the
company as it becomes available as well as adverse drug reaction data
derived from the Yellow Card Scheme. As this detail is from post-marketing
surveillance during the emergency National rollout, safety information is
subject to change if any arising safety concerns are identified; but
please be assured that these will be communicated to the general public
accordingly. This is also applicable to the Nationally authorised COVID-19
Vaccine Moderna.

Further to this, we would like to thank you for highlighting the Salk
Institute’s study concerning the COVID-19 spike protein, and would like to
reassure you, as above, that we are actively monitoring the safety of the
vaccines which includes assessing and taking into consideration the new
research continually being undertaken. Whilst the vaccines all utilise the
spike protein as part of their mechanism to elicit an immune response, we
do not currently have the evidence to consider this a risk. The Salk
Institute have also reportedly commented on the interpretation of their
study, found [3]here, stating that ‘Covid-19 vaccines are an effective and
safe way to protect people from the virus’ and that the spike proteins in
Covid-19 vaccines are safe because they only remain in a person's arm
muscle for a short period.

To address your final point of what investigations of victims reported as
suffering such injuries on the MHRA's Yellow Card system is the MHRA
undertaking and when will the MHRA publish an interim report on these
injuries, I would like to reassure you that reports where patient’s
experienced serious blood clotting events, such as cerebral venous sinus
thrombosis (CVST), and concurrent thrombocytopenia are routinely being
followed up for further information on the patients outcome and
subsequently discussed by the Agency with input from the Government’s
independent advisory body, the COVID-19 Vaccines Benefit Risk Expert
Working Group, which includes advice from lay representative and leading
haematologists. I would also like to draw your attention to the press
release issued on the 3^rd December 2020 by the Department of Health and
Social Care, prior to the initiation of the National vaccine rollout,
[4]here. This states that ‘In advance of a rollout of an authorised
COVID-19 vaccine and in line with other immunisation programmes, the
government is taking the precautionary step to ensure that, in the very
rare possibility where someone is severely disabled as a result of taking
a COVID-19 vaccine, they can access financial assistance through the
Vaccine Damage Payments Scheme (VDPS).’ Additionally, you may find this
link concerning Vaccine Damage Payment useful in conjunction with the
press release, [5]here.

Regarding your question as to when the Agency will be publishing an
interim report on the injuries, the MHRA publishes weekly updates
pertaining to the adverse drug reaction reports for each of the vaccines,
available [6]here, which includes detail of any new safety concerns as
they arise and updates to existing concerns, such as the thrombosis and
thrombocytopenia events you mentioned within your email.

Further to your query, as with all medicines and vaccines alike, it is not
possible to predict the side effects that an individual will experience
prior to treatment initiation and unfortunately, some individuals are more
susceptible to experiencing adverse events.

Please be assured that the safety of these vaccines is of paramount
importance and under constant review, and as such, we are grateful that
you raised your concerns with us. I hope this information is useful to you
however please do not hesitate to contact me again if I can be of further
assistance.

Yours sincerely,

Yellow Card Team

Vigilance Risk Management of Medicines

MHRA

From: MHRA Customer Services <[email address]>
Sent: 13 May 2021 10:15
To: Pharmacovigilanceservice <[email address]>
Subject: CSC 49802 & 48472 Freedom of Information request - SARS-CoV-2
virus spike proteins damage the lungs and arteries of an animal model.

Dear PV,

Are you able to help with the below enquiry? He has come through the what
do they know website for his previous query which Licensing helped me
with, so I’ll have to run the response past News Centre before it gets
sent out, unless you want this logged as FOI.

Could you either:

·         Send us your response to the enquiry that we can share with the
customer, or copy us into your reply if you would rather respond directly.

or

·         Confirm that this is an enquiry you can answer and confirm the
date by which you will be able to respond. This will allow us to update
the customer and manage their expectations.

Please note that we work to an overall response deadline of 18 working
days, which for this enquiry is 7^th June.

If this is not something you or your unit can assist with then please let
us know as soon as possible.

Kind Regards

Ella

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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