Russia’s coronavirus vaccine, dubbed Sputnik V, is more than 90 per cent effective and costs less than $10 (£7) per dose, according to the Russian Direct Investment Fund, bankrolled by the country’s own sovereign wealth fund.
The update interim results were announced via a hastily arranged virtual briefing and a press release sent out this morning. No clinical data has yet been published.
Moscow’s so-called Sputnik V jab is developed by the state-run N F Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow.
Today’s announcement comes after Oxford University yesterday announced its vaccine, developed with pharmaceutical giant AstraZeneca, is 90 per cent effective.
Oxford’s vaccine, based on a modified cold-causing ‘adenovirus’ from chimps, can be stored and transported at fridge temperatures of between 2 and 8°C
Now, Russia has revealed that its own vaccine, supposedly based on a human adenovirus, can also be stored at these temperatures.
Sputnik V will cost $10/£7 a dose, whereas the Oxford jab is expected to cost just £2 per dose.
However the Russian jab would be cheaper than the mRNA-based vaccines made by Pfizer (£14.80 a dose) and Moderna (£24 a dose).
It is expected to be available by February 2021 and Russia hopes to manufacture 500million doses annually.
Moscow’s so-called Sputnik V jab is developed by the state-run N F Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow
Russia’s coronavirus vaccine, dubbed Sputnik V (pictured), is more than 90 per cent effective and costs less than $10 (£7) per dose, according to the Russian Direct Investment Fund, bankrolled by the country’s own sovereign wealth fund
SPUTNIK V: THE FACTS
Sputnik V, Russia
Sputnik V is safe, according to the Kremlin
When will it be ready?: ‘Imminently’. The Russian medical research institute and Russian defence ministry have developed this vaccine. But it has faced serious criticism both inside and outside Russia because results from its human trials are yet to be published. It also hasn’t cleared large human trials, with researchers only launching one involving 40,000 volunteers on 26 August. Scientists say the vaccine has been rushed without proper checks, and could pose a risk to those taking it. The Kremlin began appealing for volunteers for the vaccine this week after a first batch was produced, according to the TASS news agency.
How does it work?: The Russian vaccine works by carrying a piece of the coronavirus genetic code into a participant via another virus. It is hoped this will produce an immune response.
Has the UK secured doses?: No. Countries lining up to try the vaccine include Mexico, which has secured 32million doses, and Kazakhstan, which is set to buy 2million.
How much does it cost?: The price of the vaccine is said to be $10 (£7) a dose,. A patient needs two doses, three weeks apart. it will be free to Russians.
Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, said: ‘The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.’
Adenovirus-based vaccines, like those made by Oxford and Russia, have been modified to make it weak so it does not cause illness in people and loaded up with the gene for the coronavirus spike protein, which the coronavirus uses to invade human cells.
When the vaccine is injected, the weakened virus delivers the coronavirus gene to human cells so they start to reproduce the spike protein.
These are detected by the immune system which produces antibodies, which the body then stores and uses to fend of the real coronavirus if they are exposed to someone who is infected.
The only data provided to stack up Russia’s claims is in a small table in the press release. It says a total of 18,794 people were involved in the study.
Seventy five per cent of these (14,095) received the vaccine and a quarter (4,699) had a placebo jab.
Eight people who had the vaccine later tested positive for the coronavirus within 28 days of receiving the first dose. Thirty-one people in the placebo group caught Covid-19.
This, the Russians say, produces an efficacy of 91.4 per cent. Efficacy is a measure of how well the vaccine performs relative to the placebo group and is related to, but not identical to, effectiveness.
Efficacy is calculated by taking the percentage of cases in each of the vaccine and placebo groups and then comparing them to one another.
If there’s no difference in the ratio of people who get sick after getting the vaccine compared to the placebo groups, the efficacy is zero, for example.
The press release for the Sputnik V vaccine, sent out by a London-based PR company, says the vaccine is delivered in two doses, the second administered three weeks after the first. Each dose costs less than $10 (£7) but will be free to Russians.
The Oxford study is larger, with 24,000 participants, and the Pfizer vaccine involves more than 40,000, a much larger sample size. Russia claims its Phase III trial involves more than 40,000 volunteers.
Commenting on the findings, Ian Jones, professor of virology at the University of Reading, said: ‘The Sputnik V vaccine data looks impressive especially as the number of participants is high and the data was analysed only seven days after the second dose, too soon for the immune response to the boost to be fully in effect.
‘On the face of it the data would appear to have the edge on the Oxford/AZ trial as the Oxford 90% protection figure was observed in only a subset of trial participants who received a lower first dose.
‘However, a full comparison will only be possible when all the data is released.’
Full clinical data will be published in a leading medical journal upon the completion of the trial, Russia claims.
The Oxford vaccine is a genetically engineered common cold virus that used to infect chimpanzees. Russia uses a similar virus, but one found in humans
Details on side-effects are scarce but Russia claims ‘there were no unexpected adverse events during the trials’ and ‘the Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has proven safe and effective with no long-term side effects’.
Mikhail Murashko, Minister of Health of the Russian Federation, said: ‘The data demonstrating high efficacy of the Sputnik V vaccine gives us hope that we will soon obtain the most important tool in the fight against the pandemic of the novel coronavirus infection.’
In the press conference, the researchers also state that by 2021 they will have the ability to roll out 500 million doses annually.
Much like the Oxford vaccine, Sputnik can be easily transported, only needing to be chilled in a ridge. This was yesterday hailed as a major breakthrough by academics.
The Pfizer/BioNtech vaccine must be stored at -70°C, a major logistical hurdle which could impede a vast vaccination programme and would nee dedicated centres.
However, if it can be stored in a fridge, it could be administered in pharmacies and GP surgeries.
Professor Andrew Pollard, who helped lead the Oxford research, said being able to store it at reasonable temperatures means a vaccine can be distributed around the world using the normal immunisation distribution system.
HOW DO THE OXFORD, MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Oxford University has published the findings from its second phase, which show the jab provokes an immune response and is safe to use – it is not yet clear how well it protects against coronavirus in the real world.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
Recombinant viral vector vaccine – a harmless cold virus taken from chimpanzees was edited to produce the ‘spike’ proteins and look like the coronavirus.
94.5% effective (90 positive in placebo group, 5 positive in vaccine group) .
95% effective (160 positive in placebo group, 8 positive in vaccine group).
62% – 90% effective, depending on dosing.
Moderna confirmed it will charge countries placing smaller orders, such as the UK’s five million doses, between £24 and £28 per dose. US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose.
The US will pay $1.95bn (£1.48bn) for the first 100m doses, a cost of $19.50 (£14.80) per dose.
Expected to cost £2.23 per dose. The UK’s full 100m dose supply could amount to just £223million.
UK has ordered five million doses which will become available from March 2021. Moderna will produce 20m doses this year, expected to stay in the US.
UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.
UK has already ordered 100million doses and is expected to be first in line to get it once approved.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.
Oxford said there have been no serious safety concerns. Mild side effects have been relatively common in small trials, with many participants reporting that their arm hurt after the jab and they later suffered a headache, exhaustion or muscle pain. More data is being collected.