Coronavirus vaccine – weekly summary of Yellow Card reporting

Updated 19 August 2021

Summary

At the time of this report, over 130,837 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19). 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.

Three COVID-19 vaccines, Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna, are currently being used in the UK. All 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, the vaccines showed very high levels of protection against symptomatic infections with COVID-19. Data are now available 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.

The Pfizer/BioNTech vaccine was evaluated in clinical trials involving more than 44,000 participants. The most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people. These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 55 years) than in younger people.

The COVID-19 Vaccine AstraZeneca was evaluated in clinical trials involving more than 23,000 participants. The most frequently reported adverse reactions in these trials were injection-site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than 1 in 10 people. The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse reactions reported after the second dose were milder and reported less frequently than after the first dose. Adverse reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.

The COVID-19 Vaccine Moderna was evaluated in clinical trials involving more than 30,000 participants. The most frequent adverse reactions in these trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), arthralgia (joint pains), chills, nausea/vomiting, axillary swelling/tenderness (swelling/tenderness of glands in the armpit), fever, injection site swelling and redness; these were each reported in more than 1 in 10 people. These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 65 years) than in younger people.

The MHRA’s role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.

Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.

This safety update report is based on detailed analysis of data up to 11 August 2021. At this date, an estimated 21 million first doses of the Pfizer/BioNTech vaccine and 24.7 million first doses of the COVID-19 Vaccine AstraZeneca had been administered, and around 15.5 million and 23.9 million second doses of the Pfizer/BioNTech vaccine and COVID-19 Vaccine AstraZeneca respectively. An approximate 1.4 million first doses and approximately 0.6 million second doses of the COVID-19 Vaccine Moderna have also now been administered.

As of 11 August 2021, for the UK, 104,446 Yellow Cards have been reported for the Pfizer/BioNTech vaccine, 228,239 have been reported for the COVID-19 Vaccine AstraZeneca, 13,325 for the COVID-19 Vaccine Moderna and 1022 have been reported where the brand of the vaccine was not specified.

For the Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna the overall reporting rate is around 3 to 7 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 4 August 2021 we have received a further 2,963 Yellow Cards for the Pfizer/BioNTech vaccine, 1,280 for the COVID-19 Vaccine AstraZeneca, 756 for the COVID-19 Vaccine Moderna and 19 where the brand was not specified.

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 all COVID-19 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.

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

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