Russian vaccine trial showed 100% of participants developed antibodies

The results of two trials were published in the Lancet on Friday.

By REUTERS, MAAYAN JAFFE-HOFFMAN
Bottles labeled "Vaccine" stand near medical syringe in front of "Coronavirus COVID-19" display (illustrative) (photo credit: REUTERS/DADO RUVIC/ILLUSTRATION/FILE PHOTO)
Bottles labeled "Vaccine" stand near medical syringe in front of "Coronavirus COVID-19" display (illustrative)
(photo credit: REUTERS/DADO RUVIC/ILLUSTRATION/FILE PHOTO)
Russia’s “Sputnik-V” COVID-19 vaccine produced an antibody response in all participants in early-stage trials, according to results published on Friday by The Lancet medical journal, which were hailed by Moscow as an answer to its critics.
The results of the two trials, conducted in June-July this year and involving 76 participants, showed 100% of participants developing antibodies to the new coronavirus and no serious side effects, The Lancet said.
Russia licensed the two-shot jab for domestic use in August, the first country to do so and before any data had been published or a large-scale trial begun.
“The two 42-day trials – including 38 healthy adults each – did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response,” the report added.
“Large, long-term trials including a placebo comparison, and further monitoring are needed to establish the long-term safety and effectiveness of the vaccine for preventing COVID-19 infection,” it said.
Commenting on the results of the early-stage trials, lead author Dr. Naor Bar-Zeev of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health, listed the mild effects as pain at the injection site, hyperthermia, headache, asthenia and muscle and joint pain.
The vaccine is named Sputnik-V in homage to the world’s first satellite, launched by the Soviet Union. Some Western experts have warned against its use until all internationally approved testing and regulatory steps have been taken.
In August, Health Minister Yuli Edelstein said: “We have already scheduled meetings over the vaccine in Russia. If we are convinced that this is a serious product, then we will also try to enter negotiations.”
He added, “But I don’t want to delude anyone.”
Furthermore, representatives of  Hadassah Medical Center told The Jerusalem Post last month that it is in negotiations to test the Russian Sputnik V vaccine both at its branch in Skolkovo and in Israel, and to potentially manufacture and distribute it in the Jewish state.

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Prof. Polina Stepensky, chairman of the Department of Bone Marrow Transplantation & Cancer Immunotherapy of Adults and Children at Hadassah, told the Post that “we are in negotiations” specifically to take part in the vaccine’s upcoming Phase III trial and to establish a production facility so that the vaccine would be available to Israelis if it proves safe and effective.
 
The Health Ministry confirmed that it is aware of the negotiations.
With the results now published for the first time in an international peer-reviewed journal, and with a Phase III, 40,000-strong later-stage trial launched last week, a senior Russian official said Moscow had faced down its critics abroad.
“With this [publication] we answer all of the questions of the West that were diligently asked over the past three weeks, frankly with the clear goal of tarnishing the Russian vaccine,” said Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, which has backed the vaccine.
“All of the boxes are checked,” he told Reuters. “Now... we will start asking questions of some of the Western vaccines.”
He added in a press conference late Friday that during a pandemic “it is especially important to use a vaccine platform with proven safety, as Sputnik V does, so as not to leave the world without an effective protection from coronavirus, but also not to risk people’s lives using untested experimental technologies. We are now witnessing a change in the global approach towards the registration of vaccines with the USA, UK, China and other countries following Russia’s path in fast-tracking registration.”
Dmitriev said at least 3,000 people had already been recruited for the large-scale trial of the Sputnik-V vaccine launched last month, and initial results were expected in October or November this year.
Bar-Zeev called the studies “encouraging but small” and noted that “a control arm was conspicuously missing.”
 
Bar-Zeev, who was not involved in the study, said “clinical efficacy for any COVID-19 vaccine has not yet been shown” and “much more remains to be learned.”
Rotstein told the Post: “I strongly recommend that authorities in Israel not focus only on the American companies manufacturing vaccines and not neglect the ability of Russian scientists. Remember, there are senior Jewish scientists participating [in the development of coronavirus vaccines] everywhere, not just in the US – also in Russia.”
Alexander Gintsburg, the head of Moscow’s state-run Gamaleya Institute, is Jewish.
RACE TO DEVELOP VACCINE
Governments and big pharmaceutical firms are racing to develop a vaccine to end the COVID-19 pandemic, which has killed more than 850,000 people globally and infected around 26 million.
More than half a dozen drugmakers are already conducting advanced clinical trials, each with tens of thousands of participants.
Several of the companies, including Britain’s AstraZeneca and US drugmakers Moderna and Pfizer, expect to know if their COVID-19 vaccines work and are safe by the end of this year.
In Israel, the Health Ministry has already signed with Moderna and the American vaccine maker Arcturus to be among the first recipients of their vaccines, if they prove successful. Israel’s Institute for Biological Research is also working on producing its own vaccine.
The Lancet said the early-stage trials suggested the Sputnik-V vaccine produced a response in a component of the immune system known as T cells.
Scientists have been scrutinizing the role played by T cells in battling coronavirus infection, with recent findings showing these cells may provide longer-term protection than antibodies.
The vaccine, developed by Moscow’s Gamaleya Institute, is administered in two doses, with each based on a different vector that normally causes the common cold: human adenoviruses Ad5 and Ad26.
Some experts have said that using this delivery mechanism could make a COVID-19 vaccine less effective, since many people have already been exposed to the Ad5 adenovirus and developed immunity to it.
In China and the US, about 40% of people have high levels of antibodies from prior Ad5 exposure. In Africa, it could be has high as 80%, experts have said.
Denis Logunov, one of the vaccine’s developers at the Gamaleya Institute, told Reuters the vaccine uses a strong enough dose of Ad5 to overcome any earlier immunity, without compromising safety.
The booster dose, based on the rarer Ad26 adenovirus, provides further support because the likelihood of widespread immunity to both types in the population is minimal, he said.
Russia has said it expects to produce between 1.5 million and 2 million doses per month of its potential COVID-19 vaccine by the end of the year, gradually increasing production to 6 million doses a month.