COVID-19 vaccines (Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca): current advice
7 January 2021 - Advice from the MHRA on the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.
The information in this article reflects understanding at the time of publication on 7 January 2021. See guidance on COVID-19 for all our latest information.
AstraZeneca COVID-19 vaccine approved
On 30 December 2020, the COVID-19 vaccine developed by Oxford University/AstraZeneca was given regulatory approval by the MHRA after meeting required safety, quality, and effectiveness standards. This followed a rigorous, detailed scientific review by the MHRA’s expert scientists and clinicians and on the basis of the advice of its scientific, independent advisory body, the Commission on Human Medicines (CHM).
See Information for Healthcare Professionals, and Information for UK recipients about the COVID-19 Vaccine AstraZeneca. The vaccine has been approved for use for people 18 years or older and consists of a course of two doses, with the second dose administered 4–12 weeks after the first dose.
Further advice for the Pfizer/BioNTech vaccine
The COVID-19 vaccine developed by Pfizer/BioNTech was approved for use by MHRA on 2 December 2020.
The CHM has reviewed further data for the Pfizer/BioNTech vaccine as they have become available. On 30 December 2020, CHM recommended the following:
- Allergies – anyone with a previous history of allergic reactions to the ingredients of the vaccine should not receive it, but those with any other allergies such as a food allergy can now have the vaccine:
- Pregnancy – the vaccine should only be considered for use in pregnancy when the potential benefits outweigh any potential risks for the mother and baby. Women should discuss the benefits and risks of having the vaccine with their healthcare professional and reach a joint decision based on individual circumstances – see also the advice from Public Health England
- Women who are breastfeeding can be given the vaccine (this advice is in line with pregnancy and breastfeeding advice for the Oxford University/AstraZeneca vaccine)
- Dosage interval – the advice has been updated to say that the second dose of the Pfizer/BioNTech vaccine should be given at least 21 days after the first dose – see also the Letter from the UK Chief Medical Officers regarding the UK COVID-19 vaccination programmes
Updates have been made to the Information for healthcare professionals and Information for UK recipients about the Pfizer/BioNTech vaccine to include these elements.
Reporting side effects
Healthcare professionals are asked to report any suspected side effects to COVID-19 vaccines. Report using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app.
Include the vaccine brand and batch/lot number in Yellow Card reports if available.
Reporting potential defects
In accordance with the published information and existing guidance, any potential defects identified by healthcare professionals should be managed as set out below (modified September 2021 to reflect current practices).
- Do not use the vial for vaccination.
- Do not discard the vial, instead please keep it aside in a secure place as further investigation may be required.
- Complete a Yellow Card or contact the MHRA Defective Medicines Report Centre directly (DMRC@mhra.gov.uk).
- Once the report has been logged via the Yellow Card system, the complaint will be assigned a UNIQUE MDR# number (please note a new MDR# number is generated for each complaint so please retain for your records).
- Samples should not be sent without being reported through the Yellow Card system and must have attached the description of complaint/Yellow Cards and reference numbers. Any unidentifiable samples will be destroyed.
- In the usual way, report the issue to the National Vaccination Operations Centre (NVOC) via the agreed escalation process, including batch number and any other relevant details.
The information in this article reflects understanding at the time of publication on 7 January 2021 and will not be actively updated with new information. See guidance on COVID-19 for all our latest information, including after publication of this article.