China National Biotec Group is applying for conditional regulatory approval to start universal vaccination programme

Whole population could get shots in two or three years, if given the go-ahead, CNBG executive suggests

Two coronavirus vaccines developed by a Chinese state drug firm are being assessed for “conditional approval” to be administered on the general public, with corporate plans for universal vaccination.China National Biotec Group vice-president Zhang Yuntao said on the weekend that its two-dose vaccines were being reviewed for “conditional approval” from the state drug regulator, and if given the green light the vaccines would be available for at most 600 yuan (US$88) for both doses, down from the 1,000 yuan suggested last month.

“I believe the vaccines are very likely to be launched by end of this year, but there are uncertainties,” Zhang said. “If the vaccines are approved it will be conditional and with the aim of universal immunisation,” he said, adding that mass inoculation was a company suggestion, not official policy.

The National Medical Products Administration can grant conditional approval to a drug that has not completed clinical trials but for which preliminary results indicate likely clinical benefits. The drug will still need to finish trials and complete the process for full approval.

“We need to check the adverse effects in the long term, especially if there are any serious adverse events when exposed to the virus. We will only get full approval after completing the continuous observation in a phase three trial,” Zhang said.

He said the company hoped to start vaccinations with the general working population, particularly workers like couriers who came in contact with a lot of other people.

“The whole population can be vaccinated within two or three years,” Zhang said.

CNBG is testing its two inactivated vaccines in nearly 10 countries outside China, including Brazil and the United Arab Emirates. The vaccines are being tested on about 40,000 volunteers to establish the candidates’ broader safety and efficacy, with the latter determined by comparing the number of coronavirus cases in an inoculated group with those in a placebo group.

“Our clinical trial must follow the guidelines set by the World Health Organization and be completed according to international practice,” Zhang said.

CNBG has built two biosafety level-three factories – one in Beijing and that other in the central city of Wuhan – to produce the inactivated vaccines.

The facilities will allow the group to more than triple its annual capacity from nearly 300 million doses to 1 billion when they are completed by early next year

China has approved three inactivated vaccines – two by CNBG and another by Sinovac – for emergency use. About 350,000 people in China, where local transmission has been controlled, have been vaccinated under the scheme.

Zhang said the people who were vaccinated were mostly high-risk groups such as health workers, people who had contact with incoming overseas citizens, workers employed offshore by state-owned companies and some diplomats.

China’s health authority is also working an inoculation strategy, weighing up plans for different age groups, and whether to combine inactivated vaccines with others.

Zhang said another question was whether individuals would pay for the vaccines.

He said the price would be “determined by the market”, and decline as more people were vaccinated. Last month Liu Jingzhen, chairman of China National Pharmaceutical Group, CNBG’s parent company, said the vaccines would be about 1,000 yuan, raising concerns that they would be too expensive for most people.

Source south china morning psot