A few days ago, the Russians announced that they had developed a vaccine for COVID-19. They stated that the vaccine was documented to be “effective and safe,” and would be made available within weeks to individuals and even other countries who wanted to be vaccinated. In addition, prominent Russian leaders such as President Vladimir Putin said on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine, after less than two months of human testing.
While the vaccine has not yet completed western-style clinical testing, Putin stated not only did he get the vaccine, but that he had vaccinated his daughter with it. The vaccine, which the Russians have likened to Sputnik, their groundbreaking launch of the first man-made satellite, is very similar to several vaccines under development in the EU, US, and China. Despite this, prominent scientists have raised concerns.
Dr. Francis Collins, director of the NIH, said during a conference call that Russia’s coronavirus vaccine skipped “fundamental parts” of the testing and approval process, noting some people have coined it “Russian roulette.” Other international scientists have questioned the safety and efficacy of Russia’s vaccine, and Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, told National Geographic in an interview that he “seriously doubts” Russia has proven its vaccine is safe and effective.
The Russians completely disagreed with these concerns: “It seems our foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express opinions that in our opinion are completely groundless,” Health Minister Mikhail Murashko said on Wednesday. Several legitimate scientists in the Soviet Union have attested to the value of the vaccine. They have stated that publication of the scientific data about the vaccine is forthcoming and will prove the safety of the vaccine.
Unfortunately, at the present time we only have second-hand reports of the vaccine structure and how it potentially might work. Despite these limitations, because of the scientific controversy I would like to make a few comments about the likelihood of this vaccine being successful.
The Russian vaccine is a live human adenovirus that has been genetically engineered to express the spike protein from the COVID-19 causing SARS-CoV-2 virus. The human adenovirus is injected into the subject where it replicates and induces an immune response. This immune response includes a response to the spike protein from SARS-CoV-2 expressed by the virus. The actual version of the spike protein produced by these vaccines will be important to know.
This approach is almost identical to the CanSino vaccine; the efficacy data for this was recently published in Lancet. It is also similar to the Oxford/AstraZenica vaccine, which uses a similar genetically modified adenovirus except from chimpanzees. The major difference is that the Russian vaccine has two different human adenoviruses that have both been genetically modified to produced coronavirus Spike protein. This is likely an insignificant difference in terms of how the vaccine would work. Both CanSino and Oxford’s approaches have been lauded by western scientists and CanSino recently did a successful IPO based on their results.
The vaccine was developed by Moscow’s Gamaleya Institute, a very legitimate biotechnology center in Russia. It was taken into a Phase I safety trial in humans at a number of institutions, including the famed Vector in Novosibirsk and Sechenov University where Elena Smolyarchuk, a department director and one of the coordinators of the trial stated, “We were primarily testing for safety.” Despite this, the trial included only 100 volunteers. Alexander Gintsburg, director of the Gamaleya Institute, said clinical trial results would be published once they have been assessed by Russia’s own experts. Russia also plans to be able to produce 5 million doses a month by December-January and appears capable of doing this manufacturing.
Bottom line: While we need to review the human data before we make any judgement, I believe the Russian vaccine will be similar to the CanSino and Oxford vaccines. If produced correctly it may be as effective as those vaccines. Large scale safety assessments are important, and the actual dose of the vaccine needs to be titrated for safety. This is especially true with any live adenovirus vaccine since other adenovirus vaccines have had significant toxicity at higher concentrations.