Freedom of Information request on the different legal classifications for vaccines (FOI 21/415)
Published 1 June 2022
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FOI 21/415
7th March 2022
Dear
Thank you for your email. Please find below answers to the questions you have raised below.
- I am trying to find out the different legal classifications for vaccines as to whether they can be required or not.
I.e. I understand that an EUA (Emergency use Authorisation) cannot be required in any way by anyone or any organisation nor coerced, for anyone. Can you please clarify.
We wish to let you know that questions concerning the requirements for mandatory vaccinations are outside our remit. Although we have provided the following information that may have necessarily answer the question you raise we are sending to you for your information.
The Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) granted emergency use authorisation (EUA) to the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech under Regulation 174 of the Human Medicine Regulations 2012 on 2 December 2020. This followed the previous authorisations for Covid-19 vaccines by China and Russia for their own vaccines. The recent announcements have created great hope for a path out of this global pandemic. This brief article seeks to demystify the concept of EUAs and highlight some important considerations as we can expect more submissions for Covid-19 vaccine authorisations in the near future. Our key take-away is that although emergency use authorisations are temporary and subject to ongoing data reviews, regulatory agencies follow rigorous evidence-based approaches to ensure the safety of vaccines authorised using this pathway.
An Emergency Use Authorisation (EUA) is a regulatory mechanism to facilitate the availability and use of medical countermeasures, including unapproved or investigational health products, during public health emergencies, such as the current Covid-19 pandemic. National Regulatory Authorities (NRAs) can issue an EUA when certain legal criteria have been met such as a national health emergency and/or no adequate, approved, and available alternatives. It is not just NRAs that can use emergency use mechanisms. After the experience during the West African Ebola outbreak from 2013-2016, the World Health Organisation (WHO) developed the Emergency Use Assessment and Listing (EUAL) procedure for health products which was updated in January 2020 with the Emergency Use Listing (EUL) procedure.
The specific conditions of emergency use mechanisms may differ among jurisdictions and in some jurisdictions similar regulatory mechanisms may have different names. A common element of most emergency use procedures is an assessment of whether submitted (and frequently limited) data demonstrate a reasonable likelihood that a product’s quality, safety, and efficacy are acceptable, and that the benefits outweigh potential risks and uncertainties in the context of a public health emergency of national or international concern.
The authorisation announced in the United Kingdom under Regulation 174 is temporary and only relates to a limited number of specific batches of the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to the increased spread of Covid-19 and deaths in the UK. The conditions of the EUA stipulate that the sponsor “must operate a comprehensive pharmacovigilance (safety monitoring) system for this product in accordance with UK legislation for licensed products, as if they were market authorisation holders.” This clause ensures that processes are in place to monitor changes in the benefit-risk profile of the vaccine, and facilitate timely revisions to its use, if required.
EUAs are a powerful tool in the public health response arsenal for countries during this pandemic. However, it is important to understand that unlike full market authorisation, they do not make Covid-19 vaccines generally available to the whole population in the same way as influenza vaccines. Rather, they allow governments to deploy available new vaccines as quickly as possible to specific groups of the most vulnerable people such as frontline healthcare workers, older people and other high-risk groups while collecting important data on the novel vaccines to make decisions about broader immunisation programmes.
Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002).
Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002).
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021 (PLGB 00242/0742).
A marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355).
- Could you please let me know if CMA (Conditional Marketing Authorisation) falls into that same category as an EUA for requiring this medication ?
The conditional marketing authorisations for each vaccine mean that each vaccine has specific conditions attached to their authorisation. The specific conditions for the authorisation of each vaccine is explained in the authorisation details for each vaccine on the EMA website:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
- And are you able to provide any links so that the public can be fully informed of the legal status of medicines and products they are being demanded to take under threat of loosing jobs.
A marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below:
A marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:
A marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). Further information is available on the MHRA website and the EMA website, links to these are provided below:
A conditional marketing authorisation was granted for Novavax vaccine on 3 February 2022. Further information is available via the below links.
- Could you please let me know if COMIRNATY Vaccines (30mg 10mg and any others) are CMA ? and can be legally required by anybody as a condition of anything?
Answers to Q2
- Are COMIRNATY vaccines currently being given in the UK and if so which ones? And by this I mean in COMIRNATY packaging with COMIRNATY batch codes? And for which age groups?
Answers to Q2
- I am confused about a specific Pfizer Biontech BN6 162B2 batch only being authorised EJ0553 in Great Britain it states on the UK Govt website in the link below.
Could you please confirm if this is the only batch that has been authorized and if not which other batches have been authorised and in what way do these batches differ ?
For Q6, MHRA published the batches of vaccine that were authorised under Regulation 174, as authorisation required testing and release of specific batches of vaccine only. The current marketing authorisations are not specific to batches of vaccine and so MHRA has no record of which batches of vaccine have been used in the nationwide vaccine rollout that were obtained since the marketing authorisations were granted.
-
Can you please provide all the Pfizer Biontech BN6 162B2 batch codes that have so far been produced and also which ones have been authorised by the MHRA and released to the market?
-
Can you please provide all the COMIRNATY batch codes that have been authorised by the MHRA and released to the market?
For Q7/8, we have published all the batch numbers of vaccine that were authorised under Reg 174 and provided an explanation that we hold no record of the batches that have been released under the marketing authorisation.
- Below are a list of the adverse event and deaths from the Pfizer bioeNtech vaccines outside of the USA - as you can see there are inconsistencies in the batches. (Data is per 100,000 injections)
If only one Pfizer bioentecn batch is authorised why are there many different and inconsistent batches?
- As the batches are extremely inconsistent , especially vs the approved batch EJ0553 what actions have the MHRA taken regarding this shocking inconsistency?
For Q9 & Q10 - As we have explained, there has been more than one batch of Pfizer/BioNTech in use in the UK, both as part of the Regulation 174 product supply and supply of the Comirnaty Conditional Marketing Authorisation product. Batches are not often of consistent size, and therefore it can be expected that there will be variation in the number of suspected adverse events reported in association with different batches.
The MHRA has a comprehensive safety monitoring strategy in place for the COVID-19 vaccines which has been published online: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events.
Part of our monitoring strategy includes identification of batch related problems. I can confirm that there have been no batch related issues identified for any of the COVID-19 vaccines in use in the UK.
For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, fever and tiredness. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.
Please be assured that safety is of paramount importance to the MHRA, and we continue to monitor the COVID-19 vaccines closely.
Q11. I saw that Hydrochloric Acid and sodium hydroxide were recent additions to the Pfizer biontech product. Could you please clarify why this was allowed to bypass animal trials as a totally new formulation and go straight to human trials?
Small quantities of pharmaceutical grade hydrochloric acid and sodium hydroxide are commonly used to adjust the pH of medicines during manufacture to ensure that the final pH is suitable for injection (close to the pH which is found naturally in the body). Hydrochloric acid and sodium chloride have been added to the list of ingredients because they are used in this way in the formulation. The excipients in a given pharmaceutical formulation include ingredients called buffers which keep the pH at safe level. The information on hydrochloric acid and sodium hydroxide has no impact on the final contents of the vial, the safety of the vaccine or its pH.
- Can you please also confirm for questions in numbers 7+8 where i can obtain this information as soon as this is released to medical staff, as this is information of interest to the public.
If this is not publicly available i am requesting that this is made available as soon as the batch numbers are released. Especially as these are already processed and given out to other sources.
For Q12, we have provided all the information we hold in Q7/8.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000FOI 21/415
7th March 2022
Dear
Thank you for your email. Please find below answers to the questions you have raised below.
- I am trying to find out the different legal classifications for vaccines as to whether they can be required or not.
I.e. I understand that an EUA (Emergency use Authorisation) cannot be required in any way by anyone or any organisation nor coerced, for anyone. Can you please clarify.
We wish to let you know that questions concerning the requirements for mandatory vaccinations are outside our remit. Although we have provided the following information that may have necessarily answer the question you raise we are sending to you for your information.
The Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) granted emergency use authorisation (EUA) to the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech under Regulation 174 of the Human Medicine Regulations 2012 on 2 December 2020. This followed the previous authorisations for Covid-19 vaccines by China and Russia for their own vaccines. The recent announcements have created great hope for a path out of this global pandemic. This brief article seeks to demystify the concept of EUAs and highlight some important considerations as we can expect more submissions for Covid-19 vaccine authorisations in the near future. Our key take-away is that although emergency use authorisations are temporary and subject to ongoing data reviews, regulatory agencies follow rigorous evidence-based approaches to ensure the safety of vaccines authorised using this pathway.
An Emergency Use Authorisation (EUA) is a regulatory mechanism to facilitate the availability and use of medical countermeasures, including unapproved or investigational health products, during public health emergencies, such as the current Covid-19 pandemic. National Regulatory Authorities (NRAs) can issue an EUA when certain legal criteria have been met such as a national health emergency and/or no adequate, approved, and available alternatives. It is not just NRAs that can use emergency use mechanisms. After the experience during the West African Ebola outbreak from 2013-2016, the World Health Organisation (WHO) developed the Emergency Use Assessment and Listing (EUAL) procedure for health products which was updated in January 2020 with the Emergency Use Listing (EUL) procedure.
The specific conditions of emergency use mechanisms may differ among jurisdictions and in some jurisdictions similar regulatory mechanisms may have different names. A common element of most emergency use procedures is an assessment of whether submitted (and frequently limited) data demonstrate a reasonable likelihood that a product’s quality, safety, and efficacy are acceptable, and that the benefits outweigh potential risks and uncertainties in the context of a public health emergency of national or international concern.
The authorisation announced in the United Kingdom under Regulation 174 is temporary and only relates to a limited number of specific batches of the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to the increased spread of Covid-19 and deaths in the UK. The conditions of the EUA stipulate that the sponsor “must operate a comprehensive pharmacovigilance (safety monitoring) system for this product in accordance with UK legislation for licensed products, as if they were market authorisation holders.” This clause ensures that processes are in place to monitor changes in the benefit-risk profile of the vaccine, and facilitate timely revisions to its use, if required.
EUAs are a powerful tool in the public health response arsenal for countries during this pandemic. However, it is important to understand that unlike full market authorisation, they do not make Covid-19 vaccines generally available to the whole population in the same way as influenza vaccines. Rather, they allow governments to deploy available new vaccines as quickly as possible to specific groups of the most vulnerable people such as frontline healthcare workers, older people and other high-risk groups while collecting important data on the novel vaccines to make decisions about broader immunisation programmes.
Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002).
Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002).
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021 (PLGB 00242/0742).
A marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355).
- Could you please let me know if CMA (Conditional Marketing Authorisation) falls into that same category as an EUA for requiring this medication ?
The conditional marketing authorisations for each vaccine mean that each vaccine has specific conditions attached to their authorisation. The specific conditions for the authorisation of each vaccine is explained in the authorisation details for each vaccine on the EMA website:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
- And are you able to provide any links so that the public can be fully informed of the legal status of medicines and products they are being demanded to take under threat of loosing jobs.
A marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below:
A marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:
A marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). Further information is available on the MHRA website and the EMA website, links to these are provided below:
A conditional marketing authorisation was granted for Novavax vaccine on 3 February 2022. Further information is available via the below links.
- Could you please let me know if COMIRNATY Vaccines (30mg 10mg and any others) are CMA ? and can be legally required by anybody as a condition of anything?
Answers to Q2
- Are COMIRNATY vaccines currently being given in the UK and if so which ones? And by this I mean in COMIRNATY packaging with COMIRNATY batch codes? And for which age groups?
Answers to Q2
- I am confused about a specific Pfizer Biontech BN6 162B2 batch only being authorised EJ0553 in Great Britain it states on the UK Govt website in the link below.
Could you please confirm if this is the only batch that has been authorized and if not which other batches have been authorised and in what way do these batches differ ?
For Q6, MHRA published the batches of vaccine that were authorised under Regulation 174, as authorisation required testing and release of specific batches of vaccine only. The current marketing authorisations are not specific to batches of vaccine and so MHRA has no record of which batches of vaccine have been used in the nationwide vaccine rollout that were obtained since the marketing authorisations were granted.
-
Can you please provide all the Pfizer Biontech BN6 162B2 batch codes that have so far been produced and also which ones have been authorised by the MHRA and released to the market?
-
Can you please provide all the COMIRNATY batch codes that have been authorised by the MHRA and released to the market?
For Q7/8, we have published all the batch numbers of vaccine that were authorised under Reg 174 and provided an explanation that we hold no record of the batches that have been released under the marketing authorisation.
- Below are a list of the adverse event and deaths from the Pfizer bioeNtech vaccines outside of the USA - as you can see there are inconsistencies in the batches. (Data is per 100,000 injections)
If only one Pfizer bioentecn batch is authorised why are there many different and inconsistent batches?
- As the batches are extremely inconsistent , especially vs the approved batch EJ0553 what actions have the MHRA taken regarding this shocking inconsistency?
For Q9 & Q10 - As we have explained, there has been more than one batch of Pfizer/BioNTech in use in the UK, both as part of the Regulation 174 product supply and supply of the Comirnaty Conditional Marketing Authorisation product. Batches are not often of consistent size, and therefore it can be expected that there will be variation in the number of suspected adverse events reported in association with different batches.
The MHRA has a comprehensive safety monitoring strategy in place for the COVID-19 vaccines which has been published online: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events.
Part of our monitoring strategy includes identification of batch related problems. I can confirm that there have been no batch related issues identified for any of the COVID-19 vaccines in use in the UK.
For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, fever and tiredness. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.
Please be assured that safety is of paramount importance to the MHRA, and we continue to monitor the COVID-19 vaccines closely.
Q11. I saw that Hydrochloric Acid and sodium hydroxide were recent additions to the Pfizer biontech product. Could you please clarify why this was allowed to bypass animal trials as a totally new formulation and go straight to human trials?
Small quantities of pharmaceutical grade hydrochloric acid and sodium hydroxide are commonly used to adjust the pH of medicines during manufacture to ensure that the final pH is suitable for injection (close to the pH which is found naturally in the body). Hydrochloric acid and sodium chloride have been added to the list of ingredients because they are used in this way in the formulation. The excipients in a given pharmaceutical formulation include ingredients called buffers which keep the pH at safe level. The information on hydrochloric acid and sodium hydroxide has no impact on the final contents of the vial, the safety of the vaccine or its pH.
- Can you please also confirm for questions in numbers 7+8 where i can obtain this information as soon as this is released to medical staff, as this is information of interest to the public.
If this is not publicly available i am requesting that this is made available as soon as the batch numbers are released. Especially as these are already processed and given out to other sources.
For Q12, we have provided all the information we hold in Q7/8.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000