EU regulator starts review of Russia's Covid vaccine
The European Medicines Agency (EMA) said it had started a rolling review of Sputnik V, many months after the vaccine was first approved for use in Russia and after dozens of countries around the world have authorised it.
The European regulator said the review was based on results from lab studies and research in adults, which suggest the vaccine may help protect against coronavirus, it said in a statement.
Despite scepticism about Russia’s introduction of the vaccine, which was rolled out before it had completed late-stage trials, the vaccine appears to be safe and effective.
According to a study published in the journal Lancet, Sputnik V was about 91% effective in preventing people from becoming severely ill with Covid-19, although it is still unclear if the vaccine can prevent the spread of the disease.
The EMA has not set a date for when its expert group might meet to assess Sputnik V data to decide if it should be approved across the European Union, but the rolling review process is meant to expedite the authorisation process, which can typically take several months.
With a global shortage of Covid-19 vaccines, some experts say boosting the use of vaccines made by China and Russia — which have not been as in demand as those made by Western companies — could offer a quicker way to increase the global supply.
The EMA has so far approved three Covid-19 vaccines – made by Pfizer/BioNtech, Moderna and AstraZeneca – for use across the 27-nation European Union.
It could license a fourth vaccine made by Johnson & Johnson at an expert meeting next Thursday.
Dr Hans Kluge, the World Health Organisation’s regional director for Europe, called the EMA announcement on Sputnik V “good news”.
“We desperately need to enlarge our portfolio of vaccines, so I see this as a very welcome development,” Dr Kluge added.
Meanwhile, dozens of countries have already authorised Sputnik V for use — including EU member Hungary — and many have agreed to purchase millions of doses of the vaccine.