CanSino granted GMP certificate from Hungary after Sinopharm, increasing EU confidence in recombinant COVID-19 vaccine

A medical staff prepares a dose of COVID-19 vaccine at the Beihang University in Beijing, capital of China, March 24, 2021. (Xinhua/Ren Chao)

China's vaccine producer CanSino Biologics announced on Saturday that its recombinant COVID-19 vaccine has been issued a Good Manufacturing Practice (GMP) certificate by Hungarian authorities. Marking the second time a Chinese COVID-19 vaccine has received such a certificate from an EU country after Sinopharm.

Industry observers said the issuance of this certificate increased confidence in Chinese vaccines in European countries as blood clot fears linger among AstraZeneca and Johnson & Johnson vaccines. The acknowledgement has paved the way for more Chinese vaccines to get international recognition.

The GMP certificate recognizes that manufacturing facilities and quality control system of CanSino meets the European Union's standards and guidelines. Giving a chance to CanSino's recombinant vaccines, namely Convidecia, to enter more markets globally, according to a notice released by CanSino Biologics.

The certificate was official issued on Friday by Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). Sinopharm received the certificate in April.

An immunologist who declined to be named told the Global Times on Saturday that as more vaccines produced by China wins certificates from the EU, Chinese vaccines will further enhance its competitiveness in Europe and even the whole world.

The certificate increased confidence in Chinese vaccines in small European countries and will also lead to more recognition of Chinese vaccines in the EU, Feng Duojia, president of the China Vaccine Industry Association, told the Global Times in an earlier interview.

Inoculation has been halted in various countries for AstraZeneca and Johnson & Johnson's COVID-19 vaccines after several cases of unusual thrombotic events and thrombocytopenia. Convidecia, a recombinant vaccine, similar in technology as those two vaccines received no report of blood clots.

CanSinoBIO said that although its vaccine uses the same technique, it uses different adenovirus than the other two companies. CanSinoBIO uses adenovirus type-5 as vector, a common adenovirus among humans, while AstraZeneca uses chimpanzee adenovirus and Johnson & Johnson uses adenovirus type-26.

CanSinoBIO recombinant vaccine has been approved for conditional marketing in China, and has also obtained emergency use authorization in Mexico, Pakistan, Hungary and Chile. It provides protection against COVID-19 and related medical conditions for a broad range of age groups above 18, including those over the age of 60, CanSino Biologics said.

The GMP is a system for ensuring that products are consistently produced and controlled according to specific quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product, according to the International Society for Pharmaceutical Engineering.