COVID-19 vaccines and medicines: updates for January 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.
Approval of Paxlovid - Oral COVID-19 antiviral treatment
We have approved Paxlovid (PF-07321332 and ritonavir) following a rigorous review of its safety, quality and effectiveness by us and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines (CHM).
Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication. Ritonavir slows the breakdown of PF-07321332 in the body, thereby increasing its effectiveness.
Based on the clinical trial data, Paxlovid is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of the start of symptoms. It has been authorised for use in people aged 18 and above who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.
Paxlovid may interact with certain other medications. Before it is prescribed, the MHRA is therefore advising that patients’ current medications should be carefully reviewed, and appropriate advice given on adjustments that may be needed to their current medications. Additional tests may also be needed for its safe use. For more information, see the contraindications, dosage and interactions sections of the Summary of Product Characteristics.
For more information about Paxlovid (PF-07321332 and ritonavir), see our Press release and Decision page which includes the Summary of Product Characteristics and Patient Information Leaflet.
Summaries of Yellow Card reporting and other recent MHRA publications
We continue to publish the summaries of the Yellow Card reporting for the COVID-19 vaccines being used in the UK. The report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.
We have also recently:
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updated the Summary of Product Characteristics and Patient Information Leaflet for Spikevax (COVID-19 Vaccine Moderna) to allow for use of the vaccine as a booster or third dose in individuals 18 years of age and older and for immunocompromised patients, and safety updates (to include diarrhoea and skin reaction as adverse reactions, further information on delayed injection site reactions, minor amendments to the hypersensitivity text, updates to myocarditis and pericarditis sections and updated shelf life and storage instructions).
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advised that the 15 minute observation period after administration of mRNA vaccines (Pfizer/BioNTech and Moderna) can be waived during the emergency response to the Omicron variant. The 15 minute observation window should remain in place for people who may have previously suffered anaphylaxis or other allergic reactions to a food, insect sting, and most medicines or vaccines – see our Press release for more information on the temporary waiver.
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approved a new paediatric formulation of the Pfizer/BioNTech COVID-19 vaccine for children aged 5 to 11 years, known as Comirnaty 10 micrograms/dose concentrate for dispersion for injection – see the Decision page for more details.
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updated the product information for Vaxzevria (previously COVID-19 Vaccine AstraZeneca) to allow for the use of the vaccine as a booster or third dose and to include safety information on immune thrombocytopenia (ITP), cerebral venous sinus thrombosis (CVST) without thrombocytopenia, and facial paralysis.
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published the Public Assessment Report (PAR) for Lagevrio (molnupiravir).
We previously included summaries of latest COVID-19 information, including in the October 2021, November 2021 and December 2021 issues of Drug Safety Update.
See guidance on COVID-19 for all our latest information, including after publication of this article.
Reporting Yellow Cards
Report suspected side effects to medicines, vaccines, medical device and test kit incidents used in coronavirus (COVID-19) testing and treatment using the dedicated Coronavirus Yellow Card reporting site or via the Yellow Card app.
As these products are under additional monitoring, this includes all suspected adverse reactions associated with these vaccines. This will allow quick identification of new safety information.
When reporting please provide as much information as possible, including information about medical history, any concomitant medications, onset, treatment dates, and vaccine product brand name and batch number.
You may be contacted following submission of a Yellow Card report so that we can gather additional relevant information for the assessment of the report. These contributions form an important part of our understanding of suspected adverse events.
Article citation: Drug Safety Update volume 15, issue 6: January 2022: 3.