Freedom of Information request on temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines which were done through an expedited rolling review (FOI 21-1228)
Published 26 May 2022
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FOI 21-1228
19th November 2021
Dear,
Thank you for your email.
The temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna 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.
The temporary authorisations for use of the 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, Moderna 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. Information on the use of the vaccines in pregnant women is included in Section 4.6 and Section 5.3 of the Information for Healthcare Professionals/Summaries of Product Characteristics. Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
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). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
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). Further information is available on the MHRA website and the EMA website, links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen
In addition, 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:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.
The MHRA closely monitors the safety of COVID-19 vaccine exposures in pregnancy, including Yellow Card reports for COVID-19 vaccines used in pregnancy. These reports have been reviewed by the independent experts of the Commission on Human Medicines’ COVID-19 Vaccines Benefit Risk Expert Working Group and by the Medicines for Women’s Health Expert Advisory Group (MWHEAG).
Pregnant women have the same risk of getting COVID-19 as non-pregnant women but they may be at an increased risk of becoming severely ill, particularly if they get infected in the third trimester or if they also have underlying medical problems, compared to non-pregnant women. The current advice of the Joint Committee on Vaccination and Immunisation (JCVI) is that the COVID-19 vaccines should be offered to those who are pregnant at the same time as non-pregnant individuals based on their age and clinical risk group. The COVID-19 Pfizer/BioNTech Vaccine and COVID-19 Moderna vaccines are currently the preferred vaccines for use during pregnancy.
The numbers of reports of miscarriage and stillbirth are low in relation to the number of pregnant women who have received COVID-19 vaccines to date (more than 96,000 up to end of September 2021 in England and Scotland) and how commonly these events occur in the UK outside of the pandemic. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage or stillbirth. Sadly, miscarriage is estimated to occur in about 20 to 25 in 100 pregnancies in the UK and most occur in the first 12 to 13 weeks of pregnancy (the first trimester). Stillbirths are sadly estimated to occur in about 1 in 200 pregnancies in the UK. A few reports of commonly occurring congenital anomalies and preterm births have also been received. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK increase the risk of congenital anomalies or birth complications.
Pregnant women have reported similar suspected reactions to the vaccines as people who are not pregnant.
Like most vaccines and medicines, clinical trials of COVID-19 vaccines in pregnant women were not carried out prior to use of the vaccines in the general population. However, evidence from non-clinical studies of the COVID-19 vaccines available in the UK has not raised any concerns about safety in pregnancy. The COVID-19 vaccines do not contain organisms that can multiply in the body, so they cannot infect an unborn baby in the womb. Extensive international experience for the COVID-19 Pfizer/BioNTech Vaccine and COVID-19 Vaccine Moderna used in pregnancy have also not raised any safety concerns.
The MHRA will continue to closely monitor safety data for use of the COVID-19 vaccines in pregnancy, including through evaluation of electronic healthcare record data.
The MHRA publishes a weekly summary of Yellow Card reporting for Coronavirus vaccines at the link below. Annex 1 of this link contains Vaccine Analysis Prints which contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme. When viewing the data at the link above you should remember that:
• Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report in the profile does not necessarily mean that the vaccine has caused the suspected reaction.
• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.
• Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.
Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK)
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000