The results of phase 3 clinical trials reveal that the Russian vaccine Sputnik V is 91.6% effective, but additional data are awaited on its effectiveness for asymptomatic forms and for those over 60 years old. The European Union, which has not pre-ordered any doses, received a marketing authorization request on January 20.
- Sputnik V is 100% effective for severe forms.
- Emmanuel Macron and Angela Merkel have opened the door to the vaccine, pending European marketing authorization.
Sputnik V has become the fourth vaccine, after those developed by Pfizer, Moderna and AstraZeneca, to be validated by the scientific community. According to a study published Tuesday, February 2 in The Lancet, phase 3 clinical trials show 91.6% efficacy. The authors of the report add that no serious side effects related to the vaccine were observed.
NEW—Interim analysis of Russian #COVID19 #vaccinated phase 3 trial involving nearly 20,000 participants suggests a two-dose regimen has an efficacy of 91.6% against symptomatic #COVID19. No serious adverse events were deemed to be associated with vaccination. https://t.co/40sM7f2nbS pic.twitter.com/Hzrs34uCWr
— The Lancet (@TheLancet) February 2, 2021
100% effective on severe forms
Last November, Russia announced a 92% effectiveness of its vaccine without this announcement being followed by a scientific publication. “The development of the Sputnik V vaccine has been criticized for being rushed, skipping stages and a lack of transparency. But the results reported here are clear and the scientific principle of this vaccination is demonstratedwrote two British specialists who were not involved in the study, Professors Ian Jones and Polly Roy, in a comment attached to the study. An additional vaccine can now join the fight to reduce the incidence of Covid-19.”
These results come from phase 3 clinical trials which were conducted on 22,000 participants, separating them into two groups: one receiving the vaccine, the other a placebo. After the injection of a second dose 21 days later, it appears that the vaccine protects up to 91.6%. These results even reach 100% for severe forms. Additional data are also awaited on asymptomatic forms and patients over 60 years of age, even if efficacy seems to be maintained for this population.
The approval procedure started on January 20
The question of the approval of the vaccine in Europe now arises as Russia has already started to vaccinate its population since last December. The vaccine was not included in the pre-order contracts signed by the European Commission. The Russian Sovereign Fund announced on January 20 that it had started the approval procedure with the European Medicines Agency (EMA). “Among the selection criteria, the vaccine manufacturer must have production capacity in the EU: the aim is to ensure that we can move to rapid deliveries the day the vaccine receives the green light from the EMA”, underlined Tuesday a spokesman of the Commission. A criterion that could play against Sputnik V for which production capacities are already under pressure in Russia.
Emmanuel Macron and Angela Merkel have opened the door to the vaccine. On TF1 on Tuesday evening, the French president assured that the “we have seen publications today that seem to indicate a very strong efficacy of the Sputnik vaccine, but we cannot distribute it in France until the Russian producer has submitted a marketing authorization request. The minute he asks for it, European and national health authorities will review it. According to its results and the evidence“France will decide whether or not to use it. The German Chancellor has offered aid for joint production. “Everyone who gets clearance from the EMA (European Medicines Agency) will be absolutely welcome“, she indicated to the public television ARD.
A relatively easy-to-use vaccine
Sputnik V is a viral vector vaccine like AstraZeneca and is therefore easier to use than messenger RNA vaccines from Pfizer and Moderna. It uses transformed adenoviruses to help the immune system fight off the virus. Adenoviruses are a family of about a hundred viruses, of which about forty can infect humans and one of them is responsible for the common cold. The Gamaleya Institute that developed it used two adenoviruses and substituted certain parts to incorporate the genetic material of SARS-CoV-2. This makes it possible to create a vectorized vaccine, that is to say a vaccine containing a viral vector which alerts the immune system of an attack but which remains harmless because it cannot infect the organism.
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