Russia Approves Vector Labs COVID-19 Vaccine For Production Without Phase Three Trials

Russia has approved a COVID-19 vaccine from the Vector State Virology and Biotechnology Center, the second time its health ministry has green-lit a vaccine without completing phase three testing. Russia has been among the countries hardest hit by the pandemic, and is rushing to produce a vaccine, Bloomberg reports.

The vaccine, named EpiVacCorona, has only completed limited phase two testing on a population of 100 subjects. While Vector reports no adverse side effects, its data is yet to be published in a peer-reviewed journal.

Vector is a former bioweapons lab in Siberia that worked to weaponize smallpox during the Cold War. Its new drug uses synthetic shards of the COVID-19 virus, called peptide antigens, to mount an immune system defense before the disease is contracted.

It will proceed to larger phase three tests while production and distribution are underway with assistance from foreign partners. Tatyana Golikova, Russia’s deputy prime minister, said that 60,000 doses will soon be available and that Russian President Vladimir Putin had already tried the drug.

“We need to increase production of our first and now our second vaccine,” Putin said. “First of all we should supply the domestic market.”

Russia has rushed approval of a vaccine before in Sputnik V, the first COVID-19 vaccine to receive state approval. Its haste comes from Russia’s difficulty managing the virus: it ranks fourth in infections after the U.S., India and Brazil despite having the ninth-largest population. Russia recently broke its record for most daily infections with 14,231 new cases in a single day.

Russia says its conditional registration is no different from other countries’ efforts to fast-track vaccines. The U.S. has several vaccines currently in phase three trials that are not yet approved for production. Meanwhile, President Donald Trump has come into conflict with his FDA over safety regulations that would likely delay a vaccine until after the November presidential election.

Vector’s vaccine will go on to a trial with 30,000 volunteers in November or December, Russia’s state news agency reports. Sputnik V is in phase three now with 40,000 volunteers and hopes to have results by November, with full data available in 2021.

U.S. vaccines have run into a number of issues in phase three testing. Johnson and Johnson, Eli Lilly and AstraZeneca have paused their trials after patients reported side effects.