European Medicines Agency rules AstraZeneca vaccine is ‘safe and effective’

‘I would be vaccinated with AstraZeneca tomorrow’ EMA’s Emer Cooke says

Sabine Strauss, the chair of the EMA's risk assessment committee (PRAC), said there was "no higher risk of thromboembolic events happening after being vaccinated," and that the risks may even be reduced. Video: Reuters

 

The AstraZeneca vaccine is safe for use and its benefits in protecting recipients from Covid-19 outweigh the risks of side effects, but patient information will carry a warning of the risk of very rare blood clots from now on, the European Medicines Agency chief Emer Cooke has announced

“The committee has come to a clear scientific conclusion. This is a safe and effective vaccine. Its benefits in protecting people from Covid-19... outweigh the risks,” Ms Cooke announced after the medical agency’s safety committee gathered experts to scrutinise evidence from across Europe.

The investigation will allow people to make “informed decisions” and allow healthcare providers and patients to be alert for such side effects and act on them according.

“If it was me, I would be vaccinated tomorrow,” Ms Cooke said. “But I would want to know if anything happened to me after vaccination what I should do about it.”

Overall, the rate of blood-clotting events seen in people who have received the vaccine are “lower than the expected in the overall population”, said the Chair of EMA’s Safety Committee (PRAC), Sabine Straus.

“PRAC has also concluded that there is no increase in the overall risk of blood clots with this vaccine, moreover because this vaccine is effective in preventing Covid-19 disease, which in itself is a cause of blood clots, it likely reduces the risk of thrombotic events overall,” Dr Straus said.

Continued investigation

However, the regulator is to continue investigating a handful of cases of a rare kind of blood clotting as the evidence is not currently sufficient to conclude whether or not there is a link to the vaccine, she said.

Out of 20 million vaccinated people, there were reports of seven cases of a rare condition of small blood clots forming throughout the body called disseminated intravascular coagulation, and 18 cases of a brain-clot condition called cerebral venous sinus thrombosis. The reports were from Germany, Italy, Norway, Spain, the United Kingdom, and India.

These will be the focus of further investigations to try to understand whether there is a link to the vaccine, and if so what risk factors could be.

The cases notably occurred particularly among younger women, who are at a higher risk of blood clots compared to the general population, and the investigation will focus on possible risk factors including smoking, the use of contraceptives, and whether the patients concerned had had Covid-19 in the past.

The current available evidence is “not sufficient to prove with certainty whether these events are indeed caused by the vaccine or not”, Dr Strauss said.

However, the EMA has recommended that patient information leaflets and the side-effect warnings that accompany the vaccine should be updated to include the rare clotting events so that healthcare providers and patients can be on the look out for them.

The fact that fewer cases were reported in the United Kingdom, which vaccinated 11 million people, may be because the vaccines were largely given to older people there instead of the younger groups that received it in EU countries.

Ms Cooke would not comment on whether national regulators had made the right decision to suspend vaccinations pending the review, but said it was important to use vaccines that prevent Covid-19, noting that the disease was killing thousands of people in Europe including 2,500 in a single day last week.

“We just have to continually remind ourselves of what a difficult situation we are in,” the Irishwoman said.

“This pandemic is costing lives. We have vaccines that are safe and effective and can help prevent deaths and hospitalisation. We need to use those vaccines within the environments that we have them.”

Irish reaction

Opposition parties welcomed the news, but called for clarity on how vaccine targets will be met.

Róisín Shortall, co-leader of the Social Democrats, called the news from the EMA “a welcome reassurance”, adding that it should “give us confidence that the EMA’s rapid review could be undertaken quickly and that NIAC is thorough and cautious about potential safety concerns”.

She called on the Government to make clear the next steps in hitting the target of 1.1 million doses administered by the end of March.

“If the 1.1 million target is still the current goal, even allowing for the 30,000 missed doses.. Then we need to be administering between 28,000 and 30,000 daily,” she said, adding that last week the average daily doses were hovering above 13,000. She said there are “real questions” for the HSE in relation to how they will meet the targets set.

“The Minister needs to be clear about the new projections to the end of Q1 and Q2, as well as the impact that delivery shortfalls and this week’s pause have had on the country’s targets. The public should also be informed about the forecasts and timelines for each cohort and especially the sub-groups within the over 70s.”

Restarting vaccinations

Earlier on Thursday afternoon, infectious diseases consultant Dr Eoghan De Barra of Beaumont Hospital said that if AstraZeneca was given the green light by the authorities they could resume their vaccination programme for the fourth cohort “within hours.”

Speaking on RTÉ News at One, Dr De Barra explained that Beaumont hospital’s programme could be “turned on again” in short order, it could proceed within hours for “in-house” patients and administration could commence organising other vulnerable patients to attend for their vaccine.

“We have AstraZeneca in the fridge. It has a shelf life of six months. We have vaccinators and could proceed within hours.

“We can do 500 patients per day. AstraZeneca is a lot easier to work with than Pfizer. We could make up lost time once we get the green light. With committed staff and longer hours we could catch up.”

Earlier on Thursday, the UK’s National Health Service warned of a “significant reduction” in weekly supply of the Covid-19 vaccine in the from the end of March for one month.

A letter to local health leaders in England asked vaccination centres and community pharmacy-led services to close unfilled bookings and “ensure no further appointments are uploaded” to booking systems in April.

NHS bosses said that as a result of the supply issues, people under the age of 50 should only get the jab if they are in a priority group, meaning younger adults could face a longer wait to be be vaccinated.

The delay in the delivery of five million doses of the AstraZeneca coronavirus vaccine from India is thought to be behind the forthcoming reduction in the UK’s supply.