70,504 cases of SERIOUS adverse effects!
At the time of this report, more than 110,000 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.
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 Oxford University/AstraZeneca vaccine 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 MHRA’s role is also to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this (https://www.gov.uk/government/publications/report-of-the-commissionon-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance). 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 31 January 2021. At this date, an estimated 6.6 million first doses of the Pfizer/BioNTech vaccine and 3 million doses of the Oxford University/AstraZeneca vaccine had been administered, and around 0.5 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered. This represents an increase of 2.7 million on the previous week.
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