Free licensing of vaccines to end the COVID-19 crisis

Abstract

The pace of COVID-19 vaccine development, authorisation, and production is unprecedented. Yet all three approved vaccines by Pfizer–BioNTech, Moderna, and AstraZeneca are already facing manufacturing delays. These delays are creating chaos for many national vaccination programmes, leading to calls for coordinated efforts by governments and manufacturers to increase production.1Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force MembersUrgent needs of low-income and middle-income countries for COVID-19 vaccines and therapeutics.Lancet. 2021; 397: 562-564Summary Full Text Full Text PDF PubMed Scopus (62) Google Scholar These pharmaceutical companies have benefited greatly from huge sums of public funding for research and development and advance purchase commitments, amounting to between US$2·2 billion and $4·1 billion (by Feb 1, 2021) from Germany, the UK, and North America combined (appendix). Yet unfortunately, these governments did not make their support conditional on measures that would enable more vaccine to be produced through, for example, patent pools (eg, the COVID-19 Technology Access Pool) or non-exclusive licensing, which would allow pharmaceutical companies with spare manufacturing capacity to increase supply. So far, most effort has gone into increasing production capacity in the vaccine developers' own facilities or through subcontracts and licensing arrangements with other developers, such as AstraZeneca's agreement with the Serum Institute of India, or Sanofi's support in filling and packing bottles of Pfizer–BioNTech's vaccine. It is not, however, too late to take bold measures to increase production. Ideally, an agreement could be reached with the patent holders to make the relevant intellectual property available. However, if this agreement is not possible, compulsory licensing is possible (ie, when a government grants permission to someone else to produce a patented product).2Wong H The case for compulsory licensing during COVID-19.J Glob Health. 2020; 10010358Crossref PubMed Scopus (14) Google Scholar Compulsory licensing is permitted in exceptional circumstances: public health emergencies,3WHOThe Doha Declaration on the TRIPS Agreement and Public Health.https://www.who.int/medicines/areas/policy/doha_declaration/enDate: Nov 20, 2015Date accessed: February 24, 2021Google Scholar such as the COVID-19 pandemic. Together, thirteen EU member states account for more than 60% of the world's major facilities for vaccine production and 90% of global vaccine production.4European Vaccine ManufacturersVaccine's contribution to Europe's future.https://www.vaccineseurope.eu/wp-content/uploads/2012/12/Vaccines-contribution-to-Europes-future-March-2010.pdfDate: March 15, 2010Date accessed: February 24, 2021Google Scholar Of course, changes would be needed to refocus production to COVID-19 vaccines, but this approach could boost production in the immediate future. It would also enable vaccine manufacturers in low-income regions to start producing immediately,5Usher AD South Africa and India push for COVID-19 patents ban.Lancet. 2020; 396: 1790-1791Summary Full Text Full Text PDF PubMed Scopus (37) Google Scholar especially benefiting those countries that are far down the list to receive vaccines. Delays in vaccine production and deployment will lead to avoidable morbidity, mortality, and repeated lockdowns with detrimental health, social, and economic consequences that are related to COVID-19. Effective and coordinated roll-out plans are urgently required to speed up deployment of existing vaccines. The EU should also use all instruments that are available, including compulsory licensing, to overcome the delays in vaccine production and to protect public health in this unprecedented crisis. Throughout the pandemic, things that were once considered to be impossible, such as lockdowns and other severe restrictions on personal and economic liberty, have become accepted. There is no reason why our approach to vaccine development and manufacture should be any different. We declare no competing interests. Download .pdf (.12 MB) Help with pdf files Supplementary appendix Urgent needs of low-income and middle-income countries for COVID-19 vaccines and therapeuticsWHO and partners have learnt from the mis-steps in the response to the 2009 H1N1 influenza pandemic1 and established the Access to COVID-19 Tools (ACT) Accelerator to promote equitable access to vaccines, therapeutics, and diagnostics.2 However, many high-income countries already have bilateral agreements with manufacturers of COVID-19 vaccines.3 The COVAX Facility of the ACT Accelerator has agreements to access 2 billion doses of WHO pre-qualified vaccines during 2021, but this represents only 20% of the vaccine needs of participating countries. Full-Text PDF