GMP Deficiencies Lead Brazil To Target Sinovac’s Chinese COVID-19 Vaccine Plant
Regulator Says Documentation Provided Is Unsatisfactory
Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.
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Bavarian Nordic is testing the potential of its ABNCoV2 vaccine as a booster dose for people with previous infection or vaccination. Brazil has received requests from Pfizer/BioNTech and AstraZeneca to trial vaccines as booster doses, and has asked for more immunogenicity data on SinoVac’s CoronaVac.
The new committee, which will initially be in place for a year, will advise the French drug regulator when it is preparing its opinions on substitution in specific biosimilar product groups.
Pharmaceutical industry stakeholders have expressed concern over the lack of clarity about the available pathways for assessing emerging health technologies such as gene and gene modified cell therapies, as well as problems with funding arrangements.