Introduction and module overview
Introduction and module overview
This year has seen community pharmacy become further established as the first point of contact in primary care for many patients, and additional pharmacy services contracted nationally and locally. The Covid vaccination programme continued and there were increasing numbers of people suffering with long Covid.
The Covid-19 pandemic
Covid-19 continued to affect the population’s health and NHS services during 2022. The vaccination programme carried on with the availability of boosters, and antiviral treatments were authorised and introduced. Community pharmacies remain key deliverers of vaccines in partnership with local primary care services.
Clinical trials showed that antivirals for Covid-19 are most effective when taken during the early stages of the infection and need to be started as soon as possible after a positive test result and within five days of symptoms starting. Some community pharmacies in Scotland were commissioned to supply oral antiviral treatments to high-risk Covid-19 patients in January 2022.
Key MHRA announcements about Covid-19 in 2022 were as follows:
Following MHRA approval of Lagevrio (molnupiravir) in November 2021, the Covid-19 antiviral treatment Paxlovid was approved. Paxlovid (nirmatrelvir and ritonavir) works by inhibiting a protease required for virus replication. Ritonavir slows the breakdown of nirmatrelvir in the body, increasing its effectiveness. Authorisation is for use in over-18s who have mild to moderate Covid-19 infection and at least one risk factor for developing severe illness. Risk factors include obesity, older age (>60 years), diabetes mellitus or heart disease.
The 15-minute observation period after administration of mRNA vaccines (Pfizer/BioNTech and Moderna) was waived during the emergency response to the omicron variant. The MHRA advised that it 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.
Nuvaxovid, the Covid-19 vaccine developed by Novavax, was given regulatory approval by the regulator.
Changes were made by the MHRA to the product information for Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech) to reflect the large amount of real-world data gathered indicating that the vaccines can be used during pregnancy and breastfeeding.
MHRA approved Valneva Covid-19 vaccine
MHRA authorised Evusheld (tixagevimab/cilgavimab) for Covid-19 prevention. This is currently undergoing evaluation by NICE with expected publication of guidance in May 2023.
Removal of 15-minute observation period following vaccination with the Pfizer/BioNTech or Moderna Covid-19 vaccines for individuals aged 12 years and over who have no history of severe allergic reaction (as outlined in the Green Book advice).
Allowance for third dose heterologous boosting (i.e. for someone having a different vaccine to their primary course as a booster). The interval between the primary course and booster dose shortened from at least six months to at least three months.
MHRA approved (and CHM endorsed) Spikevax bivalent original/omicron Covid-19 vaccine as a booster (single vaccine covering both delta and omicron variants). Safety monitoring showed that the side-effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving. No serious safety concerns were identified.
MHRA approved (and CHM endorsed) the Pfizer/BioNTech bivalent Covid-19 vaccine as a booster (single vaccine covering both delta and omicron variants; brand name Comirnaty Original/Omicron BA.1).
Safety monitoring in clinical trials showed that the side-effects observed were the same as those seen for the original Pfizer/BioNTech monovalent vaccine (Comirnaty) booster dose and were typically mild and self-resolving. No new serious safety concerns were identified.