Russian Vaccine Led to 100 Percent Antibody Generation, Trial Data Shows

Researchers from Moscow’s Gamaleya Research Institute have posted results from two phase 1/2 trials of their controversial COVID-19 vaccine, showing it was safe and induced the production of antibodies in all adult volunteers.

The results, published in The Lancet Friday, showed that the two-shot vaccine — which drew international skepticism after being approved in August by the Russian government prior to phase 3 trials (DID, Aug. 12) — produced antibodies in all 76 participants and was well-tolerated.

The researchers noted that the study had its limitations, including the lack of a placebo or control vaccine, a low number of participants and the use of “fairly young” volunteers despite an original plan to include older patients.

“Further research is needed to evaluate the vaccine in different populations, including older age groups, individuals with underlying medical conditions and people in at-risk groups,” the researchers said.

Russia drew intense criticism for its approval of the vaccine before evaluation in large-scale phase 3 trials to determine safety and effectiveness. President Vladimir Putin claimed that the vaccine “works fairly effectively” and “forms stable immunity and … has gone through all the necessary checks,” but health experts, including former FDA Commissioner Scott Gottlieb, said late-stage trials were necessary before an approval could even be considered.

“They’re certainly not ahead of us, and we certainly wouldn’t allow a vaccine to be used for mass distribution at this point based on the data that we have in hand,” Gottlieb said, following the vaccine’s approval.

Russia’s state news agency announced the start of a 40,000-volunteer phase 3 trial of the vaccine nearly two weeks after the government’s approval. The international trial is taking place in Russia, Saudi Arabia, the Philippines and the United Arab Emirates, and may also be conducted in Brazil and India, the agency said (DID, Aug. 24).

The Gamaleya Institute is also conducting a phase 3 trial of its vaccine involving more than 2,000 participants in Russia, the Middle East and Latin America.

Read the phase 1/2 trial results here: bit.ly/332NSES. — James Miessler