Keeping tabs on Covid-19: The rise and fall of the Russian-made vaccine

Following the criticism sparked by Russia’s Federal Service for Surveillance in Healthcare approving Sputnik V for emergency use in August 2020, after it was tested on just 38 people, Russia’s Covid-19 vaccine has continued to suffer a fall from grace after Gamaleya Research Institute, the developers of Sputnik V, refused to share recent clinical findings on the drug.

In September 2020, Tass reported that Denis Logunov, Deputy Research Director at the Gamaleya Research Institute, and his co-authors would provide access to health records of certain volunteers, so that all the issues around the vaccine’s efficiency would be clarified.

With the integrity of Sputnik V still being brought into question following the disclosure of information, alarm bells are ringing in the scientific community.

Current concerns and controversy

The lack of data and the mounting concerns around Sputnik V’s quality and safety has promoted the Brazilian Health Regulatory Agency to drop out of its vaccine import deal that was finalized in April 2020, with Gamaleya Research Institute, Clinical Trials Arena disclosed.

In addition, several US colleges and universities have asked students that where vaccinated with Sputnik V to get re-vaccinated with a US-approved vaccine once they arrive on campus as the Russian-made vaccine has not yet been approved by the World Health Organization (WHO).

Kirill Dmitriev, the head of the Russian Direct Investment Fund, which markets Sputnik V, told Reuters that Russia expects WHO to give the vaccine the nod of approval within two months.

He added: “We see that inspectors are keeping a professional attitude. There are no significant critical remarks, at least for now, and if we were not absolutely sure of the transparency of the process, we would not have invited anybody.”

Despite concerns, roll-out plans for Sputnik V continues

Although neither the European Medicines Agency and WHO have not approved the Sputnik V vaccine for use, Vladimír Lengvarský, the Slovak Health Minister, has announced the roll out of Russia’s Sputnik V vaccine will start in the country on 7 June 2021.

While the Slovak government has agreed to use the Sputnik V vaccine, Lengvarský said in an interview that he would not take the jab himself, and would not recommend it to his acquaintances.

“We probably do not have to worry about the safety of the vaccine,” Lengvarský stated. “The [Slovak] government will be responsible for any adverse effects of the vaccine and that those getting the Sputnik V jab will be specifically checked following inoculation.”

Similarly, the Serum Institute of India has sought for preliminary approval of Russia’s Sputnik V Covid-19 vaccine from India’s federal drug regulator, Reuters claimed.

A total of six Indian companies have signed deals to produce around 1 billion doses of Sputnik V annually and the Indian government expects 156 million doses of Sputnik V to be delivered between August and December, according to a report by Reuters.

Discover insights from Sanyam Gandhi, Regulatory Strategy Lead at Takeda, as he analyzes the regulatory framework of using real-world data and real-world evidence in clinical trials in this exclusive Pharma IQ article.