HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020.

“At the moment, a total of 22 drugs have been given urgent approval to carry out clinical trials for the treatment and prevention of new coronavirus pneumonia and related indications,” a government spokesperson said.  

From the total, 16 are vaccine candidates. Six of them are already in phase III trials, two of which have received conditional approvals, according to data from the World Health Organization (WHO).

To date, China has also granted conditional marketing approvals to two inactivated COVID-19 vaccines. The first, BBIBP-CorV, was China National Pharmaceutical Group Corp. (Sinopharm)’s vaccine on Dec. 30, 2020. The second was the Coronavac vaccine developed by Sinovac Biotech Ltd., which received its conditional green light from the NMPA administration on Feb. 5 this year. Largely based on these two vaccines and the many vaccines being given out as part of the multiple ongoing trials, China has administered tens of millions of shots.

“As of Feb. 9, China has administered 40.52 million COVID-19 vaccine doses to key groups,” said Mi Feng, a National Health Commission spokesperson.

The Chinese mainland reported no new locally transmitted COVID-19 cases on Feb. 19, according to the National Health Commission.

Deep in the clinic

Out of the six phase III candidates, four are inactivated virus vaccines. Sinopharm has two candidates in the category. The first is a collaboration with the Wuhan Institute of Biological Products and the other is another collaboration with the Beijing Institute of Biological Products Co. Ltd.

A third late-stage inactivated virus vaccines candidate was developed by Sinovac Research and Development Co. Ltd. while the Institute of Medical Biology and the Chinese Academy of Medical Sciences have developed a fourth candidate.

Another Chinese candidate belongs to Cansino Biologics Inc. and the Beijing Institute of Biotechnology, which have a recombinant novel coronavirus vaccine (Adenovirus type 5 vector) in phase III trials. It was approved exclusively for use on Chinese military personnel in June 2020.

A sixth vaccine candidates in phase III trials, developed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Sciences has also joined the list with a protein subunit vaccine.

Multiple approaches

While the list is heavy on inactivated vaccines, different developers are taking at least four other technological approaches to COVID-19 vaccines: recombinant protein vaccines, adenovirus vector vaccines, nucleic acid vaccines and vaccines using attenuated influenza viruses as vectors.

The other 10 vaccines in development in China are at various stages of development. They include:

• A protein subunit vaccine by Chengdu-based Sichuan Clover Biopharmaceuticals Inc. The company just raised $230 million in a series C financing round to fund a global phase II/III trial for its COVID-19 vaccine candidate S-Trimer (SCB-2019). It recently published its phase I data that showed that SCB-2019 combined with two different adjuvants was well tolerated and safe.

• A DNA-based vaccine that Inovio Pharmaceuticals and the International Vaccine Institute are working on with a Chinese partner, Advaccine Biopharmaceuticals Suzhou Co. Ltd. It is currently in phase II/III trials.

• An inactivated vaccine by Beijing Minhai Biotechnology Co. Ltd. that is in phase II.

• A recombinant vaccine heading into phase II trials as of late January sponsored by the Jiangsu Province Centers for Diseases Control and Prevention with West China Hospital.

• An mRna vaccine by the Academy of Military Science (AMS) with Walvax Biotechnology Co. Ltd. and Suzhou Abogen Biosciences Co. Ltd. in phase I.

• A CHO cell vaccine developed by the AMS with Zhongyianke Biotech Co. Ltd and Liaoningmaokangyuan Biotech Co. Ltd that was in early phase I trials as of mid-January 2021.

• A lentiviral minigene vaccine also by the Shenzhen Geno-Immune Medical Institute in phase I/II trials since August 2020.

• A pathogen-specific aAPC vaccine developed by the Shenzhen Geno-Immune Medical Institute that started phase I trials in March 2020.

• An inactivated SARS-CoV-2 vaccine is also being worked on by The Chinese Academy of Medical Sciences, West China Second University Hospital and Yunnan Center for Disease Control and Prevention are also working on  in phase I/II.

• A viral vector nasal spray vaccine by Xiamen University, Beijing Wantai Biological Pharmacy and the University of Hong Kong, now in phase II.

Hong Kong approvals

Hong Kong, a special administrative region of China, has approved only one of the two frontrunner Chinese candidates among the two vaccines it has approved for use so far.

The first approval in the territory was for the mRNA-based COVID-19 vaccine Comirnaty (tozinameran), originally developed by Pfizer Inc. and Biontech SE. It was advanced through a collaboration between Biontech and Shanghai Fosun Pharmaceutical Group Co. Ltd. Fosun has an early-stage trial in China for Comirnaty.

Sinovac’s Coronavac was the next to gain approval, after Hong Kong’s Department of Health exempted Coronavac from a requirement that phase III results be published in medical journals. The city’s chief executive Carrie Lam and some members of her staff received their Coronavac jabs on Feb. 22 for the kick-off of Hong Kong’s vaccination program.

Hong Kong has also ordered the Astrazeneca plc and University of Oxford’s COVID-19 Vaccine Astrazeneca but has not officially given it the thumbs up yet. Lam has expressed interest in obtaining Sinopharm’s vaccine as a backup.

“We have been very concerned about the supply of vaccines for Hong Kong people, because this is really sort of the light at the end of a tunnel. Over many months, we have worked out advance purchase agreements with three manufacturers,” said on Jan. 25. “Actually, we are still discussing a fourth in order to have at least one vaccine per technology.”

China exports

With an array of late-stage vaccines in its arsenal, China has already exported its candidates beyond its borders and will continue to do so through partnerships. In October 2020, China signed an agreement with Gavi, an international vaccine alliance, to officially join the global vaccine initiative known as COVAX, led by the WHO.

As a gesture to show its participation and accommodate the interests of other countries, China also plans to purchase COVID-19 vaccines for 1% of its population, about 15 million people, through the COVAX initiative. A foreign ministry spokeswoman reasoned that a larger order could lead to a shortages of a first batch of vaccines.