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Source: United Kingdom – Executive Government & Departments

It has been announced that the Sputnik V vaccine against COVID-19 has demonstrated 92% efficacy in the first interim analysis from the phase 3 vaccine trials by the Russian Federation.

Prof Eleanor Riley, Professor of Immunology and Infectious Disease, University of Edinburgh, said:

“I worry that these data have been rushed out on the back of the Pfizer/BioNtech announcement earlier in the week. The Sputnik data are based on only 20 cases of COVID-19 in the trial participants, compared to more than 90 cases in the earlier trial.

“This is not a competition. We need all trials to be a carried out to the highest possible standards and it is particularly important that the pre-set criteria for unblinding the trial data are adhered to avoid cherry picking the data. Anything less than this risks a public loss of trust in all vaccines, which would be a disaster.”

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

“The interim results of the Russian Sputnik vaccine Phase 3 trials mirror those of the Pfizer Phase 3 trials in terms of over 90% efficacy tested on over 40,000 humans. The main difference is that the vaccine technology platform used by the Russian group is a surrogate virus (Adenovirus, similar to the Oxford group vaccine) to deliver the SARS-CoV2 antigen in contrast to the Pfizer vaccine that uses mRNA. The advantage of this approach is that -80C freezing will not be required in the vaccine supply chain. Overall, this is more encouraging data confirming the early stage protection of a SARS-CoV2 vaccine using a different platform technology.”

 

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“This is encouraging not just for this vaccine, but it is additional evidence that vaccines can be effective in Covid-19.

“This report refers to efficacy being assessed based on 20 cases. From the description it seems likely that 1 of the about 8000 people who had received the vaccine and had available data after two doses was compared with 19 people who received placebo (Assuming the allocation was split equally between vaccine and placebo).

“The consequence is that there is considerable uncertainty because of the small number (20) of total Covid-19 cases. Further follow-up is needed because the results are compatible with a much lower efficacy (60%) based on these data. The Pfizer results announced this week were based on 94 cases (probably split 8 on vaccine and 86 on placebo) so there is more certainty that the efficacy is likely to be above 80%. The Sputnik efficacy has also been estimated, though far less reliably than in the randomised trial, using a group without a comparator of 10,000.

“There seem to be no instances of serious adverse reactions to the vaccine. The full report should give more detail on how the follow-up was done and how the trial was monitored.

“Overall efficacy is about the same for these two vaccines, and while it is possible that favourable results are seen early, it is encouraging to see higher levels of efficacy than we might have expected based on experience with flu vaccines. We need to know how efficacy varies with age and this will require much more follow-up, and we also need to know how long protection from Covid-19 lasts.

“We will need as many different vaccines as possible to meet the whole world’s needs; it is no good just providing vaccines for high-income countries; low and middle-income countries will also ned protection.”

 

Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:

“Again, we can be cautiously optimistic that SARS-CoV2 vaccines targeting the spike protein are effective. Moreover, as the Sputnik antigen is delivered via a different modality, namely using a disabled Adenovirus rather than formulated RNA, this provides flexibility in terms of perhaps one or other method providing better responses in certain age groups, ethnicities, etc., plus the storage of this vaccine ought to be more straightforward.

“However, again it will be necessary to see the complete data set before making confident assessments of how well this, or other SARS-CoV2 vaccines work and full assessment of safety must be made. In particular, we must understand whether these prevent infection itself or just severe symptoms, as well as if vaccinees might continue shedding infectious virus. In addition, efficacy in different age groups, ethnicities and in patients with compromised immune systems will need to be determined before we can decide how best to deploy these hopefully world-changing medicines.”

Prof Charles Bangham FRS FMedSci, Chair of Immunology, Imperial College London, said:

“These preliminary results provide further reassurance that it should be possible to produce an effective vaccine against COVID-19.  Whereas the Pfizer/BioNTech vaccine is based on RNA that produces a fragment of the SARS-CoV-2 S (spike) protein, the Sputnik V vaccine consists of two doses, three weeks apart, respectively of two different human adenoviruses, each one expressing the S protein.  The Sputnik V strategy has some theoretical advantages, because the use of the full-length S protein may elicit a broader immune response, but the adenoviruses used are also likely to produce more side-effects such as fever or headache – although these are expected to be mild.  However, proper evaluation of the safety and efficacy of each of these two vaccines, the duration of protection, and their effectiveness in the elderly, must await publication of the full data on the trials.”

Prof Ravindra Gupta, Professor of Clinical Microbiology, University of Cambridge, said:

“The interim announcement of vaccine efficacy for the Sputnik COVID-19 vaccine is welcome. The study uses a two dose schedule with a vaccine that produces the Spike protein in cells via a modified virus delivery system. The number of infections across placebo and the vaccine was only 20, and the data are preliminary. There is also the possibility that the human adenovirus system might be less effective in people with antibodies to this virus. However we have good reason to be optimistic as this vaccine does not need the -80C storage in contrast to the Pfizer RNA vaccine.” 

 

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

“The Sputnik data is yet more good news for Covid-19 vaccine development. Although based on fewer cases than the recent Pfizer data, the vaccine looks as efficient and, like the Pfizer data, confirms and extends the earlier phase 2 results. We still need to know about the longevity of the response and the efficiency in different age groups, but the result bodes well for the other trials currently in progress and for having enough vaccine in geographically diverse regions to enable a comprehensive vaccination program on a global scale.”

 

https://sputnikvaccine.com/newsroom/pressreleases/the-first-interim-data-analysis-of-the-sputnik-v-vaccine-against-covid-19-phase-iii-clinical-trials-/

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

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Eleanor Riley: “Eleanor Riley is a member of the UKRI Covid-19 research taskforce and the UK Vaccines Network.”

Prof Brendan Wren: “No conflict of interests.”

Prof Stephen Evans: “No conflicts of interest.  I am funded (one day per week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them.  I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI.  I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.”

Dr Stephen Griffin: “No conflicts.”

Prof Charles Bangham: “No declarations of interest.”

Prof Ravindra Gupta: “I have been involved in testing rapid diagnostic platforms for COVID-19. I am a member of the COG-UK consortium.”

Prof Ian Jones: “No conflicts.”

None others received.

MIL OSI United Kingdom