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.
You may also be interested in...
Coronavirus Notebook: Australia OKs GSK’s Sotrovimab For COVID-19, Iran Takes SpikoGen Vaccine Into Phase III
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.
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.
If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies, could be tested on other kinds of products.