The European Medicines Agency (EMA) said Tuesday (May 4) that it has begun a rolling review of China’s Kexing coronavirus vaccine (Sinovac) to assess its effectiveness and safety. The European Medicines Agency’s rolling review is considered the first step in the entry of Chinese-made vaccines into the EU-27.
The purpose of the rolling review is to allow the European Medicines Agency to review data from ongoing clinical trials as soon as possible, which will shorten the time to approval while maintaining a high standard of review.
The European Medicines Agency said the decision to initiate a review of the Chinese vaccine was based on the preliminary results of laboratory studies and clinical studies. “These studies suggest that the vaccine triggers the production of antibodies” that can fight coronavirus “and may help prevent the disease,” the FDA said in a statement. The European Medicines Agency has reportedly not yet submitted an application for marketing authorization for the vaccine.
The European Medicines Agency has so far approved four coronavirus vaccines. In addition to the Chinese Kexing vaccine, the agency is conducting a rolling review of three other vaccines, developed by German biotech company Biotech, U.S.-based Novavax Pharmaceuticals and Russia’s Gamaleya State Research Center for Epidemiology and Microbiology.
The Kexing vaccine is developed and produced by Beijing-based Kexing Holdings Biotechnology Co. The official name of the vaccine is Krelief inactivated novel coronavirus vaccine, and Kexing vaccine is the “common name”.
The European Medicines Agency said that once data on the vaccine are available, experts will evaluate the data “to determine whether the protective effect of the vaccine outweighs the risks. The agency said the rolling review will continue until “there is sufficient evidence to support a formal marketing authorisation application”. The FDA also added that it could not predict a timeline.
The announcement by the Amsterdam-based European Medicines Agency came a day after WHO Assistant Director-General Mariangela Simao said the organization would decide this week whether to approve two Chinese New Crown pneumonia vaccines for emergency use. She said there are still some “final arrangements” that need to be made before the technical advisory panel can make a key statement. The two Chinese vaccines being approved by the WHO are produced by China National Pharmaceutical Group and Kexing Biologicals.
If approved, they would mark the first time a Chinese vaccine has entered the UN health agency’s emergency use list and would trigger a wider rollout of Chinese vaccines. China has provided vaccine assistance to dozens of countries around the world prior to receiving WHO certification, but there are concerns about the effectiveness of the Chinese vaccine and the transparency of vaccine information.
Phase III clinical trials of the Kexing vaccine were conducted in four countries, with results varying widely from country to country, with effectiveness ranging from 50% to 90%. Since January 2021, at least seven countries have approved the Koxin vaccine for emergency use. To date, however, the outside world has not seen overall Phase III clinical effectiveness data for this vaccine published in a peer-reviewed journal.
Testing of the Coxin vaccine in Brazil with approximately 12,000 health workers reported a 50.7% protection rate, which is lower than the protection afforded to patients with severe disease.
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