Sputnik V is the latest COVID-19 vaccine to be targeted over safety concerns, but Brazil’s Anvisa has also raised questions over quality and manufacturing standards.
The Brazilian medicines regulatory agency Anvisa has rejected requests for the importation and use of Russia’s Sputnik V adenovirus-based vaccine, saying the product lacks adequate data on quality, safety and efficacy.
Asserting that there were “failures in product development at all stages of clinical studies” with the vaccine, Anvisa cited “troubling information” that the cells where the adenovirus is produced “allow its
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.
The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.
