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Dear Colleague,
This email updates you on details of recently published MHRA guidance on coronavirus (COVID-19) aimed at supporting healthcare partners.
Safety reports of approved COVID-19 vaccines
We have revised the format of the Summary of Yellow Card reporting to focus on the COVID-19 vaccines administered from the beginning of the Autumn 2022 booster campaign.
Any new assessments or safety issues regarding vaccines used in the primary and initial booster campaigns will also be included in this record, however previous and known information on these vaccines will remain available as a record only and can be viewed on the government website.
Yellow Card reports received via the scheme across all vaccines will be updated and reflected in the COVID-19 vaccine reports.
Sanofi Pasteur COVID-19 vaccine authorised
We approved VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, after it met our required safety, quality and effectiveness standards.
It becomes the seventh COVID-19 vaccine authorised by us following expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines (CHM).
VidPrevtyn Beta combines the spike protein from a COVID virus variant, Beta, with an ‘adjuvant’ – an additional ingredient designed to trigger a stronger immune response.
The vaccine is authorised for use in those aged 18 and over, as a heterologous booster dose, given as a single injection. This means that those who received a different vaccine (mRNA or viral-vectored) as a primary course, can receive this vaccine as a booster.
Please see the Decision page on our website which has more details about VidPrevtyn Beta, the COVID-19 vaccine.
Pfizer/BioNTech COVID-19 vaccine authorised for use in infants and children aged 6 months to 4 years
We approved a new presentation of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for use in infants and children aged 6 months to 4 years.
The Comirnaty COVID vaccine met our required safety, quality and effectiveness standards to be authorised for use in this age group. The decision was endorsed by the Commission on Human Medicines, after a careful review of the evidence.
The presentation is specially designed for this new age group and given at a lower dose compared to that used in individuals aged 5 to 11 years (3 micrograms compared with 10 micrograms).
It is given as three injections in the upper arm, with the first two doses given 3 weeks apart, followed by a third dose given at least 8 weeks after the second dose.
Please see the Decision page on our website which has more details about Comirnaty vaccine for COVID-19.
Product information update for COVID-19 Vaccine Janssen
We have made changes to the product information for COVID-19 Vaccine Janssen. We updated the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to include information about receiving a homologous booster dose in individuals aged 18 years and over.
We also made updates to the efficacy data included in the SmPC following primary series vaccination.
We updated Section 4.8 of the SmPC and section 4 of the PIL to add:
- add facial paralysis (including Bell’s palsy) as a rare adverse drug reaction (ADR) and
- cutaneous small vessel vasculitis as an ADR of unknown frequency
Please see the Decision page on our website which has more details about the COVID-19 Vaccine Janssen.
Product information update for COVID-19 Vaccines Spikevax
We have updated the product information for Spikevax bivalent Original/Omicron booster vaccine and Spikevax (formerly Moderna) for COVID-19.
We have updated the SmPC and PIL to:
- extend the indication for booster dose to the 12+ years age group (previously 18+ years)
- include urticaria as an adverse event
- include extensive swelling of the vaccinated limb as an adverse event
- include heavy menstrual bleeding as an adverse event
We also made a minor change to the SmPC text on myo/pericarditis.
For more details, please see:
- the Decision page for Spikevax bivalent Original/Omicron booster vaccine for COVID-19 and
- the Decision page for Spikevax (formerly Moderna) for COVID-19.
Updated lists: Medical devices given exceptional use authorisations during the COVID-19 pandemic
We have updated the list of medical devices given exceptional use authorisations and the list of devices no longer covered.
MHRA Yellow Card scheme
You can report suspected side effects of COVID-19 vaccines, boosters and medicines, or issues with test kits to the MHRA Yellow Card scheme.
Anyone can report, whether for themselves or on someone else’s behalf. Every report counts.
Please let your patients, their families and your colleagues know they can report via the Coronavirus Yellow Card reporting site.
Guidance for industry
We continue to update our guidance page for industry on GOV.UK as our response to COVID-19 evolves.
Subscribing to updates on GOV.UK
You can sign up for email updates about the MHRA’s work – you will then receive an email every time the MHRA publishes a new page or makes a significant edit to an existing page.
Contacting the MHRA
To get in touch, please email info@mhra.gov.uk or phone us on 020 3080 6000. For specific enquiries about our NIBSC standards or contract and control testing services, you can also email info@mhra.gov.uk or call 01707 641000.
For more information please visit www.gov.uk/mhra.
Thank you.
Patient, Public and Stakeholder Engagement team
The Medicines and Healthcare products Regulatory Agency
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