Coronavirus: Chinese vaccine developers file for approval ahead of mass inoculations of key groups
- Companies have been submitting their test data on a rolling basis to speed up regulatory process, health official says
- People working in the health care, aviation and public transport sectors, and at markets will be first to receive jabs
Some vaccines “that have advanced fast” have collected enough data for interim analysis of their phase 3 human trials and this is being provided on a rolling basis to the drugs regulator for review, Zheng Zhongwei, an official with the National Health Commission (NHC), said.
The general public would receive their jabs in a second phase, once the vaccines had been formally approved or production had been scaled up, Cui Gang, the NHC official in charge of disease control and prevention, said.
“The relevant data will be released to the public in time after unblinding [the double-blind, placebo-controlled phase 3 trial],” Zheng told reporters at a briefing on Saturday.
“If the data meets the relevant requirements, China’s drug regulatory authority will issue approval for market launch, or launch with conditions,” he said.
A document issued last month by the Centre for Drug Evaluation allows “innovative vaccines” to be approved for conditional market launch based on the interim results of their phase 3 trials.