China approves emergency usage of COVID-19 vaccines developed by select companies

Beijing: China has authorised emergency usage of COVID-19 vaccines developed by some select domestic companies, a Chinese health official has said. An emergency use authorisation, which is based on Chinese vaccine management law, allows unapproved vaccine candidates to be used among people who are at high risk of getting infected on a limited period. “We’ve drawn up a series of plan packages, including medical consent forms, side-effects monitoring plans, rescuing plans, compensation plans, to make sure that the emergency use is well regulated and monitored,” Zheng Zhongwei, head of China’s coronavirus vaccine development task force, told state-run CCTV on Saturday. One month has passed since China officially launched the urgent use of COVID-19 vaccines on 22 July, while the vaccines were going through clinical trials, Zheng said. Recipients who got their first dose since then revealed they had few adverse reactions and none reported a fever. According to China’s Law on Vaccine Management, when a particularly severe public health emergency occurs, vaccines in clinical trials can be used in a limited scope to protect medical and epidemic prevention personnel, border officers and other people working in stable city operations, Zheng said. State-run Global Times has previously reported that employees of state-owned enterprises (SOEs) preparing to go abroad and frontline medics have been offered two choices of domestic inactivated vaccine candidates developed by Sinopharm for urgent use. On Thursday and Friday, Sinopharm signed cooperation agreements on phase III clinical trials of inactivated vaccines with Peru, Morocco and Argentina. Zheng noted that for the next step of preventing a possible outbreak this autumn and winter, vaccines’ availability will be extended to people working in food markets, transport systems and services industries. The number of people being vaccinated on an urgent basis may reach hundreds of thousands across China, considering that personnel in wider sectors are being offered free injections, said Tao Lina, a Shanghai-based immunology expert, on Sunday. “But it’s difficult to give an accurate figure since the Chinese military has begun mass vaccinations but has not released details,” Tao said.. Wu, an employee of a state-owned company handling overseas construction projects along the Belt and Road Initiative (BRI) in Asian and African countries, told the Global Times on Sunday that all staff in her firm have been offered inactivated vaccine injections on a voluntary basis for free. Wu, who took the vaccine on 7 August along with many of her colleagues, said she did not experience any adverse reactions, similar to everyone else in her group. “My colleagues and I felt only a little dizzy on the afternoon of the vaccination, but we got over it pretty quickly. There was no local redness, swelling or pain, and we did not hear of anyone reporting a fever,” said Wu, who will take her second dose on day 28 after the first shot. “People seem to be relaxed over the vaccination as most of us feel confident in domestically developed vaccines,” she said. One of Sinopharm’s inactivated COVID-19 vaccines on August 13 was revealed to have had a low rate of adverse reactions for patients in phase I and II clinical trials, while also demonstrating immunogenicity results. The inactivated vaccine will be effective against all detected strains of the virus at least as of mid-July, with lower chances and degrees of adverse reactions than same-type vaccine candidates under research, Yang Xiaoming, head of Sinopharm, told the Global Times in an earlier interview. Yang said on Saturday that more than 20,000 people in the United Arab Emirates had taken inactivated COVID-19 vaccines developed by Sinopharm in phase III clinical trials, which have shown a high level of safety. The efficacy of the vaccine is under observation. “The phase III trial in the UAE has had no reported cases of side effects so far,” Yang said, adding that “volunteers joined faster than expected and the vaccine was well worth the wait”.