A Chinese COVID-19 vaccine maker explains why it hasn’t published any late-stage data yet

March 16, 2021, 3:35 AM UTC

On Feb. 29 last year, Dr. Chen Wei, virologist and major general in China’s People’s Liberation Army, became one of the first people on earth to get a COVID-19 vaccine. Appearing in military garb and standing in front of a Chinese Communist Party flag in an undisclosed location, she received the injection weeks before the devastating virus would even touch much of the planet.

Chen and her team at the military-run Academy of Military Medical Sciences co-developed the COVID-19 vaccine she received—now called Convidicea—with Cansino Biologics, a 12-year-old private vaccine maker based in Tianjin, China. At the time, experts questioned Chen’s decision to receive the injection weeks before Cansino launched human trials of the vaccine. (China’s military did not confirm which vaccine Chen received and later deleted its social media post on the injection.) But Cansino’s candidate nonetheless became one of the early favorites in the COVID-19 vaccine race.

In May 2020, Cansino published the world’s first peer-reviewed data on its phase I vaccine trials. The next month, China’s military approved its use for Chinese soldiers, the first known distribution of a COVID-19 outside of clinical trials.

But despite its early successes, Cansino fell behind counterparts in the U.S. and China in reaching the end of phase III clinical trials. American vaccine makers like Pfizer and Moderna began distributing vaccines late last year after winning emergency authorization in places like the U.S. and U.K. In December 2020, Chinese vaccine makers such as Sinopharm and Sinovac began distributing tens of millions of vaccine doses to at least 43 countries globally after winning regulatory approval.

Now Cansino appears to have caught up. In late February, Chinese authorities approved Cansino’s vaccine for general use after Cansino said its one-shot vaccine was 65.7% effective in preventing COVID-19 infections, based on global trials. Cansino also is distributing the vaccine in places like Mexico and Pakistan with plans to ramp up its production capacity and global outreach. But through it all, Cansino has not published its phase III trial data in a peer-reviewed journal, medicine’s gold standard of vetting. In fact, all four Chinese vaccines on the market have failed to take this step, a fact that’s dogged their rollouts.

Pierre Morgon, Cansino’s senior vice president for international business, spoke to Fortune about the company’s relationship with China’s military, how the company plans to roll out its vaccine internationally, and why Cansino has yet to publish phase III trial data in a medical journal. This interview has been edited for length and clarity.

Fortune: Why was your vaccine slower to earn authorization compared to Chinese makers like Sinovac and Sinopharm?

Pierre Morgon: First of all, the technology used by the other Chinese companies is very old. It’s about taking the pathogen, growing it in sufficient numbers and inactivating it. Ours is using viral vectors. There’s a difference in technology, therefore, the level of scrutiny that the authorities are putting on novel technologies is always higher.

The second thing is Cansino is still a growing company. So we have less staff, less medical affairs, and less regulatory experience, etc., than others. That said, we are only talking about a few weeks or a month. We’re still bringing a solution that actually works, so I would argue that it was worth the extra delay.

What was the Chinese military’s role in developing the vaccine?

The Beijing Institute of Biotechnology, or BIB, [part of the Academy of Military Medical Sciences] is a very credible partner and very strong with science. There’s a history of collaboration as well. We jointly developed an Ebola vaccine based on the same technology. For the COVID-19 vaccine, the BIB was more involved in the early design phase, and Cansino was more involved in the clinical development phase.

More broadly, around the world it is quite common that vaccine companies work with the public entities such as the military, especially when it comes to pandemic preparedness.

Cansino’s one-shot vaccine is now being distributed in places like Mexico after conducting trials there. How did Cansino choose where to roll out its vaccines?

There was insufficient viral circulation in China to run the phase III study in China. So the choice of the country [for trials] was largely done based on epidemiology. Criteria No. 1 was to find places with viral circulation. Criteria No. 2 was we needed to have infrastructure in place in the country, like hospitals, that was used to running immunization clinics and reporting trial data.

Now, we are very focused on ensuring access in an equitable manner. And that translates into several different aspects. The first one is we’re making sure that our vaccine is available in sufficient quantities, and we are scaling up manufacturing.

The second thing is making sure that it is affordable. In this respect, we’re practicing what is called tiered pricing, meaning, the richer the country, the higher the price, the poorer the country, the lower price. The lowest price that we give is the one that we’re bidding through COVAX.

Why hasn’t Cansino published phase III clinical results in a medical journal yet?

We have independent experts monitoring the way the study is being managed and what the data is. The idea is that the [expert] committee had access to the results before the company, so when the interim results were actually made available, they were sent directly by the independent statisticians to the investigators in the country [where Cansino has applied for approval].

That actually guarantees the integrity of the data. We’re not doing this for financial publicity, we’re doing this because we need to have indisputable clinical evidence that the vaccine is working.

When will you publish the phase III clinical data?

We are definitely planning to publish the phase III results in medical journals. I would say within a few weeks, maybe less, but honestly, I don’t know. I’m not in charge of that.

Cansino works according to the highest quality standards, and I think that is going to be increasingly visible because the vaccine that we’re launching will be increasingly accepted worldwide.