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expert reaction to press release reporting the second interim analysis of the efficacy of the Sputnik V vaccine

A new press release reports on the second interim analysis of clinical trial data for the Sputnik V vaccine against COVID-19.

 

Dr Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London and Chair of the Education and Standards Committee of the Faculty of Pharmaceutical Medicine, said:

“ Vaccine news is coming in thick and fast now and this is the latest round from our friends in the north with an update on the Gamaleya adenovirus vector vaccine. This release has updated us on the split of illness between vaccine and placebo recipients in the ongoing Phase III trial, showing similar efficacy to their first release, albeit from a very low rate of disease in the placebo group.

“This vaccine uses two different adenovirus strains to avoid stimulating an immune response which limits the effect of the second injection. However, 80% or more of humankind will have existing, occasionally very high, levels of immunity to most human adenovirus strains. This release does not provide any information on the effect in individuals with high pre-existing human adenovirus immunity prior to receipt of the first shot vector type. No information is provided on the safety profile observed or on prevention of asymptomatic infection and hospitalisations/deaths from COVID during the study.

“At this point, I encourage the various groups developing vaccines to provide more detailed data in peer-reviewed publications as soon as possible. The world will need to use all of these vaccines to control the disease and enable a return to normal life.”

 

Prof Azra Ghani, Chair in Infectious Disease Epidemiology, Imperial College London, said:

“This is yet more good news demonstrating a high interim vaccine efficacy for the Sputnik V vaccine. The press release also includes details of the data behind the calculation which indicate that, whilst the case numbers remain small, this is highly effective (91.4% efficacy) with a lower confidence bound of  approximately 80%.

“This vaccine uses a similar platform to the Oxford/AstraZeneca vaccine and so should also be distributable through existing cold-chain mechanisms, meaning that it could be delivered more easily than the mRNA vaccines from Pfizer/BioNTech and Moderna.

“The lack of any serious adverse events in approximately 20,000 trial participants is also very encouraging. In total across the four trials of the four vaccines we have seen some phase 3 results from there have been over 100,000 participants; even if only half received the vaccine (the remainder receiving the placebo), the lack of serious adverse events in >50,000 recipients suggests that the safety profile for these vaccines is excellent. However, full details of the safety profiles for all four vaccines will need to be closely scrutinised by regulators in the coming weeks.” 

 

Prof Brendan Wren, Professor of Microbial Pathogenesis, London School of Hygiene & Tropical Medicine, said:

“This update on the Sputnik V Covid-19 vaccine trials confirms the high efficacy and safety of the Spike protein delivered by a surrogate adenovirus, similar to the vaccine platform developed at Oxford University. The trial enrolled 20,000 Russian subjects but data on the age range and ethnicity of volunteers is unclear. We anticipate more trials data on different population groups and using different platform technologies, particularly from China. The more data on vaccine trials the better (good or less good). Collectively, through this data we can work towards the optimum vaccination regime (possibly single dose), reduce delivery logistics and have vaccines at the lowest cost possible. This global problem requires a global solution, and we need vaccines for all.”

 

Prof Ian Jones, Professor of Virology, University of Reading, said:

“The Sputnik V vaccine data looks impressive especially as the number of participants is high and the data was analysed only 7 days after the second dose, too soon for the immune response to the boost to be fully in effect. On the face of it the data would appear to have the edge on the Oxford/AZN trial as the Oxford 90% protection figure was observed in only a subset of trial participants who received a lower first dose. However, a full comparison will only be possible when all the data is released. Curiously the Sputnik dose of 1011 virus particles is twice that of the Oxford full dose yet appears not to have had any issues of inhibition. What exactly the ideal dose is for these adenovirus vectored vaccines is therefore a little uncertain.”

 

 

https://sputnikvaccine.com/newsroom/pressreleases/second-interim-analysis-of-clinical-trial-data-showed-a-91-4-efficacy-for-the-sputnik-v-vaccine-on-d/

 

 

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

 

 

Declared interests

Dr Penny Ward: “No COIs. I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”

Prof Azra Ghani: “I am providing advice to WHO and WHO-Europe on vaccine modelling to support allocation.”

Prof Brendan Wren: “No conflicts of interest.”

Prof Ian Jones: “No conflicts”

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