AstraZeneca
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Denmark is latest country to suspend AstraZeneca Covid vaccines amid fatal blood clot fears but regulators say it's safe
DENMARK and Iceland are the latest countries to halt the use of the Oxford/AstraZeneca Covid vaccines over fears of fatal blood clots.

Seven nations have now paused jabs while officials investigate dangerous blood clotting conditions in recently vaccinated people, including one death.

Experts say the move is "super cautious" - and may even be too strong if it denies people a life-saving jab.


Comment: Except that the roll out is essentially a massive experiment with the majority of the vaccines in the EU needing to be pushed through with emergency legislation, meaning we don't actually know for sure what the real benefit to life is yet, if any.


And regulators in the UK and EU moved to reassure people the vaccines are safe.

A spokesman for the MHRA, who safety checked the jabs in the UK, said: "People should still go and get their COVID-19 vaccine when asked to do so."

Their counterparts in the EU, the European Medicines Agency, said the vaccine can still be administered while investigations continue.

In a tweet, Denmark's health minister Magnus Heunicke said blood clots were a "possible serious side effect".

However, added: "It is currently not possible to conclude whether there is a connection."

Iceland's Chief Epidemiologist Þórólfur Guðnason said in a press briefing on March 11 that the country would also suspend the vaccine's use until more information became available, according to the Iceland Review.

While Denmark and Iceland have frozen all use of AstraZeneca's jabs, Austria, Estonia, Lithuania, Luxembourg and Latvia have suspended use of doses from one batch at the source of concern.


Comment: This may be caused by a single batch or it may be that, now that millions have been vaccinated, the correlation between the vaccines and blood clots are becoming clear.


The European Medicines Agency (EMA) said the batch - labelled ABV5300 and comprised one million doses - had been delivered to 17 EU countries.

It does not include the UK, where regulators have urged people to still get their vaccine.


Comment: So the UK is willing for its citizens to take the risk?


The Medicines and Healthcare products Regulatory Agency (MHRA) said: "This is a precautionary measure by the Danish authorities.

"It has not been confirmed that the report of a blood clot was caused by the AstraZeneca Covid-19 Vaccine.

"People should still go and get their COVID-19 vaccine when asked to do so."

Dr Phil Bryan, MHRA Vaccines Safety Lead said: "Vaccine safety is of paramount importance and we continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks.

"Blood clots can occur naturally and are not uncommon. More than 11 million doses of the COVID-19 Vaccine AstraZeneca vaccine have now been administered across the UK.

"Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population."

It comes after the EMA said a person had died of multiple thrombosis - formation of blood clots within blood vessels - 10 days after receiving a dose from this batch.

The Danish Health Authority said the death was in Denmark.

A second patient was diagnosed with pulmonary embolism - where blockages form in the arteries in the lungs - but is now recovering.

As of Tuesday this week, two other clotting conditions had been identified in patients that had received a dose from the same batch.

But the EMA said currently, there is no evidence that the vaccine caused the conditions.


Comment: The evidence can take some time to accumulate.


In an update on March 11, the agency's safety committee said "the vaccine's benefits continue to outweigh its risks and the vaccine can continue to be administered" while the investigation is carried out.

Thrombosis - the medical term for blood clotting - is not listed as a potential side effect of the vaccine.


Comment: Not yet.


It could be a coincidence that the patients' developed the life-threatening conditions - for which there are many risk factors - for other reasons.

The EMA said "the number of thromboembolic events in vaccinated people is no higher than that seen in the general population".

As of March 10, there had been 30 reports of blood clotting conditions among the five million people to receive the AstraZeneca jab in the European Economic Area.


Comment: These are reports we know about. It's unlikely all 5 million people have been reporting the side effects they've experienced. Moreover, it's possible more have experienced blood clotting, or other seriously detrimental side effects, and they just haven't yet realised it.


But the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will conduct an investigation while countries hold off using the doses.

The EMA said: "Although a quality defect is considered unlikely at this stage, the batch quality is being investigated."

It said PRAC were investigating the thrombosis conditions linked to the same batch as well as all other reports of thrombosis and related blood clotting conditions reported post-vaccination.

"The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population," it said.

An AstraZeneca spokesperson said: "Patient safety is the highest priority for AstraZeneca.

"Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes Covid-19 Vaccine AstraZeneca.

"The safety of the vaccine has been extensively studied in Phase III clinical trials and Peer-reviewed data confirms the vaccine has been generally well tolerated."


Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said: "This is a super-cautious approach based on some isolated reports in Europe.

"The first thing to do is to be absolutely certain that the clots did not have some other cause, including Covid-19."

Prof Evans said the "risk and benefit balance is still very much in favour of the vaccine in my view".

He said if there was no shortage of alternative vaccines, then the "extreme precautionary approach as taken in Denmark may be justified".


Comment: Vaccines aren't necessary for the vast majority of people, however, the EU has, for political reasons, been delaying the approval of Russia's vaccine which has been through much more rigorous testing.


"If however this action stops some people getting the vaccine who are then vulnerable to Covid-19, then it is a mistaken use of precaution", he said.

"As far as one can tell there has not been a 'signal' of such problems in the UK and even if there were a 'signal', based on spontaneous reports, there needs to be a proper, rapid, epidemiological study to see if it is coincidence or not."

Millions of Brits have received the AstraZeneca vaccine alongside the jab from Pfizer - both of which have been rigorously tested to ensure they are safe.


Comment: Switzerland and India weren't convinced that the vaccines on offer were safe.


It's normal for side effects to occur after vaccination, the most common being pain at the site of injection, fatigue and a fever.

In clinical trials, one in ten people who had the AstraZeneca vaccine suffered tenderness at the injection site, generally feeling unwell, fatigue, chills, a headache, nausea or muscle pain.


Comment: The clinical trials were small and limited in their scope in the types of people the vaccines were tested on; i.e. they experimented on young and healthy people.


There were no events of blood clotting in the trials of tens of thousands of people across the globe.

According to the MHRA, 143 Brits have died shortly after having their Covid jab. But it said the vaccines are "safe" and didn't play a role in the deaths.


Comment: Meanwhile anyone who dies after testing positive for Covid in the same period is recorded as a Covid death.


Sir John Bell, regius professor of medicine at Oxford University and a member of the Government's vaccine taskforce, has previously said any vaccine side effects of Covid vaccines "should be apparent within two to three months".


Comment: Note that the UK vaccine roll out around the 8th, which makes it about 3 months since the first doses were given.


Speaking to BBC Radio 4's Today programme, he said: "One always worries about side-effects from vaccines.

"I suspect that we will work through any issues about side-effects pretty quickly."

Previously, the Pfizer vaccine was investigated after a spate of deaths in elderly people in Norway.

But the Norwegian Medicines Agency concluded there was no "direct link" between the jab and the 33 deaths.

All of those who died were care home patients over the age of 80, and were already sick, the agency said.

Despite rife misinformation about vaccines, Brits have proven to be keen to get their jab, to the relief of ministers.


Vaccines minister Nadhim Zahawi told MPs yesterday that 94 per cent of the UK adult population had said they were likely or very likely to take up the coronavirus vaccine.


Comment: The UK public is being coerced with the looming threat of vaccine passports: 'Papers, please': Vaccine Passports have officially arrived


He told the Commons Women and Equalities Committee: "When I took this job on back in mid-November, I think if you look at the ONS data or other published polls, vaccine positivity was in the high 70s, touching 80 per cent.

"It's now at 94 per cent of the UK adult population saying that they are likely or very likely to take the vaccine.

"I think that is, for your committee, the best measure that the strategy is working, watching that number continue to climb - the highest probably in the world, I think, if I'm not mistaken, in terms of vaccine positivity."