Coronavirus vaccine – weekly summary of Yellow Card reporting

Severe Allergy

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.

The foregoing is taken from the UK Government web site on COVID-19 https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

See below the summary of the full version of the above link.

Summary

At the time of this report, more than 120,000 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. 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 14 February 2021. At this date, an estimated 8.3 million first doses of the Pfizer/BioNTech vaccine and 6.9 million doses of the Oxford University/AstraZeneca vaccine had been administered, and around 0.6 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered. This represents an increase of 2.8 million on the previous week.

As of 14 February 2021, for the UK

  • 26,823 Yellow Cards have been reported for the Pfizer/BioNTech
  • 31,427 have been reported for the Oxford University/AstraZeneca vaccine
  • 177 have been reported where the brand of the vaccine was not specified

For both vaccines, the overall reporting rate is around 3 to 5 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 7 February 2021, we have received a further 2,616 Yellow Cards for the Pfizer/BioNTech vaccine, 10,999 for the Oxford University/AstraZeneca vaccine, and 64 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.

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 vaccines 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 a 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 the 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

Further information on the type of suspected adverse reactions (ADRs) reported for the COVID-19 mRNA Pfizer/BioNTech vaccine and the COVID-19 Vaccine AstraZeneca is provided in Annex 1. It is important to read the guidance notes to ensure appropriate interpretation of the data.

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Severe Allergy

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.

The foregoing is taken from the UK Government web site on COVID-19 https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

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See below the summary of the full version of the above link.

Summary

At the time of this report, more than 120,000 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. 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 14 February 2021. At this date, an estimated 8.3 million first doses of the Pfizer/BioNTech vaccine and 6.9 million doses of the Oxford University/AstraZeneca vaccine had been administered, and around 0.6 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered. This represents an increase of 2.8 million on the previous week.

As of 14 February 2021, for the UK

For both vaccines, the overall reporting rate is around 3 to 5 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 7 February 2021, we have received a further 2,616 Yellow Cards for the Pfizer/BioNTech vaccine, 10,999 for the Oxford University/AstraZeneca vaccine, and 64 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.

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 vaccines 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 a 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

Further information on the type of suspected adverse reactions (ADRs) reported for the COVID-19 mRNA Pfizer/BioNTech vaccine and the COVID-19 Vaccine AstraZeneca is provided in Annex 1. It is important to read the guidance notes to ensure appropriate interpretation of the data.