Russia’s COVID-19 Vaccine “Approved" Despite No Phase III Data

"As far as I know, today in the morning the first vaccine against the new coronavirus infection was registered," – Vladimir Putin, President of Russia, in a televised video conference call with government ministers.

The scientific community has been left somewhat perplexed today after Russian President Vladamir Putin announced that Russian authorities have approved the world's first COVID-19 vaccine – and his daughter has already received it. The news follows the global number of COVID-19 cases exceeding 20 million, a morbid milestone shared by the Johns Hopkins Coronavirus Resource Center database.

The vaccine, developed by Moscow's Gamaleya Institute, is known as "Gam-COVID-Vac". It is an adenovirus-based vaccine – as is the ChAdOx1 vaccine being tested by the University of Oxford – and entered a Phase I clinical trial back in June which recruited 38 healthy participants to evaluate its safety, tolerability and immunogenicity. According to the National Institutes of Health clinical trials study record, this trial is still ongoing.

However, the Russian media reported that Russian Health Minister Mikhail Murashko had declared on August 1 that "clinical trials of a coronavirus vaccine developed by the Gamaleya Center are over, paperwork is underway for the vaccine’s registration." To date, Russia has not published any scientific data regarding Gam-COVID-Vac.

Vaccine testing, manufacturing and approval is typically a lengthy and laborious process that follows routine steps and can take between 10-15 years on average to complete. Clinical trials are critical for a vaccine's approval as they must demonstrate its safety, efficacy, help scientists to calculate what dosage is required to achieve immunization against a pathogen and to assess the best route of administration, number of boosters required at vaccination intervals and the duration of immunity. These trials are separated into phases, with Phase III data being required by the US Food and Drug Administration (FDA) for vaccine approval and dissemination.

In the extraordinary times of the COVID-19 global pandemic, we have witnessed a number of vaccines receive "fast track" approval from the US Food and Drug Administration (FDA). The World Health Organization (WHO) recognizes that a staggering 167 vaccines are in various stages of clinical testing against SARS-CoV-2.

However, the approval for use of a vaccine before it has even completed a Phase I trial is unheard of. The WHO maintain a draft landscape of the COVID-19 candidate vaccines which provides regular updates on their clinical testing status – but there is no mention of Gam-COVID-Vac being in a Phase III trial in this document.

So how and why has it allegedly been authorized for human use?

Speculations are forming as to whether there are political undercurrents to this move which could ultimately compromise human safety. From a scientific perspective, it is unclear as to exactly what is going on, and how a vaccine has been approved based on such little data. This has sparked controversy, and concerns are being expressed across the scientific community.

A large vaccine trial or mass vaccination?

Particular focus has been placed on a statement made just yesterday at a meeting of the Russian Government Coordination Council, in which the Mayor of Moscow Sergei Sobyanin addressed the Prime Minister of the Russian Federation Mikhail Mishustin: "Mr Mishustin, registration of a Russian vaccine is highly anticipated. Once the vaccine has been registered, we will be able to start mass production and vaccination of the public, which will be the biggest solution to this problem."

In response to the notion of mass production of the vaccine and vaccination of the public, Francois Balloux, professor of computational systems biology at University College London and Director of the UCL Genetics Institute, said, "This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”

Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh, acknowledged that there is "no justification" to the approval of a vaccine with such limited clinical testing. She said, "The individual risk of dying from COVID-19 is low, and in many countries it is falling, and we have effective public health measures to sustain this in the short to medium term. At this stage of the pandemic, with transmission low or falling in many countries, COVID-19 vaccine trials need to be large in order to gather enough data on infections to determine whether they work. But there is a big difference between a large vaccine trial (with careful and frequent follow up of all vaccinated individuals) and deployment of a vaccine to the general public."

Riley states that, at present, it's unclear as to what message is being proposed by Russia: "A large Phase III clinical trial or mass vaccination?"

Correction

The article title was updated on August 12, 2020 from "Russia’s COVID-19 Vaccine “Approved For Mass Production" Despite No Phase III Data" to "Russia’s COVID-19 Vaccine “Approved" Despite No Phase III Data." This update was made to reflect the fact that Gam-COVID-Vac has been approved by Russian authorities but mass production has not yet begun.