Sputnik V vaccine draws criticism – experts decry Russia’s lack of transparency over trial results

Medical experts are up in arms over Russia’s plan to fast-track the distribution of its controversial Sputnik V vaccine, even as the COVID-19 vaccine has yet to undergo large-scale clinical trials. They have also expressed their concern over “strange patterns” in the vaccine candidate’s phase 1 trial results. The vaccine is currently being developed at the state-run Gamaleya Research Institute of Epidemiology and Microbiology, in collaboration with the Ministry of Defense.

Experts demand release of raw data

Medical experts from 12 countries — including the U.S., U.K., Switzerland, Japan, Germany and France — have signed an open letter demanding the Gamaleya Institute release information regarding the vaccine. In particular, their concerns stem from an article published in the medical journal Lancet regarding the results of Sputnik V’s phase 1 trials. They argued that duplicating the results regarding the production of antibodies in the participants is “highly improbable.” They also noted that the trials only comprised 76 volunteers — too small to determine the vaccine’s safety and effectiveness.  (Related: Fauci says he has no faith that Russia’s COVID-19 vaccine is “safe and effective.”)

In response, through state news agency TASS, the Gamaleya Institute maintained that all data regarding the vaccine candidate has been double-checked and that the points raised by the international medical community are merely coincidences.

“The coincidences that emerged, especially at the early points (values are low and are close to baseline), are associated with the discreteness of the data, as well as with the small number of participants in the groups,” the Gamaleya scientists wrote. “We acknowledged this as a limitation of the study in the discussion section of [The Lancet article].”

Despite the backlash, the TASS report noted that Russia had received delivery orders for over one billion doses of Sputnik V from around 20 countries. The Gamaleya Institute has not made further comments regarding calls for its raw data from the phase 1 trials to be published.

Russia fast-tracks approval for second coronavirus vaccine

On Wednesday, Oct. 14, Russian President Vladimir Putin announced that the country’s second coronavirus vaccine, EpiVacCorona, has been given regulatory approval.

“We now need to increase production of the first vaccine and the second vaccine,” said Putin during a televised meeting with government officials. The Russian president said that the country’s priority will be to provide enough doses of both EpiVacCorona and Sputnik V for its own citizens.

The vaccine was developed by the Vector State Research Center of Virology and Biotechnology, a former bioweapons research lab of the Soviet Union.

EpiVacCorona’s phase two trial was conducted among 100 volunteers. None of the data regarding the trials has been published, but scientists involved in the vaccine’s development have asserted that EpiVacCorona can provide a person with up to six months of immunity from the coronavirus.

EpiVacCorona’s approval process was fast-tracked, even though it has not completed phase 3 of its clinical trials.

Tatyana Golikova, Russia’s Deputy Prime Minister, said that EpiVacCorona will be undergoing post-registration clinical trials. The trial will include 40,000 volunteers from all over Russia. Golikova also said that she tested EpiVacCorona herself and has experienced no side effects.

Learn more about the development of coronavirus vaccines in Russia, the United States and other parts of the world by reading the latest articles at Vaccines.news.

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