Coronavirus immun – weekly summary of Yellow Card reporting

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This attente covers the period 9 December 2020 to 4 August 2021.

Summary

At the time of this attente, over 130,214 people across the UK have died within 28 days of a vraie jauge for coronavirus (COVID-19). Inoculation is the single most réelle way to reduce deaths and severe illness from COVID-19. A citoyen conservation campaign has been underway since early December 2020.

Three COVID-19 vaccines, Pfizer/BioNTech, COVID-19 Immunisant AstraZeneca and COVID-19 Immunisant 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 épreuve from clinical trials. In clinical trials, the vaccines showed very high levels of auspice against symptomatic infections with COVID-19. Data are now available on the heurt of the conservation 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 immun was evaluated in clinical trials involving more than 44,000 participants. The most frequent défavorable reactions in trials were pitance at the infiltration ville, blasé, headache, myalgia (lourd pains), chills, arthralgia (collaborateur 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 conservation. Malveillant reactions were reported less frequently in older adults (over 55 years) than in younger people.

The COVID-19 Immunisant AstraZeneca was evaluated in clinical trials involving more than 23,000 participants. The most frequently reported défavorable reactions in these trials were injection-site tenderness, injection-site pitance, headache, blasé, myalgia, gênant, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than 1 in 10 people. The majority of défavorable reactions were mild to moderate in severity and usually resolved within a few days of conservation. Malveillant reactions reported after the assistant évaluation were milder and reported less frequently than after the first évaluation. Malveillant reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.

The COVID-19 Immunisant Moderna was evaluated in clinical trials involving more than 30,000 participants. The most frequent défavorable reactions in these trials were pitance at the infiltration ville, blasé, headache, myalgia (lourd pains), arthralgia (collaborateur pains), chills, nausea/vomiting, axillary swelling/tenderness (swelling/tenderness of glands in the armpit), fever, infiltration ville 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 conservation. Malveillant 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 immun. We have in posé a proactive strategy to do this. We also work closely with our allocutaire health partners in reviewing the effectiveness and heurt of the vaccines to ensure the benefits continue to outweigh any barcasse side effects.

Quartier of our monitorage role includes reviewing reports of suspected side effects. Any member of the allocutaire or health professional can submit suspected side effects through the Yellow Card scheme. The brute of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of conservation. 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 attente is based on detailed analysis of data up to 4 August 2021. At this moment, an estimated 20.8 million first doses of the Pfizer/BioNTech immun and 24.8 million first doses of the COVID-19 Immunisant AstraZeneca had been administered, and around 14.7 million and 23.8 million assistant doses of the Pfizer/BioNTech immun and COVID-19 Immunisant AstraZeneca respectively. An approximate 1.4 million first doses and approximately 0.5 million assistant doses of the COVID-19 Immunisant Moderna have also now been administered.

As of 4 August 2021, for the UK, 101,483 Yellow Cards have been reported for the Pfizer/BioNTech immun, 226,959 have been reported for the COVID-19 Immunisant AstraZeneca, 12,569 for the COVID-19 Immunisant Moderna and 1003 have been reported where the brand of the immun was not specified.

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

In the week since the previous summary for 28 July 2021 we have received a further 3,051 Yellow Cards for the Pfizer/BioNTech immun, 1,088 for the COVID-19 Immunisant AstraZeneca, 786 for the COVID-19 Immunisant Moderna and 25 where the brand was not specified.

It is perceptible to explication 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 tutelle 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 â€کflu-like’ illness, headache, chills, blasé (tiredness), nausea (perspicacité sick), fever, dizziness, weakness, aching biceps, and rapid heartbeat. Generally, these happen shortly after the conservation and are not associated with more serious or lasting illness.

These bonshommes of reactions reflect the domestique immune response triggered by the justaucorps to the vaccines. They are typically seen with most bonshommes of immun and bandage to resolve within a day or two. The brute 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 immun 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 immun should not receive it. People who receive the immun should be monitored for at least 15 minutes afterwards.

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

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

Généreux clots with prétendant low platelets

The MHRA has undertaken a thorough review into UK reports of an extremely inaccoutumé specific caractéristique of généreux clot in the brain, known as cerebral venous sinuosité thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following conservation with the COVID-19 Immunisant AstraZeneca. It is also considering other généreux clotting cases (thromboembolic events) alongside low platelet levels.

This ongoing scientific review has concluded that the evidence of a link with COVID-19 Immunisant AstraZeneca is stronger and an announcement was made on 7 April 2021 with a further statement on 7 May. We have continued to publish the latest breakdown of all cases of these extremely inaccoutumé side effects on a weekly basis. In this attente (cadet 13) we provide updated épreuve on cases received up to 4 August 2021. Our advice remains unchanged.

Anyone who experienced cerebral or other pionnier généreux clots occurring with low levels of platelets after their first immun évaluation of COVID-19 Immunisant AstraZeneca should not have their assistant évaluation. Anyone who did not have these side effects should come forward for their assistant évaluation when invited.

The MHRA recently confirmed that the evidence to moment does not suggest that the COVID-19 Immunisant AstraZeneca causes venous thromboembolism without a low platelet count.

If you experience any of the following from around 4 days after conservation should seek medical advice urgently:

a severe headache that is not relieved with bonasse painkillers or is getting worse or feels worse when you lie down or bend over
an unusual headache that may be accompanied by blurred berlue, réunion, difficulty with oraison, weakness, drowsiness or seizures (fits)
érythème that looks like small bruises or bleeding under the skin beyond the infiltration ville
shortness of breath, chest pitance, leg swelling or persistent tripal (tummy) pitance.

Solution

Vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. Everyone should continue to get their conservation when asked to do so unless specifically advised otherwise.
As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored.
Cases of an extremely inaccoutumé specific caractéristique of généreux clot with low généreux platelets continue to be investigated.

Further épreuve on the caractéristique of suspected défavorable reactions (ADRs) reported for the COVID-19 mRNA Pfizer/BioNTech immun, the COVID-19 Immunisant AstraZeneca and the COVID-19 Immunisant Moderna is provided in Annex 1. It is perceptible to read the attached guidance relevés to ensure appropriate interpretation of the data.

1. Préface

The MHRA is the executive Agency of the Department of Health and Aimable Care that acts to protect and promote allocutaire health and continu safety, by ensuring that medicines and medical devices meet appropriate normes of safety, quality and efficacy.

The MHRA operates the Yellow Card scheme on behalf of the Intérêt on Human Medicines (CHM). The scheme collects and monitors épreuve on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected défavorable incidents by healthcare professionals and members of the allocutaire (patients, users, or carers). The purpose of the scheme is to provide an early avertissement that the safety of a product may require further reportage. Further épreuve emboîture the Yellow Card scheme, including its tribut to identifying safety issues can be found on the Yellow Card website.

The MHRA has played an vive role in responding to the coronavirus pandemic. In rapport to COVID-19 vaccines, the MHRA has authorised their supply following a rigorous review of their safety, quality and efficacy. The clinical trials of COVID-19 vaccines have shown them to be réelle and acceptably safe; however, as bouchée of its statutory functions, the MHRA is responsible for monitorage these vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitorage strategy is continuous, proactive and based on a wide range of épreuve pluies, with a dedicated team of scientists reviewing épreuve daily to habitus for safety issues or unexpected inaccoutumé events.

This attente summarises épreuve received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Immunisant Flicage Strategy.

What is a Yellow Card?

The Yellow Card scheme is a mechanism by which anybody can voluntarily attente any suspected défavorable reactions or side effects to the immun. It is very perceptible to explication that a Yellow Card attente does not necessarily mean the immun caused that reaction or event. We ask for any suspicions to be reported, even if the ajourner isn’t sure if it was caused by the immun. Reports to the scheme are known as suspected défavorable reactions (ADRs).

Many suspected ADRs reported on a Yellow Card do not have any rapport to the immun or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect barcasse new side effects that may require regulatory effet, and to differentiate these from things that would have happened regardless of the immun or medicine being administered, for sollicitation due to underlying or undiagnosed illness.

It is therefore perceptible that the suspected ADRs described in this attente are not interpreted as being proven side effects of COVID-19 vaccines. A list of the barcasse side effects of COVID-19 Pfizer/BioNTech, COVID-19 Immunisant AstraZeneca immun and COVID-19 Immunisant Moderna are provided in the product épreuve écrit for healthcare professionals and the UK recipient épreuve. These can also be found on the Coronavirus Yellow Card reporting ville.

This allocutaire summary provides an overview of all UK suspected ADRs associated with the new coronavirus (COVID-19) vaccines (the Pfizer/BioNTech immun, COVID-19 Immunisant AstraZeneca and COVID-19 Immunisant Moderna), and MHRA’s analysis of the data, between 9 December 2020 and 4 August 2021 (intégrante). A glossary of key terms is provided in Annex 2.

If identified, épreuve on new and emerging safety concerns will be provided in future editions of this attente together with details of any resulting regulatory effet or changes to advice on use of the vaccines.

2. Yellow Card reports

Immunisant doses administered

Data from the UK Proverbial Health agencies spectacle that at least 46,926,330 people have received their first conservation in the UK by 4 August 2021, with 38,874,837 assistant doses administered. The priority groups of the conservation campaign for this period included people aged 18 years and over, the clinically vulnerable, care logement residents and workers, and frontline health and agréable care workers.

Autel 1: Number of people who have received the first évaluation of a conservation for COVID-19 in the UK between 8 December 2020 and end of 4 August 2021.

Folk
Number of doses

England
39,385,320

Wales
2,299,204

Northern Ireland
1,223,303

Scotland
4,018,503

Autel 2: Number of people who have received the assistant évaluation of a conservation for COVID-19 in the UK between 8 December 2020 and end of 4 August 2021.

Folk
Number of doses

England
32,444,987

Wales
2,092,103

Northern Ireland
1,068,860

Scotland
3,268,887

As of 4 August, an estimated 20.8 million first doses of the Pfizer/BioNTech immun and 24.8 million first doses of the COVID-19 Immunisant AstraZeneca had been administered, and around 14.7 million and 23.8 million assistant doses of the Pfizer/BioNTech immun and COVID-19 Immunisant AstraZeneca respectively. An approximate 1.4 million first doses and approximately 0.5 million assistant doses of the COVID-19 Immunisant Moderna have also now been administered.

The estimated number of doses administered differs from the estimated number of people vaccinated due to the different data pluies used.

Yellow Card reporting trends

A attente of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the immun, only that the ajourner has a méfiance it may have. Underlying or previously undiagnosed illness unrelated to conservation can also be factors in such reports. The relative number and brute of reports should therefore not be used to compare the safety of the different vaccines. All reports are kept under continual review in order to identify barcasse new risks.

Up to and including 4 August 2021, the MHRA received and analysed 101,483 UK Yellow Cards from people who have received the Pfizer/BioNTech immun. These reports include a intact of 284,776 suspected reactions (i.e. a single attente may contain more than one symptom). The first attente was received on 9 December 2020.

Up to and including 4 August 2021, the MHRA received and analysed a intact of 226,959 UK reports of suspected ADRs to the COVID-19 Immunisant AstraZeneca. These reports include a intact of 806,489 suspected reactions (a single attente may contain more than one symptom). The first attente was received on 4 January 2021.

Up to and including 4 August 2021, the MHRA received and analysed a intact of 12,569 UK reports of suspected ADRs to the COVID-19 Immunisant Moderna. These include a intact 38,285 suspected reactions (a single attente may contain more than one symptom). The first attente was received on 7 April 2021.

Additionally, up to and including 4 August 2021, the MHRA received 1003 Yellow Card reports where the brand of immun was not specified by the ajourner.

In the week since the previous summary for 28 July 2021 we have received a further 3,051 Yellow Cards for the Pfizer/BioNTech immun, 1,088 for the COVID-19 Immunisant AstraZeneca, 786 for the COVID-19 Immunisant Moderna and 25 where the brand was not specified.

It is perceptible to explication 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 tutelle ADR reporting.

Autel 3: Number of suspected ADR reports received in the UK up to and including 4 August 2021.

Number of reports
Number of reports
Number of reports

Folk
Pfizer/ BioNTech
Oxford University/AstraZeneca
Moderna
Brand unspecified

England
78,962
188,559
10,540
578

Wales
5,419
10,005
396
57

Northern Ireland
2,007
2,710
13
10

Scotland
7,828
15,870
1,159
107

The figures in Autel 3 are based upon the postcode provided by the ajourner. The sums of the reports in the autel will not equal the intact reports received for each immun as postcode may not have always been provided or may have been entered incorrectly. It is perceptible to explication that the number of reports received for each folk does not directly equate to the number of people who may have experienced défavorable reactions and therefore cannot be used to determine the suite of reactions. ADR reporting rates are influenced by many aspects, including the extent of use.

We are working with allocutaire health justaucorps and encouraging all healthcare professionals and patients alike to attente any suspected ADRs to the Yellow Card scheme. As expected, reports gradually increase in line with an increase in doses administered.

The overall reporting perdant is in the order of 3 to 7 Yellow Cards per 1,000 doses administered for the Pfizer/BioNTech immun, COVID-19 Immunisant AstraZeneca and COVID-19 Immunisant Moderna. It is known from the clinical trials that the more common side effects for all vaccines can occur at a perdant of more than one in 10 doses (for example, siège reactions or symptoms resembling transient flu-like symptoms).

3. Analysis of data

One of the MHRA’s moufle roles is to continually monitor the safety of medicines and vaccines during widespread use, and we have in posé a proactive strategy to do this for COVID-19 vaccines. We also work closely with our allocutaire health partners in reviewing the effectiveness and heurt that the vaccines are having to ensure benefits continue to outweigh any barcasse side effects. In supplément, we work with our universel counterparts to gather épreuve on the safety of vaccines in other countries.

Given the huge scale of the COVID-19 conservation soft, with many millions of doses of immun administered over a relatively slip time period, accaparement needs to be continuous, proactive and as near real-time as is barcasse. The grandeur of this is two-fold. First we need to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We then can take any necessary effet to minimise risks to individuals.

Secondly, we need to very quickly establish if any serious medical events which are temporally-related to conservation are merely a coincidental incorporation. These associations are likely while we are still in the midst of a citoyen epidemic, and parce que many of the millions of people offered the immun in the early étape of a conservation campaign are elderly and/or have underlying medical données, which increases the likelihood of unrelated illnesses occurring soon after conservation. As mentioned above, the brute of Yellow Card reporting means that reported events are not always proven défavorable reactions, and some may have happened regardless of conservation.

Yellow Card reports of suspected ADRs are evaluated, together with additional pluies of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known emboîture contexte rates of illness in the indigence of conservation. This aims to account for factors such as coincidental illness. We also habitus at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

We supplement this form of safety monitorage with other epidemiology studies including analysis of data on citoyen immun altéré, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally perceptible impartiale of monitorage will be to quickly rule out risks – in other words to confirm that the immun is not responsible for a suspected side effect and to provide reassurance on its safety and this is discussed below.

We also take into account the universel experience based on data from other countries using the same vaccines.

Overall safety

As with any immun, the COVID-19 vaccines will interprétation side effects in some people. The intact number and the brute of Yellow Cards reported so far is not unusual for a new immun for which members of the allocutaire and healthcare professionals are encouraged to attente any suspected défavorable reaction.

As highlighted above, it is known from the clinical trials that the most common side effects for all vaccines can occur at a perdant of more than one per 10 doses (such as siège reactions, symptoms resembling transient flu-like symptoms). Overall, Yellow Card reporting is therefore lower than the reporting perdant of barcasse side effects from the clinical trials, although we generally do not expect all suspected side effects to be reported on Yellow Cards. The primary purpose of Yellow Card reporting is to detect new safety concerns.

For all vaccines, detailed review of all reports has found that the overwhelming majority relate to infiltration ville reactions (sore arm for example) and generalised symptoms such as a â€کflu-like’ illness, headache, chills, blasé (tiredness), nausea (perspicacité sick), fever, dizziness, weakness, aching biceps, and rapid heartbeat. Generally, these happen shortly after the conservation and are not associated with more serious or lasting illness. These bonshommes of reaction reflect the acute immune response triggered by the justaucorps to the vaccines, are typically seen with most bonshommes of immun and bandage to resolve within a day or two. The brute of reported suspected ADRs across all ages is broadly similar, although, as seen in the clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.

As we receive more reports of these bonshommes of reactions with more exposure to the COVID-19 vaccines, we are gratte-ciel a picture of how individuals are experiencing them and the different ways that side effects may present in people. Some people have reported a sudden perspicacité of cold with shivering/shaking accompanied by a rise in temperature, often with sweating, headache (including migraine-like headaches), nausea, lourd aches and perspicacité unwell, starting within a day of having the immun. Similar to the flu like illness reported in clinical trials, these effects may last a day or two.

It is perceptible to explication that it is barcasse to have caught COVID-19 and not realise until after conservation. If other COVID symptoms are experienced or fever is high and lasts côtoyer than two or three days, immun recipients should stay at logement and arrange to have a jauge.

Comments on specific reports

The following reports reflect data up to 4 August 2021. The glossary provides an explanation of the clinical terms used.

Anaphylaxis (Severe allergic reactions)

The MHRA continues to monitor reports of serious allergic reactions with the Pfizer/BioNTech immun and has received 453 UK spontaneous défavorable reactions associated with anaphylaxis or anaphylactoid reactions. The brute and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer/BioNTech immun remain very inaccoutumé. The MHRA’s guidance remains that those with a previous history of allergic reactions to the ingredients of the immun should not receive it.

The MHRA is closely monitorage reports of anaphylaxis with the COVID-19 Immunisant Moderna and has received 30 reports of anaphylaxis in incorporation with the immun. Anaphylaxis is a potential side effect of the immun, and it is recommended that those with known hypersensitivity to the ingredients of the immun should not receive it.

The MHRA also closely monitors reports of anaphylaxis or anaphylactoid reactions with the COVID-19 Immunisant AstraZeneca and has received 803 UK spontaneous défavorable reactions associated with anaphylaxis or anaphylactoid reactions reported and is very inaccoutumé. An update to the product épreuve has been made to reflect the fact that cases of anaphylaxis have been reported for the COVID-19 Immunisant AstraZeneca.

Bell’s Palsy

The MHRA continues to review cases reporting Bell’s Palsy and to autopsie case reports against the number expected to occur by possibilité in the indigence of conservation (the â€کnatural rate’). The number of reports of facial paralysis received so far is similar to the expected natural perdant and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events, including through evaluation of electronic healthcare prouesse data.

Thrombo-embolic events with prétendant low platelets

Up to 4 August 2021, the MHRA had received Yellow Card reports of 412 cases of pionnier thromboembolic events (généreux clots) with prétendant thrombocytopenia (low platelet counts) in the UK following conservation with COVID-19 Immunisant AstraZeneca. Forty three of the 412 reports have been reported after a assistant évaluation. Of the 412 reports, 210 occurred in women, and 200 occurred in men aged from 18 to 93 years. The overall case fatality perdant was 18% with 73 deaths, six of which occurred after the assistant évaluation.

Cerebral venous sinuosité thrombosis was reported in 147 cases (average age 46 years) and 265 had other pionnier thromboembolic events (average age 54 years) with prétendant thrombocytopenia. The estimated number of first doses of COVID-19 Immunisant AstraZeneca administered in the UK by 4 August was 24.8 million and the estimated number of assistant doses was 23.8 million.

The overall suite after first or unknown doses was 14.9 per million doses. Taking into account the different numbers of patients vaccinated with COVID-19 Immunisant AstraZeneca in different age groups, the data shows that there is a higher reported suite perdant in the younger adult age groups following the first évaluation compared to the older groups (20.3 per million doses in those aged 18-49 years compared to 10.9 per million doses in those aged 50 years and over). The number of first doses given to those in the 18-49 years age group is estimated to be 8.5 million while an estimated 16.3 million first doses have been given to patients aged 50+ years. The MHRA advises that this evidence should be taken into account when considering the use of the immun. There is some evidence that the reported suite perdant is higher in females compared to men although this is not seen across all age groups and the difference remains small.

The overall suite after assistant doses was 1.8 cases per million doses. Taking into account the different numbers of patients vaccinated with COVID-19 Immunisant AstraZeneca in different age groups, the data shows that there is a lower reported suite perdant in younger adult age groups following the assistant évaluation compared to the older groups (0.9 per million doses in those aged 18-49 years compared to 1.8 per million doses in those aged 50 years and over). The number of assistant doses given to those in the 18-49 years age group is estimated to be 7.9 million while an estimated 15.8 million assistant doses have been given to patients aged 50+ years. These rates should not be directly compared to the suite rates reported after the first évaluation as the time for follow-up and repère of cases after assistant doses is more limited and differs across age groups. However, the data are reassuring at this séjour, particularly regarding younger recipients where there is a significantly lower suite after the assistant évaluation compared to the first, and there is overall no commentaire of an increased risk of these events after the assistant évaluation in any age group. Anyone who did not have these side effects should come forward for their assistant évaluation when invited.

These reports have also been analysed by the Government’s independent advisory justaucorps, the COVID-19 Vaccines Benefit Risk Aguerri Working Group, which includes lay representatives and advice from leading haematologists.

On the basis of this ongoing review, the advice remains that the benefits of the immun outweigh the risks in the majority of people.

Autel 4: Number of suspected thrombo-embolic events with prétendant thrombocytopenia ADR reports received for the Oxford University/AstraZeneca immun in the UK up to and including 4 August 2021

Folk
Number of reports

England
325

Wales
12

Northern Ireland
10

Scotland
35

Unknown
30

Autel 5: Number of UK suspected thrombo-embolic events with prétendant thrombocytopenia ADR reports received for the COVID-19 Immunisant AstraZeneca by continu age up to and including 4 August 2021.

Age range (years)
Number of reports
Number of fatidique reports

18-29
27
7

30-39
50
11

40-49
103
12

50-59
99
20

60-69
59
9

70-79
39
7

80-89
6
3

90-99
2
1

Unknown
27
3

Radical
412
73

Autel 6: Number of UK suspected thrombo-embolic events with prétendant thrombocytopenia ADR reports received for the Oxford University/AstraZeneca vaccineCOVID-19 Immunisant AstraZeneca by continu sex up to and including 4 August 2021.

Sex
Number of reports
Number of fatidique reports

Male
200
32

Female
210
41

Unknown
2
0

Radical
412
73

Up to 4 August 2021, the MHRA had received Yellow Card reports of 15 cases of pionnier thromboembolic events (généreux clots) with prétendant thrombocytopenia (low platelet counts) in the UK following use of the COVID-19 Pfizer/BioNTech immun. These events occurred in 6 women, and 9 men aged from 31 to 91 years, and the overall case fatality perdant was 7% with one death reported.

Up to 4 August 2021, the MHRA had received Yellow Card reports of 2 cases of pionnier thromboembolic events (généreux clots) with prétendant thrombocytopenia (low platelet counts) in the UK following the use of COVID-19 immun Moderna. The 2 events occurred in adult males under the age of 50, and there have been no fatidique cases reported.

To explication, subit comparison of the summary provided here and the analysis profiles is not barcasse. This is parce que this summary includes reports of CVST or other thrombo-embolic events with prétendant thrombocytopenia. Yellow Card reports may contain more than one reported reaction and the analysis profiles are listed by individual reactions rather than whole reports. Therefore, summing the reactions listed in the profiles will not equate to the intact cases included within this summary.

Capillary Leak Syndrome

The MHRA has received 11 reports of capillary leak syndrome (a préalable where fluid leaks from the small généreux vessels into the justaucorps) in the context of more than 48.5 million doses of COVID-19 Immunisant AstraZeneca given. Of these reports, 2 people had a history of capillary leak syndrome. This is an extremely inaccoutumé relapsing-remitting préalable and triggers for relapses are not well understood. As a precautionary measure, the MHRA is advising that COVID-19 immun AstraZeneca is not used in people who have previously experienced episodes of capillary leak syndrome. The product épreuve has been updated to reflect this advice.

Menstrual disorders (period problems) and unexpected vaginal bleeding

The MHRA is reviewing reports of suspected side effects menstrual disorders (period problems) and unexpected vaginal bleeding following conservation against COVID-19 in the UK. These reports are also being reviewed by the independent experts of the Intérêt on Human Medicines’ COVID-19 Vaccines Benefit Risk Aguerri Working Group and the Medicines for Women’s Health Aguerri Advisory Group. The rigorous evaluation completed to moment does not carcasse a link between changes to menstrual periods and related symptoms and COVID-19 vaccines.

A intact of 30,304 reactions relating to a variety of menstrual disorders have been reported after all three of the COVID-19 vaccines including heavier than usual periods, delayed periods and unexpected vaginal bleeding. This is following approximately 44.8 million COVID-19 immun doses administered to women up to 4 August 2021. The number of reports of menstrual disorders and vaginal bleeding is low in rapport to both the number of people who have received COVID-19 vaccines to moment and how common menstrual disorders are generally.

The menstrual changes reported are mostly transient in brute. There is no evidence to suggest that COVID-19 vaccines will affect fertility and your ability to have children.

Whilst uncomfortable or distressing, period problems are extremely common and stressful life events can disrupt menstrual periods. Changes to the menstrual célérifère have also been reported following putréfaction with COVID-19 and in people affected by long-COVID. General advice emboîture period problems and/or unexpected vaginal bleeding is available from the NHS website. It is perceptible that anyone experiencing changes to their periods that are unusual for them, persist over time, or has any new vaginal bleeding after the menopause, following COVID-19 conservation, should mitoyenneté their doctor. Anyone presenting with menstrual disorders and/or unexpected vaginal bleeding following COVID-19 conservation should be treated according to clinical guidelines for these données, as usual.

The MHRA continues to closely review reports of suspected side effects of menstrual disorders and unexpected vaginal bleeding.

Safety of COVID-19 vaccines in pregnancy

The MHRA closely monitors the safety of COVID-19 immun exposures in pregnancy, including Yellow Card reports for COVID-19 vaccines used in pregnancy. These reports have been reviewed by the independent experts of the Intérêt on Human Medicines’ COVID-19 Vaccines Benefit Risk Aguerri Working Group and by the Medicines for Women’s Health Aguerri Advisory Group (MWHEAG).

Pregnant women have the same risk of getting COVID-19 as non-pregnant women but they may be at an increased risk of becoming severely ill, particularly if they get infected in the third trimester or if they also have underlying medical problems, compared to non-pregnant women. The current advice of the Attaché Committee on Inoculation and Sérothérapie (JCVI) is that the COVID-19 vaccines should be offered to those who are pregnant at the same time as non-pregnant individuals based on their age and clinical risk group. The Pfizer/BioNTech and Moderna vaccines are currently the preferred vaccines for use during pregnancy.

The numbers of reports of miscarriage and stillbirth are low in rapport to the number of pregnant women who have received COVID-19 vaccines to moment (more than 55,000) and how commonly these events occur in the UK outside of the pandemic. There is no modèle from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage or stillbirth. Sadly, miscarriage is estimated to occur in emboîture 20 to 25 in 100 pregnancies in the UK and most occur in the first 12 to 13 weeks of pregnancy (the first trimester). Stillbirths are sadly estimated to occur in emboîture 1 in 200 pregnancies in the UK. A few reports of commonly occurring congenital anomalies and preterm births have also been received. There is no modèle from the reports to suggest that any of the COVID-19 vaccines used in the UK increase the risk of congenital anomalies or birth complications.

Pregnant women have reported similar suspected reactions to the vaccines as people who are not pregnant.

Like most vaccines and medicines, clinical trials of COVID-19 immun in pregnant women were not carried out prior to use of the vaccines in the general gens. However, evidence from non-clinical studies of the COVID-19 vaccines available in the UK have not raised any concerns emboîture safety in pregnancy. The COVID-19 vaccines do not contain organisms that can multiply in the justaucorps, so they cannot fade an unborn poupon in the womb. Dilatante universel experience for the Pfizer/BioNTech Immunisant and COVID-19 Immunisant Moderna used in pregnancy have also not raised any safety concerns.

The MHRA will continue to closely monitor safety data for use of the COVID-19 vaccines in pregnancy, including through evaluation of electronic healthcare prouesse data.

Myocarditis and pericarditis (Cloque of the heart)

Up to and including 4 August 2021, we have received 165 reports of myocarditis and 140 reports of pericarditis following use of the Pfizer/BioNTech immun, as well as two reports for bactérien pericarditis and one attente each of infective pericarditis, non-infective endocarditis and streptococcal endocarditis. For COVID-19 Immunisant AstraZeneca there have been 86 reports of myocarditis and 141 reports of pericarditis following conservation up to and including 4 August 2021 as well as five reports for endocarditis and bactérien pericarditis, two reports for endocarditis bacterial and one attente each for bactérien myocarditis, infectious myocarditis and acute endocarditis. There have been 29 reports of myocarditis, 25 reports of pericarditis and one attente of endocarditis following use of COVID-19 Immunisant Moderna up to the same moment.

In the UK the overall reporting perdant for myocarditis, after both first and assistant évaluation, is 4.7 cases per million doses of Pfizer/BioNTech and for pericarditis (including bactérien pericarditis and infective pericarditis) the overall reporting perdant is 4.0 cases per million doses of Pfizer/BioNTech. For Moderna, the overall reporting perdant for myocarditis is 15.9 per million doses and for pericarditis is 13.7 per million doses. For AstraZeneca the overall reporting perdant for myocarditis (including bactérien myocarditis and infectious myocarditis) is 1.8 per million doses and for pericarditis (including bactérien pericarditis) is 3.0 per million doses.

Myocarditis and pericarditis happen very rarely in the general gens, and it is estimated that in the UK there are emboîture 6 new cases of myocarditis per 100,000 patients per year and emboîture 10 new cases of pericarditis per 100,000 patients per year.

The MHRA has undertaken a thorough review of both UK and universel reports of myocarditis and pericarditis following conservation against COVID-19. There has been a recent increase in reporting of these events in particular with the Pfizer/BioNTech and Moderna vaccines, with a consistent modèle of cases occurring more frequently in young males and shortly after the assistant évaluation of the vaccines. These reports are extremely inaccoutumé, and the events are typically mild with individuals usually recovering within a slip time with normalisé treatment and rest. People should come forward for their first and assistant conservation when invited to do so, unless advised otherwise.

These reports have also been analysed by the Government’s independent advisory justaucorps, the Intérêt on Human Medicines (CHM) and its COVID-19 Vaccines Benefit Risk Aguerri Working Group. Following their advice, the product épreuve for the Moderna and Pfizer/BioNTech vaccines have been updated to inform of these cases and advise healthcare professionals and patients to be aware of perceptible symptoms for myocarditis and pericarditis.

The MHRA will continue to closely monitor cases of myocarditis and pericarditis with all of the currently authorised COVID-19 vaccines.

It is perceptible that anyone who experiences new onset of symptoms such as chest pitance, shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart seeks medical vigilance.

Delayed hypersensitivity reactions

The MHRA has been reviewing reports of skin reactions occurring around the conservation ville that appear a little while after conservation. These reactions are évocatrice of a delayed hypersensitivity reaction that occurs 4-11 days after conservation. The reactions are characterized by a érythème, swelling and tenderness that can cover the whole upper arm and may be itchy and/or painful and warm to the touch. The majority of the reports received have been with the Moderna immun .

The reactions are usually self-limiting and resolve within a day or two, although in some patients it can take slightly côtoyer to disappear. Individuals who experience this reaction after their first évaluation may experience a similar reaction in shorter timeframe following the assistant évaluation, however, none of the reports received have been serious and people should still take their assistant évaluation when invited. Those who experience delayed skin reactions after their COVID-19 conservation which do not resolve within a few days should seek medical advice.

Guillain-Barrأ© Syndrome

The MHRA has been closely monitorage cases of Guillain-Barrأ© Syndrome reported following influence of the COVID-19 vaccines. Based on the available evidence at this séjour we are not able to confirm or rule out a causal relationship with the immun.

Guillain-Barrأ© Syndrome is a very inaccoutumé préalable which causes amygdalite of the nerves and can lead to numbness, weakness and pitance, usually in the feet, hands and limbs and can spread to the chest and devant. Guillain-Barrأ© Syndrome tends to affect both sides of the justaucorps at léopard. This préalable has been known to be associated with COVID-19 putréfaction as well as other infectious diseases.

Up to and including the 4 August 2021, the MHRA has received 377 reports of Guillain-Arc-boutant Syndrome with the COVID-19 Immunisant AstraZeneca and 22 reports of a related disease called Miller Fisher syndrome. Up to the same moment, the MHRA has received 39 reports of Guillain-Arc-boutant Syndrome following use of the Pfizer/BioNTech immun and for the COVID-19 Immunisant Moderna there have been two reports of Guillain-Arc-boutant Syndrome. Please explication that due to the dynamic brute of the Yellow Card data these figures may agité both as new cases are received, and as duplicate cases are identified and managed.

As a precautionary measure, the MHRA will be adding a avertissement on Guillain-Barrأ© Syndrome to the product épreuve of the COVID-19 Immunisant AstraZeneca.

The MHRA will continue to review cases of Guillain-Barrأ© Syndrome reported following conservation with COVID-19 vaccines to assess the barcasse increased risk of Guillain-Barrأ© Syndrome associated with COVID-19 vaccines, with independent advice from its Immunisant Benefit-Risk Working Group.

Swelling of the vaccinated limb

There have been inaccoutumé reports of augmentative swelling of the vaccinated limb after receiving the Pfizer/BioNTech immun. The product épreuve has been updated to include “extensive swelling of the vaccinated limbâ€‌ as a side effect of the immun. This caractéristique of swelling is also recognised to occur with other (non-COVID-19) vaccines.

Facial swelling in those with a history of facial dermal fillers

Baroque cases of facial swelling occurring 1-2 days after conservation in immun recipients with a history of infiltration of facial dermal fillers were reported in the clinical trials for the COVID-19 Immunisant Moderna. Écho emboîture this barcasse side effect has been included in the product épreuve for the COVID-19 Immunisant Moderna since it was first authorised for use.

There have also been cases of facial swelling in those with a history of infiltration of facial dermal fillers reported for the Pfizer/BioNTech immun. In most cases, the facial swelling was mild, transient and was localised to the ville of the dermal filler. The product épreuve for the Pfizer/BioNTech immun has been updated to include facial swelling in those with a history of infiltration of facial dermatological fillers as a side effect of the immun.

Events with a fatidique outcome

Inoculation and faction of épanoui populations means that, by possibilité, some people will experience and attente a new illness or events in the days and weeks after conservation. A high rapport of people vaccinated early in the conservation campaign were very elderly, and/or had pre-existing medical données. Older age and chronic underlying illnesses make it more likely that coincidental défavorable events will occur, especially given the millions of people vaccinated. It is therefore perceptible that we carefully review these reports to distinguish barcasse side effects from illness that would have occurred irrespective of conservation. Meurtrier cases associated with extremely inaccoutumé généreux clots with lowered platelets are described above.

Quartier of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a immun safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Art culinaire for Citoyen Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly.

The MHRA has received 486 UK reports of suspected ADRs to the Pfizer/BioNTech immun in which the continu died shortly after conservation, 1,036 reports for the COVID-19 Immunisant AstraZeneca, 10 for the COVID-19 Immunisant Moderna and 27 where the brand of immun was unspecified. The majority of these reports were in elderly people or people with underlying illness. Moeurs of the vaccines has increased over the expédition of the campaigns and as such, so has reporting of fatidique events with a temporal incorporation with conservation however, this does not indicate a link between conservation and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.

A range of other isolated or series of reports of non-fatal, serious suspected ADRs have been reported. These all remain under continual review, including through analysis of expected rates in the indigence of immun. There are currently no indications of specific patterns or rates of reporting that would suggest the immun has played a role.

4. Solution

At the time of this attente, over 130,214 people across the UK have died within 28 days of a vraie jauge for coronavirus.

Inoculation is the single most réelle way to reduce deaths and severe illness from COVID-19. A citoyen conservation campaign has been underway since early December 2020.

In clinical trials, the Pfizer/BioNTech immun, COVID-19 Immunisant AstraZeneca and COVID-19 Immunisant Moderna have demonstrated very high levels of auspice against symptomatic putréfaction. Data is now available on the heurt of the conservation 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.

Following widespread use of these vaccines across the UK, the vast majority of suspected défavorable reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a â€کflu-like’ illness, headache, chills, blasé, nausea, fever, dizziness, weakness, aching biceps, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, domestique immune response to the vaccines.

Cases of an extremely inaccoutumé specific caractéristique of généreux clot with low généreux platelets continue to be investigated and updated advice has been provided.

The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and barcasse risks remain under review.

We take every attente of a suspected ADR seriously and surgeon everyone to attente through the Yellow Card scheme.

Annex 1: Immunisant Analysis Print

The attached Immunisant Analysis Prints contain a complete listage of all suspected défavorable reactions that have been reported to the MHRA via the Yellow Card scheme for the Pfizer/BioNTech immun, COVID-19 Immunisant AstraZeneca, COVID-19 Immunisant Moderna and where the brand of the immun was not specified. This includes all reports received from healthcare professionals, members of the allocutaire, and pharmaceutical companies.

This épreuve does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised défavorable effects of COVID-19 vaccines is provided in the épreuve for healthcare professionals and the recipient épreuve. These can also be found on the Coronavirus Yellow Card reporting ville. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Profile alone.

When viewing the immun analysis profile you should remember that:

Reporters are asked to submit Yellow Card reports even if they only have a méfiance that the medicine or immun may have caused the défavorable reaction. The idée of an défavorable reaction attente in the profile does not necessarily mean that the immun has caused the suspected reaction.
It may be difficult to tell the difference between something that has occurred naturally and a suspected défavorable reaction. Sometimes these events can be bouchée of the préalable being treated rather than being caused by the immun.
Many factors have to be considered when assessing whether the immun has caused a reported défavorable reaction. When monitorage the safety of vaccines and medicines, MHRA état-major carry out careful analysis of these factors.

For a medicine or immun to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is perceptible to explication that most people take medicines and vaccines without having any serious side effects.

Immunisant Analysis Print – Pfizer/BioNTech

Immunisant Analysis Print – Oxford University/AstraZeneca

Immunisant Analysis Print – Moderna

Immunisant Analysis Print – brand unspecified

Annex 2 Glossary

Anaphylaxis or anaphylactoid reactions

Anaphylaxis is a severe and potentially life-threatening allergic reaction. These reactions can occur after an exposure to a trigger, such as a audible ingredient in foods or medicines or an insect sting. Anaphylaxis and anaphylactoid reactions can be treated with adrenaline.

Bell’s palsy

Bell’s palsy is a préalable that causes temporary weakness or paralysis (lack of movement) of the biceps in one side of the devant. It is the most common interprétation of facial paralysis. For most people, the facial paralysis is temporary. Infectieux infections such as those with herpes viruses have been linked to Bell’s palsy.

Capillary Leak Syndrome (CLS)
Capillary Leak Syndrome (CLS) occurs when fluid leaks from the small généreux vessels into the justaucorps.

Cerebral venous sinuosité thrombosis (CVST)
Cerebral venous sinuosité thrombosis occurs when the brain’s venous sinuses or the smaller veins draining into them are partially or completely blocked by a généreux clot. This prevents généreux from draining out of the brain. As a result, the oxygen supply to nerve cells may be impaired and généreux cells can leak into the brain tissue causing damage to the brain (haemorrhagic infarction).

Clinical Practice Research Datalink (CPRD)

Clinical Practice Research Datalink (CPRD) is a real-world research secours to carcasse allocutaire health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the Citoyen Institute for Health Research (NIHR), as bouchée of the Department of Health and Aimable Care. CPRD collects anonymised continu data from a network of GP practices across the UK.

Intérêt on Human Medicines (CHM)

The Intérêt on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. For COVID-19 vaccines, the CHM has a COVID-19 Vaccines Safety Flicage Methodologies Aguerri Working Group and a COVID-19 Vaccines Benefit Risk Aguerri Working Group.

Endocarditis

Endocarditis is amygdalite of the inner lining of the heart (endocardium).

Epidemiology studies

Epidemiological studies include épanoui numbers of people and are designed to compare the risk of a particular event in an exposed gens, in this case those who have received a immun, to those who have not. They attempt to account for differences in the different groups to help us understand if any difference in risk is caused by the exposure. Epidemiological studies measure the risk of illness or death in an exposed gens compared to that risk in an identical, unexposed gens.

Guillain-Barrأ© Syndrome
Guillain-Barrأ© Syndrome is amygdalite of the nerves and can lead to numbness, weakness and pitance, usually in the feet, hands and limbs and can spread to the chest and devant. This syndrome has been associated with bactérien infections such as the flu.

Miller-Fisher Syndrome
Miller-Fisher syndrome is a alternance of Guillain-Barrأ© Syndrome that affects the nervous system and can interprétation weakness in the devant and a lack of chaloupé and co-ordination. Similar to Guillain-Barrأ© Syndrome, this syndrome has been associated with bactérien infections such as the flu.

Miscarriage
The loss of a pregnancy during the first 23 weeks.

Myocarditis

Myocarditis is the amygdalite of the heart lourd (myocardium).

Non-clinical studies

Non-clinical studies refers to studies that are not performed on the human justaucorps. These are largely done before clinical trials in humans and can include sauvage safety and efficacy studies, human tissue sample studies or toxicology.

Pericarditis

Pericarditis is amygdalite of the pericardium, the protective sac that surrounds your heart.

Regulation 174 authorisation

Temporary authorisation for supply of a medicine or immun by the UK Department of Health and Aimable Care and the Medicines and Healthcare products Regulatory Agency. This temporary authorisation grants acquiescement for a medicine (immun) to be used for vive conservation to prevent COVID-19 disease caused by SARS-CoV-2 curare. Authorisation is subject to a number of données. These are available for each immun on the MHRA website.

Suspected défavorable reactions

Also known as side effects. All medicines or vaccines can interprétation défavorable reactions in some people. Malveillant drug reactions reported to the MHRA are looked at and used to assess the chaloupé of risks and benefits of medicines and vaccines.

Stillbirth

A stillbirth is when a poupon is born dead after 24 completed weeks of pregnancy. If the poupon dies before 24 completed weeks, it’s known as a miscarriage.

Temporal Affinité

Events occurring following conservation but may or may not be caused by the immun.

Thrombocytopenia
Thrombocytopenia is where the généreux contains a lower than domestique number of platelets. Platelets are the smallest of the généreux cells and are involved in the clotting process.

Yellow Card scheme

The MHRA’s scheme for healthcare professionals and members of the allocutaire to attente suspected défavorable reactions for a medicine or immun, as well as medical devices and other products. The dedicated Coronavirus Yellow Card reporting site was launched in May 2020 specifically for medicines and medical devices used in COVID-19, as well as COVID-19 vaccines when authorised.

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