COVID-19 vaccines and drugs: updates for January 2022

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Paxlovid Approved – Oral COVID-19 Antiviral Treatment

We approved Paxlovid (PF-07321332 and ritonavir) following a rigorous review of its safety, quality and efficacy by us and expert advice from the government’s independent scientific advisory body, the Commission for Medicinal Products for Human Use (CHM).

Paxlovid is an antiviral drug with a combination of active ingredients, PF-07321332 and ritonavir, which works by inhibiting a protease needed for virus replication. Ritonavir slows the breakdown of PF-07321332 in the body, increasing its effectiveness.

Based on clinical trial data, Paxlovid is most effective when taken during the early stages of infection. The MHRA therefore recommends its use as soon as possible and within five days of the onset of symptoms. It has been approved for use in people aged 18 and older who have mild to moderate COVID-19 infection and at least one risk factor for developing severe disease. These risk factors include obesity, advanced age (>60 years), diabetes mellitus, or heart disease.

Paxlovid may interact with certain other medications. Before it is prescribed, the MHRA therefore advises that patients’ current medications are carefully reviewed and appropriate advice given on any adjustments that may be required to their current medications. Additional testing may also be required for safe use. For more information, see the contraindications, posology 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 reports and other recent MHRA publications

We continue to publish summaries of Yellow Card reports for COVID-19 vaccines used in the UK. The report summarizes information received through the yellow card system and will be published regularly to include further safety investigations carried out by the MHRA as part of the COVID-19 vaccine monitoring strategy.

We also recently:

  • updated the summary of product characteristics and patient information leaflet for Spikevax (COVID-19 vaccine Moderna) to allow use of the vaccine as a booster or third dose in persons 18 years of age and older and for immunocompromised patients, and safety updates (to include diarrhea and skin reactions as adverse reactions, additional information on delayed injection site reactions, minor changes to hypersensitivity text, updates updated sections on myocarditis and pericarditis and updated shelf life and storage instructions).

  • reported 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 have ever had anaphylaxis or other allergic reactions to food, insect bites, and most medications or vaccines – see our release release for more information on the temporary waiver.

  • approved a new pediatric formulation of the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years, known as Comirnaty 10 micrograms/dose concentrate for injectable dispersion – see Decision page for details.

  • updated the product information for Vaxzevria (formerly AstraZeneca COVID-19 vaccine) to allow use of the vaccine as a booster or third dose and to include safety information on immune thrombocytopenia (ITP), sinus thrombosis cerebral venous (CVST) without thrombocytopenia, and facial paralysis.

  • published the Public Assessment Report (PAR) for Lagevrio (molnupiravir).

We have previously included summaries of the latest information on COVID-19, including in the October 2021, November 2021 and December 2021 issues of Drug Safety Update.

See COVID-19 guidance for all of our latest information, including after this article was published.

Report yellow cards

Report suspected side effects of incidents related to medicines, vaccines, medical devices and test kits used in the testing and treatment of coronavirus (COVID-19) using the dedicated form Coronavirus yellow card reporting site or via the Yellow Card app.

As these products are subject to additional monitoring, this includes any suspected adverse reactions associated with these vaccines. This will allow new security information to be quickly identified.

When reporting, please provide as much information as possible, including information on medical history, concomitant medications, onset, dates of treatment, and vaccine brand name and lot number.

You may be contacted after a yellow card report has been submitted so that we can gather additional information relevant to the report’s assessment. 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.

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