WHO has developed an R&D Blueprint Team to globally coordinate candidate vaccines. The agency calls vaccine efforts ‘unprecedented’, working from ‘strengthened channels for information sharing between countries’, and the Team was developed to ‘accelerate diagnostics, vaccines and therapeutics’.[1] When WHO declared a Public Health Emergency of International Concern (PHEIC) on 30 January 2020, scientists across the globe gathered in Geneva from 11-12 February 2020 to agree to a collaborative and flexible research funding model. I do not know how the information is fed into WHO, but it seems voluntary and ‘for the global public good’.
Is this the model of global pandemic responses we will see in future? We are hearing news of mutant strains and elderly people in Norway dying after receiving the vaccine, though unclear if there is a connection.[2] Moreover, a WHO team arrived in Wuhan in mid-January 2021 to investigate COVID-19 origins, raising questions about how much information is actually freely shared with the organization to develop effective vaccines.[3]
COVID-19 therapeutics and vaccines have been much more globally coordinated than HIV/AIDS, though whether this will be effective is yet to be seen. In the mid-1980s, WHO’s GPA envisioned itself at the center of the global disease response controlling funds, donors and research, which soon fractured due to most donors preferring to work outside of WHO’s rigid framework. Moreover, WHO did not have much oversight over pharmaceutical entities by the era of AIDS, and clinical trials for the first treatments were much more uneven. AZT trial ethics were governed by the US FDA through fast-tracking AZT approval seeing the need, not WHO.[4] It seems WHO developed into this global coordinating role sometime after HIV/AIDS, perhaps witnessing MERS, Ebola, SARS and other diseases.
So how is WHO’s global coordinating to ensure that the vaccines currently being rolled are delivered with scientific rigor and medical safety? Through initiatives like the Living NMA Initiative and the COVID-19 Candidate Vaccine Landscape, updated on Tuesdays and Fridays at 17:00 CET (https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines 22 January 2021). [5] I was interested to find that the information is not generated through WHO’s links with national governments and their pharmaceutical regulatory agencies. Rather, it is developed through (a). secondary literature surveys of published medical research or corporate webpages, (b). collating information from other similar efforts, such as the Cochrane vaccine mapping tool, AND (c). voluntary contributions of information through a data submission form by those developing vaccines. There’s something very iterative about capturing global information and the limits of surveillance in a digital era.
"[B]y searching, gathering and cross-checking data from multiple sources such as the Cochrane vaccine mapping tool, Pubmed, ClinicalTrails.gov, WHO ICTRP and from a network of researchers and industry for new candidate vaccines and screening registered trials for clinical information. Where data is missing, we either do not add any information (blank cells) or we supplement information gathered from press or public releases. We welcome your feedback to help us update or make necessary changes, please note any updates will only be done twice a week."
Figure 1: Another WHO Vaccine Database, the Cochrane living NMA initiative: a more visual representation? https://covid-nma.com/vaccines/mapping/
Figure 2: Different databases, such as ClinicalTrials.gov, focus on different data. Particularly important information for ClinicalTrials.gov is the therapeutic intervention and status of the trials: recruiting or not? These are the 28 results of a quick search of COVID-19 clinical trials in Japan. https://www.clinicaltrials.gov/
By route c). voluntary information contribution, data is submitted voluntarily through an information template with a secure log-in.
Figure 3: Submission of Data (22 January 2021)
Of course, there is a disclaimer, but it is surprisingly short: doesn’t mean endorsement; no responsibility for death or injury, etc. I found the following particularly interesting because it seems to indicate WHO is unsure who or what the database is for.
"While WHO takes reasonable steps to verify the accuracy of the information presented in these landscape documents, WHO does not make any (and hereby disclaims all) representations and warranties regarding the accuracy, completeness, fitness for a particular purpose (including any of the aforementioned purposes), quality, safety, efficacy, merchantability and/or non-infringement of any information provided in these landscape documents and/or of any of the products referenced therein."
Obviously this is mostly due to COVID-19 being an emergency, but I also believe it is because the legal landscape for vaccine R&D is still not fully sorted out. It certainly wasn’t with AIDS therapeutics, since AZT was developed through a unique public-private joint venture between the American National Cancer Institute (providing the research) and UK-US pharma house Burroughs Wellcome (providing the funding and taking the product to market). BW was subsequently hit by several lawsuits by other university labs and even patient groups claiming ownership of some part of the R&D process, even before the patent expired. IP is indeed a thorny issue in medical R&D and it seems WHO would rather not get involved…
I guess an argument can be made about the digital era’s impact on data sharing in global health! But if the information is so unwieldy, who is the database for?
Next blog post, I hope to look more closely at the data informing the clinical trials of the major vaccines brought to market. I just had to get this snippet on WHO out of the way, it was so fascinating!
[1]‘R&D Blueprint and COVID-19’, WHO, <https://www.who.int/teams/blueprint/covid-19>. [2]Naomi Kresge, ‘Pfizer Vaccine Safe for Elderly Despite Norway Scare, WHO Says’, 22 January 2021, Bloomberg, <https://www.bloomberg.com/news/articles/2021-01-22/pfizer-vaccine-safe-for-elderly-despite-norway-scare-who-says>. [3] ‘WHO team arrives in Wuhan to investigate pandemic origins’, 14 January 2021, NBC News, <https://www.nbcnews.com/news/world/who-team-arrives-wuhan-investigate-pandemic-origins-n1254236>; ‘WHO-convened Global Study of the Origins of SARS-CoV-2’, 5 November 2020, <https://www.who.int/publications/m/item/who-convened-global-study-of-the-origins-of-sars-cov-2>. [4] The first placebo trials were stopped once some patients died, and it was clear the treatment was effective in reducing symptoms. After this, Burroughs Wellcome conducted much subtler trials on dosage and treatment regime, since this affected cost. Margaret A. Fischl, Douglas D. Richman, Michael H. Grieco, ‘The Efficacy of Azidothymidine (AZT)in the Treatment of Patients with AIDS and AIDS-Related Complex’, The New England Journal of Medicine, 317 (1987), 185-91. [5]I am unclear on the differences between the two, I suppose the former is more visual and pleasing to look at?
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