Blood clotting following COVID-19 vaccination Information for Health Professionals - Public Health ...

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Blood clotting following COVID-19 vaccination
 Information for Health Professionals
As with all COVID-19 programme resources, this publication is subject to extensive and
regular revisions and we recommend linking to the latest version to ensure that you are
giving the most up-to-date clinical advice and guidance.

1. What is the condition that has                     treatment of suspected cases has been published
been reported following COVID-19                      by the Expert Haematology Panel of the British
                                                      Society of Haematology and is available here.
vaccination?
Since March 2021 there have been reports from         2. What are the risk factors for
the UK and internationally of an extremely rare       developing this condition?
condition characterised by thromboembolic
                                                      This condition is known to occur naturally although
events (blood clots) accompanied by
                                                      the underlying risk factors have not yet been fully
thrombocytopenia (low platelets) following the
                                                      established. A detailed review of suspected cases
first dose of the AstraZeneca (AZ) COVID-19
                                                      of this condition following COVID vaccination is
vaccination. This includes cerebral venous sinus
                                                      ongoing by the MHRA, supported by PHE and
thromboses (CVST) where blood clots develop
                                                      other professional groups. This will help us to
in the cerebral veins occurring together with low
                                                      understand the risk factors for developing this
platelet counts. These cases are particularly
                                                      condition. The data reported in the MHRA weekly
unusual because despite low platelets, there is
                                                      report up to the 28 April 2021 estimates an overall
progressive thrombosis (formation of blood clots
                                                      incidence of around 10.5 per million first doses
which block blood vessels).
                                                      of the AZ vaccine administered in the UK. These
The cases of venous thromboses that have been         data are regularly updated based on the reports
reported include CVST and portal vein thrombosis,     received through the Yellow Card reporting
as well as the more usual presentations of deep       scheme. For the latest information please see the
vein thrombosis and pulmonary embolism.               weekly summary from the MHRA. Although cases
Whilst the cases reported to date have primarily      have been reported in all ages and genders, there
been venous clots, arterial clots have also been      appears to be a trend for increasing incidence with
reported. Up to 28 April, 242 suspected cases         decreasing age amongst adults, with the highest
have been reported across the UK through the          incidence reported in the younger adult age groups.
MHRA Yellow Card scheme following the first dose
to date, and only a small number of cases have        3. Is this condition only associated
occurred after the second dose of AZ vaccine.         with the AZ vaccine?
For the latest information please see the weekly
                                                      All suspected cases following vaccination with any
summary from the MHRA.
                                                      of the COVID-19 vaccines being used in the UK are
Typical laboratory features include a low platelet    undergoing a detailed review by the MHRA.
count, very raised D Dimer levels – above the         Up to 28 April 2021, the MHRA received 242
level expected for venous thromboembolism (VTE)       reports of thrombosis events with low platelets of
and inappropriately low fibrinogen. Antibodies        which 93 were cerebral venous sinus thrombosis
to platelet factor 4 (PF4) have been identified       (CVST), out of a total of 22.6 million first doses of
and so this has similarities to heparin-induced       COVID-19 AZ vaccine given by that date in the UK.
thrombocytopenia (HIT), but it is occurring without   For the latest information please see the weekly
the patient receiving any heparin treatment.          summary from the MHRA.
Further information on the investigation and
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

There has also been a small number of reports of a         from the 242 events reviewed with an estimated
similar syndrome following receipt of the Johnson          overall case fatality rate of 20%. This compares
& Johnson/Janssen COVID-19 vaccine (also                   with the clear demonstrable benefits from the
an adenovirus vector vaccine, although using a             COVID vaccination programme. For the latest
different vector) in the USA. Following a detailed         information please see the weekly summary from
investigation and temporary pause in the use of the        the MHRA. Since 4 January to 28 April 2021 22.6
vaccine in the USA, the CDC and FDA announced              million first doses and 5.9 million second doses of
the resumption of the use of the vaccine for all           the AZ vaccine have been administered across
age groups on 23 April 2021. This vaccine is not           the UK. It has been estimated that the vaccine
currently approved for use in the UK. There is             programme has prevented 10,400 deaths in adults
currently no evidence to suggest these rare events         aged 60 years and older up to the end of March
occur following administration of either the Pfizer/       with a vaccine effectiveness of a single dose
BioNTech or Moderna vaccines which are available           against hospitalisation estimated at 80% for both
in the UK.                                                 the Pfizer/BioNTech and the AZ vaccines.
Although these extremely rare events have been
associated with the AZ vaccine and Johnson &               6. What is the UK’s current advice on
Johnson/Janssen vaccines, further investigations           the use of the AZ vaccine?
are underway to understand the biological                  Based on a review of cases reported to the Yellow
mechanisms and whether the association is                  Card Scheme and the evidence of effectiveness
related to the vaccine platform (the way in which          of the COVID vaccines used in the UK to prevent
the vaccine delivers antigen) or some other                serious complications and deaths from COVID-19
immunological mechanism.                                   infection, the current MHRA advice remains that
                                                           the overall benefits of the use of the AZ vaccine
4. How many people have developed                          in the UK vaccine programme outweighs the
the condition?                                             extremely rare adverse events reported to date.
This condition is known to occur naturally and is          The Joint Committee on Vaccination and
thought to be extremely rare. The background               Immunisation (JCVI) has carefully assessed the
rate of cerebral venous sinus thromboses (CVSTs)           overall risk benefit of the use of the AZ vaccine in
is estimated to be around 5 to 16 per million              the UK population and continues to keep this under
annually, although there is currently limited data         active review. After considering the relative balance
on the background rate of CVSTs occurring with             of benefits (in terms of deaths, ICU and hospital
thrombocytopenia.                                          admissions averted estimated by Public Health
Based on reports to 28 April 2021, the overall             England) and risks (based on data presented by
incidence following the AZ vaccine is around 10.5          the MHRA on reported adverse events through the
per million first doses administered. For the latest       Yellow Card Scheme), on 7 April 2021, JCVI advised
information please see the weekly summary from             that, for adults aged
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

For example, the risk of dying in an individual              suffering this rare side effect, should continue
aged 40-49 years is 3 times higher than someone              to be offered the second dose to complete
aged 30-39 years and 12 times higher than                    the course (see the Green Book for further
someone aged 20-29 years.                                    information).
JCVI have continued to review the available data             The AZ vaccine should also continue to be offered
on the current epidemiology, benefit-risk profile            to those in the priority groups (which includes
by age, modelling predictions on future disease              older adults, those with underlying conditions,
trends and the current forecast on vaccine supply.           health and social care workers over 40 years
Given the risk (albeit extremely rare) of these              old) who have not yet been offered the vaccine.
adverse events associated with the AZ vaccine,               Those who have received their first dose of AZ
the current control of COVID-19 in the UK, model             vaccine without suffering this rare side effect,
predictions of the potential scale and timing of             should continue to be offered the second dose
a future wave, and promising forecasts for the               to complete the course. This includes individuals
availability of vaccines in the UK, JCVI has issued          aged 18 to 39 years who have received their first
updated advice on 7 May 2021.                                dose of AZ vaccine in the initial priority groups,
• in addition to those aged under 30, unvaccinated           which includes those who are health and social
  adults aged 30–39 years who are not in a clinical          care workers, unpaid carers and family members
  priority group at higher risk of severe COVID-19           of those who are immunosuppressed.
  disease, should be preferentially offered an               Due to its storage and transport requirements,
  alternative to the AZ vaccine, where possible              the AZ vaccine is much more easily delivered
  and only where no substantial delay or barrier in          in some settings, and in these settings may be
  access to vaccination would arise.                         the only vaccine it is practical to offer. In such
                                                             circumstances JCVI advises that the benefits of
• for those within this age group who are of older
                                                             receiving the AZ vaccine outweigh the risks, and
  age, male, obese (BMI >30), from certain ethnic
                                                             individuals in this event should be offered the AZ
  minority backgrounds or experiencing socio-
                                                             vaccine.
  economic deprivation, the risks of acquiring
  and/ or suffering complications of COVID-19 are            JCVI considers that there continues to be no
  higher. Every effort should be made to remove              safety concerns for this extremely rare adverse
  barriers to accessing vaccination in those                 event following receipt of a second dose of AZ
  individuals. These individuals can choose to               vaccine. All those who have received a first dose
  have the AZ vaccine if they have been provided             of the AZ vaccine should continue to be offered a
  with information on the risks and benefits of the          second dose of AZ vaccine, irrespective of age.
  vaccine.                                                   The second dose will be important for longer
                                                             lasting protection against COVID-19.
• for those aged 18-29 years the precautionary
  advice for a vaccine preference is stronger,               7. Can COVID-19 infection cause the
  reflecting a gradient in the benefit-risk balance
                                                             same problem?
  with age.
                                                             Thrombotic events are known to occur in
This new advice is specific to the current UK                individuals with natural COVID-19 infection
context and is based on all of the following                 and more than a fifth of hospitalised patients
remaining favourable: the current low incidence              with COVID-19 have evidence of blood clots.
of disease, the availability of alternatives to the AZ       A preprint of a study based on analysis of US
vaccine, and the strength of the whole vaccine               data showed that CVST was a complication of
programme in terms of maintaining speed and                  COVID-19 infection, with a higher incidence (42.8
uptake. Should there be a deterioration in any of            per million) compared to a matched cohort of
the above factors, JCVI advises that vaccination             patients with influenza (RR=3.83, 95% CI 1.56–
of adults aged 30-39 years with any of the UK                9.41, P
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

10.5 per million first doses administered. For the       important to ensure all health professionals are
latest information please see the weekly summary         alert to relevant symptoms which require further
from the MHRA.                                           clinical review and investigation. Advise patients
                                                         to seek urgent medical advice if they experience
8. Has this condition been reported                      any of the following symptoms more than 4 days
after both the 1st and 2nd dose of                       and within 28 days of coronavirus vaccination:
COVID-19 vaccine?                                        • new onset of severe headache, which is
As of 28 April 2021, of the 242 suspected cases            getting worse and does not respond to simple
reported to the MHRA following the AZ vaccine,             painkillers
only a very small number of cases have been              • an unusual headache which seems worse
reported after the second dose. The JCVI                   when lying down or bending over, or may be
concluded that there continues to be no safety             accompanied by blurred vision, nausea and
concerns following the second dose of vaccine.             vomiting, difficulty with speech, weakness,
Whilst currently there is no evidence to suggest           drowsiness or seizures
whether these rare events are dose specific it is
important to note that most vaccines in the UK           • new unexplained pinprick bruising or bleeding
COVID-19 programme have been administered as             • shortness of breath, chest pain, leg swelling or
first doses.                                               persistent abdominal pain
The JCVI advises that those who have received            If you have clinical concern, patients should be
their first dose of AZ vaccine should continue to        urgently referred to hospital and to appropriate
be offered the second dose unless they have              specialist services for further assessment,
developed this specific syndrome of thrombosis           particularly if the symptoms are unexplained and
and thrombocytopenia following the first dose or         present in combination with thrombocytopaenia.
have had an anaphylactic reaction. The Green             Further guidance for secondary care are available
Book has further information on contraindications        here with specific guidance produced for
to COVID-19 vaccines.                                    Emergency Departments and Acute Medical Units
                                                         and primary care.
9. Is it affecting both men and women?
                                                         Mild flu-like symptoms, including headache, chills
Suspected cases have been reported in patients
                                                         and fever remain one of the most common side
of all ages in men and women. Whilst reports from
                                                         effects of any COVID-19 vaccine. These generally
some countries have suggested a substantially
                                                         appear within a few hours and resolve within a day
higher number of cases amongst females, based
                                                         or two.
on the events reported to the MHRA in the UK,
such a distinctive gender difference has not             12. What should I do if I suspect a case?
been observed. Although, the reported incidence
rate is higher in females compared to males,             If a patient presents with symptoms suggestive
this is not seen across all age groups and the           of a blood clot in this time period please take the
difference remains small.                                following actions:
It is worth noting that more females have been           Immediately refer patients to their local Emergency
vaccinated which may partly explain the slight           Department to have a Full Blood Count and further
excess of cases reported amongst females.                investigations carried out.
                                                         Report this case via the MHRA Yellow Card System
10. Is it affecting any particular                       (https://coronavirus-yellowcard.mhra.gov.uk).
community?                                               At Emergency Departments, the standard Royal
Suspected cases have been reported in patients           College of Emergency Medicine pathway should
of all ages and genders and currently, no specific       be followed and supportive guidance is available
predisposing factors have been identified. There         through local haematology teams for cases
appears to be a trend of increasing incidence            with confirmed thrombocytopenia
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

review and investigation, PHE has established               contraindicated). The same consideration applies
an electronic clinical reporting scheme collecting          to those who experience common clotting
patient identifiable information on all suspected           episodes, without concomitant thrombocytopaenia,
cases.                                                      after the first dose of AZ vaccine.
All health professionals are also                           The Expert Haematology Panel advise that
encouraged to report any suspected case at                  there is no evidence that individuals with a
https://snapsurvey.phe.org.uk/                              prior history of thrombosis or known risk factors
snapwebhost/s.asp?k=161706705032 with details               for thrombosis are more at risk of developing
of the clinical presentation, dates of vaccination,         the immune complication reported after the
vaccine product received and any underlying                 AZ vaccine. Furthermore, for the majority of
conditions.                                                 individuals, the risk of recurrent thrombosis due
                                                            to COVID-19 infection is far greater than the risk
13. How should I report suspected cases?                    of this syndrome.
It is very important that all suspected cases are
reported to both the MHRA on the COVID-19                   15. Should we still give people their
Yellow Card scheme and to PHE’s clinical                    second dose?
reporting scheme at https://snapsurvey.phe.org.             Yes, because of the high risk of complications and
uk/snapwebhost/s.asp?k=161706705032.                        death from COVID, the MHRA, the World Health
The PHE clinical reporting scheme collects patient          Organization and the European Medicines
identifiable information with details of the clinical       Agency have concluded that the balance is very
presentation, dates of vaccination, vaccine                 much in favour of vaccination. There are currently
product received and any underlying conditions.             no safety concerns following receipt of the second
In order to minimise burden on reporters, for               dose of vaccine. There are no known risk factors
cases reported on the PHE clinical reporting                for this extremely rare condition, which appears
scheme first, the last page of the survey allows all        to be an idiosyncratic reaction on first exposure
the inputted answers to be copied, and relevant             to the AZ vaccine. The JCVI advises that those
information can then be directly pasted into the            who have received their first dose of AZ vaccine
COVID-19 Yellow Card form.                                  without suffering this rare side-effect they should
                                                            continue to be offered the second dose to complete
14. Are there any contraindications or                      the course.
cautions to receiving the AZ vaccine?
The contraindications to vaccination with the AZ            16. Can my patient receive the AZ
vaccine include individuals who have a history              vaccine if they have previously had a
of heparin induced thrombocytopaenia and                    blood clot?
thrombosis (HITT or HIT type 2). These individuals          Importantly, a history of thromboses on its own
may be offered vaccination with an alternative              is not a contraindication to the vaccine and
COVID-19 vaccine. A history of thromboses on                individuals should be reassured that they can still
its own is not a contraindication to the vaccine.           receive the AZ vaccine when offered.
Individuals who experience thrombosis with                  The contraindications to vaccination with the
thrombocytopenia following the first dose of                AZ vaccine include individuals who have a
the AZ vaccine should be properly assessed                  history of heparin induced thrombocytopaenia
and if they are considered to have the reported             and thrombosis (HITT or HIT type 2). These
condition, vaccination should be delayed until              individuals may be offered vaccination with an
their clotting has completely stabilised and they           alternative COVID-19 vaccine. Individuals who
should be considered for a second dose of an                experience thrombosis with thrombocytopenia
alternative COVID-19 vaccine. The Green Book                following the first dose of the AZ vaccine
has further information on contraindications and            should be properly assessed and if they are
cautions to receiving the AZ vaccine.                       considered to have the reported condition,
Individuals aged 40 years or older with past                vaccination should be delayed until their clotting
clotting episodes and those diagnosed with                  has completely stabilised and they should be
thrombophilia, whether or not they are on long              considered for a second dose of an alternative
term anti-coagulation, remain at risk of COVID-19           COVID-19 vaccine. The Green Book has further
disease and should be vaccinated with any of the            information on contraindications and cautions to
available vaccines (provided they are not otherwise         receiving the AZ vaccine.

                                                        5
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

Individuals over 40 years or older with past clotting       until their clotting has completely stabilised and
episodes and those diagnosed with thrombophilia,            they should be considered for a second dose of
whether or not they are on long term anti-                  an alternative COVID-19 vaccine. The Green Book
coagulation, remain at risk of COVID-19 disease             has further information on contraindications and
and should be vaccinated with any of the available          cautions to receiving the AZ vaccine. Individuals
vaccines (provided they are not otherwise                   with bleeding disorders can still be vaccinated and
contraindicated). The same consideration applies            further information is available in the Green Book.
to those who experience common clotting
episodes, without concomitant thrombocytopaenia,            18. What if someone has had a cerebral
after the first dose of AZ vaccine.                         or major blood clot with low levels of
The Expert Haematology Panel advise that                    platelets following the first dose of AZ
there is no evidence that individuals with a                vaccine?
prior history of thrombosis or known risk factors           Individuals who experience thrombosis with
for thrombosis are more at risk of developing               thrombocytopenia following the first dose of the AZ
the immune complication reported after the                  vaccine should be properly assessed and if they
AZ vaccine. Furthermore, for the majority of                are considered to have the reported condition,
individuals, the risk of recurrent thrombosis due           vaccination should be delayed until their clotting
to COVID-19 infection is far greater than the risk          has completely stabilised and they should be
of this syndrome.                                           considered for a second dose of an alternative
If a patient has a history of, for example, a deep          COVID-19 vaccine (see the Green Book).
venous thrombosis (DVT) or pulmonary embolus
(PE) without concurrent thrombocytopenia, then              19. Can my patient still have a second
they can receive the AZ vaccine. Likewise, if they          dose of AZ vaccine if they had a blood
have had an arterial thrombosis e.g. myocardial             clot after the first dose?
infarction without thrombocytopenia then they               Importantly, a history of thromboses on its own
can receive the AZ vaccine.                                 (without thrombocytopaenia) following the first
Many patients who have had a history of blood               dose of AZ vaccine is not a contraindication
clots may be concerned as to whether they also              to receiving their second dose and individuals
had low platelets at the same time. This is likely to       should be reassured that they can still receive the
have been communicated at the time of diagnosis             AZ vaccine when offered.
of the blood clot and be recorded in the patient’s          The contraindications to vaccination with the AZ
medical records. In the absence of this being               vaccine include individuals who have a history
recorded in the patient’s medical records, such             of heparin induced thrombocytopaenia and
individuals can be offered the AZ vaccine.                  thrombosis (HITT or HIT type 2). These individuals
A revision to the COVID-19 Green book chapter               may be offered vaccination with an alternative
is available with updated information on cautions           COVID-19 vaccine.
and contraindications for the AZ vaccine.                   A history of thromboses on its own is not a
                                                            contraindication to the vaccine. Individuals who
17. Can my patient receive the AZ
                                                            experience thrombosis with thrombocytopenia
vaccine if they have been or are                            following the first dose of the AZ vaccine should
currently thrombocytopenic?                                 be properly assessed and if they are considered
Thrombocytopaenia on its own is not a                       to have the reported condition, vaccination should
contraindication to receiving the AZ vaccine.               be delayed until their clotting has completely
The contraindications to vaccination with the AZ            stabilised and they should be considered for a
vaccine include individuals who have a history              second dose of an alternative COVID-19 vaccine.
of heparin induced thrombocytopaenia and                    The Green book has further information on
thrombosis (HITT or HIT type 2). These individuals          contraindications and cautions to receiving the AZ
may be offered vaccination with an alternative              vaccine.
COVID-19 vaccine. Individuals who experience                The Expert Haematology Panel advise that there
thrombosis with thrombocytopenia following the              is no evidence that individuals with a prior history
first dose of the AZ vaccine should be properly             of thrombosis or known risk factors for thrombosis
assessed and if they are considered to have the             are more at risk of developing the immune
reported condition, vaccination should be delayed           complication reported after the AZ vaccine.

                                                        6
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

Furthermore, for the majority of individuals, the risk       21. Will taking aspirin before vaccination
of recurrent thrombosis due to COVID-19 infection            with the AZ vaccine reduce the clotting
is far greater than the risk of this syndrome.
                                                             risk for my patients’?
Individuals who experience a clotting episode
WITH concomitant thrombocytopenia following                  It is NOT recommended to take aspirin before
the first dose of AZ vaccine should be properly              vaccination with AZ, unless this is already part of
assessed; if they are considered to have the                 your patient’s regular medications.
reported condition, further vaccination should               Investigations are underway to understand the
be deferred until their clotting has completely              biological mechanisms behind this extremely
stabilised and should then be boosted with an                rare condition of thromboembolic events with
alternative product.                                         thrombocytopenia and whether the association
In the UK about 1 in 1,000 people are affected               is related to the vaccine platform (the way in
by venous thrombosis each year. This compares                which the vaccine delivers antigen) or some other
with reports up to 28 April to the MHRA of 242               immunological mechanism. Whilst aspirin may be
thrombosis events with low platelets out of a total          used to reduce clotting risk in other conditions, it
of 22.6 million first doses of AZ vaccine given by           is not currently thought to have the same effect in
that date.                                                   this condition and may in fact worsen the outcome
                                                             by increasing the risk of bleeding. Therefore no
Therefore, by chance a lot of people will have               one should self-medicate with aspirin to cover the
blood clots after vaccination which are not due to           period around and after the vaccination.
this syndrome.
                                                             22. How can I communicate the
20. What if somebody under 40 years
                                                             potential benefits and risks of the AZ
has had AZ for their first dose – should
                                                             vaccine to my patients?
they have the second?
                                                             Resources, such as patient information leaflets,
The AZ vaccine should continue to be offered                 have been produced which explain the benefits
to those in priority groups who have not yet                 and risks of the AZ vaccination by different age
been offered the vaccine. This includes older                bands. Older age groups, such as those aged
adults, those with underlying conditions, health             50 or older or with underlying medical problems,
and social care workers 40 years or older.                   have a higher risk of hospitalisation, intensive care
There are currently no known risk factors for this           admission or death from COVID-19 infection than
extremely rare condition, which appears to be an             younger age groups:
idiosyncratic reaction on first exposure to the AZ
vaccine.                                                     • for those aged 50 and older or with underlying
                                                               medical problems, the risk of this very rare side
Those who have received their first dose of AZ                 effect is around 1 in every 100,000 first doses
vaccine and have not suffered this rare side-                  and the benefit of one dose of the vaccine is
effect should continue to be offered the second                an 80% reduction in deaths, hospitalisation and
dose to complete the course. Individuals aged                  intensive care
18 to 39 years who have received their first
dose of AZ vaccine, without suffering this rare              • for people aged 40–49, the risk of this very
side effect, should complete their course with                 rare side effect is around 1 in every 100,000
the same vaccine. This will include those who                  first doses and the benefit of one dose of the
are eligible as part of the initial priority groups,           vaccine is 60 – 70% reduction in catching and
such as health and social care workers, unpaid                 passing on the infection
carers and family members of those who are                   • for people aged 18–39, the risk of this very
immunosuppressed.                                              rare side effect is around 1 in every 50,000
There is currently no evidence on the                          first doses and the benefit of one dose of the
interchangeability of the COVID-19 vaccines                    vaccine is 60%–70% reduction in catching and
although studies are underway. Therefore,                      passing on the infection
every effort should be made to determine which               Someone who is vaccinated will continue to
vaccine the individual received and to complete              accrue benefits from the vaccination in the longer
with the same vaccine.                                       term by being protected against COVID-19, whilst
Please see the Green Book for further advice on              the risk of vaccination occurs only in the few
vaccination.                                                 weeks after vaccination.

                                                         7
Blood Clotting following COVID-19 Vaccination
Information for Health Professionals

23. What if my patient refuses the AZ                          CEU statement: Cerebral venous sinus thrombosis
vaccine?                                                       AstraZeneca COVID-19 vaccination and CHC –
                                                               Faculty of Sexual and Reproductive Healthcare
To make an informed decision it is important that all
individuals are provided with the relevant information,        26. What is the current advice for
including the benefits and risks, and that they have
                                                               pregnant women?
the opportunity to discuss this with their healthcare
provider if they wish. If the patient is under 40 years,       There have been no confirmed cases of this
an alternative vaccine will become available, but              syndrome in pregnant women to date, and
they may need to go to a different vaccination site.           prothrombotic states such as pregnancy and
Resources, including patient leaflets, are available to        contraception are not likely to confer a higher risk.
support decision making.                                       The Expert Haematology Panel advise that there is
                                                               no evidence that individuals with a prior history of
24. What if my patient under 40 years old                      thrombosis or known risk factors for thrombosis are
wants to have the AZ vaccine?                                  more at risk of developing the immune complication
                                                               reported after the AZ vaccine. However, because
Patients under 40 who decide to go ahead after
                                                               of more extensive experience and available safety
they have considered all the risks and benefits can
                                                               data for Pfizer and Moderna vaccines from the USA,
be vaccinated with the AZ vaccine. You should
                                                               these vaccines are preferred in pregnancy. Further
document that you have had a full conversation
                                                               information is available in the Green Book.
with the patient and that you have provided them
with sufficient information for them to give informed          27. What investigations do I need to
consent to vaccination. Resources, including patient
                                                               organise for cases?
leaflets, are available to support decision making.
                                                               If a patient presents with symptoms suggestive
25. Can patients taking the combined                           of a blood clot in this time period please take the
oral contraceptive pill have the AZ                            following actions:
vaccine?                                                       Immediately refer patients to their local Emergency
Yes, patients taking the combined oral                         Department to have a Full Blood Count and further
contraceptive pill can have the AZ vaccine, if                 investigations carried out.
they do not have any of the contraindications or               Report this case via the MHRA Yellow Card System
cautions to its use (see the Green Book for further            (https://coronavirus-yellowcard.mhra.gov.uk).
information).                                                  At Emergency Departments, the standard Royal
The JCVI has concluded that for adults under 40                College of Emergency Medicine pathway should
years of age who are not in a clinical risk group, it is       be followed and supportive guidance is available
preferable to offer an alternative to the AZ vaccine           through local haematology teams for cases with
if available. Healthy adults aged 40-50 years are              confirmed thrombocytopenia
Sources
Guidance produced from the Expert Haematology Panel (EHP) focussed on syndrome of Thrombosis
and Thrombocytopenia occurring after coronavirus Vaccination Guidance produced from the Expert
Haematology Panel (EHP) focussed on syndrome of Thrombosis and Thrombocytopenia occurring after
coronavirus Vaccination | British Society for Haematology (b-s-h.org.uk)
COVID-19: the green book, chapter 14a COVID-19 Greenbook chapter 14a (publishing.service.gov.uk)
Use of the AstraZeneca COVID-19 vaccine: JCVI statement www.gov.uk/government/publications/use-of-
the-astrazeneca-covid-19-vaccine-jcvi-statement-7-may-2021/use-of-the-astrazeneca-covid-19-azd1222-
vaccine-updated-jcvi-statement-7-may-2021
MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and
extremely rare, unlikely to occur blood clots www.gov.uk/government/news/mhra-issues-new-advice-
concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-
blood-clots
Coronavirus Yellow Card reporting site Official MHRA side effect and adverse incident reporting site for
coronavirus treatments and vaccines | Coronavirus (COVID-19)
Public Health England – reporting Thrombotic events with thrombocytopenia following immunisation
to COVID-19 https://cutt.ly/haem_AE
COVID-19 vaccination and blood clotting resources www.gov.uk/government/collections/covid-19-
vaccination-and-blood-clotting
Expert Haematology Panel: https://b-s-h.org.uk/media/19537/letter-to-mhra-from-expert-haematology-
group-endorsed-by-thrombosis-uk-1300-8th-april-2021.pdf
PHE monitoring of the effectiveness of COVID-19 vaccination: www.gov.uk/government/publications/phe-
monitoring-of-the-effectiveness-of-covid-19-vaccination
RCEM: Management of patients presenting to the Emergency Department/Acute Medicine with symptoms
ED-AM Vaccine pathway concerns - RCP - SAM - RCEM.pdf
JCVI final statement on phase 2 of the COVID-19 vaccination programme: 13 April 2021: www.gov.uk/
government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-
advice-from-the-jcvi
MHRA: Coronavirus vaccine – weekly summary of Yellow Card reporting Coronavirus vaccine – weekly
summary of Yellow Card reporting – GOV.UK
(www.gov.uk)
RCGP Primary Care Management of Suspected Thromboembolism with Thrombocytopenia after COVID-19
Vaccination Headaches after AZ_April 2021: https://elearning.rcgp.org.uk/pluginfile.php/166267/mod_
resource/content/5/Headaches%20after%20AZ_April%202021_V2.pdf

Vaccination, helping to protect those most vulnerable.
Information correct at time of publication. For the latest version of this factsheet,
visit the PHA website www.publichealth.hscni.net/publications

© Crown copyright 2021. This information was originally developed by Public Health
                                                                                                           07/21

England and is used under the Open Government Licence v3.0
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