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Sputnik vaccine: side effects, efficacy – is it safe?

There was much scepticism about the Russian Sputnik V vaccine when it emerged on the world stage last year and was hailed as the first vaccine to be approved against Covid.

Russian president Vladimir Putin gave the vaccine the go-ahead before phase one or two trial results had been published and final phase three trials – which are all important for establishing safety and efficacy – had even begun. 

Russian officials either took a massive gamble or had access to early data when they began vaccinating their citizens in December. But this was a gamble that appeared to have paid off when the researchers behind Sputnik, named after the satellite that Moscow sent into orbit in a world-first in 1957, published promising phase three results in February. 

So promising, in fact, that Germany and France are now in talks with Russia over introducing the vaccine into their programmes. Other countries that have already started using the jab include Argentina, Hungary and Pakistan. 

Sputnik V use in Kenya

Late March, Chief Administrative Secretary at the Ministry of Health Mercy Mwangangi confirmed Sputnik V had been approved for emergency use in Kenya.

However, a few days after this announcement, the Kenyan government banned the importation and distribution of COVID-19 vaccines including the Sputnik by private businesses.

The ban was announced on Friday 2nd April 2021 by health minister Mutahi Kagwe, after days of controversy surrounding the importation of the Sputnik V vaccine by a private entity.

“The government is effective today closing the window of private sector importation, distribution and administration of vaccines until such a time when it is confident that there is greater transparency and accountability in the entire process,” said Kagwe.

Efficacy of the Sputnik V vaccine

The results published in the peer-reviewed Lancet – based on a trial of 14,964 people who had the vaccine and 4,902 who had a placebo – show that the jab is 91.6 per cent effective at preventing infection. This compares to around 70 per cent for the AstraZeneca jab and 95 per cent for the Pfizer shot.  

Efficacy is not the only thing that counts when it comes to Covid-19 jabs, however. All of the leading jabs, including Sputnik and AstraZeneca, have so far proven fully effective at stopping severe cases – those that lead to hospitalisation or death.

The vaccine, developed by researchers at Moscow’s Gamaleya Institute, is based on the common cold virus. Researchers used two different adenovirus vectors – the same delivery method as the AstraZeneca and Johnson and Johnson vaccines – administered separately in a first and second dose, 21 days apart. 

The use of two different adenoviruses reduces the risk of the body developing an immune response to the first vector and reacting to it when the booster dose is given. Scientists believe this is probably why Sputnik scored better on efficacy than the Oxford-AstraZeneca vaccine, which only used one adenovirus. 

In terms of safety 7,966 adverse events were reported – 94 per cent of which were considered “grade one”, meaning they were mild such as headaches, pain at injection site – and required no further treatment or follow up. 

Doses of the Sputnik vaccine arrive in Argentina in January
Doses of the Sputnik vaccine arrive in Argentina in January CREDIT: Agustin Marcarian/Reuters

There were 45 severe adverse events in the group that received the vaccine and 23 in the group that received the placebo, but researchers said none were associated with the vaccine. Four people who took part in the research died – but, again, none of the deaths were associated with the vaccine.  These results are similar to other Covid vaccines. 

Scientists welcomed the results when they were published in February. Dr Penny Ward, visiting professor in pharmaceutical medicine at King’s College London, said: “As expected given the origins of this programme in the Gamaleya Institute, this is a good quality study which confirms the clinical effectiveness of the Gamaleya combined viral vector vaccine.”

Dr Peter English, consultant in communicable disease control, welcomed the jab as “another highly effective vaccine in our armoury!”

But he called the Russian vaccination strategy into question. 

“Implementing a vaccine in a large population before seeing your phase III results is hugely risky, and is definitely not to be recommended. The ethics of giving a product that has the potential to make you ill (or iller) is hugely different when you’re giving a vaccine to a large number of healthy patients, than when you are giving a medicine to a seriously ill patient, who might be prepared to take a risk.

“Apart from not knowing about efficacy or likelihood of harm, there is the potential to severely damage confidence in all other vaccines.” 

Additional report from Telegraph.

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