J&J should prioritize initial supply of vaccines to COVAX Facility, make full clinical trial data public
NEW YORK/GENEVA, JANUARY 29, 2021—Johnson & Johnson (J&J) announced today that preliminary data from a phase III trial testing a potential COVID-19 vaccine suggest that the vaccine is 66 percent effective at preventing moderate to severe COVID-19 28 days after vaccination. The vaccine could be a potential gamechanger in the world’s response to this pandemic—particularly in low-resource settings since it could require only one dose and could be stored at normal refrigerator temperatures. However, to make this a reality, J&J must prioritize fulfilling its pledge to the COVAX Facility, a global initiative under Gavi, the Vaccine Alliance, to ensure equitable access to vaccines for all countries, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF). Additionally, there needs to be a more in-depth analysis of the full clinical trial data before conclusions on the vaccine’s efficacy and utility can be made, said MSF.
Although J&J has pledged to supply up to 500 million doses of the vaccine to COVAX over the next few years (only 100 million doses in 2021), the agreement remains a non-binding memorandum of understanding so the company could instead decide to give the doses to a country that could pay more. Nearly 1.5 billion doses of J&J’s potential vaccine are already tied up in advance purchase agreements, the majority of which (56 percent, or 801 million out of 1.439 billion doses) are committed to high-income countries, according to data from AirFinity.
It’s even more appropriate that J&J shares its full clinical trial data since the company received $1.5 billion from the US government for research and development of its potential COVID-19 vaccine. Additionally, the UK government is co-funding a global clinical trial, testing a two-dose regimen of the vaccine.
From early on in the pandemic, in light of this significant public investment, MSF has called for any potential future COVID-19 vaccines to be priced at cost, though it’s difficult to know what these vaccines cost to make since companies haven’t been fully transparent about the costs associated with the vaccines’ research and development. J&J has committed to a $10 “non-profit” price for emergency use during the pandemic. In a US Senate hearing last year, J&J committed to having its prices audited externally, and MSF urges the corporation to open its books.
MSF has also called for corporations producing COVID-19 vaccines to share all the necessary intellectual property, technologies, data, and know-how so that other vaccine manufacturers can produce these potentially lifesaving vaccines and increase global supply. The company has so far failed to commit to sharing its technology openly with other vaccine manufacturers.
Dr. Manuel Martin, medical innovation and access policy advisor for MSF’s Access Campaign, said of today’s announcement:
“It is shocking to see that nearly two months after the first COVID-19 vaccines started to be injected into arms of health care workers and others in high-income countries, there is still virtually no vaccination taking place in the lowest-income countries. This inequity is shameful and unacceptable and isn’t how the world is going to emerge from this pandemic.
“J&J must help level the grossly unfair playing field of vaccine access by making its vaccine accessible and affordable for health care workers and high-risk people, whether or not they live in a country that was able to strike a deal with the company. If the vaccine is approved, J&J should send its first shipments to the COVAX Facility in order to make good on its pledge of up to 500 million doses over the next couple of years. Right now, the majority of J&J’s vaccine doses are promised to high-income countries, which is plainly unfair.
“J&J conducted part of their vaccine trials in South Africa, where 300 million doses of the vaccine are also being filled in vials and packaged by a commercial partner this year, yet it is not clear when the country is slated to get the mere nine million doses they’ve been promised. The second wave of the pandemic is raging across southern Africa, and frontline health care workers and people at greatest risk from severe disease and death remain without the protection of a COVID-19 vaccine.
“J&J must also take swift action to open up its books so it can be held accountable on important details like pricing and supply. The corporation should follow through on its commitment to have its supposed ‘not-for-profit’ price externally audited. It must publish in full the terms and conditions of the deals it has struck with countries and the COVAX Facility. Public money has paid for the development of the vaccine and the resources and people in countries around the world has made these clinical trials possible.”