China confirms its first Covid-19 vaccine patent. The National Intellectual Property Administration has granted the China’s first patent for a Covid-19 vaccine. This inactivated Covid-19 vaccine had a low rate of adverse reactions and demonstrated immunogenicity. The patent was jointly applied for by a research team with the Academy of Military Sciences and CanSino Biologics Inc., a Chinese high-tech biopharmaceutical company.
The team led by Chen Wei, a researcher at the Institute of Military Medicine under the academy, developed the recombinant Covid-19 vaccine, with the modified defective adenovirus as the vector. In March, the vaccine became the first in China to be approved to enter clinical trials. According to the patent abstract, the vaccine shows good immunogenicity in both mouse and guinea pig models and can induce strong cellular and humoral immune response in a short period of time.
It can be produced quickly on a large scale to cope with a Covid-19 outbreak.
The vaccine has now finished phase-1 and phase-2 clinical trials, which have verified its safety and immunogenicity. More than 21.5 million Covid-19 cases have been reported worldwide, with recoveries exceeding 13.5 million, according to figures compiled by US-based Johns Hopkins University.
China has a comparatively strict and complete patent examination system, requiring a technology or product to be fundamentally different from existing similar technologies and products all over the world to be granted the patent. China has 5,300 to 7,000 local pharmaceutical manufacturers, each with a small share of the Chinese domestic market.
This structure helps keep the local vaccine cost low but poses regulatory difficulties and hinders investment in capacity building aimed at the international market. So far there are fewer than 40 vaccine producers in China that meet the GMP standards and only a handful of vaccines made in China have achieved WHO PQ and have been made available for procurement/purchasing by United Nations agencies like UNICEF and other global health organizations like the Global Alliance for Vaccine Initiative.
Covid-19 may prove to be a game changer in providing an incentive for the Chinese government and vaccine manufacturers to scale up the motivation and capacity to enter the global market. Sinovac Biotech, the first private Chinese company to launch a phase III clinical trial on one Covid-19 vaccine candidate, is building a facility to manufacture up to 100 million doses annually.
Who will benefit from Chinese vaccines? Other than the clinical trial partner countries, other low- and median-income countries covered by the WHO’s vaccine distribution plan could also benefit if China’s Covid-19 vaccine receives the pre-qualification. For a world waiting anxiously for an effective vaccine, it is very likely that China will be working with the WHO to increase the capacity of Chinese manufacturers for a world market.
The writer is a research assistant, school of pharmacy, Lanzhou University, China. E-mail: firstname.lastname@example.org
- سيعجبك أيضاً