Europe’s drug regulator has found a possible link between the Oxford/AstraZeneca’s Covid-19 vaccine and rare blood clotting issues in adults who had received the shot and said it had taken into consideration all currently available evidence.

The European Medicines Agency has said the “benefit-risk remains positive” for the Oxford/AstraZeneca Covid-19 vaccine.

The EMA said blood clots should be listed as a “very rare” side effect of the AstraZeneca coronavirus vaccine but that the jab’s benefits continue to outweigh the risks.

“EMA’s safety committee has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects” of the shot, the agency said in a statement.

“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin,” the EMA said.

The findings come as a major hurdle in the global fight against the pandemic and a shift in the stance of the regulator,which had last week backed the vaccine and said there was no increased risk of blood clots in general from the shot.

It is also a blow to AstraZeneca, which was a front runner in the race for making an effective vaccine against Covid-19 ever since it began working with the University of Oxford.

The EMA’s safety committee, which was assessing the vaccine, has requested more studies and changes to the current ones to get more information.

AstraZeneca said it is working with European and British regulators to change the product information on the vaccine.

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“Both of these reviews reaffirmed the vaccine offers a high-level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks,” the company said in a statement.

“However, they came to the view that these events have a possible link to the vaccine and requested they be listed as an extremely rare potential side effect … AstraZeneca has been actively collaborating with the regulators to implement these changes to the product information.”

Oxford University said the identification of rare blood clots that might be linked to the jab showed safety systems worked, emphasising that British and European regulators had found its benefits outweigh the risks.

“We are reassured to see that safety monitoring continues under the close scrutiny of regulators … The identification of rare cases of blood clots, which might be associated with the vaccine, shows that the safety system works,” Andrew Pollard, director of the Oxford Vaccine Group, said of the reviews into the jab.

“(The system) has also allowed MHRA (Medicines and Healthcare products Regulatory Agency in UK) and EMA to conclude that the benefits of vaccination continue to outweigh the risks, while putting in measures to help mitigate any possible risk.”

EMA Executive director Emer Cooke told a press briefing: “First of all, I want to start by stating that our safety committee, the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency, has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects.

“Covid-19 is a very serious disease with high hospitalisation and death rates and everyday Covid is still causing thousands of deaths across the EU.

“This vaccine has proven to be highly effective – it prevents severe disease and hospitalisation, and it is saving lives.

“Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.

“The PRAC, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”

The EMA said most of the cases of blood clots reported have occurred in women under 60 within two weeks of vaccination with the AstraZeneca jab, but that no specific risk factors had been identified based on current evidence.

The agency said symptoms associated with the blood clots include shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin beyond the area where the injection wad administered, and anyone who displayed them should seek medical attention.

The committee carried out an in-depth review of 62 cases of clots in the brain and 24 cases of clots in the abdomen as of 22 March, with 18 of the combines cases proving fatal.

They came from reporting systems in the European Economic Area and the UK, from around 25 million people who had received the vaccine.

The “unusual” blood clotting following vaccination with the AstraZeneca jab should be listed as a “possible side effect of the vaccine”, said Dr Sabine Straus, safety committee chairwoman at the EMA.


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The head of the Pharmacovigilance Risk Assessment Committee (Prac) said the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects.

Dr Sabine Straus said: “This vaccine has proven to be highly effective, it prevents severe disease and hospitalisation and it is saving lives.

“Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.

“Prac, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination of the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”

Here, the National Immunisation Advisory Committee (NIAC) said it notes the finding from the EMA and its current advice regarding the AstraZeneca vaccine still applies.

In a statement it said that as previously advised, healthcare professionals and people receiving vaccines should be informed that very rare, complicated clotting events have been reported in a small number of people who have recently received the AstraZeneca vaccine.

NIAC said it would meet to discuss the EMA’s statement and would consult with EU colleagues.

It will also consider whether any further advice is required to be issued to the Department of Health.

Under-30s in UK offered alternative to AstraZeneca jab

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said there were still huge benefits of the AstraZeneca vaccine in preventing Covid-19 and serious disease.

However, due to a very small number of blood clots in younger people, those under the age of 30 will be offered Pfizer or Moderna jabs instead.

Up to 31 March, the MHRA has received 79 reports of blood clots accompanied by low blood platelet count, all in people who had their first dose of the vaccine.

Of the 79, a total of 19 people have died, although it has not been established what the cause was in every case.

The 79 cases occurred in 51 women and 28 men, aged from 18 to 79.

Of the 19 who died, three were under the age of 30, the MHRA said.

Fourteen of the cases were cerebral venous sinus thrombosis (CVST), a specific type of clot that prevents blood from draining from the brain.

The other five cases were thrombosis.

The MHRA has concluded that the balance of risk for the vaccine is “very favourable for older people” but more finely balanced for younger groups.

British Prime Minister Boris Johnson said the government believes the Oxford/AstraZeneca vaccine is “safe”, telling reporters on a visit to Cornwall: “But the crucial thing for everybody is to listen to what the scientists, the medical experts have to say.”

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