Moderna’s COVID Vaccine Is 95% Effective – Independent NIH-Appointed Board Assessment – Higher Storage Temperature Make It Even Better News COVID-19 Science 16/11/2020 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Moderna’s mRNA research and innovation centre Moderna’s mRNA vaccine candidate has had a vaccine efficacy of 94.5%, the company announced today. unveiling the stunning, initial analysis of Phase 3 clinical trial results by an independent Data Safety Monitoring Board, appointed by the US National Institutes of Health. And news that the vaccine can be stored at 2° to 8°C (36° to 46°F) for up to 30 days, make the results even more significant for low- and middle-income countries that lack ultra-cold storage facilities required for storage of the other candidate mRNA vaccine, which is being developed by Pfizer, and showed almost as good – 90% results last week – in interim analysis of its Phase 3 trial. . The Moderna vaccine only requires a long-term storage temperature of around -20 C° (-4 F°) , in comparison to Pfizer’s requirement of ultracold storage temperatures of -70 C° or below. Overall, the data makes the Moderna candidate a prime candidate for vaccine rollout in low- and middle income countries, and even in rural regions of high-income countries that lack ultra-cold storage facilities. Last month, Moderna also pledged to “not to enforce our patents” on the COVID-19 vaccine for the duration of the pandemic – meaning that generic vaccine manufacturers could also step in very soon after the vaccine is approved by regulatory authoriities to support massive production. According to the company’s press release of the results, of the first 95 adults who developed COVID-19, 90 were in the placebo group of the trial, while only 5 were in the control group of participants who actually received the vaccine. Among the severe cases, all 11 occurred among people who did not receive the vaccine at all. Moreover, Moderna’s results were obtained from a diverse group of participants, as evidenced by the fact that among the 95 reported COVID-19 cases, there were 15 older adults (ages 65+) and 20 participants identifying as being from diverse ethnic communities, including 12 Hispanic or LatinX, 3 Black or African Americans, 3 Asian Americans and 1 multiracial participant. There were no significant safety events, and most adverse events were short-lived fatique or mild or moderate headache or muscle pain. “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. Stéphane Bancel, CEO of Moderna Vaccine Stability & Potential Protection Against More Severe Disease Hailed Reaction in the health community was swift, albeit cautious. At a WHO press conference on Monday, Chief Scientist Soumya Swaminathan said that while the results were encouraging: “Of course, we need to wait and see what the final efficacy and the safety profile of this vaccine will be when the whole data is analysed after they reach their primary endpoint.” While storage temperatures for the vaccine open up the possibility of worldwide distribution in low- and middle income countries, WHO’s Vaccine Depatment head Katherine O’Brien cautioned that the logistics remain formidable: “This is a two-dose vaccine, and certainly any vaccine that can achieve a one-dose vaccine is certainly easier to deliver than a two-dose vaccine,” she pointed out. In addition, most existing vaccine programmes are geared towards children – while this vaccine will first need to be rolled out for adults. “It is incredibly promising that the vaccines we urgently need are now on the horizon,” said Charlie Weller, Head of Vaccines at The Wellcome Trust, which has supported COVID vaccine R&D through the Oslo-based Coalition for Pandemic Preparedness (CEPI) funding of vaccine R&D “To have multiple vaccine candidates with interim results that surpass our expectations is phenomenal, and testament to the incredible global research effort this year…. 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.” On a more cautionary note, Weller added that while “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. CEPI’s CEO Richard Hatchett also noted that information released by Moderna “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. Fair Distribution & Logistics Hurdles: The Next Big Challenges Once vaccine efficacy is proven, the world will face huge challenges in getting the first doses to the most vulnerable groups around the world – particularly health care workers. Adding to that anxiety is the fact that in the case of the first, and apparently high-performing vaccine candidates, like Moderna’s – rich countries have already queued up already in line with big pre-orders. Moderna has said that through its a collaboration with the Swiss-based company Lonza, it will be able to launch production of up to 1 billion vaccine doses in 2021 at the company’s USA and Swiss sites. By next month, Lonza’s Swiss-based plant in Visp will already be poised to start producing some 300 million doses said Lonza site manager, Torsten Schmidt in an interview last month: “Everything will be ready for the production of the first doses in December.” Moderna has also been negotiating with the WHO co-sponsored COVAX facility about distribution through the WHO co-sponsored global procurement network of some 186 countries. The facility promises to secure and distribute sufficient doses to immunize health workers and at-risk populations first of all. But in the press conference today, WHO officials refrained from saying if Moderna had in fact signed an agreement with COVAX – although Wellcome Trust’s Weller indicated that it has saying in his statement: “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…. ,” but adding, ““It is critical that we urgently and decisively work on the wider issues of Covid-19 vaccine allocation and delivery. Overcoming the logistical hurdles ahead will take unparalleled levels of global collaboration.” More significant, perhaps, is Moderna’s it’s pledge to not enforce its patents for the duration of the pandemic. That opens up the way for other generic manufacturers to produce Moderna’s COVID-19 vaccine for the COVAX pool. Tal Zaks, chief medical officer at Moderna Countries Representing Just 12% of World’s Population Hold Options on 78% of Moderna’s 2021 Vaccine Supply Indeed, production of the Moderna vaccine by generics may become the only way out for the rest of the world since high-income countries, including the United States, the European Union, Canada, Switzerland and Japan, have already made vaccine pre-orders to Moderna for some 300.5 million doses, and have options to purchase another 480 million more – for a total of 780.5 milion out of the 1 billion doses to be produced in 2021. That would mean that up to 78% of Moderna’s own available vaccine supply next year could be gobbled up by countries representing only 12% of the world’s population, pointed out a coalition of medicines access campaigners in a press release today. The groups, including the UK-based STOPAIDs, also noted that Moderna has so far received some US$ 2.48 billion in United States government public subsidies, and yet its reported price tag for the two-dose vaccine at $US 50-60 per course is the “highest cited for a potential vaccine so far.” The coalition called on Moderna to “openly share their vaccine technology so doses can be produced at needed scale, at the lowest possible price.” In any case, most experts still agree that ultimately, a large pool of effective, but diverse, vaccines will be the best assurance that everyone can get a fair share. Said Weller, “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 [vaccine] candidates.” However, the innovative mRNA technology being used by Moderna as well as Pfizer still has certain inherent advantages, insofar as it takes less time to develop and also is less bulky in terms of the vaccine volumes. That is becaue the vaccine consists merely of an RNA protein that “instructs” the body’s own cells to produce the main antigen of the virus. In comparison traditional vaccines typically rely upon an inactivated portion of the virus itself to provoke an immune response. For more details on the vaccine’s mechanism of action, see our exclusive interview with Moderna Chief Medical Officer, Tal Zaks. Updated 18 November, 2020 Image Credits: Moderna, Moderna, Moderna TX. 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