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Coronavirus vaccine report by MHRA: period December 2020 to June 2021


At the time of this report, over 127,892 people across the UK have died within 28 days of a positive test for coronavirus ( COVID-19 ).

All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.

The report covers the period 9 December 2020 to 9 June 2021.

Anaphylaxis ( severe allergic reactions )

The MHRA [ Medicines and Healthcare products Regulatory Agency ] continues to monitor reports of serious allergic reactions with the Pfizer / BioNTech vaccine and has received 376 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions.
The nature and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer / BioNTech vaccine remain very rare.
The MHRA’s guidance remains that those with a previous history of allergic reactions to the ingredients of the vaccine should not receive it.

The MHRA is closely monitoring reports of anaphylaxis with the COVID-19 Vaccine Moderna and has received 12 reports of anaphylaxis in association with the vaccine.
Anaphylaxis is a potential side effect of the vaccine, and it is recommended that those with known hypersensitivity to the ingredients of the vaccine should not receive it.

The MHRA also closely monitors reports of anaphylaxis or anaphylactoid reactions with the COVID-19 Vaccine AstraZeneca, and has received 740 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions reported and is very rare.

Bell’s palsy

The MHRA continues to review cases reporting Bell’s palsy and to analyse case reports against the number expected to occur by chance in the absence of vaccination ( natural rate ).
The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines.

Thrombo-embolic events with concurrent low platelets

Up to 9 June 2021, the MHRA had received Yellow Card reports of 390 cases of major thromboembolic events ( blood clots ) with concurrent thrombocytopenia ( low platelet counts ) in the UK following vaccination with COVID-19 Vaccine AstraZeneca.
Twenty seven of these events have been reported after a second dose.
Of the 390 reports, 207 occurred in women, and 180 occurred in men aged from 18 to 93 years.
The overall case fatality rate was 18% with 71 deaths, 4 of which occurred after the second dose.
Cerebral venous sinus thrombosis was reported in 140 cases ( average age 46 years ) and 250 had other major thromboembolic events ( average age 54 years ) with concurrent thrombocytopenia.

The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 9 June was 24.6 million and the estimated number of second doses was 17.7 million.
The overall incidence after first or unknown doses was 14.8 per million doses.
Taking into account the different numbers of patients vaccinated with COVID-19 Vaccine AstraZeneca in different age groups, the data shows that there is a higher reported incidence rate in the younger adult age groups following the first dose compared to the older groups ( 20.2 per million doses in those aged 18-49 years compared to 10.7 per million doses in those aged 50 years and over ).
The MHRA advises that this evidence should be taken into account when considering the use of the vaccine.

There is now some evidence that the reported incidence rate is higher in females compared to men although this is not seen across all age groups and the difference remains small.
The overall incidence after second doses was 1.5 per million doses.
Taking into account the different numbers of patients vaccinated with COVID-19 Vaccine AstraZeneca in different age groups, the data have shown that there is a lower reported incidence rate in younger adult age groups following the second dose compared to the older groups ( 0.7 per million doses in those aged 18-49 years compared to 1.5 per million doses in those aged 50 years and over ). The number of second doses given to those in the 18-49 years age group is estimated to be 4 million while an estimated 13.7 million second doses have been given to patients aged 50+ years.
These rates should not be directly compared to the incidence rates reported after the first dose as the time for follow-up and identification of cases after second doses is more limited and differs across age groups.
However, the data are reassuring at this stage and suggest that the reported incidence rate following a second dose is smaller than that seen following a first dose.

Capillary leak syndrome

The MHRA has received 8 reports of capillary leak syndrome ( a condition where fluid leaks from the small blood vessels into the body ) in the context of more than 40 million doses of COVID-19 Vaccine AstraZeneca given.
Of these reports, 2 people had a history of capillary leak syndrome.
This is an extremely rare relapsing-remitting condition and triggers for relapses are not well understood.
As a precautionary measure, the MHRA is advising that COVID-19 vaccine AstraZeneca is not used in people who have previously experienced episodes of capillary leak syndrome.

Menstrual disorders and unexpected vaginal bleeding

The MHRA is closely monitoring reports of menstrual disorders and unexpected vaginal bleeding following vaccination against COVID-19 in the UK.
The current evidence does not suggest an increased risk of either menstrual disorders or unexpected vaginal bleeding following the vaccines.

A range 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.
The number of reports of menstrual disorders and vaginal bleeding is low in relation to both the number of females who have received COVID-19 vaccines to date and how common menstrual disorders are generally.

Myocarditis and pericarditis

The MHRA is closely monitoring cases of myocarditis and pericarditis received with the COVID-19 vaccines.
MHRA has received 39 reports of myocarditis and 27 reports of pericarditis following use of the Pfizer / BioNTech vaccine, as well as one report each of viral pericarditis and Streptococcal endocarditis up to and including 2 June 2021.

For the COVID-19 Vaccine AstraZeneca there have been 34 reports of myocarditis and 61 reports of pericarditis following vaccination up to and including 9 June 2021.

There has been two reports of myocarditis and no reports of pericarditis following use of COVID-19 Vaccine Moderna up to the same date.

These cases have been analysed against the number of cases expected to occur by chance in the absence of vaccination ( background / natural rate ).
The number of cases of myo carditis and pericarditis reported with the vaccines in the UK remains similar or below the expected background rate in different age groups within the general population and does not currently indicate an increased risk following vaccination against COVID-19.

Events with a fatal outcome

The MHRA has received 421 UK reports of suspected ADRs to the Pfizer / BioNTech vaccine in which the patient died shortly after vaccination, 885 reports for the COVID-19 Vaccine AstraZeneca, 4 for the COVID-19 Vaccine Moderna and 22 where the brand of vaccine was unspecified.
The majority of these reports were in elderly people or people with underlying illness.

Usage of the COVID-19 Vaccine AstraZeneca has increased rapidly and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported.
Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death. ( Xagena )

Source: MHRA, 2021

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