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ASTRAZENECA

AstraZeneca vaccine ‘safe and effective’ against Covid-19, European Medicines Agency concludes

The European Medicines Agency (EMA) concluded on Thursday that the AstraZeneca vaccine was a "safe and effective" tool in the battle against Covid-19 but its investigation could not rule out whether the jab had caused rare cases of blood clotting.

AstraZeneca vaccine 'safe and effective' against Covid-19, European Medicines Agency concludes
Photo: Joe Giddens/AFP

The EMA’s Executive Director Emer Cooke said the agency’s expert committee came to “a clear and scientific conclusion”.

“This is a safe and effective vaccine whose benefits in protecting people from Covid-19 hugely outweigh the risks,” she said but added that further studies would take place to probe possible links between the injection and rare blood clotting cases.

While millions of doses of the vaccine developed with Oxford University have been administered, small numbers of people have developed blood clots, which prompted countries including the European Union’s three largest nations – Germany, France and Italy – to suspend injections pending the EMA investigation.

The EMA’s expert committee was convened at short notice to hold an emergency investigation into the cases of blood clotting.

Cooke said that the vaccine was not associated with an increased risk of thromboembolic events or blood clotting but did add that based on the available evidence “we still cannot rule out definitely a link between these cases and the vaccine.”

In the report on its website the EMA said: “The vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).

“A causal link with the vaccine is not proven, but is possible and deserves further analysis.”

Cooke said the EMA was in favour of “raising awareness of the possible risks of the vaccine and making sure they are included in the product information.”

“If it was me I would want to be vaccinated tomorrow but if something happened to me after vaccination I would want to know what to do about it and that’s what we’re saying today,” said Cooke.

Chair of the EMA’s vaccine safety committee Dr Sabine Strauss said there was no higher risk of thromboembolic events happening after being vaccinated in fact the risks may be reduced.

The EMA will carry out further studies into the vaccine. Those EU countries who paused the rollout of the AstraZeneca vaccine will not have decide whether to continue the injections after the EMA’s conclusions.

‘We have found the cause’

Earlier on Thursday, a group of health experts at Oslo University Hospital concluded that the blood clots in three health workers who took the AstraZeneca vaccine were triggered by an immune system response.

Three health care workers under the age of 50 were admitted to hospital with severe blood clots after taking the vaccine. One of the three later died of a brain haemorrhage.

“We have found the cause. There is nothing but the vaccine that can explain the immune reaction that occurred,” Pål Andre Holme, professor and chief physician at Oslo University Hospital told newspaper VG.

Holme led a team that worked round the clock to find out why the health workers were admitted to hospital with blood clots after taking the vaccine.

Asked about whether the EMA had taken into account the conclusions of Oslo University the agency’s Dr Sabine Straus said committee had taken into account the cases in Norway but had not looked at the report from Norwegian health officials in Oslo.

The World Health Organization on Thursday renewed a call for countries to continue the use of AstraZeneca’s
Covid-19 vaccine, shortly before expected assessments by EU and UN agencies.

The WHO’s Global Advisory Committee on Vaccine Safety (GACVS) — created in 1999 to address safety issues related to vaccines of potential global importance — is due to publish the conclusions of its assessment of the safety of AstraZeneca’s vaccine on Friday.

But as of now, “the benefits of the AstraZeneca vaccine far outweigh its risks and its use should continue, to save lives,” the WHO’s regional director for Europe Hans Kluge told a press conference.

“In vaccination campaigns, it is routine to signal potential adverse events. This does not necessarily mean that the events are linked to the vaccination,” Kluge said

AstraZeneca billed as vaccine of choice

In Britain, which has administered more than 11 million AstraZeneca doses, experts see no evidence of more frequent blood clots among the inoculated.

Prime Minister Boris Johnson wrote in The Times newspaper that the shot “is safe and works extremely well”.

More than 382 million doses of Covid vaccines have been administered globally, the vast majority in wealthier countries while many poorer nations have yet to receive a single dose.

AstraZeneca’s shot, among the cheapest available, was billed as the vaccine of choice for poorer nations and the clot reports have had an impact beyond Europe.

Other countries that halted or delayed the rollout include Indonesia, Venezuela, Denmark, Norway, the Netherlands, Cyprus, Lithuania, Luxembourg and Sweden.

The pandemic spurred unprecedented efforts to develop vaccines, with a number of successful options now available.

Rollouts have been hampered by export controls, bitter diplomatic disputes and production issues – in addition to the AstraZeneca suspension.

Member comments

  1. Already the damage is done. Now a lot of people will hesitate to take this. Hopefully, they distribute this to people who are ready to take it and the age restriction should be removed or relaxed to 45 and above.

    1. The delays caused by this scaremongering is more damaging than anything else. The number of people who have had blood clots after taking this vaccine is minimal, almost negligible compared to the millions who have been given the AZ vaccine. I almost feel that we should all be even more strongly advised to have the jab, the exceptions being those who have a medical condition which exempts them.

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MADRID

UPDATE: What next for the 2 million people in Spain who had the first dose of AstraZeneca vaccine?

Due to side-effect concerns, the Spanish government has decided that the AstraZeneca vaccine is now only going to be given to those aged 60 to 69. But hundreds of thousands of other people in Spain who have received the first dose of this vaccine now find themselves in limbo.

UPDATE: What next for the 2 million people in Spain who had the first dose of AstraZeneca vaccine?
People in the northern Spanish city of León queue to get the Covid vaccine. Photos: CESAR MANSO, GABRIEL BOUYS / AFP

On April 7th, the Spanish government announced it would reserve the AstraZeneca vaccine for those over 60, after an EU regulator said blood clots should be listed as a rare side effect of the jab.

This decision has left 23 percent of those who received at least one dose of the vaccine, in limbo. 

The circa two million people who received just their first AstraZeneca dose, before this announcement was made, mostly includes key workers such as teachers, police, firefighters, physiotherapists and chemists, the majority of them under the age of 59.

Spain’s Ministry of Health has confirmed that only 97 people received both AstraZeneca doses, which were spaced 10 weeks apart.

Those who received the first dose who are between ages 60-69 will still receive their second AstraZeneca vaccine, but what will happen to those who are younger?

Currently, there are two different scenarios that are being considered. 

READ ALSO: Spain reserves AstraZeneca vaccine for those over 60

Will the AstraZeneca vaccine be combined with another inoculation?

A clinical trial conducted by the Carlos III Health Institute is currently taking place, with 600 participants in two hospitals in Madrid, two in Barcelona and one in Bilbao to determine what should be done.

Director of the Institute Raquel Yotti announced that those taking part in the trial will be receiving a second dose of the Pfizer vaccine instead of the AstraZeneca one.

The volunteers were all given their first AstraZeneca vaccine nine weeks previously and out of these, 400 of the participants will receive their second dose of Pfizer.

“This will assess the impact of the intensification of the immune response when the second dose is the Pfizer one,” explained Jesús Antonio Frías, coordinator of the Carlos III Health Institute’s clinical research network.

If the trial is successful, this same method could be carried out on all of the roughly two million people in Spain, who have only received one dose of the AstraZeneca vaccine. 

The study, which has been named CombiVacs, has already been approved by the European Medicines Agency.

The goal was to have the results of the trial as soon as possible, but on April 30th the Health Ministry announced that would delay the fate of those who had received just one dose by an extra four weeks. 

This will take the amount of time between most people’s doses from 12 to 16 weeks. The decision will give extra time for the results of the clinical trial. 

However, the announcement has caused opposition from the Community of Madrid, as well as authorities in Castilla-La Mancha and Aragón.

Even experts from the Spanish Vaccine Commission have proposed that it would be safe to administer the second dose of Astrazeneca to those over the age of 40.

Will those who have been vaccinated with AstraZeneca receive only one dose? 

The second option being considered is that those left in limbo won’t receive a second dose at all. 

It is believed that even a single dose of AstraZeneca provides 70-75 percent protection against Covid-19, according to the news site OK Diario.

Will Spanish regions change their vaccine strategy?

The current government vaccine strategy in principle is to vaccinate those between 60-69 with AstraZeneca and those 70 and above with either Pfizer, Moderna or Janssen.

However, the government recently announced that it will give each autonomous community free reign on which vaccine it will use for the over 60s, depending on its availability.

The Health Ministry said: “Regions can vaccinate with all available vaccines” given that “there will be more than enough”.

AstraZeneca will not be used on a voluntary basis

The government however has categorically rejected the proposals of some regions, including Madrid and Catalonia, to allow those under 60 to be vaccinated with AstraZeneca on a voluntary basis.

It said that it does not seem appropriate to offer the vaccine to those under the age of 60, who wish to be vaccinated with AstraZeneca. 

“Once again, we must remember that which vaccine people receive cannot be based on individual choice, but must be based on efficacy and different population groups,” the Health Ministry wrote. 

READ ALSO: Region by region: What foreigners in Spain should do to register for the Covid-19 vaccine

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