How safe is Russia’s COVID-19 vaccine?

Russian scientists have published the first report on their coronavirus vaccine, saying early tests showed signs of an immune response.

The report published by medical journal, The Lancet, said every participant developed antibodies to fight the virus and had no serious side effects.

Russia licensed the vaccine for local use in August, the first country to do so and before data are published.

Experts say the trials were too small to prove effectiveness and safety.

But Moscow has hailed the results as an answer to critics. Some Western experts have raised concerns about the speed of Russia’s work, suggesting that researchers might be cutting corners.

Last month, President Vladimir Putin said the vaccine had passed all the required checks and that one of his own daughters had been given it.

What does the report say?

Two trials of the vaccine, named Sputnik-V, were conducted between June and July, The Lancet paper said. Each involved 38 healthy volunteers who were given a dose of the vaccine and then a booster vaccine three weeks later.

The participants – aged between 18 and 60 – were monitored for 42 days and all of them developed antibodies within three weeks. Among the most common side effects were headaches and joint pain.

The trials were open label and not randomised, meaning there was no placebo and the volunteers were aware they were receiving the vaccine.

“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,” the report said.

Russia plans mass vaccination for October

A third phase of trials will involve 40,000 volunteers from “different age and risk groups,” according to the paper.

The Russian vaccine uses adapted strains of the adenovirus, a virus that usually causes the common cold, to trigger an immune response.

Still a long way to go

“Encouraging” and “so far so good” are some of the reactions from scientists in the UK – but there is still, clearly, a long way to go. Although the vaccine showed an antibody response in all participants in phase 2, this does not necessarily mean it would protect them from the virus. That still has not been established yet.

From these results, we can tell that the vaccine appeared to be safe in healthy people between the age of 18 and 60 for 42 days, because that was how long the study lasted. But what about older people and those with underlying health conditions who are most at risk of COVID-19 – how safe is it for them and over a longer period of time?

This can only be answered after much larger, long-term randomised trials where the people taking part do not know if they are receiving the vaccine or a dummy injection. These will also tell scientists how effective the vaccine really is among a much wider population.

There have also been calls for openness and transparency. Of the many vaccines currently being tried around the world, some will work better than others in certain situations and in certain groups of people, perhaps. So knowing exactly how well they work and for whom is paramount – it is unlikely that one vaccine will be suitable for everyone.

According to the World Health Organization, there are 176 potential vaccines currently being developed worldwide. Of those, 34 are currently being tested on people. Among those, eight are at stage three, the most advanced.

No Russian virus vaccine in Nigeria – Minister

Meanwhile the Minister of state for Health, Dr. Olorunnimbe Mamora, has said the Russian vaccine for COVID-19 is not yet in Nigeria.

Mamora said the Russian Ambassador and the Deputy Head of Mission, Alexey Shebarshin, merely visited the ministry and gave an update on the vaccine.

He said when the vaccine eventually arrived, it would be tested by the National Agency for Food and Drug Administration and Control (NAFDAC), which is lawfully empowered to do so.

The minister said, “We have not yet received the vaccine and, to the best of my knowledge, it is not yet ready.

“The Russian Ambassador and the Deputy Head of Mission only visited us to give us an update. Many other stakeholders joined the meeting virtually.

“When the vaccine is ready and we have received it, it will be subjected to the usual test by NAFDAC and other relevant authorities.”

An earlier report had insinuated that the federal government referred the Russian-made vaccine to NAFDAC and the Nigerian Institute for Pharmaceutical Research and Development (NIPRD) for evaluation.

However, it was established that an aide-memoire of the vaccine was formally handed over to Nigeria Friday.

The document reportedly provides details of the vaccine for Nigerian teams to study and get ready for further research, patronage and application.

A statement by the director (Information, Media and Public Relations) in the Federal Ministry of Health, Olujimi Oyetomi, said the handover took place Friday during a courtesy visit to the Minister of Health, Dr. Osagie Ehanire, and Mamora, by the Russian Ambassador.

He added that other top management staff members of the ministry and Nigerian scientists, researchers and advisors also participated in an online meeting.

The statement read, “As expected, the issue on the front burner for discussion is the recently announced Russian-made vaccine against COVID-19. Alexey L. Shebarshin, who admitted that he is a non-scientist, said he was in the Federal Ministry of Health to formally hand over the aide-memoire, which explains the details for Nigerian teams to study and get ready for further researches, patronage and application.

“The consensus of decision reached was to quickly refer the vaccine to the necessary professional institutes and agencies of the Federal Ministry of Health, beginning with NAFDAC, NIPRD, and for a team of scientists and advisors to the ministry to get to work on possible patronage of the Russian vaccine to alleviate the plight of Nigerians under the COVID-19 pandemic.”

About Duro Joseph with BBC health news

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