BioNTech and Fosun Pharma Begin Phase 2 COVID-19 Vaccine Trial in China

German drugmaker BioNTech and China’s Fosun Pharmaceutical Group have announced that the Pfizer/BioNTech COVID-19 vaccine candidate, BNT162b2, will be evaluated in a phase 2 study in China, building on an agreement the companies signed in March.

The phase 2 study aims to enroll 960 noninfected participants aged 18 to 85 to assess the vaccine’s safety and efficacy in support of a filing for approval in China. Fosun Pharma said the phase 2 study will “provide key data for the launch of the vaccine in China.”

Earlier this month, Pfizer/BioNTech reported that BNT162b2 showed 95 percent effectiveness in a global phase 3 trial, based on an analysis of 170 confirmed cases, in which 162 infections were among participants who received a placebo, while just eight were from the group that received the vaccine (DID, Nov. 19).

The companies filed for an Emergency Use Authorization from the FDA on Nov. 20 and the agency is expected to make a decision by the second week of December (DID, Nov. 25). The vaccine is also being reviewed by the European Medicines Agency (EMA) and by regulators in Canada and the UK. ― Jason Scott