It’s named after a Soviet-era satellite and was looked on with scepticism by European scientists.
But now Russia’s Sputnik V jab could help solve some of the Covid-19 vaccine shortage that has chastened EU countries like Ireland.
The European Medicines Agency (EMA) has began a rolling review of the vaccine. If approved, there is a promise of enough for 50 million Europeans from June.
What do we know about the vaccine and what could it mean for Ireland?
For a long time there was mistrust around news from Russia that it had developed a successful Covid-19 vaccine. It was approved for use in Russia a month in advance of its final stage clinical trials being published. There was strong criticism that it was cutting corners.
On par with the best
However, a study published in The Lancet last month, which looked at its phase three trial involving 20,000 volunteers, showed the two-dose vaccine was more than 90pc effective in protecting people against Covid-19 illness.
The results referred to symptomatic cases and more research is needed on how it affects asymptomatic disease.
However, that efficacy rate would put it on the same scale as the top-performing vaccines like the Pfizer BioNTech and Moderna jabs.
It works on the same technology used in the Oxford AstraZeneca vaccine.
The German government gave it new status when it announced that it would give it to its citizens if it passed all relevant clinical trials and would help it in getting European approval.
The promise is that around 1.4 billion doses could be produced this year – enough for 700 million people.
It is also undergoing evaluation by the World Health Organisation. The Czech Republic, Austria, Hungary and Slovakia have all expressed interest in the vaccine.
Safety and quality
The EMA said its decision to start the rolling review is based on results from laboratory studies and clinical studies in adults.
These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target coronavirus and may help protect against Covid-19.
It will evaluate data as they become available to decide if the benefits outweigh the risks.
The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
It will assess its compliance with the usual EU standards for effectiveness, safety and quality. While it cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.
The Johnson and Johnson vaccine is expected to be approved by the EMA next week.
This is a one-shot vaccine and has been called a “game-changer” – although there is something of a jinx on that term now when it comes to vaccines.
It will mean four vaccines have been approved for use here. In the Government’s new Covid plan, it expects to get around 200,694 doses each month from April to June.
The problem is not that Ireland has not ordered enough vaccine – it’s that supplies are too slow arriving to meet demand. Health Minister Stephen Donnelly has said we have ordered enough doses of Covid-19 vaccine to inoculate 10.3 million people.
However, manufacturing capacity means these are coming in limited deliveries and even then there are gaps in the schedule.
It is expected more than 250,000 a week are due here and could be administered each week from April.
That is a big logistical exercise and will test the HSE, not just in terms of having enough vaccinators but also ensuring its registration system is running efficiently.
Source: Irish News