China grants conditional approval to its homegrown COVID-19 vaccine
(Sourced from PTI)
China has granted conditional approval to the country's first homegrown COVID-19 vaccine developed by state-owned pharmaceutical giant Sinopharm, an official announcement said on Thursday. The approval comes a day after Sinopharm said its vaccine showed 79.34 percent efficacy and a 99.52 percent antibody-positive conversion rate in the interim results of the Phase III clinical trials.
"The inactivated vaccine, developed by Beijing Biological Products Institute under Sinopharm's subsidiary China National Biotec Group (CNBG), got official authorization from China's National Medical Products Administration on Wednesday," Chen Shifei, deputy head of the National Medical Products Administration, told the state-run Global Times.
The Sinopharm's vaccine results are better than the 50 percent standard of the World Health Organization (WHO) and Chinese authorities, the report said, adding that the vaccine also showed a good safety level. Beijing Biological Products Institute Co, a Sinopharm subsidiary, stated that interim results show the Sinopharm vaccine is safe and people who received two doses produced a high-level of antibodies.
The announcement of China's approval for one of its vaccines came after the US authorized Pfizer and Moderna jabs. Britain has approved the Oxford-AstraZeneca vaccine for use in the UK, with the first doses due to be given on Monday. Russia too has approved its vaccine Sputnik-V. Both Moderna's and the Pfizer-BioNTech vaccines have shown similar efficacy levels of nearly 95 percent.
The CNBG chairman Yang Xiaoming had earlier said, "A vaccine has to undergo strict review by each country's national drug administration before being authorized for public use. All data and processes are reviewed by professional third-party committees."
"Yang was inoculated with a CNBG vaccine in March along with his colleagues," the report said. "They had tested the level of antibodies six months after vaccination and results were good," Yang said. Yang noted that data on safety and efficacy collected in Phase III clinical trials is better than expected. "Reported side effects of the vaccines are milder than expected," Yang added.
The side effects of CNBG's inactivated vaccines include aches or redness at the injection site, fever, muscular soreness, sickness, and headache, the report said. "To form an immunology barrier, at least 700 million Chinese residents should be vaccinated, which requires at least 1.4 billion doses," Yang said.
"China has established a complete cold-chain industry for vaccine delivery," Yang said. "Sinopharm's inactivated vaccines have been administered to one million people for emergency use in China and no serious reactions have been reported," the paper stated. "About 70,000 volunteers have participated in Phase III clinical trials in more than 10 countries," it further said.
"CNBG's production capacity of inactivated vaccines has reached 120 million doses by end of the year and will expand to one billion doses per year in 2021," Yang said. Meanwhile, Wuhan has started emergency use of COVID-19 vaccine on several key groups from December 19.