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The death of a teenager who developed blood clots after having the Oxford/AstraZeneca vaccine is igniting a political storm in Italy — with most of the fire coming from the right.
At issue is the practice of regional health authorities running vaccination “open days” as a way to get rid of unused Oxford/AstraZeneca doses. Some regions took this route despite a national government recommendation that the jab should “preferably” be used only for those aged over 60, for whom the risk is lower.
Rome is now getting heat for not being clear enough.
Camilla Canepa, 18, got the shot on one of those open days, organized by regional health authorities in Liguria, and quickly fell ill. Despite undergoing surgery twice, she died on June 9. An autopsy later revealed she died from a brain hemorrhage 16 days after the shot. It was also later revealed that she suffered from an autoimmune disorder, which should have disqualified her from receiving the vaccine.
But medical authorities administering the shot were apparently unaware of her prior condition.
The national health ministry is now in the crosshairs, as regional executives accuse Rome of generating confusion by failing to issue precise guidance. Meanwhile, the right is tapping into the outpouring of public grief to attack the government for incompetence and shirking responsibility on setting guidelines.
Matteo Salvini, leader of the far-right League party, called for an end to open days and said it was “absurd” to use children as young as 12 “for experiments.”
“Who authorized mass vaccines?” he asked on Rete 4 television. “Is there a minister of health?”
“The government is incapable of managing the pandemic and vaccine campaign, in particular communications, and of taking tough decisions,” Marcello Gemmato, a pharmacist and lawmaker with Brothers of Italy, another hard-right party, told POLITICO. The health ministry “must be clear and non-contradictory or it does a disservice to Italians,” he said.
As it happens, Health Minister Roberto Speranza is an especially attractive target for the right, as a member of a small left-wing party, Article One. He has been the punching bag for the right for months, repeatedly dueling with Salvini over coronavirus restrictions.
The tragic episode is just one more black eye for the Oxford/AstraZeneca vaccine, which Italy had initially cleared for under 55-year-olds. In March, however, anxiety over the safety of the adenovirus jab surfaced after the vaccine was linked to a small number of blood-clot related deaths, including three in Italy, among younger people. Most EU countries temporarily suspended use of the vaccine until the European Medicines Agency gave it the all-clear after examining safety data.
Following the EMA’s decision, Italy’s national drug regulator, AIFA, cleared the shot for all adults but recommended “preferential use” in the over-60 age bracket, effectively flipping its earlier stance. Other countries took similar measures. France, for example, recommended its use for those over 55, while Denmark suspended use of the shot altogether, donating doses abroad.
Italy, however, took a more muddled approach. While the national recommendation held, some regional governments, faced with unwanted excess doses, went ahead with “open days” that opened up vaccination for younger people, allowing them to skip the line, despite safety warnings from some experts.
It was just one example of how Italy’s decentralized health system, which has devolved considerable powers to the regions, sometimes confounded the pandemic response, with regions pursuing policies that sometimes clashed with each other and with Rome.
Amid the public outcry after Canepa’s death, both regional governments and the national health ministry found themselves on the back foot. On June 11, the health ministry said the Oxford/AstraZeneca vaccine should be used only in those aged over 60, basing the decision on revised recommendations from AIFA’s technical scientific body. That statement represented a move away from its previous “recommendation” of the shot for the older age group.
As for people under 60 who had a first dose of the Oxford/AstraZeneca vaccine, the government said, an mRNA vaccine, namely BioNTech/Pfizer or Moderna, should follow as the second jab.
Alessandro D’Amato, a health administrator in the Lazio region, told La Repubblica that clearer guidance was needed, and faulted AIFA’s latest opinion as imprecise.
It needs to say “yes or no,” D’Amato said, adding that more clarity on the Johnson & Johnson vaccine, another adenovirus jab, is also needed.
For their part, both national and regional authorities are pushing back.
Giovanni Toti, governor of the Liguria region, defended the open days on grounds that AIFA signed off on them. AIFA’s director Nicola Magrini, for his part, told La Stampa that the regions were to blame for going it alone. The improving pandemic situation, meanwhile, had further shifted the risk-benefit calculation away from distributing the Oxford/AstraZeneca jab to younger people.
The EMA’s own vaccine strategy head, Italian Marco Cavaleri, also entered the fray. In a separate interview in La Stampa, he took the same line as Magrini, arguing that given the availability of other vaccines, regions should have taken a “more cautious approach” on the open days.
Color me skeptical
Aside from the regulatory muddle, critics have pointed to the controversy’s impact on vaccine skepticism. While not as widespread as elsewhere in Europe, Italy has long struggled on this front. A study linking vaccines to autism, later discredited, caused not only a decline in vaccine coverage between 2013 and 2016, but a measles epidemic. And a major political party, the 5Stars, tapped into these sentiments for years, although its stance has softened during the pandemic.
Gemmato, of the Brothers of Italy, accused the national government of flip-flopping and “acting on emotion,” thereby stoking unwarranted fears. “They have made the public afraid for no reason,” he charged.
Vincenzo de Luca, president of the Campania region, also warned that trust in the state had been “severely compromised.”
The death “radically changed the level of trust, sensitivity and willingness of citizens in relation to the vaccination campaign, creating a level of confusion that risks jeopardizing the vaccination campaign itself,” de Luca said, shortly after his government temporarily banned the Oxford/AstraZeneca jab for all age groups.
Even though Italy’s vaccination campaign has generally been going strong, the country can’t afford a setback, experts say. The new restrictions on the Oxford/AstraZeneca vaccine are likely to create supply issues, particularly for regions with younger populations such as Campania. More broadly, Italy may struggle to reach herd immunity in some areas — roughly pegged at 70 percent of the population or higher — if the doubtful remain unconvinced.
As one local example: Following Canepa’s death, only 50 people booked for an Oxford/AstraZeneca open day that was planned for 1,440 in Naples, where the jab is still available for older Italians.
Francesco Vaia, director of health at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome, pinned the blame on “too many errors in communication” and poor timing rather than bad faith. But he insisted all the approved vaccines are valuable.
“There are no premier-league and second-division vaccines,” he said in comments to journalists last week. “All the ones we are using prevent serious illness and hospitalization and all have some adverse effects.”
The benefits continue to outweigh the risk, he added: “It has always been clear that some could provoke adverse reactions. Is it a reason not to get the vaccine? No.”
For his part, Prime Minister Mario Draghi, who got the Oxford/AstraZeneca vaccine as his first dose, decided not to take any chances. He’s set to receive a different jab for his second dose due to a low-antibody count.
Italians of all ages concerned about mixing jabs, however, are free to receive a second shot of Oxford/AstraZeneca if they wanted, he said.
Unlike the prime minister, however, ordinary Italians have no way of making sure that their antibody count is sufficiently high to inform their decision. While some are rushing to get tested at private clinics, according to virologist Massimo Galli, many others will be left scratching their heads as to which vaccine to get after the barrage of confusing messages.
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
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