COVID Vaccine Fever: Moderna Announces US FDA and European Medicines Agency Submissions; Pfizer and AstraZeneca First In Line For UK Approvals Medicines & Vaccines 30/11/2020 • 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 print (Opens in new window) Moderna’s mRNA research and innovation centre. Moderna on Monday announced that it would immediately request emergency authorization today for its mRNA COVID-19 vaccine candidate from both the U.S. Food and Drug Administration (US FDA) and the European Medicines Agency – as well as asking the World Health Organization for an emergency use listing. The announcement came in a week that will see movement towards the first approval of COVID vaccines anywhere in the world outside of Russia and China. The United Kingdom’s independent regulatory agency was set to review the Pfizer mRNA candidate this week and possibly approve it as early as next Monday or Tuesday (7 or 8 December). US FDA approval for the Pfizer vaccine could come as early as 10 December, the day after the Moderna review is scheduled, followed by a 17 December FDA review – and likely approval – of the Pfizer candidate. The UK government also asked its Medicines and Healthcare Products Regulatory Agency, to evaluate AstraZeneca’s potential COVID-19 vaccine for an accelerated release of a temporary supply. A letter from top officials at Britain’s National Health Service to NHS hospitals, already outlined plans for a staged rollout of vaccines to high-risk groups, saying that “latest advice indicates that the very earliest we will have the first vaccine approved is early December.” The AstraZeneca adenovirus vaccine candidate, developed in partnership with researchers at Oxford University, is the least expensive and easiest to manage of the three front-running options. The UK has also signed a supply agreement with AstraZeneca for 100 million doses of the vaccine, 4 million doses of which are anticipated to be delivered by the end of 2020 and 40 million by the end of March 2021. “We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator, the MHRA,” said Matt Hancock, UK Health and Social Care Secretary. Stéphane Bancel, CEO of Moderna Moderna Vaccine 100% Efficacious Against Severe COVID In a press release by Moderna, the company announced that its vaccine had a 94.1% efficacy rate, in a just completed, primary efficacy analysis of results from 30,000 study participants in the USA. Significantly, efficacy against severe COVID was 100%, the company said, and efficacy was consistent across age, race, ethnicity and gender demographics. Release of today’s results, which updated an interim analysis reported earlier, found a total of 196 COVID-19 cases among Moderna’s 30,000 trial participants, of which 185 cases were in the placebo group, versus 11 in the group that received the vaccine. All 30 severe cases, including one COVID-19 related death, occurred in the placebo group, the company reported. “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Moderna Chief Executive Officer. As a result, the company said in its press release that it is taking the following immediate steps: Moderna plans today to request Emergency Use Authorisation (EUA) from the U.S. FDA. The next step will be a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273, which the FDA has told Moderna to expect on December 17, 2020 Moderna plans today to apply for a conditional marketing authorization with the European Medicines Agency (EMA) Moderna intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO) The company also said that it would be submitting its results to a peer reviewed journal for publication. WHO Emergency Use Listing Or Prequalification? While Moderna so far has made no commitment to license its vaccine to other manufacturers, its move to apply for recognition of its vaccine with WHO could position the company to open the doors to generic vaccine production, in collaboration with global health agencies – if it chose. Currently, the Moderna vaccine carries an estimate US$ 25 per dose, for the two-dose regime, as compared to the AstraZeneca vaccine, which will cost only about US$ 3 per dose – for a two dose regime – placing it beyond the budgets of many countries in the world. Access to affordable vaccines has loomed as the dominant global health issue of 2021 as the world’s rich nations, along with a few low- and middle-income countries such as India, Mexico and Brazil have already bought up – or placed options on – a dominant proportion of available supplies from the first vaccines becoming available – outside of Russian and Chinese vaccines which have not yet released full details of their data. The Brazil-based Oswaldo Cruz Foundation (Fiocruz) signed an agreement with AstraZeneca to acquire and distribute its COVID-19 vaccine. Globally and Nationally – Countries Watch To See Who Will Be First In Line As the pace of vaccine reviews and approvals picked up, so was the anticipation about timelines and logistics around vaccines rollout. In the United States, active preparations were already underway to facilitate distribution of the Pfizer/BioNTech vaccine, including test flights on American Airlines and United to check shipment processes for the vaccine, which needs to be stored at -70°C. Pfizer has two main facilities producing its COVID-19 vaccine, one in Michigan and the other in Puurs, Belgium to support European distribution. But late last week, US officials acknowledged that some Pfizer vaccines were in fact being moved from Europe to the United States – in anticipation of the earlier rollout in the latter. “Operation Warp Speed leaders are aware of and facilitating vaccine shipments coming to the US from Belgium. In an effort to minimize the potential risk to delivery and distribution, we are unable to provide specific details regarding where vaccines are produced and stored,” said a statement from the US Department of Health and Human Services. An Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC), was to be convened Tuesday to decide which individuals will be prioritized to receive the vaccine once it is approved. “We foresee imminent authorization if this vaccine is shown to be effective and safe in the near future and we want to be at the point where we are providing appropriate guidance to the states and jurisdictions for the use of these vaccines,” said Jose Romero, ACIP chair. Canada and Switzerland May Wait Much Longer But in neighboring Canada there was also disappointment over news that Canadians might not get access to the vaccine until later in 2021. In Switzerland, meanwhile, Moderna said it was ready to swing into action with vaccine production at the manufacturing facility of its partner Lonza in the country’s Valais region. But that depends on the vaccine’s approval by the independent Swiss medicines Agency, Swiss Medic – which might only happen in early 2021, a Moderna spokesperson told Health Policy Watch. “There is no fixed timeline for the rolling review process,” said a Moderna spokesperson. “Our best estimate is that the SwissMedic approval will be granted at the start of 2021… As you may also know, Switzerland was one of the first to conclude an agreement for the procurement of 4.5 million vaccine doses. Therefore, vaccine delivery to Switzerland is dependent on the approval of the vaccine candidate by SwissMedic.” He added that Switzerland is manufacturing Moderna’s vaccines “for all markets outside of the USA,” while for the US, there is another dedicated manufacturing and supply chain. While Moderna so far has made no commitment to license its vaccine to other manufacturers, the move to apply for recognition of its vaccine with WHO could also position the company to open the doors to more production in collaboration with global health agencies – if it chose. However, for now, the Moderna vaccine carries a price tag of US$ 25 per dose, for the two-dose regime, as compared to the AstraZeneca vaccine, which will cost only about US$ 3 per dose – pricing the Moderna option out of the budgets of many countries. WHO – Vaccine Logistics Huge Challenge While access to COVID-19 vaccines looms as the defining global health issue of 2021 – it’s not only an issue of price, WHO experts pointed out at Monday’s press briefing. While the world’s rich nations have bought up huge stocks of vaccines, a few low- and middle-income countries such as India, Mexico and Brazil, also are positioned to get earlier access to supplies – by virtue of their domestic manufacturing base. WHO’s Mariangela Simão blamed it on excessive global concentration of manufacturing. “We have seen the world not so much divided, not so much between high, low and middle income countries… but between countries that have manufacturing capacity – and there are low and middle-income countries that do have manufacturing capacity – and countries that do not have manufacturing capacity,” said Simão, who is Assistant Director General for Drug Access, Vaccines and Pharmaceuticals. There’s a need for government to reflect about the concentration that we have nowadays on the global supply chain of medicine and vaccines, and health products in general. “I think it’s the time that when also when we think of the future, to really establish policies where we can have a more diversified supply chain that don’t risk shortages, not only for vaccines. We are seeing for example some shortages of ICU medicines that we didn’t expect like injectable opioids. The need for countries to think of development policies or infrastructure policies that actually enhance local production of health products is extremely important – and I think is one of the lessons learned from this pandemic. In the near-term, meanwhile,concerns being expressed even by rich countries like Canada about vaccine access, highlight the importance of making the WHO COVAX vaccine procurement facility work well – so that the highest risk groups around the world can get access to the first available vaccine supplies,regardless of their local manufacturing base, said WHO’s Katherine O’Brien, head of the department of vaccines, biological and immunologicals. Pan American Health Organization (PAHO) administering vaccines in Venezuela. The COVAX facility, which is to serve 187 countries has so far raised US$ 2 billion this year. But it remains US$ 5 billion short for 2021 to raise the funds sufficient to produce and distribute 2 billion vaccine doses, O’Brien noted, saying: “The ability to procure vaccines, on behalf of the facility is dependent on the funding that is available for procuring those vaccines. “So I think we really do have to take…. the expectations and turn that on the global lens – that really, the scientifically and epidemiologically impactful thing to do is to have adequate supply in equal time, in equal measure around the world for every country to …be immunizing those populations that highest priority, and to move as quickly as possible through those priority groups onto those who have a lower risk of serious disease.” Along with that, she said, the delivery infrastructure of vaccines is going to be the equivalent of “building base camp at Everest”, she added. “The competence in communities, the acceptance of vaccines, and assuring that people are in fact immunized with the right number of doses, with the products that are available, is what it’s going to take to scale to the peak of the mountain. “And so as we anticipate that the year ahead for every country, it’s not only about assuring that there is supply, it’s also about a massive unprecedented scale of readiness and implementation of delivery and all that that will take in every community in every country around the world.” News Hailed By Experts – WHO’s Dr Tedros Talks About Hope Dr Tedros Adhanom Ghebreyesus, WHO Dicrector General. Despite the obstacles, news of the Moderna submission was greeted as a kind of watershed, with gleeful expressions of hope and delight even among normally sober scientists. “Moderna Covid vaccine has 94% efficacy, final results confirm. Looking forward to seeing the results published in scientific journals,” tweeted Didier Pittet, an infectious disease expert and director of the infectious control programme at the University Hospital of Geneva. “It’s a Monday in November which means a #COVID19 vaccine press release. Today’s is from @moderna_tx reporting data from its primary analysis and showing a 94.1% efficacy in the prevention of COVID-19 disease and 100% efficacy in preventing severe disease. A game changer!” said Carlos del Rio, executive associate dean of Emory School of Medicine, in Atlanta Georgia. Said Director General, Dr Tedros Adhanom Ghebreyesus at the WHO press conference: “There is a lot of hope, especially with the advent of the vaccines that have been announced. In the last few weeks. And from the WHO side. We are sure that we can defeat this pandemic using the existing tools, and also the vaccines that are in the pipeline. The most important thing is we need to have hope. And not only hope. But solidarity, to work together to fight a common enemy, using the existing tools, and also the new announcements of vaccines, in the pipeline.” –Madeleine Hoecklin contributed to this story. Image Credits: Moderna, Ministério da Saúde , WHO/PAHO, WHO. 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 print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. 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