Moderna Vaccine Set For United States FDA Approval After Endorsement by Expert Panel – Prices Paid By European Union For Vaccines Disclosed In Tweet Medicines & Vaccines 18/12/2020 • James Hacker 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 COVID-19 vaccine received 20 votes of confidence with only 1 abstention. Moderna’s COVID-19 vaccine was set to be approved by the US Food and Drug Administration (FDA), following a near-unanimous endorsement by an expert panel that reviewed its clinical trial results. Meanwhile, at US$ 18 per dose, the Moderna vaccine will also be the most expensive vaccine to go on the market soon, according to a tweet by Belgium’s secretary of state, listing prices per dose of the six vaccines procured by the European Union. The post was quickly deleted, but not before going viral. In the FDA review, the vaccine candidate from the Boston-based firm received 20 votes in its favour, with a single abstention and no opposition, a stark comparison to the 17-4 vote delivered for the European Pfizer and BioNTech vaccine. The four votes against the Pfizer/BioNTech vaccine were largely centred on the lack of evidence as to how safe the vaccine may be for people aged 16-17 years old. Michael Kurilla, the director of clinical innovation at the National Center for Advancing Translational Sciences, who was the only panel member to abstain against the Moderna emergency use authorization (EUA), claimed that approving the vaccine for all people over 18 years old was “far too broad”. The critical difference, however, appeared to be the sheer volume of trial data provided by Moderna. University of Michigan microbiologist, A Oveta Fuller, cited the biotech company’s transparency as being highly impressive. She had voted against the Pfizer candidate Moderna enrolled more than 30,000 participants in its placebo-controlled trial. Several weeks after the participants’ second dose (7 November) there were only 5 cases of COVID-19 in the vaccine group, with 90 in the placebo group. This gave an efficacy of 94.5%. In the new data, published yesterday by the FDA, the efficacy was revealed to have decreased by a statistically inconsequential amount, to 94.1%. The data also seems to suggest Moderna’s mRNA vaccine is more effective (if only slightly) in younger people, with an efficacy of 95.6%, compared to 86.4% in those over 65 years old. Stanford professor Hayley Gans noted at the hearing that the emergency approval of the Moderna vaccine – the second vaccine approved for public administration – would “finally provide a safe and effective way to get herd immunity”. The current volumes of the Pfizer/BioNTech vaccine, approved just last week, are not, on their own, “sufficient for mass vaccination needed to address a pandemic in the US,” said Doran Fink, deputy clinical director of the FDA’s vaccine division, at the hearing. The US is currently seeing its deadliest surge yet of infections, with unprecedented daily records of new infections and around 3,400 deaths recorded on 16 December alone. EU’s Vaccine Prices Leaked in Tweet Meanwhile, a Belgian politician’s tweet of the image of a spreadsheet detailing the price-per-dose paid for the six leading vaccines that the European Union has pre-ordered was picked up widely on the web – by media and public advocates hungry to see how the prices of the leading vaccine candidates compare. Such information is usually a closely guarded secret by companies who require even public procurement agencies, such as health ministries and governments, to sign non-disclosure agreements about the prices that they pay for medicines and vaccines. The tweet by Eva De Bleeker, Belgium’s Secretary of State, has now been deleted but not before the Belgian news site HLN captured and published a screenshot. She has claimed the post was a mistake on behalf of the communications team. The screenshot indicates that Belgium will spend €279 million on around 33.5 million vaccines, broken down as below: Oxford/AstraZeneca: 7.7m units at €1.78 Johnson & Johnson: 5.1m units at $8.50 Sanofi/GSK: 7.7m units at €7.56 Pfizer/BioNTech: 5m units at €12 CureVac: 5.8m units at €10 Moderna: 2m units at $18 Despite long standing lobbying by medicines access groups, as well as some European members of parliament (MEPs) who claim that prices paid on goods purchased with taxpayers’ money should be disclosed, the practice seems unlikely to change. The European Commission declined to comment about the incident. Speaking at a parallel event, Seth Berkley, head of the public-private Gavi, The Vaccine Alliance, said that Gavi also would not disclose the prices paid for large scale purchases of vaccine for the WHO co-sponsored COVAX vaccine facility. The facility aims to help all countries, and particularly low- and middle-income countries, cover some 20% of their population with COVID-19 vaccines over the course of 2021. Berkeley said that details on vaccine purchase deals by COVAX would not be disclosed “given the nature of these types of commercial and legal agreements.” Reuters reported that the table briefly published by De Bleeker showed the Belgian government paid 12 euros ($14.7) per dose to buy about five million shots of the Pfizer/BioNTech vaccine. Sources familiar with the matter have told Reuters the EU agreed to pay 15.50 euros ($18.34) per dose for the Pfizer/BioNTech vaccine. The Belgian price does not factor in unrefundable downpayments of hundreds of millions of euros that the EU has made to many vaccine makers to secure their shots, one EU official told Reuters. Image Credits: Moderna. 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