ROME (Reuters) – When alarm over potential side effects from AstraZeneca’s COVID-19 injection halted vaccines in Europe this month, many people were concerned that this would damage public confidence in the vaccine. In Italy, legal action has added to the turbulence.
On March 11, a prosecutor in the Sicilian city of Syracuse placed two doctors and a nurse under investigation for possible homicide, following the sudden death of a naval officer a few hours after being shot by AstraZeneca PLC.
Prosecutor Gaetano Bono also ordered the nationwide seizure of tens of thousands of doses from the same batch of vaccine. He told Reuters it was a precautionary measure. But his move angered healthcare professionals, who said they saw no need to do so.
Italy, as elsewhere, is pinning its hopes on mass vaccines to overcome the crisis after recording some 105,000 deaths from COVID-19, more than any of its EU partners, and suffering its worst economic recession since World War II. .
The country’s campaign to vaccinate the vast majority of its 60 million citizens in September got off to an unfavorable start, hit by slower-than-expected vaccine deliveries and bad publicity for the AstraZeneca vaccine, considered crucial in the pandemic because it’s easier. and cheaper to transport than other outlets.
Days after the Syracuse case, a magistrate in northern Italy ordered police to seize nearly 400,000 shots from a separate batch of AstraZeneca after another sudden post-puncture death.
The Italian legal action predates the decision by more than a dozen European countries, including Germany, France and Italy, to halt use of the vaccine after reports linked it to a rare blood clotting disorder. in a very small number of people.
The European Medicines Agency said last week that a preliminary review suggested the vaccine was not associated with an increased overall risk of blood clots, prompting most governments to resume use.
But doctors in Italy said prosecutors have increased mistrust in a country with an entrenched anti-vaccination movement. Only 62% of Italians said they planned to receive a COVID injection, according to a survey by British research company Ipsos MORI published in December.
“How can we expect that we will vaccinate millions of people under these conditions?” said Massimo Galli, head of the infectious diseases department at Sacco Hospital in Milan, Italy’s financial capital.
“The doctors I know are absolutely furious about this absurd situation.”
The World Medical Association, which represents doctors from 115 countries, said doctors and nurses in other parts of Europe do not face the same kind of legal threat.
“In any other country in the European Union, this would not be considered involuntary manslaughter,” said Dr. Frank Montgomery, president of the WMA council. “The possible side effects of a vaccine would never lead to a doctor’s prosecution.”
AstraZeneca said it is willing to cooperate with the investigation and has confidence in the justice system. Its vaccine has been found in trials to be up to 79% effective, and the company said Sunday that further testing had given no reason to worry about its safety.
Legal experts say there is nothing doctors and the government can do to influence the magistrates’ response. The health ministry declined to comment.
Under the Italian constitution, prosecutors are completely independent and cannot be subjected to external pressure of any kind. Furthermore, they are required by law to investigate any case that comes to their attention.
“An investigation has to run its course and public opinion cannot be taken into account,” Syracuse prosecutor Bono told Reuters, rejecting suggestions that he had overreacted to the naval officer’s death. Emphasizing that he had no fear of the vaccine, Bono said he had received a puncture from AstraZeneca hours after speaking with the family of the deceased.
The naval officer, Stefano Paterno, 43, did not have any known medical conditions when he went to get vaccinated at the Augusta military hospital, on the east coast of Sicily, on the morning of March 8, his wife told television La7. Hours later he developed a slight fever, but it had disappeared when he went to bed.
At around 2:00 a.m. he had an apparent seizure and, although an ambulance quickly arrived, he died shortly after.
His wife said the family had asked the local prosecutor’s office to find out if there was a link between the death and the vaccine.
Prosecutor Bono immediately opened an investigation into a possible homicide and subsequently cited a nurse and two doctors as possible suspects, as well as the head of AstraZeneca in Italy. The names of the doctors were not released.
Bono said that by targeting the suspects so early, he allowed them to appoint attorneys to follow up on the subsequent autopsy.
“It is a guarantee for them. It gives them the right to participate in the proceedings and to express their opinion, ”he told Reuters.
Medical unions say these investigations are deeply upsetting to their staff.
“This is a simple intramuscular injection. He cannot be held responsible for possible side effects, ”said Carlo Palermo, director of the ANAAO-ASSOMED physicians union.
“Can you imagine the negative personal repercussions for each doctor caught in this way? They have to find a lawyer, a technician to attend the autopsy … It is very disturbing ”.
Under Italy’s penal code, a doctor can only be prosecuted for intent or gross negligence. The unions say the Syracuse case suggests possible gray areas and want the government to offer specific legal protection to those carrying out the vaccines.
Health Minister Roberto Speranza told Corriere della Sera newspaper that it would be a good idea.
At the corporate level, AstraZeneca and the EU have agreed that the company would have the responsibility to defend its shot in court in any eventual legal fight. But an EU official told Reuters in September that the bloc’s governments had agreed that they would pay claims on possible side effects above an agreed limit.
Unlike prosecutor Bono, another prosecutor in the northern city of Biella did not cite any suspects when she launched an investigation last week into the death of Sandro Tognatti, a 57-year-old music teacher who died the day after his gunshot. AstraZeneca.
However, that prosecutor, Teresa Ángela Camelio, did order the kidnapping of 393,600 doses of AstraZeneca that came from the same batch, as a preventive measure to see if the vaccines were damaged.
Camelio declined to comment on the case.
A police officer confirmed that the Carabinieri police had visited vaccine storage centers throughout Italy and placed doses from the batch in sealed boxes. These will remain at the centers while the investigation continues.
Government data showed that the seized doses accounted for around 20% of the AstraZeneca injections Italy had in storage at the time. Vaccines have been blocked even though limited supplies have hampered the EU’s vaccination efforts.
The hijacked vaccines will expire in six months. Both Syracuse and Biella prosecutors have declined to say how long their investigations will take, saying they need time to complete their analysis.
Prosecutors in the Sicilian city of Catania took less than a week to open and close their investigation into the case of a 50-year-old police officer, who died in March after falling ill from his AstraZeneca vaccine.
In a statement on March 18, prosecutor Carmelo Zuccaro said there was nothing to suggest that the death was related to the vaccine. “The strength of our opinion is demonstrated by the fact that I and the vast majority of the magistrates and staff of this office have received the vaccine,” Zuccaro wrote.