While American lawmakers have taken steps to shield US pharma companies from any legal blowback caused by COVID vaccines, drugmakers in Europe haven't been so lucky. And after widespread skepticism of the AstraZeneca-Oxford vaccine, what was supposed to be the workhorse of the global immunization rollout before reports of rare and deadly blood clots inspired regulators around the comment to either halt the jab, or impose limits on its use.
And now, all these issues will be dredged up again as AstraZeneca is hit by lawsuits filed by the families of those who died from rare blood clots potentially linkted to the vaccine. In what appears to be a first, Sky News reported Monday that the family of an Italian woman who died from a case of vaccine-linked clots are suing to officially establish whether the jab was at fault in her death.
The case involves 55-year-old Augusta Turiaco from Messina, Sicily, who received her COVID jab on March 11, but started experiencing severe symptoms a few days later.
Despite feeling unwell afterwards, Turiaco returned to work, posting two days later to reassure worried friends saying: "Andra tutto bene" - or "everything will be alright" in Italian.
She fell into a coma on March 28 March and died on March 30 March, 19 days after having the AstraZeneca injection. Her conditions also found in others who died after having the Oxford-AstraZeneca vaccine.
Here's more from Sky News:
Her brother Nunzio Turiaco told Sky News: "For us it was a bolt from the blue that such a clinical picture occurred.
"My sister was in excellent health, she did not take drugs because she did not have diseases such as hypertension or diabetes."
Medical records seen by Sky News showed blood clots had formed in Ms Turiaco's body, including in her brain.
Her platelet levels had fallen.
According to Sky, the family's suit is one of several legal actions in Europe directed at AstraZeneca over the clotting issue.
The legal proceedings launched by the family are just one of a number of cases across Europe being mounted against AstraZeneca.
The family's lawyer, Daniela Agnello, told Sky News: "The excellent state of health of Ms Turiaco, the absence of previous pathologies, the very short period of time between the administration of the vaccine, the appearance of the first illnesses and the very serious clinical picture and then death.
Messy clinical trial data, manufacturing issues and - of course - the rare blood clots that have resulted in more than a dozen deaths have all damaged the AstraZeneca jab’s reputation, experts say.
Despite this, both the European Medicines Agency and the World Health Organization consistently stressed that the vaccine’s benefits far outweigh the risk of any side effects and advised against any restrictions to its use. Still, national health authorities have moved ahead with their own risk and benefit assessments, which, remarkably, have drawn dissimilar conclusions – ranging from limiting the vaccine’s use in different age groups to suspending its usage and even ditching it entirely.
Whether the vaccine will ever be approved for use in the US remains unclear; although AstraZeneca has said it has applied for review by regulators in the US, reports cited uneasiness with the vaccine's safety record, which include a halt to a Phase 3 trial in the US for a month last fall.