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AstraZeneca Vaccine - Q&A Update


DHSC Questions & Answers

Yes. We are on track to hit our targets to offer a first doses dose to everyone in the priority groups 1-9 by mid-April and all adults by the end of July.

Yes we are on track to hit our targets to offer a first doses dose to everyone in the priority groups 1-9 by mid-April and all adults by the end of July.

Vaccine No of Doses Clinical Trial Phase
Oxford/AstraZeneca 100 million Approved
Janssen  30 million  MHRA reviewing
Pfizer/BioNTech 40 million  Approved
Moderna 17 million

Approved

Curevac 50 million  Phase 2b/3
GlaxoSmithKline/Sanofi Pasteur 60 million Phase 2
Novavax 60 million Phase 3
Valneva 100 million  Phase 3

 

The MHRA process is independent of government and we do not comment on when or if a vaccine may be authorised.

NHSE will be contacting those under 40 who already have a booking in the next couple of weeks. The NHS will give the vaccine that is most appropriate for you.

The MHRA advice is that 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 of that vaccine.

All reported cases of these rare blood clots have occurred after the first dose of vaccine. The JCVI advise that those who have had a first AZ dose should take up the offer of the 2nd dose, which is very important for full protection. They will continue to keep the data under review.

This isn’t known yet but the JCVI have noted that there has been no evidence to date of this event occurring after a 2nd dose. They will continue to keep the data under review.

If someone was 39 when their received their first dose of Astra Zeneca, but becomes 40 before the 2nd they should come forward for their second dose as normal when invited. As everyone who has had a first dose of AZ should come forward for a second dose.

Everybody who has already had a first dose of the AstraZeneca vaccine should receive a second dose of the same brand, irrespective of age, except for the very small number of people who experienced blood clots with low platelet counts from their first vaccination.

Age Range:18-79 years

Age Range (Years) Number of Cases
18-29 11
30-39 16
40-49 10
50-59 12
60-69 13
70-79 5
Unknown 12


Female: 51
Male: 28

The number of fatal cases stratified by age is:

Age Range (Years) Number of Cases  Number of fatal cases
18-29 11 3
30-39 16 6
40-49 10 2
50-59 12 2
60-69 13 3
70-79 5 1
Unknown 12 2

The number of fatal cases stratified by gender is:

Female: 13
Male: 6

We fully evaluate all Yellow Card reports as soon as they come in. Reports we have received over the past few days are still under careful review. Should any safety issues arise these will be communicated at the earliest point the scientific evidence allows.

The reports show that more women have been affected than men. This could potentially be influenced by the groups the vaccine has been rolled out to first, which may include a higher proportion of women than men.

All reports are being followed up for clinical details. A frequent finding was platelet factor 4 (PF4) antibodies and elevated D-dimer levels and this is being looked at closely.

We are still investigating whether they had any underlying conditions.

Our scientific review of UK reports of very rare and 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. We will continue to investigate the clinical details of any new and existing case reports as well as the background rate of CVST, including during the pandemic. Should any safety issues arise from this ongoing review, these will be communicated at the earliest point the scientific evidence allows.

We fully evaluate all Yellow Card reports as soon as they come in but it is important to note that Yellow Card reports are not always submitted to us immediately. Therefore, some of the reports received between 24 March and 31 March are of blood clots in combination with low platelets that occurred outside of this period.

It is also possible that increased awareness of this potential signal has led to a subsequent increase in reporting.

If you have had a major venous or arterial blood clot (thrombosis) and are unsure as to whether or not this occurred in combination with low platelet levels (thrombocytopenia), you should talk to your doctor who will be able to review your medical records.

Currently, both the Pfizer/BioNTech vaccine and Moderna vaccine are also authorised in the UK, with plans to roll the Moderna vaccine out in X. Individuals with a history of major blood clots with low platelets should talk to their doctor about whether either of these options is right for them.

People who experienced a specific type of blood clot occurring with low levels of platelets after their first vaccine dose of COVID-19 Vaccine AstraZeneca should not have their second dose. Individuals should talk to their doctor to determine the suitability of another COVID-19 vaccine.

The currently available evidence does not establish a causal association between the AstraZeneca COVID-19 Vaccine and these events, but further investigations into the clinical details of the case reports and the background rate of CVST, including during the pandemic, is needed.

There are currently more reports  in women than in men,  but this is not confirmation that these events are most common in women. This could potentially be influenced by the groups the vaccine has been rolled out to first, which may include a higher proportion of women than men.

At present, the evidence does not suggest that different actions should be taken in relation to use of the vaccine in women and men.

There are many different causes of thrombocytopenia.

Common causes include vitamin deficiencies due to alcohol excess, viral infections, chemicals, and certain medicines.  In some cases, the body produces antibodies against platelets (immune thrombocytopenia). Some pregnant women can develop mild thrombocytopenia in the last 2 trimesters of pregnancy.

Up to and including 31 March we have 2 cases of blood clots (thromboembolism) reported with thrombocytopenia for the Pfizer/BioNTech vaccine. However, following a detailed medical review it is considered very unlikely that these cases relate to the vaccine.

Our expert safety scientists and clinicians have developed a case definition that helps determine  whether a report is likely linked to the vaccine or not. We will analyse every report of a suspected blood clot to determine if it meets this case definition.

The reports were of one women and one man, aged 55 and above. One report was of a pulmonary embolism with thrombocytopenia and the other was a report of CVST and thrombocytopenia.

There have been reports of these rare types of blood clots with low platelet count following vaccination in other countries. Questions on the details of these reports would be for the regulator or health authority of that country to answer directly.

We are working closely with international counterparts in understanding the global safety experience of COVID-19 vaccines and on the rapid sharing of safety data and reports.

Published literature suggests rates between 5-16 cases per million for CVST on its own, with more recent publications at the higher end.

It’s important to note that a report of a suspected side-effect is not proof that the vaccine caused it but a suspicion by the reporter that the vaccine may have caused the side effect. Factors such as underlying or previously undiagnosed, coincidental illness can also be a factor in such reports.

Yellow Card reports of suspected adverse reactions are evaluated, together with additional sources of evidence, by a team of safety experts to identify whether the vaccine may have caused the event, or whether the event was coincidental or due to some other reason. Investigations are undertaken on a case-by-case basis, and there is no set trigger to determine whether something may be linked to a vaccine.

We continually review Yellow Card data, as well as other data sources, to determine if reports may indicate a “signal” of any previously unrecognised risks. We apply statistical techniques which can tell us if we are seeing disproportionately more cases than we would expect to see based on what is known about background rates of illness in the absence of vaccination. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

For more information on signal detection and evaluation, please see Section 4 of the COVID-19 Vaccines Surveillance Strategy.

We look at a range of risk windows in our statistical analysis, we never exclude a case.

We have not identified any patterns with specific batches.

Given the extremely rare rate of occurrence of these events among the millions of people vaccinated with the AZ vaccine, and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects. Our scientific and clinical experts are continuing to investigate these reports closely, and our advice remains that you should continue to get the vaccine when invited to do so.

We fully evaluate all reports of serious suspected side effects as soon as they come in to consider whether the vaccine may have caused the event, or whether the event was likely to be purely coincidental.

Cerebral venous sinus thrombosis is a rare form of blood blot that is more common in younger adults. In the UK, the vaccines have been rolled out to people in order of age and clinical risk factors, meaning the elderly and vulnerable were prioritised first. This could explain why we are only receiving these reports now. However, it is important to note that a causal association with the vaccine has not yet been established.

The reports we have received were after the first dose.

There have been no cases reported for the Moderna vaccine.

Of the 51 cases reported amongst women, 5 reported hormonal contraceptive use.

“We are aware of the pre-print published today by the Drug Research Safety Unit.

“The DSRU pre-print is a rapid assessment, and the authors note the potential for inaccuracies caused by the assumptions they used, for example about the proportion of women vaccinated.”

“Our thorough and detailed review is ongoing into reports of very rare and specific types of blood clots with low platelets following the COVID-19 Vaccine AstraZeneca.”

“People should continue to get their vaccine when invited to do so.”

 

Richard Roberts, Head of the Vaccine Preventable Disease Programme (VPDP) at Public Health Wales, said:

“Over 35 million people in the UK, and 1.9 million in Wales, have so far been protected by COVID-19 vaccines, and over 22 million people in the UK have received the Oxford AstraZeneca vaccine, of which nearly 6 million have had the second dose. We continue to advise people to get their COVID-19 vaccine when they are invited. It is estimated that COVID-19 vaccines have prevented over 10,000 deaths in the UK so far.

“The JCVI has advised it is essential to keep rapidly rolling out vaccination, and any delay increases the chances of an earlier and larger third wave.

“After ongoing review, the Joint Committee on Vaccination and Immunisation (JCVI) has today advised that in addition to those aged under 30 advised on 7 April, unvaccinated adults aged 30 - 39 years who are not in a clinical priority group because of long term health conditions, should where possible be offered an alternative to the AstraZeneca COVID-19 vaccine, where it would not significantly delay vaccination.

“JCVI is not advising against using AstraZeneca vaccine in 30-39 year olds, only that other vaccines are preferred. JCVI advise that anyone who has already received a first dose of AstraZeneca should continue to receive the same vaccine for their second dose, there are no clotting safety concerns with the second dose. It is the second dose which gives stronger and longer protection.

“Extremely rare cases of thrombosis (blood clots) with thrombocytopenia (low platelet count) following the first dose of the AstraZeneca vaccine have been reported to the MHRA after the first dose of the AstraZeneca vaccine at a rate of 10.5 per million doses. There is a trend to a higher rate in younger age groups. The condition can be severe, with a fatality rate of 20 per cent.

“Coronavirus itself also causes clotting, and blood clots have been a very common complication in the hundreds of thousands of people admitted to hospital with COVID-19 infection in the UK, also causing deaths. The COVID-19 vaccine can reduce the risk of you getting seriously ill or dying from coronavirus by over 90 per cent, including preventing blood clots caused by COVID-19. The balance of risks and benefits have been taken into account by the JCVI.

“In Wales 9 cases of this rare type of blood clot have been reported by the MHRA, 2 of the cases sadly died.  Over 1 million people in Wales have received the AstraZeneca COVID-19 vaccine.

“Information on how to identify this rare condition is available in the PHW website. You should seek prompt medical advice if you get any of these symptoms starting from around 4 days to 4 weeks after being vaccinated:

  • a severe headache that is not relieved with painkillers or is getting worse
  • a headache that feels worse when you lie down or bend over
  • a headache that's unusual for you and occurs with blurred vision, feeling or being sick, problems speaking, weakness, drowsiness or seizures (fits)
  • a rash that looks like small bruises or bleeding under the skin
  • shortness of breath, chest pain, leg swelling or persistent abdominal (tummy) pain”

DHSC statement

A Government spokesperson said:

“The Oxford/AstraZeneca vaccine is safe, effective and has already saved thousands of lives.

“As the MHRA – the UK’s independent regulator – and the JCVI have said, the benefits of the vaccine far outweigh the risks for the vast majority of adults.

“Everybody who has already had a first dose of the AstraZeneca vaccine should receive a second dose of the same brand, irrespective of age, except for the very small number of people who experienced blood clots with low platelet counts from their first vaccination.

“The government will follow today’s updated advice, which sets out that, as a precaution, it is preferable for people under the age of 40 with no underlying health conditions to be offered an alternative vaccine where possible once they are eligible.

“When people are called forward, they should get their jab. Vaccines are the best way out of this pandemic and provide strong protection against Covid-19.

“We are very grateful for the work of our world-leading regulator and our expert advisors as they continue to address this issue.

“More than 37 million jabs overall have already been administered, and we are on track to offer jabs to all over 50s by 15 April and all adults by the end of July.”

BACKGROUND

  • Public Health England (PHE) analysis indicates that the COVID-19 vaccination programme prevented 6,100 deaths in those aged 70 and older in England up to the end of February.
  • All safety reports are rigorously investigated and anyone with unexpected symptoms should speak with a healthcare professional.
  • All medicines have a risk of side effects.

 

MHRA statement

MHRA issues new advice as it concludes there is possible evidence of link between COVID-19 Vaccine AstraZeneca and extremely rare and unlikely to occur blood clots

  • MHRA not recommending new age restrictions in COVID-19 Vaccine AstraZeneca vaccine use
  • The benefits of vaccination continue to outweigh any risks but MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition.
  • 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.

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.”

Notes to Editor

  • Up to and including 31 March we have received 2 reports of blood clots (thromboembolism) reported with thrombocytopenia for the Pfizer/BioNTech vaccine. By this date, approx. 11 million first doses and 3.5 million second doses had been given.
  • The British Society for Haematology has issued guidance on thrombosis and thrombocytopenia possibly occurring after vaccination with COVID-19 vaccines [link].   This includes information on presentation and typical laboratory features, and treatment recommendations. The guidance also includes advice on recommended investigations for possible cases.
  • The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  • The Medicines and Healthcare products Regulatory Agency (‘the agency’) has three centres. The MHRA, the National Institute for Biological Standards and Control (NIBSC)and the Clinical Practice Research Datalink (CPRD). The agency is an executive agency of the Department of Health and Social Care.
  • The Commission on Human Medicines is the UK Government’s independent advisory body. It advises ministers on the safety, efficacy and quality of medicinal products.
  • The COVID-19 Vaccines Benefit Risk Expert Working Groupof the Commission on Human Medicines is formed from 27 experts from outside of the MHRA, including virologists, epidemiologists, immunologists and toxicologists.
  • The MHRA encourages anyone to report any suspicion or concern they have beyond the known, mild side effects on the Coronavirus Yellow Card site. Reporters do not need to be sure of a link between a vaccine and a suspected side effect but are still encouraged to report.
  • For more information on COVID-19 vaccine adverse reactions, see the MHRA’s weekly report

JCVI statement - Updated 07/05/2021

A government spokesperson said:

“The Oxford/AstraZeneca vaccine is safe, effective and has already saved thousands of lives in the UK and around the world.

As the MHRA – the UK’s independent regulator – and the Joint Committee on Vaccination and Immunisation have said, the benefits of the vaccine far outweigh the risks for the vast majority of adults.

The government will follow today’s updated advice, which sets out that, as a precaution, it is preferable for people under the age of 40 with no underlying health conditions to be offered an alternative vaccine where possible once they are eligible, and only if doing so does not cause a substantial delay in accessing a vaccination.

More than 50 million vaccines overall have already been administered, and our current vaccine supply and rate of infection means we are able to take this precautionary step while remaining on track to achieve our target of offering a vaccine to all adults by the end of July.

Everybody who has already had a first dose of the Oxford/AstraZeneca vaccine should receive a second dose of the same jab, irrespective of age, except for the very small number of people who experienced blood clots with low platelet counts following their first vaccination.

When people are called forward, they should get their jab. Vaccines are the best way out of this pandemic and provide strong protection against COVID-19.”

Link to statement: https://www.gov.uk/government/publications/use-of-the-astrazeneca-covid-19-vaccine-jcvi-statement

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