Ontario to continue AstraZeneca rollout as Denmark, Norway temporarily suspend its use

Ontario says it plans to proceed ahead with its rollout of the AstraZeneca vaccine despite reports at least two European countries have suspended its use following reports of blood clots in some people.

Denmark temporarily suspended use of the AstraZeneca vaccine, but its health authority said Thursday it has no evidence the vaccine was responsible for the health issues.

Other experts pointed out that of the millions of AstraZeneca vaccine shots administered elsewhere, including in Britain, there have been no reported cases of the vaccine causing blood clots or related problems.

Denmark’s Health Authority said its decision was “based on a precautionary principle” and that one person who developed a blood clot after vaccination had died.

“At present, it cannot be concluded whether there is a link between the vaccine and the blood clots,” authorities said. Danish officials did not say whether the patient had any underlying conditions and did not provide any other details.

In a statement on Thursday, the European Medicines Agency said “the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered” while a closer evaluation of the blood clot cases continues.

“There is currently no indication that vaccination has caused these conditions,” the regulator said. It said the number of people with blood clots in vaccinated people was no higher than those who hadn’t been inoculated.

Some doctors pointed out that people now being immunized against COVID-19 are more likely to already have health problems and that it would be difficult to determine whether a vaccine shot is responsible.

“The vast majority of people being vaccinated at the moment are elderly or have got underlying diseases,” said Dr. Paul Hunter, a professor of medicine at the University of East Anglia. “They will be at increased risk for all sorts of adverse outcomes, regardless of whether or not they have been vaccinated.”

Hunter said there were 11 reports of blood clots in Britain among the more than 11 million people given the AstraZeneca vaccine, and none have been shown to have been caused by the shot. He said pausing immunizations was also a risky decision in itself.

“When you stop vaccinating, you know that some people will die of COVID-19,” he said.

Denmark’s suspension of the AstraZeneca vaccine will last for at least two weeks, the agency said, adding it hinged on an evaluation by the EU medical regulator.

“Like others, I find (the pausing) and its consequences annoying. It’s too early to conclude in this case and when there is a risk, it must be investigated,” Danish Prime Minister Mette Frederiksen said.

After the Danish announcement, Norway decided to follow suit and temporarily suspend the Anglo-Swedish company’ s vaccine, which was developed by the University of Oxford, also saying that there are no proven links. In addition, Italy’s pharmaceutical agency on Thursday ordered a precautionary ban on a particular batch of the AstraZeneca vaccine after what it said were “serious adverse events.”

ONTARIO MOVING FORWARD

Ontario health minister Christine Elliott says the AstraZeneca vaccine has been approved by Health Canada “for both safety and efficacy,” adding the province will continue rolling out the vaccine across pharmacies.

“We don’t have any plans to discontinue AstraZeneca at this time. However, we will be following the investigation and working with Health Canada to determine if any changes need to be made in Ontario’s plan.”

“We are continuing with our AstraZeneca inoculations and we know that several million doses [of different vaccines] have already been administered,” she added.

AstraZeneca released the following statement on Thursday:
“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 AstraZeneca COVID-19 Vaccine. 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.

“We immediately shared this global information with Health Canada and will continue to share evolving data on our vaccine from both Canada and around the world as part of our ongoing pharmaco-vigilance activities.

“An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country with COVID-19 Vaccine AstraZeneca. In fact, the observed number of these types of events are significantly lower in those vaccinated than what would be expected among the general population.”

Eligible Ontarians started standing in lines, making calls and going online to snap up COVID-19 vaccine appointments as shots are being given to those between the ages of 60 to 64 at 325 pharmacies in the Toronto, Windsor and Kingston health units.

The program – which is set to launch broadly Friday – had a “rolling start” Thursday, with some sites already administering vaccines.

Pharmacists association CEO Justin Bates says pharmacies are on track to use up the supply of 165,000 Oxford-AstraZeneca doses they’ve been sent before the shots expire in a few weeks, based on interest from the public so far and capacity at each site.

Canadian health authorities say they are keeping a watchful eye on European investigations of the Oxford-AstraZeneca vaccine.

Dr. Zain Chagla, an infectious disease doctor at St. Joseph’s Hospital in Hamilton, says that Health Canada is constantly reviewing data on vaccines and it is a normal part of the post-approval process to see these types of investigations occur.

He says he will give the vaccine as planned to his patients unless Health Canada changes its current decision that the benefits of the vaccine outweigh the risks.

A DRAMATIC STEP

In an interview with the broadcaster La Sexta, Spanish Health Minister Carolina Darias said there had been no similar incidents in Spain and said only minor side effects had been reported from the AstraZeneca vaccine.

Dr. Bharat Pankhania, an infectious diseases expert at Britain’s University of Exeter, called Denmark’s decision to pause its use of AstraZeneca shots “a dramatic step.”

“The vaccine has been given to several million people all over the world and we have not had similar reports of vaccine-induced clotting,” he said, adding that the blood clots were more likely to be “separate, unconnected events.”

Britain’s medicines regulator reacted by noting there was no confirmation that the reported blood clot was caused by the AstraZeneca vaccine. “People should still go and get their COVID-19 vaccine when asked to do so,” it said.

But Hendrik Streeck, a German virologist at the University of Bonn, said the Danish decision was the right one.

“It’s not clear what the cause was, that’s why the vaccinations are being stopped for now,” Streeck told German broadcaster n-tv. “In very rare cases, there can be a problem with a specific batch. Now they are looking to see what caused the clot.”

“We don’t want to put anybody at risk, but I’m not concerned,” he said. “The exact right thing is being done in Denmark.”

SUSPECT VACCINE BATCH

On Wednesday, the EMA said Austria had suspended the use of a batch of COVID-19 vaccine made by AstraZeneca after a person had been diagnosed with multiple blood clots died 10 days after vaccination, and another was hospitalized with blockage in arteries in the lungs after being vaccinated. The latter is now recovering.

Two other reports of similar problems had been received for this batch as of March 9, the EMA said, though there is no indication that the problems were caused by the vaccine.

The EMA said the 1 million-dose batch in question was delivered to 17 EU countries.

Germany’s Paul Ehrlich Institute, which oversees vaccine matters, said it was in contact with Danish authorities and the EMA on the issue but that no doses from the batch used in Austria were on the German market.