The National Ombudsman’s Office investigates the regulatory situation of the AstraZeneca vaccine

The National Ombudsman’s Office investigates the regulatory situation of the AstraZeneca vaccine
The National Ombudsman’s Office investigates the regulatory situation of the AstraZeneca vaccine

Due to the developments at the national and international level regarding the safety of the Oxford/AstraZeneca ChAdOx1-S (recombinant) vaccine against Sars-Cov-2, the National Ombudsman’s Office promoted an ex officio action with the purpose of inquiring about the regulatory situation of said vaccine in our country.

For this reason, reports were requested from the National Administration of Medicines, Food and Technology (Anmat) to determine the following aspects.

Regulatory situation. It seeks to know if it is approved, requesting that Anmat report the administrative acts issued by the competent authority that contemplate the registration, marketing authorization, modifications to labels and leaflets and any other measure adopted in relation to the safety of said vaccine.

Adverse reactions. What have been the notifications of adverse reactions received by Anmat for the AstraZeneca ChAdOx1-S vaccine, since the moment of its commercialization in Argentina, detailing date, name of the reaction according to current coding, organ-class system involved, assignment of causality, seriousness, outcome of the event and jurisdiction where the event occurred.

Thrombosis. For notifications that have included thrombotic events with thrombocytopenia, what actions has been carried out by Anmat and what health measures, if applicable, has been adopted.

Security. Safety alerts, communications or any other type of information for health professionals, the pharmaceutical industry and the general population issued by Anmat in relation to the AstraZeneca ChAdOx1-S vaccine. Please attach these documents or the corresponding hyperlinks to web publications.

The information collected will be disseminated in a press release.

The case took on new momentum at a local level due to the complaint of a woman from Río Cuarto who was diagnosed with the consequences of the vaccine with an adverse effect that left her with almost complete disability and severe pain.

The woman decided to take AstraZeneca to court, filing a lawsuit for damages and the costs of her treatment for 100 million pesos.

 
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