Under 30s in the UK should be offered an alternative to Oxford-AstraZeneca vaccine
The benefits of vaccination continue to outweigh any risks but the MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition.
- The MHRA is not recommending age restrictions in COVID-19 Vaccine AstraZeneca vaccine use.
- The MHRA’s scientific review of UK reports of extremely rare and unlikely to occur specific blood clots with lowered platelets has concluded that the evidence of a link with COVID-19 Vaccine AstraZeneca is stronger but more work is still needed.
- By 31 March 20.2 million doses of the COVID-19 Vaccine AstraZeneca had been given in the UK meaning the overall risk of these blood clots is approximately 4 people in a million who receive the vaccine.
- Anyone who did not have these side effects should come forward for their second dose when invited.
- The data suggest there is a slightly higher incidence reported in the younger adult age groups and the MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine.
- The MHRA is now issuing updated guidance for healthcare professionals on how to minimise risks, as well as further advice on symptoms for vaccine recipients to look out for 4 or more days after vaccination.
- Vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. Everyone should continue to get their vaccination when asked to do so unless specifically advised otherwise.
The Joint Committee on Vaccination and Immunisation (JCVI) have also published a statement (see below) following reports of an extremely rare adverse event after vaccination with the first dose of the AstraZeneca COVID-19 vaccine.
This includes information on the use of the vaccine in those under 30.
Updated information is being provided for people and healthcare professionals on the possible risk of extremely rare and unlikely to occur specific types of blood clots following vaccination with the COVID-19 Vaccine AstraZeneca, the Medicines and Healthcare products Regulatory Agency (MHRA) said today.
The MHRA has undertaken a thorough review into UK reports of a very rare and unlikely to occur specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination with the COVID-19 Vaccine AstraZeneca. It is also considering other blood clotting cases (thromboembolic events) alongside low platelet levels.
These reports have been analysed by the Government’s independent advisory body, the Commission on Human Medicines (CHM) and its COVID-19 Vaccines Benefit Risk Expert Working Group, which includes lay representatives and advice from leading haematologists.
Up to and including 31 March 2021, the MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca:
- 44 of the 79 cases were of CVST with thrombocytopenia
- 35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia
- 79 cases occurred in 51 women and 28 men, aged from 18 to 79 years. It should be noted that more women have been vaccinated with COVID-19 Vaccine AstraZeneca than men.
- Sadly, 19 people have died out of the 79 cases – 13 females and 6 males. 11 out of the 19 people who died were under the age of 50, 3 of whom were under 30. 14 of these 19 cases were of CVST with thrombocytopenia and 5 were of thrombosis with thrombocytopenia.
- All 79 cases occurred after a first dose of the vaccine.
This risk, based on reports up to and including 31 March, is slightly higher than the risk calculated from the reports published up to and including 24 March. However, likelihood of these blood clots occurring is still extremely rare.
As a precaution, administration of COVID-19 Vaccine AstraZeneca in people of any age who are at higher risk of blood clots because of their medical condition should be considered only if benefits from the protection from COVID-19 infection outweighs potential risks.
Anyone who experienced cerebral or other major blood clots occurring with low levels of platelets after their first vaccine dose of COVID-19 Vaccine AstraZeneca should not have their second dose. Anyone who did not have these side effects should come forward for their second dose when invited.
Pregnancy predisposes to thrombosis, therefore women should discuss with their healthcare professional whether the benefits of having the vaccine outweigh the risks for them.
The MHRA recently confirmed that the evidence to date does not suggest that the COVID-19 Vaccine AstraZeneca causes venous thromboembolism without a low platelet count.
It is important to note that this type of blood clot together with lowered platelets can rarely occur naturally in unvaccinated people as well as in people with COVID-19 disease.
While the MHRA continues to investigate these cases, as a precautionary measure, anyone who has symptoms four days or more after vaccination is advised to seek prompt medical advice, such as:
- a new onset of severe or persistent headache, blurred vision, confusion or seizures
- develop shortness of breath, chest pain, leg swelling or persistent abdominal pain,
- unusual skin bruising or pinpoint round spots beyond the injection site
Dr June Raine, MHRA Chief Executive, said: “Over 37 million doses of vaccines against COVID-19 have now been administered in the UK, saving thousands of lives through the biggest vaccination programme that has ever taken place in the UK.
“No effective medicine or vaccine is without risk. We continually monitor safety during widespread use of any vaccine. This is to ensure vaccines are performing as expected, to identify any new side effects that may arise, and to ensure the benefits continue to outweigh the risks.
“The public’s safety is always at the forefront of our minds and we take every report of a suspected side effect very seriously indeed. We thoroughly analyse each and every report as we receive it and although the number of reports of CVST and other thromboembolic events has increased over the last week, so has the overall number of vaccinations administered, therefore these blood clots remain extremely rare and unlikely to occur.
“We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.
“It is still vitally important that people come forward for their vaccination when invited to do so.”
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “The independent Commission on Human Medicines (CHM) and its COVID-19 Expert Working Group, together with leading haematologists, has conducted a rigorous scientific analysis of all available evidence regarding reports of thromboembolic events occurring together with low platelets and COVID-19 Vaccine AstraZeneca and usage of the vaccine in different age groups.
“We have a rich source of data – the best data there is – and the MHRA and CHM will continue to keep this under close observation. The public deserve nothing less.”
JCVI statement on use of the AstraZeneca COVID-19 vaccine: 7 April 2021
Since the start of the pandemic over 4 million COVID-19 infections have been confirmed in the UK causing more than 120,000 deaths. Over 30 million people have received their first dose of COVID-19 vaccine since the start of the programme, which Public Health England (PHE) estimate has prevented at least 6,000 deaths in the first 3 months of 2021. Analysis of infection data since the introduction of the COVID-19 vaccines in the UK demonstrates that vaccination is highly effective and substantially reduces the risk of infection and severe COVID-19 disease.
There have been reports of an extremely rare adverse event of concurrent thrombosis (blood clots) and thrombocytopenia (low platelet count) following vaccination with the first dose of AstraZeneca ChAdOx1 nCoV-19 vaccine (AZD1222).
There has been no signal for thrombosis/thrombocytopenia following receipt of other COVID-19 vaccines approved for use in the UK (Pfizer-BioNTech and Moderna).
Given the very low numbers of events reported overall, there is currently a high level of uncertainty in estimates of the incidence of this extremely rare adverse event by age group.
However, the available data do suggest there may be a trend for increasing incidence of this adverse event with decreasing age, with a slightly higher incidence reported in the younger adult age groups.
In contrast, the risks of severe disease associated with COVID-19 increases steeply with age, with the youngest adults at lowest risk.
There are currently no known risk factors for this extremely rare condition, which appears to be an idiosyncratic reaction on first exposure to the AstraZeneca COVID-19 vaccine.
Alternatives to the AstraZeneca COVID-19 vaccine currently approved for use in the UK include the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 vaccines.
JCVI has weighed the relative balance of benefits and risks and advise that the benefits of prompt vaccination with the AstraZeneca COVID-19 vaccine far outweigh the risk of adverse events for individuals 30 years of age and over and those who have underlying health conditions which put them at higher risk of severe COVID-19 disease.
JCVI currently advises that it is preferable for adults aged <30 years without underlying health conditions that put them at higher risk of severe COVID-19 disease, to be offered an alternative COVID-19 vaccine, if available.
People may make an informed choice to receive the AstraZeneca COVID-19 vaccine to receive earlier protection.
There are some adults <30 without underlying health conditions who are in phase 1, who were prioritised due to an increased risk of exposure and/or to reduce the risk of passing the infection on to vulnerable individuals.
This includes health and social care workers, unpaid carers and household contacts of immunosuppressed individuals. Acting on a precautionary basis, if these persons are still unvaccinated, it is preferable for them to be offered an alternative COVID-19 vaccine, if available.
JCVI is currently finalising its advice on phase 2 of the programme, particularly for healthy people under 30 years of age, and this will be published in due course.
To date, there are no reports of the extremely rare thrombosis/thrombocytopenia events following receipt of the second dose of the AstraZeneca COVID-19 vaccine. All those who have received a first dose of the AstraZeneca COVID-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age. The second dose will be important for longer lasting protection against COVID-19.
JCVI advises that all individuals offered a COVID-19 vaccine should be fully informed about the benefits and risks of vaccination. This should include clear information on the extremely rare thrombosis/thrombocytopenia adverse event, how to monitor for symptoms that might be related to the adverse event, and what action should be taken by individuals and health professionals in the event of such symptoms arising.
PHE is preparing updated information for those being offered COVID-19 vaccines, and for health professionals, which will be available through the GOV.UK website.
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