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It has been announced that the UK government has accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve the Moderna COVID-19 vaccine for use.
Dr Zoltán Kis, Research Associate at the Future Vaccine Manufacturing Hub, Imperial College London, said:
“Approval of Moderna’s Covid-19 vaccine for use in the UK offers an additional tool and hope for overcoming this pandemic. Currently, immunisation against Covid-19 in the UK is limited by the amount of vaccine that can be manufactured and having additional vaccines approved can help with overcoming this limitation.
“Moderna’s vaccine and the Pfizer/BioNTech vaccine are both mRNA vaccines, thus the way they work and the way they are produced is very similar. A key difference is that Moderna’s vaccine contains 100 micrograms of mRNA per dose, whereas the BioNTech/Pfizer vaccine contains 30 micrograms of mRNA per dose. This means that by manufacturing the same number of grams of mRNA of these vaccines, the number of doses produced of the BioNTech/Pfizer vaccine would be 3 times higher than the Moderna vaccine. The BioNTech/Pfizer vaccine can be mass-produced at volumes and rates 3 times higher compared to the Moderna vaccine, assuming the same production capacity and same production time.
“Overall, the production bottleneck for these and other Covid-19 vaccines could be the vial filing process (aka. fill-to-finish) as all of these vaccines share the same type of fill-to-finish facilities, of which there is a limited amount globally. Moderna’s vaccine is distributed at -20 degrees C, whereas the BioNTech/Pfizer vaccine requires distribution at -70 degrees C, thus the Moderna vaccine can be supplied to patients more easily than the BioNTech/Pfizer vaccine.
“The approval of a third Covid-19 vaccine in the UK is great news for overcoming this pandemic. Moreover, the development and validation of the RNA vaccine production platform technology puts humanity in a much better position to faster develop and mass produce vaccines against future outbreaks.”
Dr Charlie Weller, Head of Vaccines at Wellcome, said:
“This is another significant milestone in this pandemic. Emergency use authorisation for Moderna’s vaccine from the MHRA is very encouraging and to be in this position in just one year is testament to the incredible collaborative, global research effort.
“Logistical hurdles remain to roll out all three currently approved vaccines at the speed and the scale required, in the UK or anywhere in the world. As normal for any vaccine, we will need to continually and closely monitor safety and efficacy. It remains critical that groups most at risk globally, such as the elderly, the vulnerable and frontline healthcare and essential workers, are still prioritised to receive the first doses.
“We have made huge progress to be at a stage where we can begin rolling out multiple vaccines in 2021. But we cannot be complacent. There is clear concern over the unchecked spread of newer variants of this virus around the world. Therefore, it is vital there is significant global investment to not only ensure current vaccines can reach populations around the world, but for the continued development of future vaccines, more effective tests and crucially, a range of treatments.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“This is extremely good, but not unexpected, news. The more vaccines that are given authorisation, even if it is under emergency legislation, the better.
“We need many vaccines to be shown to be efficacious, to have no serious harms and to be of high quality. This is firstly because we need as many doses as we can get in this pandemic. Secondly, it is possible that we will find differences in some aspect of efficacy or safety between vaccines and having multiple options will enable this coronavirus to be suppressed worldwide.
“This vaccine has very good efficacy, though the emphasis on the exact value of “94.1%” efficacy is misplaced since the statistical uncertainty is such that a value little below 90% is compatible with the data, but even this is clearly extremely good.
“As with all vaccines, there are frequent mild effects like a sore arm or a rash, but these do not usually last a long time.
“This vaccine, like the Pfizer vaccine needs to be kept frozen for long term storage but can be kept in a fridge for up to 30 days. Each vial has 10 doses so again, once the vaccine has reached room temperature there is a need to ensure that it is all used within 18 hours at most so the logistics of delivering the vaccine are more complicated than for say flu vaccines.
“While the second dose is recommended at 28 days, the report from the EMA states “A dosing window of –7 to +14 days for administration of the second dose (scheduled at day 29) was allowed for inclusion in the PPS [“The primary efficacy analysis population (referred to as the Per Protocol Set or PPS)]. 98% of vaccine recipients received the second dose 25 days to 35 days after dose 1 (corresponding to -3 to +7 days around the interval of 28 days)”. This shows that having the second dose precisely at 28 days was not what was done in the trial, and is not an absolute requirement when it is used in practice.
“Inevitably, we do not yet know how long efficacy will last, though the participants were followed for a median of 92 days. Although data do not yet show that efficacy lasts beyond this time, it is extremely likely that efficacy will persist for months after that time. We will probably have to rely on monitoring effectiveness in observational studies for this and all the vaccines to know how long efficacy will last. It will become increasingly difficult to recruit patients to inactive treatment or placebo-controlled trials, and so evaluation of the very long term effects will not be based on randomised studies.
“Moderna is one of the vaccines partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI)1. CEPI, Gavi and the WHO have launched COVAX to ensure equitable access to COVID-19 vaccines and end the acute phase of the pandemic by the end of 2021. We will not end the pandemic by introducing vaccines only in the UK and this vaccine is one that will aid the global response, including bringing vaccines to other than the richest countries.”
Dr Julian Tang, Honorary Associate Professor/Clinical Virologist, University of Leicester, said:
“The Moderna vaccine is a welcome and timely addition to the list of COVID-19 vaccine options – though it will only be available later in the year.
“Like the Pfizer-BioNTech vaccine, it is based on a non-self-amplifying mRNA design, so you will need two jabs 4 weeks apart, and it has similar efficacy to the Pfizer vaccine (>90%).
“It is slightly easier to store, at -20 C (like a home freezer) rather than the ultra-low -70 C storage required for the Pfizer vaccine, so it should be easier to distribute to various vaccine centres across the country.
“It is just as efficacious as the Pfizer vaccine (>90%) after both doses – and the FDA report1 indicates that up to 80% efficacy after one dose of the Moderna vaccine is possible – though this cannot be guaranteed (from the clinical trial data) beyond 28 days (4 weeks), after which the second dose should be administered.
“As with the Pfizer vaccine, we expect it to work reasonably well against the UK and probably the South African variant viruses, as the number of S protein RBD (receptor binding domain) mutations are few, causing relatively minor conformational changes – though more investigation is required to confirm this, particularly for the South African variant which has more mutations in the RBD.
“Both the Pfizer and Moderna vaccines are significantly more costly than the Oxford-AstraZeneca vaccine, and we still have no evidence yet of how all these vaccines will perform if they are mixed. Yet, I strongly suspect that this will be fine as they all target the same viral antigen and individually produce mostly tolerable side effects. Additional, clinical trials will be needed to further investigate/confirm this.”
1 https://www.fda.gov/media/144434/download (Page 28, Table 15)
Dr Brian Ferguson, expert in viruses and vaccine development at the University of Cambridge, said:
“The MHRA’s approval of Moderna’s COVID19 mRNA vaccine is excellent news for the UK’s vaccine programme. There are now three vaccines approved for use in the UK at a time when the programme is being ramped up quickly in an attempt to vaccinate as many people as possible in the shortest period of time. Having multiple suppliers of safe and effective vaccines helps to reduce any potential supply chain issues and increases the number of doses available for use. Moderna’s vaccine is similar to the Pfizer/BioNtech vaccine as it uses mRNA that encodes for the SARS-CoV-2 Spike protein. The lipid coating is different from the Pfizer/BioNtech vaccine allowing Moderna’s vaccine to be stored at -20 degrees, making it easier to distribute. Moderna’s vaccine was 95% effective against COVID19 in the phase III trial, making it undoubtedly an excellent vaccine to use against this disease. The UK has bought 17 million doses to be supplied from spring 2021, so it will start to arrive at a time when the bulk of the UK population is being offered vaccinations, and will help that process.”
Prof Paul Hunter, Professor in Medicine, The Norwich School of Medicine, University of East Anglia, said:
“This is definitely good news at a time when we need it that we have another source of an effective vaccine for use in the UK. The Moderna vaccine is another mRNA vaccine and very similar to the Pfizer vaccine. The results of the trials of this Moderna vaccine mRNA-1273 have recently been published in the New England Journal of Medicine1.
“The overall efficacy at 94% was very similar to the quoted figure for the Pfizer vaccine and rather better than that quoted for the Oxford AstraZeneca vaccine. Of note is that strong protection was evident from 14 days after the first injection and before the second injection, also about 94%. Importantly the phase 3 trial included participants up to 95 years old, though at publication there were still too few infections reported in older people to be confident about its exact efficacy.
“The Moderna vaccine will undoubtedly play an important role in the UK vaccination programme providing that we can obtain sufficient doses.”
1 https://www.nejm.org/doi/full/10.1056/NEJMoa2035389.
Prof Nilay Shah, Head of Department of Chemical Engineering, Imperial College London, said:
“This is good news; it is an mRNA vaccine which means manufacturing is in principle fairly rapid, although the amount per dose is higher than the Biontech vaccine. The less stringent storage requirements will simplify logistics and distribution and we have time to plan how best to utilise and administer it given that the first doses are due in the spring. Having this additional capacity at that time will be important because it will still be a time of peak vaccination administration.”
Prof Beate Kampmann, Professor of Paediatric Infection & Immunity, London School of Hygiene and Tropical Medicine, said:
“After approval in the USA and Europe, this mRNA-based vaccine is now also approved in the UK. We need more product and more supplies as soon as possible, and this is another step in the right direction.
“There are storage challenges but can all be overcome as we have already seen. The target for the immune response is again the spike protein, hence the make-up of the vaccine is very similar to the Pfizer/BioNTech vaccine. The efficacy data also looked excellent – we can have even more confidence in this new technology!”
Dr Andrew Garrett, Executive VP, Scientific Operations, ICON Clinical Research, said;
“Moderna is the second mRNA vaccine to be approved by the MHRA. Its efficacy and safety profile very much mirrors that of the previously approved mRNA vaccine from Pfizer.
“The Moderna vaccine has already been approved for emergency use in the US, while the EMA has also recommended authorization. In this respect it is not a surprise that the MHRA has also moved to approve quickly. Although supplies will not be available until the spring in the UK, we are in it for the long haul in terms of controlling the pandemic. The MHRA approval of this third vaccine is therefore very welcome – although somewhat expected.”
Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said:
“It’s great news that another vaccine has been approved to help in the fight against the coronavirus pandemic. It is unclear when it will become available for distribution, but like the other mRNA vaccine, which is made by Pfizer, the reported effectiveness of the Moderna vaccine is very impressive.
“In an ideal world we would be able to prioritise the use of the mRNA vaccines to protect those most vulnerable from severe COVID disease; and the fact that the Moderna vaccine can be stored at -20 degrees, rather than -70 for the Pfizer vaccine, will help overcome some of the logistical challenges faced by the mRNA vaccines.
“We desperately need an effective vaccination programme so the more options available the better.”
Prof Arne Akbar, President of the British Society for Immunology, said:
“We need all the help that we can get to fight this COVID-19 pandemic, so news that the Medicines and Healthcare products Regulatory Authority (MHRA) has approved a third COVID-19 vaccine for use in the UK is extremely welcome.
“The Moderna vaccine is an mRNA vaccine like the Pfizer/BioNTech vaccine and works in a similar manner. The main difference between these two vaccines however is that the Moderna vaccine can be stored at -20C rather than the -75C needed for the Pfizer/BioNTech vaccine, which makes shipping it a lot easier.
“The UK has doses of the Moderna vaccine on order for delivery in the Spring, so while this approval won’t have an immediate impact on the UK’s COVID-19 vaccination programme, it is reassuring to know that stocks of this vaccine will be delivered in due course.
“As always, safety in vaccines is paramount and the MHRA will have carefully scrutinised the evidence on this COVID-19 vaccine to ensure that it is both safe and effective. Although development of this vaccine has occurred quickly, all the same rigorous safety standards and checks have still been carried out. Although the full dataset has yet to be made public, the previously reported efficacy of approximately 95% gives us great optimism that this vaccine will be an important tool in stopping the spread of COVID-19 within our communities.”
Prof Lawrence Young, Virologist at the University of Warwick, said:
“This is great news and means that we now have three different vaccines approved for use in the UK.
The Moderna vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that carries the SARS-CoV-2 spike gene.
“It is given as two injections 28 days apart and offers a high level of protection against COVID-19. The main clinical trial of over 30000 volunteers showed a 94.1% reduction in the number of symptomatic COVID-19 cases in those who received the vaccine. Unlike the Pfizer/BioNTech mRNA vaccine, the Moderna mRNA vaccine can be stored in a refrigerator for up to 30 days – this will make distribution to GP practices, care homes and vaccination centres much easier.”
Dr Michael Head, Senior Research Fellow in Global Health, University of Southampton, said:
“This is excellent news and a further crumb of comfort amid the huge levels of COVID-19 currently circulating around the UK. Matt Hancock confirmed yesterday that vaccine supply is a key rate-limiting factor in scaling up the roll-out to meet demand. When these Moderna vaccines arrive, they will help to ease any bottlenecks or delays in the administration programme.
“The Moderna vaccine is based on an mRNA platform and is broadly similar to the Pfizer vaccine in design and level of effectiveness, which is over 90%. The early administrations in other countries such as the USA have been successful with no significant issues raised in terms of safety.”
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Dr Garrett: “I am employed by ICON which is a Contract Research Organization. ICON provides pharmaceutical services to the pharmaceutical and biotechnology industries. ICON conducts clinical trials on behalf of Sponsors, including vaccine trials. I am a member of the UK Statistics Authority’s (UKSA) Research Accreditation Panel.”
None others received.