September 4, 2020, 7:01 AM EDT Updated on September 4, 2020, 8:09 AM EDT
Shot produces antibody response, no adverse effects: Lancet
Publication is first time Russia data has been peer-reviewed
Russia Registers First Covid-19 Vaccine as Trials Continue
Russia’s proposed Covid-19 vaccine induced an antibody response in all participants in early trials and found no serious adverse effects, according to the first vetted data on the controversial project.
The vaccine also produced a response in T-cells -- a type of white blood cell that helps the immune system destroy infection -- according to preliminary results from phase 1 and 2 trials that were published Friday in the Lancet medical journal. Russian officials had previously made broadly similar statements about the shot, prior to review by outside experts.
Despite limitations in the trials, the peer-reviewed data bolster Russia’s prospects in the race with the U.S., China and Europe to secure a vaccine, following widespread skepticism. Health officials elsewhere criticized the country’s regulatory approval of the shot last month, before it had gone through wider phase 3 trials. Concerns about so-called vaccine nationalism were fueled by allegations that Russian intelligence services orchestrated the hacking of western development programs -- which the Kremlin denied.
The ‘Gam-COVID-Vac’ at the Gamaleya National Research Center in Zelenograd, Russia.
Photographer: Andrey Rudakov/Bloomberg
Friday’s publication marks a “turning point” following “attacks” on the project, said Kirill Dmitriev, chief executive officer of the Russian Direct Investment Fund, which is backing the vaccine.
“Russia has answered the questions that have been asked about it,” he said on a conference call. “And we are convinced that we have the best vaccine in the world.”
The trials took place in two Russian hospitals and involved 76 healthy adults aged 18 to 60. The vaccine uses two different human adenoviruses -- relatively harmless germs that normally cause common colds -- that were altered to carry coronavirus proteins that induce an immune response.
All participants were given the vaccine and there was no placebo group -- one of several limitations to the trials that were cited in the report.
What Bloomberg Intelligence Says
“Data for Russia’s Covid-19 vaccine show it’s active with acceptable side effects, but this doesn’t change the fact that it was approved way too early, based on data from a 76-subject trial.”
-- Sam Fazeli, pharma analyst
First Blush at Russia’s Covid-19 Vaccine
The investigators took convalescent plasma from 4,817 people who had recovered from mild or moderate Covid-19 to compare post-vaccination immunity with natural immunity. Antibody responses were higher in those vaccinated, according to the data.
The government has announced plans to begin administering the shot more widely to medical personnel and teachers in the coming weeks, ahead of a broader national campaign slated for late this year. The move has led to concerns that political pressure could prevail over safety considerations and risk public health as the world seeks an end to the pandemic.
The Russian investigators tested two forms of the vaccine - frozen and freeze-dried. Phase 1 participants were given one of the two-part shots, while phase 2 groups also received a second shot 21 days after the first. All 40 participants in the phase 2 trial produced antibodies, with higher levels found in those who had received the frozen vaccine. Neutralizing antibody responses were found in all phase 2 subjects, while only 61% of phase 1 participants produced them from the single shot.
All phase 2 participants showed T-cell responses within 28 days of vaccination, with the frozen shots again proving more effective than the freeze-dried.
The investigators said limitations to the study include its size, the short follow-up time of 42 days and the fact that some parts of the phase 1 trial used only male volunteers. The trial also largely focused on people in their 20s and 30s.
Russia has also been giving the vaccine to officials and other prominent people outside the trial groups for months without waiting for the full study results. On Friday, Moscow Mayor Sergei Sobyanin, 62, told Russian President Vladimir Putin in a televised video conference that he’d had the shot and felt only minor discomfort at the time. Putin said last month that one of his daughters also had the inoculation and was feeling fine. The Kremlin hasn’t disclosed whether Putin has been vaccinated.
A phase 3 trial was approved on Aug. 26 for 40,000 volunteers from different age and risk groups.
“The immunogenicity bodes well, although nothing can be inferred on immunogenicity in older age groups, and clinical efficacy for any Covid-19 vaccine has not yet been shown,” said Naor Bar-Zeev, an associate professor at the Johns Hopkins Bloomberg School of Public Health, in a linked commentary in The Lancet. “Showing safety will be crucial with Covid-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly.”
— With assistance by Gregory White
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