UPDATED – EU regulator says AstraZeneca vaccine ‘safe and effective

Reading Time: 7 minutes

AMSTERDAM, March 18 (Reuters) – The EU’s drug watchdog said on Thursday it is still convinced the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks following an investigation into reports of blood disorders that prompted more than a dozen nations to suspend its use.

The news came as the European Medicines Agency (EMA) director Emer Cooke said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

But she said in a briefing the “clear” conclusion of the review was that the vaccine “benefits in protecting people from COVID-19 with the associated risk of death or hospitalisation outweighs the possible risks.”

The agency will however update its guidance to include an explanation about the potential risks on both the patient leaflet and in the information for healthcare professionals, she said.

“This is a safe and effective vaccine,” said Cooke.

The agency has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review covering 5 million people, included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

The EMA’s focus and primary concern has been on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST).

More than 45 million of the shots have been administered across the EEA.

At least 13 European countries, including France, Germany and Italy, have stopped administering the shot pending the review.

Britain’s medicines regulator said on Thursday it was investigating five cases of CVST among people given AstraZeneca’s vaccine but it reaffirmed that the benefits of the shot far outweighed any possible risks.

The World Health Organization also this week reaffirmed its support for the shot.

AstraZeneca has said a review covering more than 17 million people who had received its shots in the EU and Britain had found no evidence of an increased risk of blood clots.

Many governments have said the decision to pause inoculations was out of an abundance of caution.

But experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants.

The bloc’s vaccine roll-out has lagged the United States and former EU member Britain.

What was said:

Following are reactions after the European Medicines Agency (EMA) gave an update on its views on the Oxford-AstraZeneca vaccine.

MORGANE BOMSEL, VACCINES EXPERT & RESEARCHER, FRANCE’S NATIONAL CENTRE FOR SCIENTIFIC RESEARCH (CNRS)

On the information available, it is a good general stance taken by EMA, Bomsel said. “A restart in vaccinations with this vaccine will be a positive signal for the public.”

ENRICO BUCCI, BIOLOGIST AND EXPERT IN SCIENTIFIC DATA ANALYSIS AT TEMPLE UNIVERSITY IN PHILADELPHIA, U.S.

“The communication disaster of the past few days is unrepairable, so EMA could not today make any possible communication to repair what the governments have done.

“On the other hand, EMA has always said that vaccination should not be interrupted. It is the governments that have made political and emotional decisions. The important thing is that the EMA today reiterated what it has always said, and which is also what all scientists except a few German scientists have always said: that there is not the slightest significant percentage of cases of thrombosis, and that the vaccine is safe.

“EMA also said other interesting things, such as the possibility that these rare events may be due to previous infections and not to the vaccine.”

JESSE GOODMAN, PROFESSOR OF MEDICINE AND INFECTIOUS DISEASES AT GEORGETOWN UNIVERSITY AND A FORMER CHIEF SCIENTIST DIRECTOR OF THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH AT THE U.S. FOOD AND DRUG ADMINISTRATION

“When people have cerebral venous clots, among the most common underlying conditions are oral contraceptives and pregnancy.”

Goodman also said there are several hereditary and acquired defects in the system that regulates blood clotting.

“It could be when you look at cerebral venous thrombosis that patients often have some unusual predilection to thrombosis, like they were pregnant or had oral contraceptives or some of these were coagulation disorders. My guess is if this ends up being a rare event associated with vaccine, it could be through one of those kind of mechanisms. It could be that it occurs in individuals who perhaps have a predisposition along one of those lines, but I think this is totally speculative at this point.

“I think EMA’s position, which is to allow informed immunization while this continues to be investigated is a reasonable assessment of risk and benefit based on the current situation.

“I think transparency and honesty with the public is always the best approach, even though it’s often difficult to explain to people.”

PROF. ANDREW POLLARD, CHIEF INVESTIGATOR ON THE OXFORD VACCINE TRIAL

“I welcome the news that both the MHRA and EMA have reiterated that the vaccine’s benefits continue to outweigh any potential risks, and the vaccine should continue to be administered.

“Thousands of cases of COVID-19 are occurring across Europe every day, the rate of covid is rising in many countries on the continent and vaccination remains a central component of our fight against the pandemic virus.

“It is important that public health bodies monitor the roll out of the vaccine, and safety has to be paramount with any new medicine. Importantly, real-world data shows the clear impact of the vaccine on public health – with far fewer cases and hospitalisations from coronavirus in those who have been vaccinated.”

DR DOUG BROWN, CHIEF EXECUTIVE OF THE BRITISH SOCIETY FOR IMMUNOLOGY

“When developing a new vaccine, the two most important factors are safety and effectiveness. All vaccines have to go through rigorous clinical trials before they are approved for use and they are then monitored during subsequent rollout by the appropriate safety authorities, which in the UK is the Medicines Healthcare products Regulatory Agency (MHRA). The approved COVID-19 vaccines in the UK have all been through this thorough process.

“Over the last few days, a number of countries decided to pause the rollout of the AstraZeneca-Oxford COVID-19 vaccine to double check that having the vaccine is not linked to any cases of blood clots. These reports can sound worrying but we need to put the risk into perspective. As we all know, people fall ill for a multitude of reasons. As has happened in this case, it is right the medicines regulators review the evidence to work out what the cause is behind the rare reports of blood clots and whether it is linked to having been given the vaccine or not.

“We must remember that COVID-19 is a disease that can have serious consequences in its own right, including the development of coagulation problems. In the case of the AstraZeneca-Oxford vaccine, the European Medicines Agency have concluded the vaccine is safe and effective and recommend the continuation of the vaccine rollout, a viewpoint backed up by the UK regulator, the MHRA.”

STEPHAN LEWANDOWSKY, AN EXPERT IN COGNITIVE PSYCHOLOGY AT THE UNIVERSITY OF BRISTOL, UK

Risk management is “a very difficult issue, and different member states and countries may well come to different decisions on it”.

“Exercising precaution is one possible way in which policy makers manage risk, and it is more prevalent in European countries than the U.S. or U.K., where the emphasis is more on weighing of risks and benefits.

“Given that the European public is generally risk averse, the suspension and careful examination of the cases by the EMA may therefore help maintain public trust in the vaccination process, even though it may also mean that more people will get sick from COVID-19 than if the vaccinations had continued.”

PROF. GINO MARTINI, CHIEF SCIENTIST, ROYAL PHARMACEUTICAL SOCIETY, UK

“I hope that any concerns about potential links between the Oxford-AstraZeneca COVID-19 vaccine can now be discarded given the positive verdicts delivered by the EMA, the WHO and the MHRA (UK’s Medicines and Healthcare products Regulatory Agency), who have all now said it is safe, effective and can continue to be used. The vaccine is playing a crucial role in protecting vulnerable groups from hospitalisation and death and helping to decrease infection rates across the UK.

“As trusted health professionals, pharmacists are playing a key role in administering COVID-19 vaccinations and have contributed enormously to the success of the programme so far. We have full confidence in these vaccines and can confidently state that pharmacists can continue administering them to patients. It is so important that we get all those at risk from the virus vaccinated as soon as possible.”

ANTONELLA VIOLA, PROFESSOR OF IMMUNOLOGY AT ITALY’S UNIVERSITY OF PADUA

“EMA reiterates that the benefits outweigh the risks … very few cases of thrombosis and in line with what would be expected anyway from the non-vaccinated population. However, they do not exclude the possibility of a link between the vaccine and these rare episodes … and therefore pharmacovigilance will continue.

“So what we have to do is this: we must reassure everyone, these events are extremely rare and the vaccine continues to show a very high level of safety.”

JACQUES BATTISTONI, HEAD OF FRENCH DOCTORS’ UNION MG “We are delighted with the EMA’s announcement which paves the way for a restart of vaccination with the AstraZeneca vaccine in France. General practitioners will be able to do so as soon as Friday if the French government authorizes us to do so.”

(Reporting by Anthony Deutsch and Toby Sterling in Amsterdam and Ludwig Burger in Frankfurt Writing by Josephine Mason in London;Editing by Elaine Hardcastle; Kate Kelland, Julie Steenhuysen, Emilio Parodi and Matthias Blamont)

This is a developing story

Related Stories