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expert reaction to Moderna announcement of its phase 3 vaccine interim results

Moderna have announced that their vaccine candidate against COVID-19 has demonstrated 94.5% efficacy in the first interim analysis from the phase 3 vaccine trials.

 

Prof Adrian Hill, Professor of Human Genetics, Director of the Jenner Institute, Co-Director, Oxford Martin Programme on Vaccines, and Fellow of Magdalen College, said:

“We welcome the news indicating encouraging efficacy findings from another candidate vaccine, adding further evidence that it is possible to create a vaccine in response to this global pandemic.”

 

Prof Jonathan Stoye, Group Leader, Retrovirus-Host Interactions Laboratory, The Francis Crick Institute, said:

“Again, enormously encouraging.  This news reinforces the idea that mRNA encoding the coronavirus Spike protein can provide a safe and effective vaccine for SARS-CoV-2.”

 

Dr Gillies O’Bryan-Tear, Chair, Policy and Communications, Faculty of Pharmaceutical Medicine, said:

“Moderna has announced positive efficacy data from their large phase 3 trial. 30,000 people aged 18 or over were enrolled in the US, and these included older people (7,000 over 65) as well as younger people with risk factors for severe disease (5,000).  The estimate of efficacy is very similar to that reported for the similar, mRNA vaccine trial announced last week by Pfizer/BioNTech, 94.5%, and they provided more detail than Pfizer: amongst 95 cases of confirmed Covid illness occurring at least two weeks after the second dose of vaccine, 90 occurred in the placebo group and 5 in the vaccinated group. The 95 cases included 15 patients older than 65, and 25 from diverse communities including 4 Black or African Americans. No breakdown was provided within this subgroup, but all 11 severe cases of Covid occurred in the placebo group. 

“The number of confirmed Covid cases reported was similar (95) to those in the interim analysis of the Pfizer trial (94 cases), though Pfizer will shortly announce results on its full cohort of 164 cases.

“Moderna also provided more detail than Pfizer also on the side effects seen with this vaccine: the majority of these were mild or moderate, and severe effects included pain at the injection site in 2.7%, tiredness in nearly one in ten, and muscle pain and joint pain – flu like symptoms which are expected with all vaccines. They commented that the safety and efficacy profile was similar across the subgroups – ie that it looks as if it works as well in the elderly and the high risk patients, as in others. 

“The Moderna vaccine is a mRNA vaccine against the spike protein of the coronavirus, similar to the Pfizer vaccine. These results confirm that these novel vaccines are effective in preventing Covid illness. 

“Moderna has also announced that the vaccine can be shipped at -20 degC, standard freezer temperature, in contrast to the Pfizer vaccine at -70, and is stable at normal refrigerated temperatures for 30 days. This will give the vaccine a big advantage in distribution, especially in the developing world, but it is likely that Pfizer will announce new stability data in future as the stability studies are done, or even reformulate the vaccine, for example to freeze dried form, to avoid refrigeration. 

“Moderna, who were supported by the US Warp Speed Initiative, has said they will produce 20 million doses by year end and 500 million to 1 billion doses next – fewer than Pfizer has promised who said they will produce 50 million this year and 1.3 billion next. The UK has not yet secured a deal with Moderna on the supply of these vaccines.  

“As with the Pfizer/BioNTech study, Moderna should be commended for managing to enrol these patients so rapidly, although only US people were enrolled. Moreover, mention should be made of the significant support the company received from the US government – support which BioNTech and Pfizer elected not to seek.”

 

Dr Charlie Weller, Head of Vaccines at Wellcome, said:  

“Hopes of ending this pandemic rest on having effective vaccines, treatments and tests. It is incredibly promising that the vaccines we urgently need are now on the horizon. To have multiple vaccine candidates with interim results that surpass our expectations is phenomenal, and testament to the incredible global research effort this year.

“The results from Phase III of Moderna’s Covid-19 vaccine trial are highly encouraging, however as with other results, we must remember they are interim and we are yet to see the full data. Urgent questions remain to be answered, including how long these vaccines will be effective for and whether these vaccines work across different populations, in all age groups, ethnicities, and those with prior health conditions.  Only upon trial completion will we be able to assess the full efficacy and safety of any vaccine candidate.

“There are important considerations to ensure doses can be delivered safely around the world, especially in low- and middle-income countries. However, it is promising to hear Moderna report that doses can be stored at clinics at more regular refrigeration temperatures for up to a month once delivered to healthcare facilities. It is critical that we urgently and decisively work on the wider issues of Covid-19 vaccine allocation and delivery. Moderna’s vaccine is part of the COVAX Facility, which will be instrumental to ensuring any effective vaccines are prioritised for those most in need globally.

“We cannot become complacent. If we are to have enough doses for the entire world and vaccines that work across different groups and settings, we must continue developing and investing in a wide range of candidates.

“Overcoming the logistical hurdles ahead will take unparalleled levels of global collaboration. We cannot underestimate the importance of building public understanding, trust and confidence, which will be strongest if the response is locally led. Covid-19 vaccines will face the largest and fastest vaccine manufacturing scale-up and roll-out in history but the light at the end of the tunnel is looking brighter.”

 

Dr Jonathan Stoye, Group Leader, Retrovirus-Host Interactions Laboratory, The Francis Crick Institute, said:

“Again, enormously encouraging.  This news reinforces the idea that mRNA encoding the coronavirus Spike protein can provide a safe and effective vaccine for SARS-CoV-2.”

 

Dr Gillies O’Bryan-Tear, Chair, Policy and Communications, Faculty of Pharmaceutical Medicine, said:

“Moderna has announced positive efficacy data from their large phase 3 trial. 30,000 people aged 18 or over were enrolled in the US, and these included older people (7,000 over 65) as well as younger people with risk factors for severe disease (5,000).  The estimate of efficacy is very similar to that reported for the similar, mRNA vaccine trial announced last week by Pfizer/BioNTech, 94.5%, and they provided more detail than Pfizer: amongst 95 cases of confirmed Covid illness occurring at least two weeks after the second dose of vaccine, 90 occurred in the placebo group and 5 in the vaccinated group. The 95 cases included 15 patients older than 65, and 25 from diverse communities including 4 Black or African Americans. No breakdown was provided within this subgroup, but all 11 severe cases of Covid occurred in the placebo group. 

“The number of confirmed Covid cases reported was similar (95) to those in the interim analysis of the Pfizer trial (94 cases), though Pfizer will shortly announce results on its full cohort of 164 cases.

“Moderna also provided more detail than Pfizer also on the side effects seen with this vaccine: the majority of these were mild or moderate, and severe effects included pain at the injection site in 2.7%, tiredness in nearly one in ten, and muscle pain and joint pain – flu like symptoms which are expected with all vaccines. They commented that the safety and efficacy profile was similar across the subgroups – ie that it looks as if it works as well in the elderly and the high risk patients, as in others. 

“The Moderna vaccine is a mRNA vaccine against the spike protein of the coronavirus, similar to the Pfizer vaccine. These results confirm that these novel vaccines are effective in preventing Covid illness. 

“Moderna has also announced that the vaccine can be shipped at -20 degC, standard freezer temperature, in contrast to the Pfizer vaccine at -70, and is stable at normal refrigerated temperatures for 30 days. This will give the vaccine a big advantage in distribution, especially in the developing world, but it is likely that Pfizer will announce new stability data in future as the stability studies are done, or even reformulate the vaccine, for example to freeze dried form, to avoid refrigeration. 

“Moderna, who were supported by the US Warp Speed Initiative, has said they will produce 20 million doses by year end and 500 million to 1 billion doses next – fewer than Pfizer has promised who said they will produce 50 million this year and 1.3 billion next. The UK has not yet secured a deal with Moderna on the supply of these vaccines.  

“As with the Pfizer/BioNTech study, Moderna should be commended for managing to enrol these patients so rapidly, although only US people were enrolled. Moreover, mention should be made of the significant support the company received from the US government – support which BioNTech and Pfizer elected not to seek.”

 

Dr Charlie Weller, Head of Vaccines at Wellcome, said:  

“Hopes of ending this pandemic rest on having effective vaccines, treatments and tests. It is incredibly promising that the vaccines we urgently need are now on the horizon. To have multiple vaccine candidates with interim results that surpass our expectations is phenomenal, and testament to the incredible global research effort this year.

“The results from Phase III of Moderna’s Covid-19 vaccine trial are highly encouraging, however as with other results, we must remember they are interim and we are yet to see the full data. Urgent questions remain to be answered, including how long these vaccines will be effective for and whether these vaccines work across different populations, in all age groups, ethnicities, and those with prior health conditions.  Only upon trial completion will we be able to assess the full efficacy and safety of any vaccine candidate.

“There are important considerations to ensure doses can be delivered safely around the world, especially in low- and middle-income countries. However, it is promising to hear Moderna report that doses can be stored at clinics at more regular refrigeration temperatures for up to a month once delivered to healthcare facilities. It is critical that we urgently and decisively work on the wider issues of Covid-19 vaccine allocation and delivery. Moderna’s vaccine is part of the COVAX Facility, which will be instrumental to ensuring any effective vaccines are prioritised for those most in need globally.

“We cannot become complacent. If we are to have enough doses for the entire world and vaccines that work across different groups and settings, we must continue developing and investing in a wide range of candidates.

“Overcoming the logistical hurdles ahead will take unparalleled levels of global collaboration. We cannot underestimate the importance of building public understanding, trust and confidence, which will be strongest if the response is locally led. Covid-19 vaccines will face the largest and fastest vaccine manufacturing scale-up and roll-out in history but the light at the end of the tunnel is looking brighter.”

 

Dr Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), said:

“The Moderna results are as good as we could have hoped for and really terrifically encouraging.

“Today’s announcement provides further confirmation that spike-directed vaccines can provide a strong protective immune response.

“Moderna has also released information which suggests that the vaccine may protect against more severe disease (although they don’t address the statistical significance of this finding), and the reported side effects appear to be manageable. The fact that the vaccine shows stability when stored in a normal refrigerator for up to 30 days is also terrific news and will allow the vaccine to be distributed broadly.

“All in all this is another great day in the struggle against COVID-19. We have a long way to go, of course, but we are accumulating the tools we will need to end the pandemic.”

 

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:

“The Moderna vaccine is similar tech to the BioNTech/Pfizer vaccine, this time the release has clearly stated the number of illnesses in the vaccinated population (5) and the number in the unvaccinated group (90) giving a protection rate of 95% (or so) from vaccine. Importantly they also state that the 11 severe illnesses were seen only among the unvaccinated population while no severe illness was observed in the vaccinated group. They report no safety concerns – the main side effects are injection site pain, fatigue, muscle or joint aches and pains and headache which seemed to occur more frequently after the second injection. Clearly we still need to see the complete scientific details in a publication to be able to judge the outcomes independently.

“Given the general similarity of the vaccine target and the immunological responses observed for all vaccines, these data generally suggest that vaccination will protect against severe illness and thereby should protect people from needing hospitalization or from dying from COVID. We still need to know if there is protection against infection, as the latter leads to herd protection while protection against illness has a value for an individual it will not prevent circulation of virus and risk of disease in unvaccinated persons, or in people not responding adequately to vaccination.”

 

Dr Zoltán Kis, Research Associate at the Future Vaccine Manufacturing Hub, Imperial College London, said:

“This is very promising news for the RNA vaccine production platform technology. If mRNA vaccines against Covid-19 gain regulatory approval, this will be a huge validation of the RNA vaccine production platform technology. Using this technology, vaccine candidates can be produced substantially faster in the future to combat virtually any infectious disease, by producing vaccines against both existing pathogens and future, currently unknown pathogens. Vaccine candidates can be produced against virtually any disease, because this is a platform technology, meaning that the production process, the purification processes and the formulation processes can remain the same no matter what vaccine or vaccine candidate is produced.

“This is a huge advantage in terms of the speed at which vaccine candidates can be developed and produced in the future. In the case of conventional vaccine production technologies, each vaccine required the development of a new production process, whereas in the case of the RNA vaccine production platform technology one process can produce vaccines and vaccine candidates against virtually any disease.

“Moderna’s Covid-19 vaccine candidate has a higher mRNA amount per dose, 100 micrograms per dose, compared to the BioNTech/Pfizer vaccine candidate which has 30 micrograms of RNA per dose. This means that the BioNTech/Pfizer vaccine can be produced at a substantially higher number of doses compared to the Moderna vaccine when using the same scale/size of mRNA production process. In addition, due to the lower amount per dose, the production cost per dose of the BioNTech/Pfizer vaccine will also be lower compared to the Moderna vaccine.

“On the other hand, Moderna’s Covid-19 vaccine candidate is stable at -20 degrees C, compared to the -70 degrees C of the BioNTech/Pfizer vaccine candidate. Therefore, once approved by the regulatory authorities, Moderna’s Covid-19 vaccine can be distributed substantially easier and at lower costs compared to the BioNTech/Pfizer vaccine.”

 

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

“This vaccine is very similar in design to the Pfizer/BioNtech vaccine that reported interim results last week. The results of this trial from Moderna are broadly similar to the Pfizer/BioNtech data, which is very encouraging. Each of these trials is still in the early phases of reporting and as more cases accrue the efficacy estimates may change slightly, but the fact that two independent trials are giving very similar results is very reassuring.

“Although the numbers are small, this trial also gives an indication that vaccination is effective in older and BAME individuals and prevents severe disease, all of which are key to allowing the world to start opening up again. The absolute prerequisite for a COVID-19 vaccine is that is stops people becoming ill enough to require hospital treatment and stops people dying. The preliminary data reported here suggest that this vaccine – and by extension, the Pfizer/BioNtech vaccine – will achieve this goal.  

“The safety data also look promising. The side effects of vaccination appear to be in line with those typically seen for other adult vaccinations, including the seasonal influenza vaccination which is administered in many millions of doses every year.

“One important unknown is whether this vaccine, or any of the vaccines currently in trials, prevents disease transmission. It is likely that vaccines that prevent symptomatic disease will reduce the duration and level of infectiousness, and thus reduce transmission, but we don’t yet know if this effect will be large enough to make any meaningful difference to the spread of the virus within communities.

“But, overall, this is excellent news. Having more than one source of an effective vaccine will increase the global supply and, with luck, help us all to get back to something like normal sometime in 2021.”

 

Prof Peter Openshaw, Professor of Experimental Medicine at Imperial College London, said:

“This news from Moderna is tremendously exciting and considerably boosts optimism that we will have a choice of good vaccines in the next few months. First we heard 90% efficacy from Pfizer and BioNTech, then the Russians said 92% and now Moderna says 94.5%.

“This latest press release is based on a study of 30,000 US adults, including many high-risk or elderly persons. This gives us confidence that the results are relevant in the people who are most at risk of covid-19 and in most need of the vaccines.

“Moderna have also announced that the vaccine can be kept in a conventional freezer (-20 centigrade) for up to  6 months, and that once thawed the vaccine can be kept for up to 30 days at standard refrigerator (2 to 8 degrees centigrade). This makes the vaccine much easier to deliver.

“In terms of side effects, news is also quite good. The first dose caused injection site pain in in about 3% of people; the second dose was associated with transient generalized symptoms in about 10% of people with fatigue, muscle aches and flu like symptoms. This seems to indicate that they got the dose about right with acceptable adverse events. These effects are what we would expect with a vaccine that is working and inducing a good immune response. 

“We need more complete details than we have in this press release, but this announcement adds to the general feeling of optimism about vaccines for Covid-19. What we still don’t know is how long any protective immunity may last. For that, we will need to wait.”

 

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

“This announcement from Moderna is a further encouragement that vaccines will be found to not only have an acceptable efficacy, but an efficacy that is much greater than we had anticipated. This press release is more specific than that of others, in that it confirms the numbers in each group, which was able to be guessed at but to have it confirmed is helpful.

“The range of minor adverse effects reported are unsurprising and typical of almost any vaccine. These reactions tend to be local to where the injection was given and are rarely long-lasting or severe.

“As with previous announcements, this is encouraging for other vaccines that may be expected to also have worthwhile efficacy.

“Although they reported efficacy being over 94%, there is statistical uncertainty in this; but based on these data, the likely efficacy will be better than 85% which would be greater than most scientists would have expected. This is the first study to report on severe cases and, while uncertainty remains, the finding of no severe cases with the vaccine and 11 cases with placebo is very strong evidence that the vaccine prevents severe as well as mild disease. It is likely that convincing evidence in respect to deaths will probably only be obtained when the vaccine is in use.

“A wide range of people with illnesses and from minority groups were included in the trials as well as substantial numbers of older patients. We will need much more data and a full report or publication to see if the benefit is consistent across all groups, notably the elderly, but this is definitely encouraging progress.

“The data on stability of the vaccine suggests, that although it requires a good freezer for a full six-month life of the vaccine, an ordinary refrigerator seems adequate for up to 30 days and it will be OK at room temperature for up to 12 hours.

“These factors, while useful in high-income countries, will be of great value in low- and middle-income countries where there is a massive need for a vaccine that is able to be delivered to the population. This will be of encouragement to the Coalition for Epidemic Preparedness Innovations (CEPI) which not only helped with initial funding for the trials but are committed to ensuring that all countries have good access to vaccines.”

 

Prof Trudie Lang, Director, The Global Health Network, Nuffield Department of Medicine, University of Oxford, said:

“It is very good news indeed to see another vaccine coming through with similar efficacy results as were reported last week from Pfizer. This is also an interim analysis, which means that there were enough cases within the vaccinated volunteers to give statistical significance and allow the team to break the blind to determine who had the active vaccine and who had placebo.

“Here they found that of 95 cases of COVID, 90 had received the placebo and 5 the active vaccine. These early results suggest that there was a representation across different age groups and diverse communities in the protected group. This is really encouraging and it further demonstrates that a vaccine for COVID is a real probability and that having more than one supplier should help assure better and more equitable global availability.

“This vaccine is also an mRNA vaccine, so many of the same questions remain as we have been discussing with the Pfizer vaccine and these will be looked at carefully by the regulators.”

 

 

Declared interests

Prof Lang: “No conflicts.”

Prof 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.”

Prof Riley: “is a member of the UKRI COVID-19 research task force and the UK Vaccines network.”

Dr Weller: “Wellcome co-founded and co-funds CEPI, which provided early catalytic investment to Moderna’s mRNA-1273 Covid-19 vaccine candidate.”

None others received.

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