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At the time of this report, nearly 125,000 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19). Rates of COVID-19 infection and hospitalisation remain high.Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.Two COVID-19 vaccines, Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, are currently being used in the UK. Both have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. In clinical trials, both vaccines showed very high levels of protection against symptomatic infections with COVID-19. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness in the UK.All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.

As of 28 February 2021, for the UK, 33,207 Yellow Cards have been reported for the Pfizer/BioNTech, 54,180 have been reported for the Oxford University/AstraZeneca vaccine, and 251 have been reported where the brand of the vaccine was not specified.For both vaccines the overall reporting rate is around 3 to 6 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 21 February 2021 we have received a further 3,492 Yellow Cards for the Pfizer/BioNTech vaccine, 11,263 for the Oxford University/AstraZeneca vaccine and 74 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.

It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.

For both vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected side effects is broadly similar across age groups, although, as was seen in clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.

Severe allergy
On 9 December 2020, the MHRA issued preliminary guidance on severe allergic reactions after the Pfizer/BioNTech vaccine due to early reports of anaphylaxis. Following further detailed review, this advice was amended on 30 December to the current advice. This advice is that people with a previous history of severe allergic reactions to any ingredients of the vaccine should not receive it. People who receive the vaccine should be monitored for at least 15 minutes afterwards.

Widespread use of the vaccine now suggests that severe allergic reactions to the Pfizer/BioNTech vaccine are very rare. Anaphylaxis can also be a very rare side effect associated with most other vaccines.

Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received so far.

Conclusion

The increases in number of ADR reports reflects the increase in vaccine deployment as new vaccination centres have opened across the UK The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines    The overall safety experience with both vaccines is so far as expected from the clinical trials Based on current experience, the expected benefits of both COVID-19 vaccines in preventing COVID-19 and its serious complications far outweigh any known side effects   

As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored