Information for the recipient of COVID-19 mRNA Vaccine BNT162b2

Roland Gilmore made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,

The information leaflet issued by MHRA appears to be deficient regarding the following: -

1. The mRNA vaccines are intended to induce an immune response to spike proteins of SARS-CoV-2, however; these spike proteins (transcribed for replication within cellular ribosomes) also contain a homologous form of syncytin-1. This natural protein (syncytin-1) is created from human endogenous retroviruses and is responsible for the placenta development in mammals and humans. This protein is required for a successful pregnancy, but after covid-19 vaccination, an individual’s immune cells will be trained to attack syncytin-1 (leading to potential miscarriages, birth defects and infertility). The study designs do not test for mutagenic or reproductive defects, yet the science of the mRNA vaccine shows potential to cause long term autoimmune destruction of the female reproductive system.

Why is this potential for serious harm not listed in your leaflet as a possible side effect?

2. The mRNA nano-particles (active ingredients) are coated with PEG. The development of auto-antibodies to polyethylene glycol (PEG) will not only make the vaccine less effective but may cause allergic reactions with deadly adverse events.

Why is this potential for serious harm not listed in your leaflet as a possible side effect? What scientific evidence does MHRA have that deems PEG safe for injection which is not the same as it being eaten?

3. The vaccines also contain mNeonGreen, an ingredient not listed in your leaflet. This has bio-luminescent properties.

Why is this ingredient, taken from marine invertebrates, being used in the vaccines?

4. Why does your leaflet not make it clear that the vaccine will not prevent recipients from being infected with SARS CoV-2 thus becoming infectious?

5. The American NIH published a list of potential ADRs that includes Guillain Barre Syndrome, Transverse Myelitis, Encephalitis, Stroke, Arthritis and even Death among other conditions.

Does the MHRA have evidence that such side effects will not occur? If not, why do these do not appear in your leaflet?

6. Is the MHRA not aware that the approach of vaccinating people with experimental mRNA vaccines violates the precautionary principle, which requires that a medical intervention be proven safe before being released. How can the omission of extended trials deem them safe?

7. If it is known that the product may cause harm, and especially death, in advance and is still released without the public being fully informed of these risks, does this not constitute an egregious violation of the medical ethical principles established through the Nuremberg Code in order to prevent human rights violations?

8. if recipients are vaccinated without knowing the potential side effects, how can they give their “informed consent”?

9. It s understood that the Pfizer/BioNTech trial did not include anyone over the age of 55 and anyone with co-morbidities.

Why is it therefore deemed appropriate to vaccinate the over 80s first; most of whom will have at least one co-morbidity when the risks to them are unknown? (If this is a political question it may be more appropriate to ask the DHSC rather than the MHRA).

Yours faithfully,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency


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Our Ref: FOI 20/574

Dear Roland Gilmore,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17 December 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 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 20/574
 
Dear Mr Gilmore,
 
Thank you for your email.
 
Details on the administration of the vaccine, including the groups of
patients who should not receive the vaccine,  undesirable effects, and
advice for elderly recipients and those with underlying health conditions,
are available in the Information for Healthcare Professionals on the
Pfizer/BioNTech COVID-19 vaccine and the Information for Recipients of the
Pfizer/BioNTech COVID-19 vaccine. These are available online and can be
accessed via the following link:
[1]https://www.gov.uk/government/publicatio...
 
Information on the studies and their results are available in a
peer-reviewed journal, the New England Journal of Medicine. A link to this
is provided below:
[2]https://www.nejm.org/doi/full/10.1056/NE...
 
Furthermore, MHRA has published a Public Assessment Report (PAR), which
consists of the non-confidential aspects of MHRA’s assessment of this
vaccine. A link to the MHRA PAR is provided below:
[3]https://assets.publishing.service.gov.uk...
 
The MHRA will routinely publish data on reported side-effects suspected to
be caused by a Covid-19 vaccine, to provide reassurance on the vaccine
safety and in accordance with our commitment to transparency.
Regarding your specific questions:

 1. Administration of this vaccine is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before
vaccination. In addition, women of childbearing age should be advised
to avoid pregnancy for at least 2 months after their second dose.
There is no evidence that administration of the vaccine causes "long
term autoimmune destruction of the female reproductive system."

 
2. Polyethylene glycol (macrogol) has been used in injections for many
years (since before 1980). Administration of the vaccine is
contraindicated in anyone with a hypersensitivity to the active substance
or to any of the excipients. Furthermore, any person with a history of
immediate-onset anaphylaxis to a vaccine, medicine or food should not
receive the COVID-19 mRNA Vaccine BNT162b2.
 
3. This vaccine does not contain an excipient called "mNeonGreen". There
are no components of animal or human origin in the vaccine.
 
4. The study data submitted to MHRA to date do not show that "the vaccine
will not prevent recipients from being infected with SARS CoV-2 thus
becoming infectious." This information is currently unknown.  The
expectation is that vaccine recipients will be less infectious, but there
are currently no data available to support this.
 
5. The list of undesirable effects in the Information for Healthcare
Professionals on the Pfizer/BioNTech COVID-19 vaccine and the Information
for Recipients of the Pfizer/BioNTech COVID-19 vaccine is derived from the
adverse events observed with administration of the vaccine, either from
data obtained during the clinical study or data obtained post
authorisation.
 
6. No medicinal product is ‘completely safe’. All medicines can cause side
effects, although not everybody gets them.  The safety of all medicines is
actively monitored by the MHRA on an ongoing basis through various
channels, including the Yellow Card scheme, and the Product Information of
the drug is regularly updated with new relevant information. With regards
to this particular vaccine, safety is MHRA's overwhelming priority, and
MHRA is committed to reporting all new safety information to the public as
soon as possible.
 
7.  Please see our response to Question 6 above.
 
8. As we have stated, the undesirable effects are published in the
Information for Healthcare Professionals on the Pfizer/BioNTech COVID-19
vaccine and the Information for Recipients of the Pfizer/BioNTech COVID-19
vaccine. These documents are actively updated with any new safety
information as soon as it becomes available.
 
9. Links to the PAR and the New England Journal of Medicine article, which
contain information on the demographics of the patients studied in the
trial, have been provided. The trial did include participants over the age
of 55 and participants with co-morbidities.
 
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Yours sincerely
 
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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Dear MHRA Customer Services,

Thank you for your response.

I am not satisfied with with your response to my question 1.
Are you categorically claiming that after vaccination, an individual’s immune cells will not be trained to attack syncytin-1? If so, where is your evidence for this assertion? It appears that the MHRA is presuming that 2 months after receiving the vaccine, there is an undefined process whereby fertility is restored? What is that process and where is the MHRA evidence for such an assertion?

Having decided to dismiss animal testing as a requirement for your approval of the vaccine, the MHRA appears to be presuming safety whereas there is no empirical evidence to justify such a position. Are the vaccine providers continuing with animal testing or not?

I am not satisfied with with your response to my question 2.
How is an individual to know in advance whether they are allergic or not?

With regard to your response to question 4 and admission that you do not know whether vaccine recipients will be protected or not, why isn't the MHRA advising vaccine recipients that the vaccine may not protect them from infection or from becoming infectious?

With regard to your response to question 6, when will the MHRA publish Yellow Card scheme submissions and how often will updated publication take place? Reports are coming in from various countries of adverse reactions to the vaccine, including death. This is therefore of significant public interest.

In view of the above, I am writing to request an internal review with answers to my questions.

Yours sincerely,

Roland Gilmore

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...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Gilmore,

Thank you for your email.

We confirm that an internal review is being carried out on FOI 20/574.

Please note the deadline for reply for Internal Reviews is 20 working days from our date of receipt and the date for this request is 2nd March.

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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Bartholomeus Lakeman left an annotation ()

FOI 20/574 of 17 Dec, info- request is of a similar nature as #712098 dated 10 Dec- and FOI 21/611 of 2 June. Which MHRA answered by Pfizer’s own publication in the New England Journal of Medicine; a publication that was heavily critiqued for it being without proof of evidence and contrary to the scientific literature. E.g., the BNT162b2’ training antibodies to attack syncytin-1 is proven by the in the yellow cards and VAERS reported miscarriages, birth defects, infertility and menstrual dysfunctions: The addition of mNeonGreen to scan and check whether one is vaccinated has been acknowledged in an American Court case and by the European Medicine Agency: Regarding balancing benefits with risk: MHRA has no criteria for putting up a red flag to the number of crippling morbidities and deaths being reported. Showing that public health care is no more than an economic and political commodity.