‘Approvals without publishing full phase 3 data are becoming something of a trend’

Chinese and Russian manufacturers are seeing growing appetite from foreign buyers for their COVID-19 vaccines as the international scramble for jabs intensifies, says The Financial Times. Both Russia and China have already signed agreements with a number of countries worldwide, and for both governments, vaccine sales represent a significant political and commercial coup, as they are keen to see their pharmaceutical sectors compete internationally.

Promising results from early-stage clinical trials of leading Chinese and Russian vaccines were published in peer-reviewed international journals such as The Lancet. According to experts, phase 3 safety and efficacy trials were carried out later in accordance with international standards in terms of scale and process. However, complete interim results from those trials, which normally underpin conclusions about efficacy, were not released before the vaccines received regulatory approvals.

“Approvals without publishing full phase 3 data are becoming something of a trend,” considers Professor Raina MacIntyre, an infectious diseases specialist at the University of New South Wales in Sydney adding that “when you are talking about rolling out a vaccine to the public, you want to see that data published”.

Phase 3 trials of Russia’s Sputnik V began in September on 30,000 volunteers. In November, the state-run Gamaleya Research Institute of Epidemiology and Microbiology said that according to interim data from the trials, the jab’s efficacy totalled 92%, which was comparable to western vaccines. Sputnik V is based on a harmless adenovirus that delivers the immunising protein into the body. The same technology is used in the Oxford/AstraZeneca shot.

In China, the limited use of several vaccines has been allowed since the summer. In December, the state gave conditional approval to a vaccine developed by Sinopharm after the manufacturer stated of 79% effectiveness in an interim analysis of phase 3 results. According to Bahrain and the UAE, which also trialled the Chinese vaccine, it was 86% effective. However, the announcements lacked some key information normally considered by regulators, such as the number of infections among trial participants. Another Chinese vaccine developed by Sinovac Biotech also has conflicting efficacy data.

“I am very confident about the data we have on the mRNA vaccines,” commented Fiona Smaill from McMaster University in Ontario, Canada. She was referring to the shots developed by US Moderna and the German-American partnership of BioNTech and Pfizer. “Because we don’t see that same data for the Chinese vaccines, it is much more challenging for us to have that same confidence,” she added.