AstraZeneca’s coup and the cost of fragmented decision-making | News on the coronavirus pandemic

Elena Hugony was sure of one thing when she walked into a COVID-19 vaccination center in the Italian city of Palermo last week: She was not going to be injected with the AstraZeneca vaccine.

Sure enough, when a healthcare professional approached her with a photo of the jab developed by the Anglo-Swedish pharmaceutical giant and the University of Oxford, the 75-year-old stuck to her belief. With Hugony refusing to leave, a doctor finally relented after four hours and gave him an injection of the Moderna vaccine.

“No way I’m going to get the AstraZeneca, with all the confusion around it,” Hugony said.

The confusion felt by Hugoni – and shared by many others around the world – is apparently the result of a number of missteps that have delayed a vaccine long touted as one of the world’s best hopes for beating the coronavirus. Disorderly clinical trial data and manufacturing issues have all damaged the reputation of the AstraZeneca jab, experts say, while recent reports linking it to very rare blood clots have further undermined public confidence.

All this, although the European Medicines Agency (EMA) and the World Health Organization (WHO) constantly stress that the benefits of the vaccine far outweigh the risk of side effects and advise against any restrictions on its use. Yet national health authorities have moved forward with their own risk-benefit assessments, which, remarkably, have drawn different conclusions – ranging from limiting the use of the vaccine in different age groups to suspending the vaccine. its use and even its complete abandonment.

Such fragmented decision-making, experts warn, can undermine efforts to build public confidence, and have unintended implications for countries that do not have access to other vaccination options besides the AstraZeneca vaccine, whose last clinical trial in the United States showed an effectiveness of 76%. to the prevention of symptomatic diseases.

“It is not clear why some countries have made certain decisions, especially when regulators have not suggested that there should be restrictions based on age,” said Penny Ward, visiting professor of pharmaceutical medicine. at King’s College London.

“There was a lot of heat, but little light as the vaccine is clearly effective in preventing deaths and hospitalizations,” she added.

European medicines regulator stressed that the benefits of the AstraZeneca vaccine outweigh all the risks [File: Alessandro Garofalo/Reuters]

The possible link between blood clots and the AstraZeneca vaccine was first detected in Norway in early March, followed by cases found in Germany and the Netherlands. The results prompted at least 16 European countries to suspend or limit deployment of their AstraZeneca vaccine pending further investigation.

In the United Kingdom, the country’s health authorities, as of April 5, had received 100 cases of blood clots, including 22 fatalities. The country had then administered more than 20.6 million first doses of the AstraZeneca vaccine. Following a review, the UK regulator estimated the risk of hospitalization from COVID-19 to be greater than the threat of severe harm from the vaccine for all age groups, but for those under 30 years, for which he recommended the use of another vaccine. .

For its part, the EMA mentionned its surveillance system, as of April 4, had received 169 cases of blood clots in the brain (CVST) and 53 in the veins of the abdomen (SVT), out of a total of 34 million doses administered in the European Union and Great Britain. Most cases have occurred in women under the age of 60 within two weeks of the first injection.

The regulator said on April 7 that it had conducted a thorough review of 62 cases of CVST and 24 cases of SVT, including 18 fatalities. He said his analysis found that the benefits of the vaccine outweighed the risks and that there was no evidence for specific risk factors such as age.

The UK, which is leading the way in its vaccine rollout with nearly 50% of its population already vaccinated, has taken a more relaxed approach by swapping the vaccine only for people under 30. [File: Tolga Akmen/AFP]

However, Germany decided to suspend its administration for people under the age of 60, a move which experts said was in line with the country’s “more conservative approach” of the health authority.

Italy has done the same, while France and Belgium have restricted the use of the vaccine to those under 55. Spain, meanwhile, has left health experts scratching their heads by choosing to restrict its use to people aged 60 to 70.

German and French health authorities went further by recommending that those who had received a first dose of AstraZeneca use a different vaccine for the follow-up vaccine, despite the limited clinical data supporting the effectiveness of the mixture of the products.

Norway has suspended use of the vaccine pending further investigation, while Denmark on Wednesday became the first country to withdraw it entirely from its national immunization program.

Explaining their reasoning, the Danish authorities said that beyond the risk of possible blood clot links, they could opt for such an approach as the epidemic curve is currently largely under control, as well as thanks to the country’s access. COVID-19 vaccines developed by Pfizer and Moderna.

Indeed, it is this access to alternative offers that underlies some of the decisions of these richer countries regarding the AstraZeneca vaccine.

“In Germany we have a lot of other vaccines, so we can only use AstraZeneca doses for people over 60 years old,” said Johannes Oldenburg, professor of transfusion medicine at the University of Bonn.

“In this way, we can use all our vaccine resources while reducing the risk of complications,” he added.

However, as the coronavirus pandemic continues to ravage the world (recorded global infections per week have almost doubled in the past two months), experts warn countries with better access to vaccines should think beyond their audiences. national and be more responsible with the message they convey. nations struggling with shortages.

WHO estimates that out of all doses administered worldwide, an average of one in four people in high-income countries has received a vaccine, compared to one in 500 in low-income countries.

The AstraZeneca vaccine, a “not-for-profit” product that is cheaper to buy and easier to store compared to other vaccines, is considered a key element in achieving vaccine equity because it is an essential component of COVAX, a mechanism global designed to ensure that the poorest countries receive their share of blows. COVAX aims to deliver 600 million vaccines, mainly AstraZeneca vaccine, to around 40 African countries.

“When the information comes out and you poison an idea, such as the safety of a vaccine, it’s hard to take it away,” said Abdhalah Ziraba, epidemiologist and researcher at the Africa Population and Health Research Center. in Nairobi.

However, Ziraba noted that in Kenya, a country affected by a major resurgence of the virus and where only 0.7% of the population has received a single dose of the vaccine, people “prefer to fight the side effects rather than needing an intensive care unit bed and not finding one “.

Regina Osih, physician and infectious disease specialist at the Aurum Institute in Johannesburg, said there should be a “common approach” to tackling these challenges.

“What happened in the UK and the US has consequences for other countries,” she said, referring to South Africa’s decision last week to pause its use of Johnson & Johnson’s single-injection vaccine after the United States suspended administration of the vaccine.

The move, which US officials say was made with “great caution,” came after six cases of blood clotting, one of which became fatal, was reported. To date, the United States has administered approximately seven million doses of the Johnson & Johnson vaccine.

But while the United States had already inoculated around 37% of its residents, South Africa has barely reached 0.5% of its population and faces supply issues after abandoning the AstraZeneca vaccine in February. as a result of reports of its limited effectiveness against a dominant variant there.

“People were tired before; now the number of people refusing will increase with serious consequences for our vaccination effort, ”said Osih.

“This pandemic has shown us that there is no such thing as global solidarity,” she said, “and that everyone is for themselves”.

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