The publicly funded epidemic response agency CEPI has been criticised for the lack of transparency in its grant agreements with COVID-19 vaccine developers. Ann Danaiya Usher reports.
Donors have contributed US$1·4 billion in public money, mainly development assistance, to the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate COVID-19 vaccine research and ensure vaccines are available for low-income and middle-income countries (LMICs). Over the past year, CEPI has provided grants to ten different vaccine developers, some of which have started receiving regulatory approval for their vaccines (Moderna and AstraZeneca) or are in phase 3 trials (Novavax). CEPI says that the organisation's agreements contain strong provisions on equitable access and include sanctions that can be used if companies do not live up to their promises of making cheaper vaccines available to LMICs. But the agency has been criticised for being too secretive about the conditions in its contracts and for not pushing vaccine developers harder to achieve better terms.
Inger Berg Ørstavik, law professor at the University of Oslo, Oslo, Norway, specialising in patent licensing law and research and development agreements, says that without more openness, neither CEPI nor the vaccine manufacturers the organisation funds can be held accountable. She wants donors to place stronger demands on the transparency requirements of CEPI's agreements. “CEPI is doing important and commendable work. But it surprises me that CEPI is so much into individually negotiated secret agreements and that there has been so little transparency about the terms”, she said.
CEPI is part of a complex mechanism for allocating vaccines fairly around the world, the COVAX facility, managed by Gavi, the vaccine alliance. CEPI-funded developers must, as a condition of their grant agreements, supply part of their product at an affordable price to COVAX, which in turn ensures that doses are made available to LMICs, covering 20% of their populations.
A year into the pandemic, vaccine access is badly skewed. More than 12 billion doses of vaccines have been purchased or reserved, mainly by high-income countries, and approximately 39 million people have already received a vaccine. COVAX, meanwhile, has made no deliveries yet. It has only one agreement with AstraZeneca to deliver 170 million doses. Additionally, the facility has 1·8 billion more potential doses reserved with two firms not funded by CEPI, Johnson & Johnson and Sanofi/GSK, and through manufacturing deals with Serum Institute of India.
In this global vaccine race, COVAX is lagging behind. WHO Director Tedros Adhanom Ghebreyesus stated at the opening of WHO's executive board meeting on Jan 18, 2021, that many member states are starting to wonder whether COVAX will get the vaccines it needs. Noting that only 25 doses have been given in one lowest-income country (Guinea), he said, “not 25 million; not 25 thousand; just 25…the promise of equitable access is at serious risk…I need to be blunt: the world is on the brink of a catastrophic moral failure”.
Of the ten developers that have received CEPI grants, four—AstraZeneca, Novavax, CureVac, and Moderna—have entered into bilateral vaccine deals outside of COVAX totalling more than 3 billion doses. AstraZeneca, which received a CEPI grant of US$383 million for development of its AZD1222 vaccine in June, has purchase agreements with the EU, the USA, Canada, and many other countries for at least 1·9 billion doses.
An AstraZeneca spokesperson says that in addition to the 170 million doses promised to COVAX, Serum Institute of India has committed to supply 100 million doses of the Oxford–AstraZeneca vaccine to LMICs through COVAX, with a further option of up to 900 million doses of the AstraZeneca or Novavax candidate, dependent upon regulatory authorisation. “This means that hundreds of millions of doses of the AstraZeneca vaccine could be made available to COVAX”, she said.
Asked whether he is worried about how few vaccine doses COVAX has secured from CEPI-funded developers, Richard Wilder, CEPI's general counsel and director of business development, says that the agreements with companies contain obligations that vaccines corresponding to CEPI funding must go to the COVAX facility. “In the AstraZeneca arrangement, we have an obligation that they provide 300 million doses to COVAX and there can be more. The agreement with Novavax enhances the capabilities of several manufacturing facilities. 100% of the output from those facilities is to go to COVAX”, he said.
Manuel Martin, medical innovation and access policy adviser at Médecins Sans Frontières, says that the test of CEPI's equitable access policy will be the roll-out of the AstraZeneca vaccine. “We will see who receives [the vaccine] first and how it will be distributed. That will be the first opportunity to truly evaluate how CEPI's equitable access policy is being applied in COVID-19”, he said.
Wilder says CEPI is monitoring the bilateral vaccine deals closely to be sure that there is no interference between what the companies are doing on a bilateral basis and what they have agreed to do for CEPI.
Novavax received the largest CEPI grant, $388 million, for preclinical studies and phase 1 and phase 2 clinical trials of its NVX-CoV2373 vaccine candidate, as well as manufacturing activities. CEPI states that if the company is successful, vaccines “are expected to be procured and allocated through the COVAX facility”, but it does not specify numbers of doses. This contrasts with the terms negotiated with the US Department of Health and Human Services (HHS) as part of a US$1·6 billion grant to Novavax. According to an HHS press release, the US Government “will own the 100 million doses of investigational vaccine expected to result from the demonstration projects”.
Asked why CEPI was not able to achieve more concrete terms in its agreement with Novavax, Wilder said, “we did get good, strong terms in that agreement. The difference is that when the US Government through HHS was negotiating its agreements, it was able at once to negotiate the two parts that we are now dealing with in succession through COVAX”. In other words, CEPI first negotiates funding and promises of access with companies, and then details regarding numbers of doses and price per dose are negotiated by Gavi.
Splitting grants for research and development and price negotiations between CEPI and Gavi lies at the heart of the problem, Martin says. “You cannot separate these two parts. If you want an affordable price, you need to bring up the issue of pricing at an early stage. CEPI should be having these conversations. It is not good enough to say that Gavi will negotiate”, he said. “In a pandemic situation, where high-income countries are not particularly price sensitive and are willing to pay pretty much anything just to get access to these vaccines, Gavi has very little power to negotiate with companies”, he added.
A Novavax spokesperson said, “we are currently in discussions with the COVAX facility and CEPI and remain fully committed to making doses available worldwide for equitable access. Together with our partners at Serum Institute of India, we have substantial capacity to provide vaccine throughout the world”.
When the COVID-19 pandemic hit, CEPI moved quickly to provide funding for promising vaccine candidates. But CEPI's negotiations with companies are subject to confidentiality and agreements are not made public. Until recently, not much was known about the contents of the CEPI contracts.
In November, 2020, Zain Rizvi at Public Citizen, a Washington-based advocacy organisation, published an analysis of the public interest safeguards in CEPI grant agreements and found from Novavax's financial filings to the US Securities and Exchange Commission that its contract with CEPI contains a public health licence. Such a licence allows a patented invention to be used without the consent of the patent holder for public health purposes.
Wilder confirmed to The Lancet that a public health licence is, in fact, included in the three largest CEPI agreements with Novavax, AstraZeneca, and Clover, but not in the other seven. This inclusion means that if these three companies do not fulfil their equitable access commitments, CEPI can invoke this licence, allowing the agency to access intellectual property that arises from its funding. CEPI could then, in theory, move forward with another party to manufacture and distribute that vaccine.
“The public health licence is intended to be the ultimate backstop if the companies fail to follow through on their obligations to supply the vaccine, either quantity of doses or percentage of output. We will use it if necessary. We make that clear in the negotiations”, Wilder said. However, he added that invoking the licence would be complicated and time consuming, and unsuited to a pandemic situation when time is of the essence. “We put this public health licence in place as a remedy. And we are not shy about using it if we have to. But it is not a preferred solution. Going down that path would be difficult, practically, to achieve”.
A month after Rizvi's report came out, CEPI published its first overview of the equitable access provisions in the agreements with vaccine developers. Rizvi says the document is a welcome step forward but falls short of the kind of transparency required. Martin agrees, and wonders why CEPI took almost a year to make such basic information public. Wilder concedes that his organisation needs to improve on its transparency and the timeliness of publication of such materials.
Martin warns that transparency about cost of goods and terms in contracts is not only important for ensuring fair access in this pandemic, but is also necessary to deal with the next. Without such transparency, learning from the mistakes—or successes—of this effort will be difficult. “When the next pandemic comes, there will be public–private partnerships and conversations about access and what kinds of provisions you need in contracts will come up again. People will look to COVID-19 and ask what did they do the last time? But we won't know because there is so little transparency.”
For CEPI's review of equitable access to COVID-19 vaccines see https://cepi.net/wp-content/uploads/2020/12/Enabling-equitable-access-to-COVID19-vaccines-v1-17Dec2020.pdf