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Wednesday, August 5, 2020

August 05, 2020
A scientist examines Covid-19 infected cells during research for a vaccine at a laboratory in Saint Petersburg in May. Photograph: Anton Vaganov/Reuters

The Russian government claims to have stolen a march on dozens of global rivals – including the US and UK – in the race to produce a viable coronavirus vaccine, saying it would start production of a vaccine next month and begin mass immunisation by October.

The announcement came amid controversy over how Russia has rushed its two vaccine candidates through safety testing, in which researchers dosed themselves as part of truncated human trials.

Russian officials previously suggested they planned to approve the main vaccine candidate by 10 August with foreign sales aimed at countries including India, Brazil and Saudi Arabia – which officials say have expressed an interest.

Numerous countries and research groups are working to produce a vaccine, including the UK, which also announced its plans to step up preparations for mass production.

Some experts, including those at the World Health Organization (WHO), have cautioned that any vaccine that emerges may not be the “magic bullet” that ends the pandemic.

More than 140 candidate vaccines are being tracked by the WHO, including the British candidate being trialled by AstraZeneca and Oxford University, two by the Chinese firms CanSino and Sinovac and one by the US biotech company Moderna.

The CanSino vaccine was approved by China for use on its military at the end of June pending full-scale human trials, but not for civilians, underlining how more authoritarian countries have approached the hunt for a vaccine.

Most are unlikely to be tested and licensed before the end of the year. While vaccines usually require years of testing and development, the coronavirus pandemic has prompted hugely accelerated timelines, including for the US government’s “Operation Warp Speed”.

Experts are cautioning that even with successful candidates being approved, they may not offer protection at the same level to all of the population, while scaling up of global deliveries is likely to be slow at first, leaving the virus in circulation.

A weak vaccine could also give people a false sense of security and be worse than no vaccine at all if people assume they are protected, some experts say.

Researchers are applying different approaches, including using existing viruses to carry a harmless section of coronavirus that can trigger an immune response, or using messenger RNA to trick the body into producing antibodies.

Writing in the New York Times, Natalie Dean, an assistant professor of biostatistics at the University of Florida, warned that potential vaccines that skip widespread phase 3 testing, as it is known, might not only fail to pick up rare side effects but – due to a perception of their having been rushed into service – might not be taken up in sufficient numbers.

“What we have right now is a collection of animal data, immune response data and safety data based on early trials and from similar vaccines for other diseases. The evidence that would convince me to get a Covid-19 vaccine, or to recommend that my loved ones get vaccinated, does not yet exist,” wrote Dean.

While much is known about the trials being undertaken elsewhere, details of the Russian vaccines under development have been more opaque, with unconfirmed reports last month suggesting that the most advanced prototype vaccine had already been made available to Russia’s elite in the midst of its outbreak.

While the mechanism for the Russian vaccine has been described, no data on its safety has been published after two groups of volunteers, comprising Russian servicemen and civilians, were given the vaccine in June at the 48th Central Research Institute of the Russian defence ministry.

According to the industry minister, Denis Manturov, in an interview with Tass, most interest is focused on a vaccine being developed at the Gamaleya institute in Moscow, which is expected to begin mass production next month.

“We are very much counting on starting mass production in September,” said Manturov.

“We will be able to ensure production volumes of several hundred thousand a month, with an eventual increase to several million by the start of next year,” he said, adding that one developer was preparing production technology at three locations in central Russia.

On Saturday, the Russian health minister, Mikhail Murashko, told reporters that clinical trials had been completed and paperwork was under way for the vaccine’s registration.

The Gamaleya vaccine is a so-called vector vaccine using another virus fused with the key spike protein of Sars CoV-2 to stimulate an immune response. It is similar to the vaccine being developed by CanSino Biologics, which is already in phase 2 trials with plans for more in Canada.

Another Russian vaccine, developed by the Siberia-based lab Vektor, is undergoing clinical trials, and two more will begin human testing within the next two months, Murashko said.

The Gamaleya institute came under fire after researchers and directors injected themselves with the prototype months ago, with specialists criticising the move as an unorthodox and rushed way of starting human trials.

On Friday, the leading infectious disease expert in the US, Dr Anthony Fauci, said he hoped that Russia – and China – were “actually testing the vaccine” before administering them to anyone.

“I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines,” he told US legislators.

Also offering caution over the efficacy of new vaccines was the head of the WHO, Tedros Adhanom Ghebreyesus.

“A number of vaccines are now in phase three clinical trials and we all hope to have a number of effective vaccines that can help prevent people from infection. However, there’s no silver bullet at the moment - and there might never be,” he said.


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