Russia Approves Fast-Track Covid-19 Vaccine Without Testing In Large Trials

Russia has announced mass vaccination will begin against Covid-19 in October, but scientists fear that important testing steps have been skipped, meaning anyone taking the vaccine is operating blind. PhotobyTawat/Shutterstock

The Russian government has approved a vaccine against Covid-19 and is promoting its effectiveness, despite just two months of testing. Outside Russia, however, scientists are alarmed by irregularities in the testing process, including its small size. In particular, there are fears that any problems with the fast-tracked vaccine, known as Sputnik V will undermine confidence in vaccines that do pass standard testing.

Russian President Vladamir Putin announced on state television that mass vaccination will start in October, with doctors and teachers given the opportunity to go first, although Bloomberg reports families of Russian leaders are already getting access. Putin himself said that his daughter had been given the vaccine.

The response from the scientific community in the rest of the world is probably best summed up by Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases on a virtual panel discussion to be screened by National Geographic. "I hope that the Russians have actually, definitively proven that the vaccine is safe and effective," Fauci said. "I seriously doubt that they've done that."

“The issue is nothing is published or reported, in terms of immunity and safety, so no one can actually tell what’s going on. More importantly, without a phase 3 trial, it's impossible to know that it even gives any protection against COVID-19, let alone how long protection will last,” said Professor Nigel McMillan of Australia's Griffith University in a statement. Numerous other immunologists made similar comments.

Even the World Health Organization, often wary of offending powerful governments, has issued a warning, with spokesperson Tarik Jasarevic saying “absolutely essential clinical trial data” needs to be available before approval can be granted.

Under normal circumstances vaccine development is a slow process, starting with cultured cells, usually followed by animal testing. Very small phase I trials rule out common, serious side-effects. Phase II and III trials are larger to detect rarer reactions and assess the level of protection provided.

This rigorous testing sadly doesn't prevent people whose scientific education comes from Youtube spreading wild and baseless allegations about vaccine dangers, but it does mean genuine vaccine harms are rare and getting rarer.

The urgency of freeing the world from lockdown has caused some bending of these rules with certain vaccine candidates skipping the animal testing stage. Instead of being conducted sequentially, Phase II and III trials have overlapped in some cases. There is plenty of debate in scientific circles about how far we should go in allowing this, but few have even contemplated the Russian approach.

In the absence of a Phase III trial there is simply no way to know whether Sputnik V induces rare effects – for example causing flare-ups of certain pre-existing conditions.

Moreover, even the data that has been collected hasn't been made public leaving the world entirely dependent on the word of Sputnik V's inventors at Moscow's Gamaleya Research Institute.

The skipping of the Phase III trials, while risky, might be defended on the basis of the urgency of the situation, but there is no obvious justification for not releasing earlier phase data for peer review.

Russian officials raised the possibility of a mid-August approval two weeks ago, but no one knew how serious they were.

Naturally Russia is as desperate as everyone else to stop Covid-19's spread, but many suspect there are other motivations in the quest to be first. Even the name Sputnik V harks back to a time when the country led the world in a major scientific endeavor, leading Prof McMillan to call the move “vaccine nationalism” and warn “If there are issues going forward with this vaccine, in terms of efficacy or safety, it will put the entire vaccine effort in a very difficult position, as people will lose trust or hope that any vaccine will work."

Nevertheless, Russian reports claim at least 20 nations have expressed interest in getting early access to stocks.

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