EU clears AstraZeneca shot for use after blood clot scare – With Insights from The Wall Street Journal

Concerns around the AstraZeneca Covid-19 vaccine causing blood clots in individuals prompted a number of countries to suspend use until further investigatory work had been done. Now, just a few days after a number of European nations stopped using the shot, the EU’s health agency has said the vaccine is ‘safe and effective’. Spain, Italy, Portugal and France have said they will begin using the AstraZeneca shot once again. According to The Wall Street Journal, Canada and Mexico are in negotiations with the United States, ‘to receive a combined four million doses of the AstraZeneca vaccine’. Despite being the world’s most widely used inoculation, studies have shown the shot to have little efficacy on the 501.v2 variant that is common in South Africa.  – Jarryd Neves

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AstraZeneca’s Covid-19 vaccine cleared by EU after blood-clot concerns

Benefits of using the shot outweigh its potential risks and inoculations should proceed, says bloc’s medicines agency

The European Union’s health agency said the Covid-19 vaccine produced by AstraZenecaPLC was “safe and effective” and didn’t increase the risk of blood clots, a decision that prompted four major bloc members to say they would resume inoculation campaigns.

France, Italy, Spain and Portugal said they would start vaccinating residents again after the European Medicines Agency on Thursday said new expert analysis concluded that the benefits of using a Covid-19 vaccine produced by AstraZeneca outweigh its potential risks.

EU authorities are hoping the EMA’s statement could put a problem-plagued vaccination campaign back on track, although it remains to be seen whether the new analysis will overcome mistrust of the AstraZeneca shot—the world’s most widely used vaccine—among many Europeans.

Many European countries, including Germany, France and Italy, suspended the vaccine’s use over the past week following reports that people who had received it developed rare blood clots, and some had died, further slowing Europe’s already sluggish vaccination rollout. Those reports compounded the delays and uncertainties surrounding a drive that has left the EU far behind the U.S. and the U.K. in vaccinating its citizens.

AstraZeneca said after the EMA’s announcement and a similar judgment from British health authorities that the opinions affirmed the vaccine’s benefits. “We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe,” said Ann Tayler, the company’s chief medical officer.

In a sign of European leaders’ impatience to do that, Italian Prime Minister Mario Draghi said after the EMA announcement that the country would resume giving AstraZeneca vaccinations on Friday. France, Spain and Portugal also said inoculations would resume.

Canada and Mexico are also in talks with the U.S. to receive a combined four million doses of the AstraZeneca vaccine.

Europe urgently needs vaccine doses because case numbers are rising amid the spread of new virus strains. French Prime Minister Jean Castex on Thursday announced a partial lockdown for Paris and other parts of the country.

Europeans’ reactions to the EMA announcement were mixed. Rita Szigeti, a retired Parisian who earlier this month received an initial dose of the AstraZeneca vaccine and wants her second dose, voiced pleasure with the announcement. But Corinne Graillot, an assistant engineer at a medical school in Paris who hasn’t been vaccinated, said she preferred to wait for a different option.

“They’ve made such a mess of it that people don’t know what to think anymore,” she said. “They’ve flip-flopped so many times.”

The EMA’s safety committee found the vaccine to be “safe and effective in preventing Covid-19, and its benefits outweigh its risk,” said committee chair Sabine Straus. Dr. Straus said that since blood clots are associated with Covid-19, by inoculating people against the disease, the vaccine “likely reduces the risk of thrombotic incidents overall.”

Health officials have noted that blood clots are widespread for a variety of reasons. Clots have also been noted among people receiving other Covid-19 vaccines and can be caused by medications as common as birth-control pills.

EMA Executive Director Emer Cooke said the experts found a limited number of blood clots that require further study, and the agency “still cannot rule out definitively a link.”

Dr. Straus said a predominance of the blood clots found were among women, particularly younger women. She said it remained “premature to conclude” whether this is linked to greater risk among the groups or the makeup of the populations receiving the vaccine.

Attention to potential side effects of the vaccine is growing. Lucía Ejarque, a 25-year-old teacher from Madrid, had high fever and strong headaches for two days after getting the AstraZeneca vaccine on Sunday. Then the arm where she got the shot started hurting and grew inflamed.

“I got very worried,” she said. She saw her doctor on Thursday, who said the symptoms were among those expected and would likely pass, but that if her arm reddened more she should go to the hospital as a caution, including about thrombosis. Ms. Ejarque said she still trusts the vaccine. “I just hope the pain disappears quickly,” she said.

The EMA on Thursday recommended “raising awareness” by including a warning with the vaccination and informing the public. Such a campaign could help people who receive the AstraZeneca vaccine know what to look for after getting the shot.

Ms. Cooke on Tuesday had expressed concern that doubts being cast on it could hurt public trust in vaccines. Asked in a news conference Thursday if she personally would get the AstraZeneca shot, she said, “If it was me, I would be vaccinated tomorrow, but I would want to know that if something happened to me,” what to do.

Ms. Cooke, noting that many EU countries had suspended use of the AstraZeneca vaccine pending the EMA’s review, said its conclusions should give them “the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns.”

So far, roughly seven million people in the EU, and 11 million in the U.K., have received the vaccine, Ms. Cooke said. It is the world’s most widely used Covid-19 vaccine.

Analysis of the vaccine took on extra urgency this week after the Paul Ehrlich Institute, Germany’s medicines regulator, Monday recommended suspending the vaccine’s rollout pending further investigation.

Institute President Klaus Cichutek defended the recommendation, saying his experts identified seven cases in Germany of cerebral vein thrombosis, a severe brain condition, and three of the people died. Germany’s healthcare ministry said that, based on the number of vaccinations given, it would have expected as many as 1.4 cases of cerebral vein thrombosis, and the seven cases merited a pause.

The EMA collected reports from across Europe, giving it a much larger data set to analyze.

EU countries, including Greece and Belgium continued to use the vaccine, as have Australia, Canada and India.

The U.K., where AstraZeneca developed the vaccine with scientists from University of Oxford, is relying heavily on the vaccine for its relatively fast vaccination campaign. British politicians have criticized their EU counterparts for suspending the vaccine’s use against expert advice.

Many medical experts in Europe and beyond criticized politicians’ decisions to halt vaccinations, saying the known risks posed by the coronavirus are greater than possible ones from AstraZeneca shots. German officials said their suspension was merited because they are urging citizens to take the vaccine, unlike other medications such as contraceptives, which are a personal choice.

European officials who paused vaccinations framed their decisions as precautionary. But based on available data and Covid-19 risks, “the cautionary approach would be to carry on vaccinating,” said Prof. David Spiegelhalter, an expert on statistics and risk at the University of Cambridge. “Casting doubt—lasting doubt—on the safety of the vaccines is not a precautionary position.”

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