Sinopharm unit, CanSinoBIO apply in China for COVID-19 vaccines' public use approval

(Reuters) - A unit of China National Pharmaceutical Group (Sinopharm) and CanSino Biologics Inc (CanSinoBIO) have applied for public use of their COVID-19 vaccines in China, which if granted would mean China has four locally developed approved vaccines.

FILE PHOTO: Vials of a COVID-19 vaccine candidate, a recombinant adenovirus vaccine named Ad5-nCoV, co-developed by Chinese biopharmaceutical firm CanSino Biologics Inc and a team led by Chinese military infectious disease expert, are pictured in Wuhan, Hubei province, China March 24, 2020. China Daily via REUTERS

While China has yet to approve vaccines developed by Western drug makers, it has granted authorisation to domestic products for use in select groups or by the wider public, which have also gained ground in developing countries battling a surge in coronavirus infections.

Sinopharm affiliate Wuhan Institute Of Biological Products said on Wednesday its vaccine has an efficacy rate of 72.51% against the COVID-19 disease caused by the virus, citing interim analysis of late-stage clinical trial data, without offering more details.

The vaccine has already been given to limited groups of people at higher infection risk under an emergency vaccination program started in July.

It is one of two candidates from Sinopharm that have entered Phase III clinical trials overseas.

The other, developed by a Beijing-based subsidiary of Sinopharm, received public use approval in December, following months of emergency use among targeted groups such as medical workers and state-owned company employees travelling abroad for work.

In a separate filing on Wednesday, CanSinoBIO said interim analysis of data from its multi-country trial showed its candidate one-shot vaccine, known as Ad5-nCoV, had a success rate of 68.83% at preventing all symptomatic disease and 95.47% at preventing severe disease 14 days after vaccination.

This fell to an efficacy rate of 65.28% at preventing all symptomatic cases and 90.07% at preventing severe disease 28 days after a single dose.

Ad5-nCoV has gained emergency use authorisation in Pakistan and Mexico, and was cleared last year for use by Chinese military personnel.

China has given public use approval for a vaccine from Sinovac Biotech earlier this month, which is also being used in mass inoculation drives in countries including Indonesia, Turkey and Brazil.

These four Chinese vaccines can be stored at normal freezer temperatures, making them a potentially attractive option to many developing countries, which struggle to use rival products such as vaccines from Pfizer and Moderna, which require much colder temperatures for longer-term storage.

China is exporting vaccines to 27 countries and providing free doses to 53 countries, a foreign ministry spokesman said on Tuesday.

Reporting by Anushka Trivedi in Bengaluru and Roxanne Liu in Beijing; editing by Kim Coghill and Jason Neely