Rabu, 07 April 2021

Covid: Under-30s offered alternative to Oxford-AstraZeneca jab - BBC News

Under-30s in the UK are to be offered an alternative Covid vaccine to the AstraZeneca jab due to the evidence linking it to rare blood clots.

The recommendation comes after a review by the UK drugs regulator found that by the end of March 79 people had suffered rare blood clots after vaccination - 19 of whom had died.

The regulator said this was not proof the jab had caused the clots.

But it said the link was getting firmer.

The review by the Medicines and Healthcare products Regulatory Agency (MHRA) found:

  • The 79 cases and 19 deaths occurred after 20 million doses were administered - giving a risk of about four in one million of developing a blood clot, and one in a million of dying
  • Nearly two-thirds of the cases of rare clots were seen in women
  • The people who died were aged between 18 and 79, with three of them aged under 30
  • All the recorded cases occurred after the first dose, although the lower number of second doses meant it was not possible to draw any conclusions from this

Meanwhile, the EU's medicines regulator says unusual blood clots should be listed as a possible very rare side effect of the AstraZeneca jab, but that the benefits outweighed the risks. Some European countries have restricted the vaccine's use.

The World Health Organization said the link between the vaccine and blood clots was "plausible" but not confirmed, adding that the clotting incidents were "very rare" among nearly 200 million people who have received the jab worldwide.

Presentational grey line

Analysis: Should we be worried about a one-in-a-million risk?

No treatment or vaccine is risk free. The key question is whether it does more good than harm.

Wednesday's update once again demonstrates the AstraZeneca vaccine does - even if you assume it's causing these clots, which has not been proven yet.

The risk of dying from one of them following vaccination is incredibly small - about one in a million.

By contrast, Covid kills one in eight people who are infected over the age of 75, and one in 1,000 infected in their 40s among those who develop symptoms.

It is less clear cut for those under 30, who are much less likely to die of Covid - although the AstraZeneca vaccine still presents more benefit than risk.

However, other vaccines may be an even better bet.

The risk might look worrying, but it is actually very low, and usually we don't think about things just in terms of risk.

For example, travelling 250 miles in a car also carries with it a one-in-a-million chance of dying in an accident. How many think about that when they get behind the wheel?

Graphic showing harm vs benefits of AZ vaccine
Presentational grey line

Health Secretary Matt Hancock said the UK's review confirmed that the Oxford-AstraZeneca jab is "safe, effective and the benefits far outweigh the risks for the vast majority of adults".

Prime Minister Boris Johnson said the AstraZeneca vaccine had "already saved thousands of lives" and the new advice should ensure people of all ages "continue to have full confidence in vaccines".

Labour leader Sir Keir Starmer also urged people to "trust in our doctors and scientists" and said he was looking forward to receiving his second AstraZeneca dose.

The UK reported a further 45 deaths from Covid-19 and another 2,763 confirmed cases on Wednesday. Vaccinations remained low after the Easter weekend, with 186,793 second doses administered and 85,227 first doses.

June Raine, chief executive of the MHRA, said the side-effects of the AstraZeneca vaccine were "extremely rare" - and more work was going to identify if the vaccine was definitely causing the clots.

"The balance of benefits and known risks is still very favourable for the majority of people," she said.

But she said for younger age groups it was more "finely balanced".

She added: "The public's safety is at the forefront of our minds."

Dr Raine said there was a "reasonably plausible" link between the vaccine and the blood clots, although AstraZeneca has said its studies have found no causal connection.

The review prompted the UK government's vaccine advisory group, the JCVI, to recommend that people aged 18 to 29 be offered an alternative vaccine where available.

Professor Lim Wei Shen, of the JCVI, said the move was being made "out of the utmost caution rather than because we have any serious safety concerns".

Chart showing vaccine use across Europe
Presentational grey line

Professor Sir Munir Pirmohamed, chairman of the Commission on Human Medicines, said the risks had to be weighed against the consequences of Covid-19, which also causes clotting.

He said 7.8% of coronavirus patients suffer blood clots on the lungs, while 11.2% will suffer deep vein thrombosis (DVT) in the legs.

People who have had their first dose of the AstraZeneca vaccine should still get their second dose, the MHRA said. Only those who suffered one of these rare blood clots after the first dose should not get vaccinated, it added.

Pregnant women and people with blood disorders that leave them at risk of clotting should discuss the benefits and risks of vaccination with their doctor before going for a jab.

Anyone who suffers symptoms such as a persistent headache, blurred vision or confusion for four days or more after vaccination or who experience unusual skin bruising, shortness of breath or chest pain are being asked to seek medical advice.

England's deputy chief medical officer, Prof Jonathan Van-Tam, described the move as a "course correction" - and said it was normal in medicine to change preferences in this way.

He also said the impact on the government's promise to offer all adults a jab by the end of July should be "zero or negligible" as long as the expected supplies of the Pfizer and Moderna vaccines - the other two Covid vaccines in use in the UK - arrived as expected in the coming months.

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2021-04-07 17:26:21Z
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Covid: Under-30s offered alternative to Oxford-AstraZeneca jab - BBC News

Under-30s in the UK are to be offered an alternative Covid vaccine to the AstraZeneca jab due to the evidence linking it to rare blood clots.

The recommendation comes after a review by the UK drugs regulator found that by the end of March 79 people had suffered rare blood clots after vaccination - 19 of whom had died.

The regulator said this was not proof the jab had caused the clots.

But it said the link was getting firmer.

The review by the Medicines and Healthcare products Regulatory Agency (MHRA) found:

  • The 79 cases and 19 deaths occurred after 20 million doses were administered - giving a risk of about four in one million of developing a blood clot
  • Nearly two-thirds of the cases of rare clots were seen in women
  • The people who died were aged between 18 and 79, with three of them aged under 30
  • All the recorded cases occurred after the first dose, although the lower number of second doses meant it was not possible to draw any conclusions from this

It comes as the EU's medicines regulator says unusual blood clots should be listed as a possible very rare side effect of the AstraZeneca jab, but that the benefits outweighed the risks. Some European countries have restricted the vaccine's use.

Health Secretary Matt Hancock said the review confirmed that the Oxford-AstraZeneca jab is "safe, effective and the benefits far outweigh the risks for the vast majority of adults".

Prime Minister Boris Johnson said the AstraZeneca vaccine had "already saved thousands of lives" and the new advice should ensure people of all ages "continue to have full confidence in vaccines".

The UK reported a further 45 deaths from Covid-19 and another 2,763 confirmed cases on Wednesday. Vaccinations remained low after the Easter weekend, with 186,793 second doses administered and 85,227 first doses.

June Raine, chief executive of the MHRA, said the side-effects of the AstraZeneca vaccine were "extremely rare" - and more work was going to identify if the vaccine was definitely causing the clots.

"The balance of benefits and known risks is still very favourable for the majority of people," she said.

But she said for younger age groups it was more "finely balanced".

She added: "The public's safety is at the forefront of our minds."

Dr Raine said there was a "reasonably plausible" link between the vaccine and the blood clots, although AstraZeneca has said its studies have found no causal connection.

The review prompted the UK government's vaccine advisory group, the JCVI, to recommend that people aged 18 to 29 be offered an alternative vaccine where available.

Professor Lim Wei Shen, of the JCVI, said the move was being made "out of the utmost caution rather than because we have any serious safety concerns".

Chart showing vaccine use across Europe
Presentational grey line

Professor Sir Munir Pirmohamed, chairman of the Commission on Human Medicines, said the risks had to be weighed against the consequences of Covid-19, which also causes clotting.

He said 7.8% of coronavirus patients suffer blood clots on the lungs, while 11.2% will suffer deep vein thrombosis (DVT) in the legs.

People who have had their first dose of the AstraZeneca vaccine should still get their second dose, the MHRA said. Only those who suffered one of these rare blood clots after the first dose should not get vaccinated, it added.

People with blood disorders that leave them at risk of clotting should discuss the benefits and risks of vaccination with their doctor before going for a jab.

Anyone who suffers symptoms such as a persistent headache, blurred vision or confusion for four days or more after vaccination or who experience unusual skin bruising, shortness of breath or chest pain are being asked to seek medical advice.

England's deputy chief medical officer, Prof Jonathan Van-Tam, described the move as a "course correction" - and said it was normal in medicine to change preferences in this way.

He also said the impact on the government's promise to offer all adults a jab by the end of July should be "zero or negligible" as long as the expected supplies of the Pfizer and Moderna vaccines - the other two Covid vaccines in use in the UK - arrived as expected in the coming months.

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Are you under 30 and waiting to be vaccinated? Share your views and experiences by emailing haveyoursay@bbc.co.uk.

Please include a contact number if you are willing to speak to a BBC journalist. You can also get in touch in the following ways:

If you are reading this page and can't see the form you will need to visit the mobile version of the BBC website to submit your question or comment or you can email us at HaveYourSay@bbc.co.uk. Please include your name, age and location with any submission.

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2021-04-07 16:47:24Z
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Covid: Under-30s offered alternative to Oxford-AstraZeneca jab - BBC News

Under-30s in the UK are to be offered an alternative Covid vaccine to the AstraZeneca jab due to the evidence linking it to rare blood clots.

The recommendation comes after a review by the UK drugs regulator found that by the end of March 79 people had suffered rare blood clots after vaccination - 19 of whom had died.

The regulator said this was not proof the jab had caused the clots.

But it said the link was getting firmer.

The review by the Medicines and Healthcare products Regulatory Agency (MHRA) found:

  • The 79 cases and 19 deaths occurred after 20 million doses were administered - giving a risk of about four in one million of developing a blood clot
  • Nearly two-thirds of the cases of rare clots were seen in women
  • The people who died were aged between 18 and 79, with three of them aged under 30
  • All the recorded cases occurred after the first dose, although the lower number of second doses meant it was not possible to draw any conclusions from this

It comes as the EU's medicines regulator says unusual blood clots should be listed as a possible very rare side effect of the AstraZeneca jab, but that the benefits outweighed the risks. Some European countries have restricted the vaccine's use.

Health Secretary Matt Hancock said the review confirmed that the Oxford-AstraZeneca jab is "safe, effective and the benefits far outweigh the risks for the vast majority of adults".

Prime Minister Boris Johnson said the AstraZeneca vaccine had "already saved thousands of lives" and the new advice should ensure people of all ages "continue to have full confidence in vaccines".

The UK reported a further 45 deaths from Covid-19 and another 2,763 confirmed cases on Wednesday. Vaccinations remained low after the Easter weekend, with 186,793 second doses administered and 85,227 first doses.

June Raine, chief executive of the MHRA, said the side-effects of the AstraZeneca vaccine were "extremely rare" - and more work was going to identify if the vaccine was definitely causing the clots.

"The balance of benefits and known risks is still very favourable for the majority of people," she said.

But she said for younger age groups it was more "finely balanced".

She added: "The public's safety is at the forefront of our minds."

Dr Raine said there was a "reasonably plausible" link between the vaccine and the blood clots, although AstraZeneca has said its studies have found no causal connection.

The review prompted the UK government's vaccine advisory group, the JCVI, to recommend that people aged 18 to 29 be offered an alternative vaccine where available.

Professor Lim Wei Shen, of the JCVI, said the move was being made "out of the utmost caution rather than because we have any serious safety concerns".

Chart showing vaccine use across Europe
Presentational grey line

Professor Sir Munir Pirmohamed, chairman of the Commission on Human Medicines, said the risks had to be weighed against the consequences of Covid-19, which also causes clotting.

He said 7.8% of coronavirus patients suffer blood clots on the lungs, while 11.2% will suffer deep vein thrombosis (DVT) in the legs.

People who have had their first dose of the AstraZeneca vaccine should still get their second dose, the MHRA said. Only those who suffered one of these rare blood clots after the first dose should not get vaccinated, it added.

People with blood disorders that leave them at risk of clotting should discuss the benefits and risks of vaccination with their doctor before going for a jab.

Anyone who suffers symptoms such as a persistent headache, blurred vision or confusion for four days or more after vaccination or who experience unusual skin bruising, shortness of breath or chest pain are being asked to seek medical advice.

England's deputy chief medical officer, Prof Jonathan Van-Tam, described the move as a "course correction" - and said it was normal in medicine to change preferences in this way.

He also said the impact on the government's promise to offer all adults a jab by the end of July should be "zero or negligible" as long as the expected supplies of the Pfizer and Moderna vaccines - the other two Covid vaccines in use in the UK - arrived as expected in the coming months.

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If you are reading this page and can't see the form you will need to visit the mobile version of the BBC website to submit your question or comment or you can email us at HaveYourSay@bbc.co.uk. Please include your name, age and location with any submission.

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2021-04-07 16:00:57Z
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EU drug regulator: Unusual blood clot is 'very rare AstraZeneca side effect' - BBC News

The EU's medicines regulator says unusual blood clots should be listed as a very rare side effect of the AstraZeneca vaccine for Covid-19.

After a study looking at 86 such cases in the EU, the European Medicines Agency (EMA) concluded the benefits of the vaccine outweighed the risk.

There was no definite causal link, and although most cases were in women under 60, they also occurred in men.

The EU has vaccinated more than 20 million people.

At a press briefing, EMA executive director Emer Cooke said that the combination of blood clots and low blood platelets was very rare but was seen in "all ages, and in men and women", and there was no available evidence of "specific risk factors such as age, gender, or previous medical history of clotting disorders".

"Our safety committee... has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects," she said.

Ms Cooke added: "This vaccine has proven to be highly effective - it prevents severe disease and hospitalisation, and it is saving lives."

AstraZeneca has said its studies have found no causal link with blood clots.

AstraZeneca
Reuters

The EMA said that one plausible explanation was an "immune response, leading to a condition (heparin-induced thrombocytopenia, HIT) similar to one seen sometimes in patients treated with heparin".

Heparin is a blood thinner used to prevent the formation of clots, and HIT is a potentially dangerous immune-driven adverse reaction to the drug.

EU health ministers will begin a meeting shortly to discuss the findings.

The EMA evaluates and supervises medicine use for all of the EU, including drug approval.

However, this does not mean there has been unity on tackling Covid-19.

Countries within the bloc have diverged widely on vaccination campaigns and on the use of the AstraZeneca jab.

In France, it is now recommended that AstraZeneca vaccinations should be given only to those aged 55 or over. In Germany it is over 60, plus high-priority groups. Norway, not an EU member, and Denmark have a full suspension.

Germany says its under-60s who have received an AstraZeneca first dose should now get a different vaccine for their second.

France, Finland and Norway could consider similar moves.

Studies are still being done on the effectiveness of mixed vaccines.

Graphic: How does the Oxford vaccine work
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2021-04-07 15:18:10Z
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Covid: Under-30s offered alternative to AstraZeneca jab - BBC News

Clinical Pharmacist Ellie Morton prepares to administer the Oxford AstraZeneca COVID-19 Vaccine at the community vaccination centre at Kingston University's Penrhyn Road campus on March 12, 2021
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Under-30s are to be offered an alternative Covid jab to the AstraZeneca vaccine due to the evidence linking it to rare blood clots, the UK's vaccine advisory body says.

A review by drugs regulator MHRA found by the end of March 79 people in the UK had suffered rare blood clots after vaccination - 19 of whom had died.

The regulator said this was not proof the jab had caused the clots.

But it said the link was getting firmer.

Dr June Raine, of the MHRA, said the side-effects were "extremely rare" - and more work was going to identify if the vaccine was definitely causing the clots.

"The balance of benefits and known risks is still very favourable for the majority of people."

But she said for younger age groups it was more "finely balanced".

She added: "The public's safety is at the forefront of our minds."

The review prompted the government's vaccine advisory group, the JCVI, to recommend that people aged 18 to 29 be offered an alternative vaccine where available.

People who have had their first dose of the AstraZeneca vaccine should still get their second dose. Only those who suffered one of these rare blood clots after the first dose should not get vaccinated, the MHRA said.

People with blood disorders that leave them at risk of clotting should discuss the benefits and risks of vaccination with their doctor before going for a jab.

Nearly two-thirds of the cases of rare clots were seen in women. The people who died were aged between 18 and 79.

However, it was not possible to identify whether age or gender made people more at risk of these rare blood clots.

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2021-04-07 14:14:47Z
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COVID-19: MHRA and JCVI to hold news conference at 3pm over Oxford-AstraZeneca jab blood clot concerns - Sky News

Blood clot concerns linked to the Oxford vaccine will be addressed by the UK's drugs watchdog at a news conference this afternoon.

The briefing, together with the Joint Committee on Vaccination and Immunisation (JCVI), will be held at the Department of Health at 3pm.

England's deputy chief medical officer Professor Jonathan Van-Tam will be among those attending, along with Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) and JCVI chairman Professor Wei Shen.

Follow live COVID updates from the UK and across the world

Use of the Oxford/AstraZeneca jab for younger Britons has been reviewed following concerns at the weekend when it was revealed that of the 18.1 million people who have had the vaccine in the UK, 30 people have developed blood clots.

The MHRA confirmed that of those 30 people, seven had died as of 24 March.

But the drugs watchdog maintained there was no evidence to suggest a causal link between the rare blood clots and the Oxford jab, and that the benefits continue to outweigh any risk.

More from Covid-19

The same message has been echoed by ministers.

The EU's medical regulator is also expected to announce the findings of its own review into the jab, after several European nations paused rollout of the vaccine to younger people, following reports of the condition that prevents blood draining from the brain.

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It comes after the head of the European Medicines Agency's (EMA) head of vaccine strategy said it was "increasingly difficult" to say there is "no cause and effect relationship" between the Oxford jab and "rare cases of unusual blood clots".

However, Marco Cavaleri added that full evaluation work was still "far from being completed" and that the risk-benefit ratio was still in favour of the vaccine.

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'Follow advice of MHRA on Oxford vaccine'

Any move to restrict use of the jab will inevitably raise questions over the rollout of the UK's vaccination programme.

The government has secured a total of 457 million doses, of which 100 million are from the Anglo-Swedish firm.

However, the government has continued to express confidence that all adults would be offered a first jab by the end of July, pointing to other vaccines coming onstream, including the Moderna jab.

Meanwhile, Ravi Gupta, professor of clinical microbiology at the Cambridge Institute of Therapeutic Immunology and Infectious Diseases, has urged people to keep their vaccine appointments.

He told Sky News: "I think that's on balance at the moment - there's still transmission of COVID, and there is a risk to all of us of being infected, particularly as the economy is being opened up and society's opening up, we are at risk of getting severe infection.

"So I would certainly be going forward for that vaccine in the current situation."

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2021-04-07 12:15:32Z
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COVID-19: MHRA and JCVI to hold news conference at 3pm over Oxford-AstraZeneca jab blood clot concerns - Sky News

Blood clot concerns linked to the Oxford vaccine will be addressed by the UK's drugs watchdog at a news conference this afternoon.

The briefing, together with the Joint Committee on Vaccination and Immunisation (JCVI), will be held at the Department of Health at 3pm.

England's deputy chief medical officer Professor Jonathan Van-Tam will be among those attending, along with Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) and JCVI chairman Professor Wei Shen.

Follow live COVID updates from the UK and across the world

Use of the Oxford/AstraZeneca jab for younger Britons has been reviewed following concerns at the weekend when it was revealed that of the 18.1 million people who have had the vaccine in the UK, 30 people have developed blood clots.

The MHRA confirmed that of those 30 people, seven had died as of 24 March.

But the drugs watchdog maintained there was no evidence to suggest a causal link between the rare blood clots and the Oxford jab, and that the benefits continue to outweigh any risk.

More from Covid-19

The same message has been echoed by ministers.

The EU's medical regulator is also expected to announce the findings of its own review into the jab, after several European nations paused rollout of the vaccine to younger people, following reports of the condition that prevents blood draining from the brain.

Subscribe to the Daily podcast on Apple Podcasts, Google Podcasts, Spotify, Spreaker

It comes after the head of the European Medicines Agency's (EMA) head of vaccine strategy said it was "increasingly difficult" to say there is "no cause and effect relationship" between the Oxford jab and "rare cases of unusual blood clots".

However, Marco Cavaleri added that full evaluation work was still "far from being completed" and that the risk-benefit ratio was still in favour of the vaccine.

Please use Chrome browser for a more accessible video player

'Follow advice of MHRA on Oxford vaccine'

Any move to restrict use of the jab will inevitably raise questions over the rollout of the UK's vaccination programme.

The government has secured a total of 457 million doses, of which 100 million are from the Anglo-Swedish firm.

However, the government has continued to express confidence that all adults would be offered a first jab by the end of July, pointing to other vaccines coming onstream, including the Moderna jab.

Meanwhile, Ravi Gupta, professor of clinical microbiology at the Cambridge Institute of Therapeutic Immunology and Infectious Diseases, has urged people to keep their vaccine appointments.

He told Sky News: "I think that's on balance at the moment - there's still transmission of COVID, and there is a risk to all of us of being infected, particularly as the economy is being opened up and society's opening up, we are at risk of getting severe infection.

"So I would certainly be going forward for that vaccine in the current situation."

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2021-04-07 11:48:45Z
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