Summary
At the time of this report, over 162,719 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 - the COVID-19 Pfizer/BioNTech Vaccine, 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 available on the impact of the vaccination campaign in reducing infections and illness in the UK.
The MHRA confirmed on 9 September 2021 that the COVID-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses. Following review of data for the COVID-19 Vaccine Moderna vaccine, the MHRA and Commission on Human Medicine (CHM) experts also concluded that this vaccine can be used as a safe and effective booster dose.
All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.
The COVID-19 Pfizer/BioNTech Vaccine was evaluated in clinical trials involving more than 44,000 participants. The most frequent adverse reactions in these 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, and 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 after vaccination. 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 continually monitors 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 vaccines are being given to the most elderly people and people who have underlying illness.
As of 9 March 2022, for the UK, 167,234 Yellow Cards have been reported for the COVID-19 Pfizer/BioNTech Vaccine, 244,183 have been reported for the COVID-19 Vaccine AstraZeneca, 36,337 for the COVID-19 Vaccine Moderna and 1,570 have been reported where the brand of the vaccine was not specified.
For the COVID-19 Pfizer/BioNTech Vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna the overall reporting rate is around 2 to 5 Yellow Cards per 1,000 doses administered.
In the 7 days since the previous summary for 2 March 2022 we have received a further 454 Yellow Cards for the COVID-19 Pfizer/BioNTech Vaccine, 133 for the COVID-19 Vaccine AstraZeneca, 111 for the COVID-19 Vaccine Moderna and 10 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 vaccines 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.
A number of detailed assessments of safety topics have been undertaken and we have updated our advice on these topics accordingly. Overall, our advice remains that the benefits of the vaccines outweigh the risks in the majority of people. Further comments on use in specific populations and details on the specific safety topics can be found within Section 3.
Conclusion
Vaccines are the best way to protect people from COVID-19 and have already saved tens of thousands of lives. Everyone should continue to get their vaccination when invited to do so unless specifically advised otherwise.
- As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored.
- The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects in the majority of patients.
Further information on the type of suspected adverse reactions (ADRs) reported for the COVID-19 Pfizer/BioNTech Vaccine, the COVID-19 Vaccine AstraZeneca and the COVID-19 Vaccine Moderna is provided in Annex 1. It is important to read the attached guidance notes to ensure appropriate interpretation of the data.
Entire content available on: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
