Sputnik V and Patient Safety

by Helen Ramscar

Recent analysis of the rollout of Sputnik V has been called ‘moral panic’ and a ‘Western blunder’.[1] It is worth reminding that reasonable concern over the distribution of Sputnik V has been centred around the safety of human lives. For Russia has been distributing Sputnik V to countries worldwide before the vaccine’s data has been interrogated by serious regulatory bodies and given approval, which raises two major points: Russia’s credibility as a regulator and its scientific transparency.

If you are inclined to trust Russia’s domestic healthcare regulator, Roszdravnadzor, then you may consider its scientific rigour sufficient regarding its approval of Sputnik V. As it stands, however, the World Health Organisation does not list Russia among the thirty-five countries it designates as Stringent Regulatory Authorities (SRAs).[2]

Sputnik V’s twitter account proudly announced that the vaccine has been approved by regulators in 50 territories.[3] Out of that list of 50, the WHO considers 2 to be a Stringent Regulatory Authority. Just two: Hungary and Slovakia. Even those considered stringent, however, cannot offer patients the same degree of confidence that data compares favourably against other vaccines being reviewed by the major regulators like the US’s FDA, the EU’s EMA and the UK’s MHRA.

Within the current international regulatory community, major regulators reviewing multiple vaccine candidates are in a position uniquely valuable to patients; they can ask the same questions of all data sets, compare the responses, identify gaps in some that are answered by others, demand more data before approval and, therefore, offer overall a more scientifically informed judgement on the benefit/risk to patients. Major regulators offer patients both rigour and confidence across the board. This is why their approval is so important. Why Russia chose to bypass these processes before distributing Sputnik V remains a valid question.

Russia’s current lack of data transparency remains a valid concern too. The Russian Ministry of Health approved Sputnik V for emergency use in August 2020 despite there being very limited data in the public domain,[4] and to the dismay of Russia’s own Association of Clinical Trials Organizations (ACTO).[5] Yet when the EMA approves a medicine for use, it publishes an EPAR – a European Public Assessment Report.[6] The purpose of the EPAR is to provide information on the medicine, how it was assessed by EMA and the grounds for the committee opinion on whether or not to approve it. The EMA is legally required to be transparent and publish this full technical assessment for every approved medicine alongside a public-friendly version for the lay reader.[7] EPARs for Covid-19 vaccines by Pfizer,[8] Moderna,[9] Astrazeneca[10] and Johnson & Johnson[11] have been published.

Distributing vaccines for use prior to transparent scrutiny of their safety self-evidently cannot be placing lives first. So Russia has let itself be exposed to rational analysis that its actions are led more by opportunistic attempts to open up new markets and expand geopolitical influence.

As has been said many times, Sputnik V may well be genuinely welcome worldwide once full data has been shared and appropriately scrutinised. Russia should not be afraid to fully embrace scientific transparency. Doing so would seem to be in Russia’s own national self-interest, in the long run, as a future Russian biomedical sector considered credible has a greater chance of ultimately benefitting more lives.

[1] Mark Galeotti, ‘Moral Panic About Russian ‘Vaccine Diplomacy’ Is a Western Blunder’, The Moscow Times, 17 March 2021, https://www.themoscowtimes.com/2021/03/17/moral-panic-about-russian-vaccine-diplomacy-is-a-western-blunder-a73264

[2] WHO, List of Stringent Regulatory Authorities, WHO, https://www.who.int/medicines/regulation/sras/en/

[3] @sputnikvaccine, ‘Sputnik V is approved in 50 countries’, Twitter, 11 March 2021, https://twitter.com/sputnikvaccine/status/1370017919128702978/photo/1

[4] There were two trials in the public domain at this time. They had 38 participants each. See, https://clinicaltrials.gov/ct2/show/NCT04437875?term=GAMALEYA+RESEARCH+INSTITUTE&draw=2 and https://clinicaltrials.gov/ct2/show/NCT04436471?term=GAMALEYA+RESEARCH+INSTITUTE&draw=3

[5] See, for example, Vladimir Isachenkov and Daria Litvinova, ‘Scientists uneasy as Russia approves 1st coronavirus vaccine, AP News, 11 August 2020, https://apnews.com/article/ap-top-news-moscow-health-ebola-virus-vladimir-putin-fcda62ad992db414d65f23b2adb78e44

[6] EMA, ‘European public assessment reports: background and context’, https://www.ema.europa.eu/en/medicines/what-we-publish-when/european-public-assessment-reports-background-context

[7] Regulation (EC) No 726/2004 of the European Parliament and of The Council, https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF

[8] https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

[9] https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

[10] https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-astrazeneca

[11] https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-covid-19-vaccine-janssen_en.pdf