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EU Drug Regulators Say AstraZeneca Vaccine Benefits Outweigh Risks

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The drug regulatory authority of the EU, the European Medicines Agency, released the results of its intensive investigation into the safety of the AstraZeneca coronavirus vaccine on Tuesday, saying its benefits still outweighed any potential risk of blood clot formation.

The drug regulator admitted on Wednesday that it found a “possible link” between the AstraZeneca coronavirus vaccine and a rare clotting disorder but EMA officials refused to impose any new age restrictions, saying the benefits of the AstraZeneca vaccine still outweigh risks.

In a surprising move, however, the U.K. drug regulatory body said that it would offer people under 30 the choice of another product and it stopped the ongoing trials of the vaccine on teenagers.

EMA admits “very rare” blood clotting events after AstraZeneca vaccination

The EMA described the clots which have occurred as “very rare” side effects. It said most of the cases reported have occurred in women under 60, and within two weeks of vaccination. However, based on the currently available evidence, it was not able to identify specific risk factors.

Experts reviewed several dozen cases that came mainly from Europe and the United Kingdom, where around 25 million people have received the AstraZeneca vaccine so far.

Emer Cooke, the agency’s executive director, stated on Wednesday “The reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”

However, the body placed no new age restrictions on using the vaccine in people 18 and over, as some countries have done.

“The risk of mortality from COVID is much greater than the risk of mortality from these side effects.” Cooke noted in his remarks.

“Benefits continue to outweigh risks”

Dr. June Raine, the head of Britain’s Medicines and Healthcare Products Regulatory Agency, agreed with the EMA finding, saying that, in her opinion, the benefits “continue to outweigh the risks for the vast majority of people.”

She admitted that the unusual cases of thrombosis are a “potential side effect” of the vaccine and said the evidence for this was “firming up,” but more study was needed to be sure.

The vaccine has been the focus of many reports of thrombosis, or the formation of blood clots, and even deaths, across the European Union since its administration began in January of this year.

Greek professor collapses after receiving vaccine

In February, a 63-year-old university professor collapsed within the first 24 hours after receiving the first dose of the AstraZeneca vaccine in Athens, Greek Reporter learned exclusively, as concerns over the side effects of the vaccine grew throughout Europe.

The 63-year-old professor, who spoke exclusively to Greek Reporter, collapsed on February 18, one day after he received the first dose of the AstraZeneca vaccine.

“I suddenly fainted as I was talking to a colleague in the office,” he tells Greek Reporter.

“I was standing up and fell to the floor like a sack of potatoes. I was told I remained unconscious for about two minutes.”

The professor says that he sustained an injuries to his face and head from the fall — but things could have been worse if the incident had happened a few minutes before as he had been driving his car. After the man regained consciousness, he received first aid from colleagues and an ambulance was called.

He was taken to Thriasio Hospital where a series of tests were carried out. However, the results showed that there was nothing wrong with his general health and no indication of what had caused the collapse.

“It was the first time in my life that something like that happened to me,” the Professor says, adding that he suffers from no underlying health issues.

Several other Greek people have reported thrombosis events after receiving the shot, including a man who airlifted from a Greek island to an Athens hospital, and a woman who died after receiving the shot, although her death has not officially been tied to the vaccination at present.

Vaccine has been given to 25 million individuals

The vaccine, created by Oxford University and the Anglo-Swedish form AstraZeneca, has been given to at least 25 million individuals in both the EU and the UK since its approval earlier this year.

The eagerly-awaited recommendations had been feared to have far-reaching effects on the rollout of the vaccine, which is less expensive than the mRNA-based Pfizer and Moderna shots and has been used extensively in many countries across the world.

The AstraZeneca vaccine is currently before the US drug regulator FDA, which is are continuing to determine its safety before it gives the green light to its use in the United States.

UK study on AstraZeneca vaccination of teenagers halted

But alarm bells sounded when testing of the AstraZeneca vaccine in children was halted on Tuesday due to these lingering fears of thrombosis.

Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, said in comments to Rome’s Il Messaggero newspaper on Tuesday that “it is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets.”

But Cavaleri acknowledged the agency hadn’t yet figured out how exactly the vaccine might be causing these rare side effects. The agency said its evaluation “has not yet reached a conclusion and the review is currently ongoing.”

The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It is also evaluating reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding.

Blood clots “very unusual”

The EMA, the World Health Organization and numerous other health authorities have said repeatedly that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risks of rare blood clots.

As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected. To date, most of the cases have been reported in younger women, who are more susceptible to developing such rare clots anyway, making understanding what is causing the clots potentially more difficult.

“The problem is these clots are very unusual, and we don’t really know what the background rate of them is, so it’s very hard to know if the vaccine is contributing to this,” said Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee.

A full investigation would likely take months, but English said given the urgency of the continuing pandemic, regulators would likely make a quick decision.

“It’s very likely we will see a suspension of the vaccine’s use in certain groups while they do the further investigations to give us clearer answers,” English said.

More than a dozen European countries halted Astra Zeneca use in March

In March, more than a dozen countries, including Austria, Norway, Italy, France and other European nations, suspended their use of the AstraZeneca product over the blood clotting issue. Most restarted their campaigns, however, albeit with some with age restrictions, like Canada, after the EMA encouraged countries to continue using the potentially life-saving vaccine.

The suspensions are still viewed as particularly damaging for AstraZeneca because they came after several missteps in how the company reported data on the vaccine’s effectiveness and lingering concerns over its efficacy in older people.

This situation has led to frequently changing advice in some countries on who can receive the vaccine, leading to concerns that AstraZeneca’s credibility could be permanently damaged.

In another nightmare scenario, the concern could lead to yet more vaccine hesitancy amongst the public, prolonging the pandemic even further.

“We can’t afford not to use this vaccine”

“We can’t afford not to use this vaccine if we are going to end the pandemic,” declares English, the former chair of the BMA’s Public Health Medicine Committee.

The AstraZeneca product is not only cheaper but is also easier to store than many others, making it critical to Europe’s immunization campaign.

It has become a standby of the U.N.-backed program known as COVAX, which is tasked with getting coronavirus vaccines to some of the world’s poorest countries.

The latest suspension of AstraZeneca came in Spain’s Castilla y Leon region, where health chief Veronica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary.

“If there are in fact individuals of a certain age group that could have a higher risk (of clotting) then we need to adjust its use,” Casado told Spanish public radio. “We are not questioning AstraZeneca. We need all the vaccines possible to reach the goal of 70% of the adult population.”

U.K. regulator reports 30 thrombosis cases linked to AstraZeneca vaccine

French health authorities said they, too, were awaiting the EMA’s conclusions and would follow the agency’s recommendations, especially for the 500,000 people who have already received a first dose of AstraZeneca.

English said that even rare, serious side effects are seen with established vaccines and that policymakers often decide that overarching public health goals makes their use feasible; the polio vaccine is an example of this, he states.

For every one million doses that are given of the oral polio vaccine, for example, approximately one child is paralyzed from the live virus contained in the vaccine.

Yesterday, AstraZeneca and Oxford University, the joint developers of the vaccine, stopped a study of the shot in children while the U.K. drug regulators evaluate the link between the shot and rare blood clot formation in adults.

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