How Chinese researchers fast-tracked COVID-19 vaccine trial overseas and guaranteed it meets protocols

On Chinese New Year's Eve, Gou Jinbo, who was spearheading the Chinese scientific team in Pakistan for the COVID-19 vaccine Phase III clinical trials, scoffed up a few dumplings and rushed back to the clinical trial site.

Their work entered a critical phase with a grueling vaccine trial data reduction schedule, a mandatory step for data analysis in the subsequent stages.

Gou and his colleagues sacrificed this year's Chinese New Year celebrations, hoping for more and much safer family reunions in the future, as many global researchers work at a breakneck pace to outmaneuver the deadly virus.

Researchers achieved in one year what would normally take upwards of three to four years of vaccine research and development, with no steps compromised in design, testing, and production. This is how one Chinese COVID-19 vaccine manufacturing front-runner, CanSino Biologics Inc. (CanSinoBIO), developed a new one-shot vaccine named Ad5-nCoV with an interim data of 65.7 percent overall efficacy against COVID-19 in an equally safe and fast manner. The Global Times had a conversation with Gou to learn about CanSinoBIO's Chinese scientists currently working in the all-important overseas Phase III clinical trials, their scientific brilliance and any unanticipated challenges.

Pakistan is one of the earliest countries in the world in which CanSinoBIO started its Phase III clinical trials. Since September 2020, CanSinoBIO has sent two groups of Chinese experts to Pakistan to supervise the clinical trial. It is the largest clinical trial ever undertaken by the 10-year-old manufacturer and the largest in Pakistan.

"We are working 10 times harder in developing a COVID-19 vaccine than in a normal one," Gou told the Global Times. "We never skip the core steps, strictly following Good Clinical Practice and our own Standard Operating Procedure (SOP), but we compressed a lot of work in a much tighter timeframe to race against the virus."

A Pakistani medical worker innoculates a volunteer of the Phase III trials of CanSinoBIO's COVID-19 vaccine. Photo: Courtesy of CanSinoBIO

The local regulator has given "rolling reviews" on safety, manufacturing standards and efficacy of the vaccine candidate considering the COVID-19 pandemic has killed over 12,000 people in Pakistan.

The recombinant adenovirus vector vaccine, jointly developed by CanSinoBIO and researchers from the Beijing Institute of Biotechnology under the Academy of Military Medical Science led by prominent Chinese COVID-19 vaccine developer Chen Wei, received emergency use approval in Pakistan on February 12.

Back in March, 2020, the manufacturer launched the world's first COVID-19 vaccine trial in Wuhan, Central China, to test its safety and efficacy.

It reported 65.7 percent efficacy against symptomatic COVID-19 cases and 90.98 percent against severe infection, according to its global Phase III interim data released this February. The trials were carried out among more than 40,000 volunteers, aged 18 and older, in 78 clinical trial sites across five countries on three continents.

The role of the Chinese team was to design the trial and to guide its every step to meet with protocols in their design, Gou mentioned, stressing that they do not interfere with the data produced. Their Pakistani partners were in charge of the recruitment of volunteers and roll out of the trials.

"No Phase III clinical trial of this large scale has ever been conducted in Pakistan. This collaboration is a breakthrough for Pakistan, as they never expected to efficiently handle a large-scale, high-standard, fast-paced clinical trial likes this," said Gou.

The local clinical trial team, learning from their Chinese coordinator, built a complete quality management system for large-scale clinical drug studies, through frequent online or offline training sessions open to local researchers, offered by the Chinese team of experts.

Gou Jinbo (first from right) with his work partners in Pakistan Photo: Courtesy of CanSinoBIO

Unheralded challenges

The development of a COVID-19 vaccine at record-breaking speed was an unprecedented challenge, comparable only to sending a man to Mars, some industry insiders suggested. CanSinoBIO's path in overseas trials was also littered with disappointment and unexpected challenges.

Challenges recruiting volunteers and language barrier between the Chinese team and their Pakistani partners threw a wrench in the initial progress.

"Recruiting tens of thousands of volunteers was the first challenge we had when we came to Pakistan. On the day of the Mid-Autumn Festival last year, one of my male colleagues shed tears over the phone as he felt frustrated and guilty for only having gotten a few recruits over half a month after his arrival," Gou told the Global Times.

The success of every vaccine candidate is a tale of group perseverance, scientific "eureka" moments, and soaring public expectations.

The study team listened to the concerns of locals taking part in the trials and then clarified their doubts through video advertising campaigns and psychological counseling. Research team members mobilized their friends and families to join the trials, which exceeded expectations with over 17,000 participants, Gou told the Global Times.

The language barrier when interpreting and translating technical terms in English, Chinese and Urdu was also a remarkable challenge. Many of the Chinese experts work as supervisors by day and learn English by night, which adds to the already existent physical struggle to adjust to a different diet and weather conditions.

Working at such an unprecedented pace, Gou and other researchers have not stopped for a single day in nearly two months to gain enough time to compile the database tens of thousands of people strong. Their Pakistani counterparts, inspired by the Chinese researchers, also sacrificed their weekends in the race against the virus, though their overtime work application required special approval by the local health ministry.

Compared with foreign traditional pharmaceutical giants like Pfizer, younger CanSino still has a long road ahead to mobilize global resources. But with only one year to develop a COVID-19 vaccine, the dedication and foresight of its Chinese scientists is historically groundbreaking.