Astra Zeneca Coronavirus vaccine ChAdOx1 nCov - 19 vaccine / AZD 1222

Fiona Marian made this Freedom of Information 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.

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare Products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Dear Medicines and Healthcare products Regulatory Agency,

I would like to ask that you supply the results from the Phase 3 clinical trial of Astra Zeneca Coronavirus vaccine AZD 1222 or known as ChAdOx nCov- 19

I have already seen the trial results of the phase 2 / 3 detailed in the Lancet which was published on 8th December 2020, so I don’t need that information again.

Please could you send me all the clinical trial data that was submitted to the MHRA after the 8th December 2020. I would like all the information including the tables detailing its efficacy and also the details of any / all adverse events.

Yours faithfully,

Fiona Marian

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

Our Ref: FOI 21/028

Dear Fiona Marian,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 11 January 2021.

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

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/028
 
Dear Fiona Marian,
 
Thank you for your email.
 
The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca
vaccines was done through an expedited rolling review. A ‘rolling review’
can be used to complete the assessment of a promising medicine or vaccine
during a public health emergency in the shortest time possible. This is
done as the packages of data become available from ongoing studies on a
staggered basis. The temporary authorisation under Regulation 174 permits
the supply of identified vaccine batches, based on the safety, quality and
efficacy data submitted to MHRA. These authorisations do not constitute a
marketing authorisation.
 
All vaccines are tested through three phases of clinical trials to ensure
they meet the gold standard. Phase 1 trials are with a small group of
people to make sure there are no safety concerns and determines the
appropriate dosage for the best immune response. Phase 2 trials are
conducted on a larger group of people to check the vaccine works
consistently and that the immune response is sufficient. Phase 3 trials
test the vaccines on thousands of people for scientists to assess if the
vaccine is producing immunity that will prevent disease. Usually, these
phases are run in sequence, but in an effort to find a safe and effective
Covid-19 vaccine as quickly as possible, once safety has been ascertained
through Phase 1, Phases 2 and 3 are being run in parallel. Extensive
checks and balances are required at every stage of the development of a
vaccine, and this is no different for a Covid-19 vaccine. No stages in the
vaccine development processes were bypassed.
 
Information on the study conducted using the Pfizer/BioNTech vaccine and
its results are available in a peer-reviewed journal, the New England
Journal of Medicine. A link to this is provided below:
[1]https://www.nejm.org/doi/full/10.1056/NE...
 
The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca
COVID-19 vaccines in the UK followed a rigorous scientific assessment of
all the available evidence of quality, safety and effectiveness by the UK
regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA expert scientists and clinicians reviewed data from the
laboratory pre-clinical studies, clinical trials, manufacturing and
quality controls, product sampling and testing of the final vaccine, and
also considered the conditions for its safe supply and distribution. The
decision was made with advice from the Commission on Human Medicines
(CHM), the government’s independent expert scientific advisory body.
Regarding the MHRA approval of the Pfizer/BioNTech and the
Oxford/AstraZeneca COVID-19 vaccines, further information (including
information for physicians and recipients of the vaccine, and Public
Assessment Reports [PARs] for each vaccine) are available on the MHRA
website. The PARs contain useful information on the mechanism of action of
the Pfizer/BioNTech and Oxford/AstraZeneca vaccines. Links to these are
provided below:
[2]https://www.gov.uk/government/publicatio...
[3]https://www.gov.uk/government/publicatio...
 
Further to the above, the Moderna vaccine has also recently been
authorised for use. Further information on this is provided below:
[4]https://www.gov.uk/government/publicatio...
 
The following Department of Health and Social Care (DHSC) webpage for the
independent report ‘Optimising the COVID-19 vaccination programme for
maximum short-term impact’ from the Joint Committee on Vaccination and
Immunisation (JCVI) provides the rationale for the government’s
implemented dosing strategy: 
[5]https://www.gov.uk/government/publicatio...
 
Further, the scientific basis from the JCVI concerning the current
evidence on efficacy after single doses of the Pfizer/BioNTech,
Oxford/AstraZeneca and Moderna vaccines is provided below:
[6]https://www.cas.mhra.gov.uk/ViewandAckno...
 
Regarding your request for all the data submitted to MHRA for the grant of
these vaccines, as no marketing authorisation has been granted for any of
these vaccines, this information is exempt under Section 41 (information
provided in confidence) and Section 43 (commercial interests) of the
Freedom of Information (FOI) Act. Section 41 is an absolute exemption and
no consideration of the public interest is required, except to state that
we would consider the release of this information to be an actionable
breach of confidence. Section 43 is a qualified exemption and requires
that we consider the public interest. We have considered the public
interest and cannot see any public interest argument that outweighs the
commercial harm in releasing information that would give competitors
commercial secrets that would aid the development of their own products
and/or help them overcome regulatory hurdles. MHRA’s assessment of each
vaccine’s efficacy and safety is available in the PAR, a link to this is
provided above. Additionally, data from the clinical studies conducted for
the Pfizer/BioNTech vaccine are available in the New England Journal of
Medicine, also linked above.
 
MHRA continuously monitors the safety of vaccines through a variety of
pharmacovigilance processes, including the Yellow Card scheme. The MHRA,
together with independent expert advice from the Commission on Human
Medicines (CHM), is responsible for ensuring that the overall balance of
benefits in terms of effectiveness, and risks of medicines and vaccines is
positive at the time of licensing and remains so thereafter. Any emerging
evidence relating to possible risks associated with medicines and
vaccines, would be carefully reviewed and, if appropriate, regulatory
action would be taken if any serious risks were confirmed. 
 
In response to your request for information about adverse reactions (ADR)
to Covid-19 vaccines, I can confirm that the MHRA does hold this data. 
 
We intend to publish details of all suspected reactions reported in
association with available COVID-19 vaccines, along with our assessment of
the data on a regular basis.  This is to provide reassurance in the
ongoing benefit and risk assessment of available vaccines.  
 
As we plan to publish the data, we consider that your request is covered
by section 22 of the Freedom of Information Act (information intended for
future publication) and the information you have asked for is therefore
exempt from disclosure. 
 
Section 22 is a qualified exemption which means we have considered whether
there is a greater public interest in releasing the information requested
or withholding it.  We recognise there is strong interest in seeing this
data and accept it should not be withheld. We believe that the public
interest will be best served by accompanying the publication of the data
with an analysis to aid its interpretation which is currently under
preparation.
 
We will send you a link to the ADR data report once it has been published.
 
 
If you have a query about the information provided, please reply to this
email.
 
If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
submitted within two months of the date you receive this response and
addressed to: [7][MHRA request email]
 
Due to the ongoing Covid-19 situation, we are not able to accept delivery
of any documents or correspondence by post or courier to any of our
offices.
 
Please remember to quote the reference number above in any future
communications.
 
If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:
 
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
 
Yours sincerely
 
 
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
 

show quoted sections

Dear MHRA Customer Services,

Thank you for your email.

I do not accept that the information I requested about the Astra Zeneca vaccine is commercially sensitive this is based on the fact that Astra Zeneca has already published the data from the Phase 1/2 clinical trial on this vaccine. This data was published on the 8th December 2020 it’s available in the Lancet.

You have decided to hold back the data pertaining to the Phase 3 clinical trial that included people over the age of 55 which was an age group that was under represented in the former clinical trials 1/2 done by Astra Zeneca.

The fact that you’ve chosen to hide this data from public scrutiny claiming that its commercially sensitive sends a very strong message to the public that Astra Zeneca has something to hide.
This is a disgusting way for the MHRA to operate you are a public body and your remit is to evaluate drugs and medicines and ensure they are safe for the public.
The manufactures of these vaccines are exempt due to this pandemic from prosecution and I understand that however how can anyone over the age of 55 decide if a vaccine will confer a high enough protection if you will not release the data from that phase 3 trial ?

I look forward to seeing the adverse events data from the yellow card scheme and hope as per the VAERS reporting it will be done in age groups such as 18-44 years old, 45-75 years old etc this is so that people can decide which vaccine is best suited to their age and underlying conditions. Also it would be most helpful if you could tabulate this data and have a column showing recovered / not recovered please ?

Pfizer and Moderna are not hiding this information from the public and it is being reported by VAERS please ensure that the MHRA follows suit so people can make an informed decision about the Astra Zeneca vaccine.

Please could you let me know when you feel this data will be made available ?

Yours sincerely,

Fiona Marian

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...

Dear Medicines and Healthcare products Regulatory Agency,

I have seen the data released by the government re the side effect profile of both the Astra Zeneca vaccine and the Pfizer vaccine from the Yellow Card Scheme, so this covers some of my Freedom of Information Request to you.

This is the report

https://www.gov.uk/government/publicatio...

However what this data does not tell me is the ages of the patients that suffered these side effects.
This publication states that most of the severe side effects and deaths happened in elderly patients over the age of 70 and whilst that’s no doubt true what is of concern to myself and the public is which of these severe adverse reactions occurred in young patients under the age of 70 ?

As someone with a chronic CNS infection , under the age of 70 it’s very difficult for me or any other patient in a similar situation with a chronic disease to decide which vaccine is most suited to our health concerns. Asking my GP is of little use as he’s not an expert on either my condition or the vaccines. For instance the Pfizer vaccine had many more deaths attributed to brain haemorrhage and other brain fatality causes than the Astra Zeneca vaccine but is that relevant to someone of my age ?

Again both vaccines have caused a single event of Transverse Myelitis but is this a permanent disability or merely transient ? This level of information would be critical in deciding the risk I’m prepared to take versus the benefit of the vaccine.

With this is mind please would you put this data into a format where the public can see which of the side effects more specifically the severe / life threatening / permanent disability side effects occurred in people under the age of 70?
It would be very useful if you could also enable the public to see if the severe adverse events were permanent or transient in nature.
The VAERS reporting system groups the side effects into age brackets such as 17-44 years, 45 - 68 years etc so it retains patient confidentiality but provides more useful data.

I do hope you will consider this request.

Yours faithfully,

Fiona Marian

Dear Medicines and Healthcare products Regulatory Agency,
I’ve asked for some information on side effects to the Astra Zeneca vaccine and you’ve not provided that so far.

You did agree that the side effects needed to be made public and I asked that the side effects be grouped into age brackets so that patients could see what sort of side effects may be expected from someone of a similar age, which is important as the majority of deaths / disability is in the elderly.

Whilst the data has been released from the U.K. government on side effects for both the Astra Zeneca vaccine and the Pfizer vaccine the data is of limited use as again there’s no indication of age.

You did send me some info on immune suppression and the use of monoclonal antibodies but that isn’t appropriate for me as I won’t be eligible for that product.

Please could you try to deal with my request and give me some idea when you will respond.

Yours faithfully,

Fiona Marian

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/156

Dear Fiona Marian,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 8 February 2021.

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

show quoted sections

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Ms Marian,

Please find attached the response to your FOI request.

Kind regards,
 
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
 

show quoted sections