Comment

12 Seff I, Koris A, Giuffrida M, et al. Exploring the impact of a family-focused, 14 Speizer IS, Bremner J, Farid S. Language and measurement of contraceptive
gender-transformative intervention on adolescent girls’ well-being in a need and making these indicators more meaningful for measuring fertility
humanitarian context. Int J Environ Res Public Health 2022; 19: 15357. intentions of women and girls. Glob Health Sci Pract 2022; 10: e2100450.
13 Pulerwitz J, Blum R, Cislaghi B, et al. Proposing a conceptual framework to
address social norms that influence adolescent sexual and reproductive
health. J Adolesc Health 2019; 64: S7–9.

The 100 Days Mission: how a new medical-countermeasures

network can deliver equity and innovation
During the early days of the COVID-19 pandemic, Negotiating Body for a Pandemic Accord and the G20 Published Online
September 5, 2023
science delivered so much, so fast. Based on a strong deliberations on a global medical-countermeasures https://doi.org/10.1016/
foundation of rapid genomic sequencing, an initial network. We believe that genuine multisectoral partner­ S0140-6736(23)01775-0

test, a repurposed treatment, and the first vaccines for ships are crucial for the main functions of such a network,
COVID-19 were available relatively quickly.1,2 Despite which could be globally coordinated and regionally
these advances, millions of lives were lost worldwide,3 connected to enable rapid and equitable development
with long-term effects on health systems and and delivery of medical countermeasures (panel).
wellbeing.4 Overall, efforts should focus on a system that
The 100 Days Mission—an initiative that was endorsed maintains virtual-prototype portfolios of diagnostics,
by the G7 in June, 2021, and G20 in November, 2021— therapeutics, and vaccines for the top ten pathogens of
aims to focus attention on efficiently and equitably pandemic potential, as defined by WHO,8 that would be
preparing for future disease outbreaks. Integral to ready to put into predesigned clinical trials as soon as a
this aim are identifying barriers to product discovery; pandemic threat is detected. Prioritisation of diagnostics,
developing platform technologies (eg, mRNA vaccines); therapeutics, and vaccines that offer broad coverage with
and streamlining timelines so that diagnostics, little necessary updating would be ideal to deliver rapid
therapeutics, and vaccines can be ready for initial benefits against entire pathogen families. Investment,
authorisation and manufacturing at scale within the first coordination, and innovation are needed to make this
100 days of a new disease outbreak that has pandemic ambition a reality; there should also be progress in five
potential. The first 100 days of any disease outbreak are specific areas.
crucial to establishing its course. In the first 100 days after First, new products should have inherent timely
COVID-19 was declared a Public Health Emergency of and equitable access. Diagnostics, therapeutics, and
International Concern (PHEIC) by WHO on Jan 30, 2020,5 vaccines are often developed for high-income contexts,
more than 2·5 million cases of COVID-19 were recorded even when primarily intended for use in low-income
and more than 200 000 people had died worldwide.6 and middle-income countries. This approach does not
To track the progress of and advise on the work for global deployment, especially deployment
implementation of the 100 Days Mission, an international in low-income and middle-income countries. An
coalition of experts was convened to form a Science and inclusive partnership approach is crucial to ensuring
Technology Expert Group (STEG). The COVID-19 PHEIC that diagnostics, therapeutics, and vaccines work for
is now over and countries are balancing competing everyone. For example, by improving the thermostability
crises, including conflict, climate change and economic of vaccines, increasing administration options, and co-
inflation.7 As members of this STEG, we believe that the designing products with affected communities.
global community should use lessons from the COVID-19 Second, there should be enhanced international
pandemic as a mandate for improved pandemic coordination in research and development to best
preparedness. use limited funding. The update to the WHO priority
Governments, organisations, scientists, industries, pathogen list, which is expected to be released later in
and civil society are working tirelessly to initiate reforms 2023, will lead to updated target-product profiles and a
in numerous fora, including the Intergovernmental review of diagnostics, therapeutics, and vaccines to assess

www.thelancet.com Vol 402 October 28, 2023 1507

 Comment

hampered at the start of the COVID-19 pandemic

Panel: Importance of multisectoral partnerships to develop a new medical-
countermeasures network due to a lack of international coordination of clinical
trials. We advocate for regionally dispersed clinical-
• Increased global transparency, cooperation, and collaboration are needed through
whichever mechanism supersedes the Access to COVID-19 Tools Accelerator
trial infrastructure to be a main tenet of universal
• Increased regional and national cooperation would increase efficiencies health coverage, which should remain in use between
• This cooperation should be at regional, national, and local levels and pandemics, with capacities for rapid assessment and
representatives from regional authorities should be part of the network approval and with funding for trials in emergencies.
• Many of the potential functions of a global medical-countermeasures network would
Fourth, we advocate for an ambitious, preparatory,
benefit from being replicated in a coordinated way at the regional level,
encompassing agreements on priority pathogens and target-product profiles,
regulatory vision (ie, an all-encompassing programme)
research and development budget coordination, investment in regional clinical-trial that focuses on strengthening and harmonising
infrastructure, regional manufacturing and testing capacity, demand generation, and national regulatory requirements (ie, whereby technical
market shaping to ensure sustainability requirements and guidelines for the development and
• The technical expertise of civil-society organisations that represent patient
marketing of pharmaceutical products are developed to
communities should be meaningfully involved
• The private sector from high-income, middle-income, and low-income countries has be consistent across regulatory authorities) under the
been crucial in the development of; scale up of; and access to diagnostics, WHO framework of listed authorities.11 The COVID-19
therapeutics, and vaccines; as future pandemics will undoubtedly require pandemic showed that many regulatory processes can be
collaboration between public, private, voluntary, and civil-society sectors, guidelines expedited but are not sufficiently harmonised, resulting in
should be preagreed to govern interactions while ensuring that any future framework
lengthy approvals with various regulators. We encourage
is workable in facilitating preparedness and a rapid response to future pandemics
• This need for preagreed guidelines is particularly true in complex areas, including increased collaboration between organisations such as
intellectual property, access to pathogen and clinical samples, surge financing, and the European Medicines Agency, the African Medicines
product-liability sharing Agency, the US Food and Drug Administration, and
the WHO prequalification programme. Patient safety
should never be compromised. Reducing complexity and
the current status of research and development, mapping expediting these processes through innovation, such as
candidates against funding priorities. This landscaping prepositioned protocols and cloud-based data-sharing
exercise should support global and regional conversations platforms,12 could be transformative.
among stakeholders to discuss barriers to new product Finally, a sustainable, regional manufacturing strategy
development, neglected investment areas, and who could enable improved availability of diagnostics, thera­
is best placed to address them. As part of this work, peutics, and vaccines and equitable access in low-income
diagnostics and therapeutics should be given the priority and middle-income countries, as well as supporting local
they deserve. For example, in the final commitments of product confidence (ie, trust in these products). Currently,
the Access to COVID-19 Tools Accelerator,9 COVAX (ie, the ten manufacturers provide 70% of vaccine doses globally
vaccines pillar) attracted almost 70% of the total funding, (excluding COVID-19 vaccines) and 85% of the global
with 30% left for the other three pillars (ie, diagnostics, value of vaccines.13 Although every country having its own
therapeutics, and health systems).10 The availability of production is not realistic or desirable because of risks of
diagnostics is an integral first-line defence for tracking duplication and redundancy, there is value in a regionally
outbreaks and informing policy and public health action; coordinated approach that encompasses research,
therapeutics are crucial due to multiple uncertainties development, and workforce and will ensure resilience in
about the next pandemic; the world should invest a pandemic; any future global mechanism should support
accordingly. this approach with technical assistance and market-
Third, a global clinical-trials network should be shaping coordination. Understanding market dynamics
developed and maintained to ensure that diagnostics, and the ability for any new facilities to quickly change
therapeutics, and vaccines are evaluated in regions to manufacturing different products provides the best
where they are likely to be used. Only 4% of COVID-19 chance of sustainability and preparedness.
studies between March 1, 2020, and July 15, 2021, Ongoing discussions about the development of a
were conducted in Africa,10 and progress in trials of new medical-countermeasures network14 are an opportunity
diagnostics, therapeutics, and vaccines was particularly to translate political will into a reshaped global health

1508 www.thelancet.com Vol 402 October 28, 2023

 Comment

architecture (ie, the systems and capacities at national, Prevention (Africa CDC). TL received support through a grant from the University of
Oxford (Oxford, UK) to support the running of the Vaccine Taskforce via the UK
regional, and global levels that are crucial to the collective National Institute for Health and Care Research trial and the AstraZeneca
ability of the world to prepare for and respond to health partnership for development of COVID-19 vaccines, was a consultant to Vaccitech,
and is an inventor on a patent application for a vaccine against SARS CoV-2. SM is
emergencies) and make the 100 Days Mission achievable Chief Science Officer for Africa CDC. J-AR is the Ambassador for Global Health at the
by considering every part of the process, coordinating Norwegian Ministry of Foreign Affairs; is a Gavi, the Vaccine Alliance board member
representing the Nordic+ constituency; and is the former technical-level Co-Chair
work across product areas, and improving the integration of the Access to COVID-19 Tools Accelerator Facilitation Council. US is the Executive
of regional entities into global structures. Leaders should Director of the Serum Institute of India. MS is the former WHO Assistant Director-
General for Drug Access, Vaccines and Pharmaceuticals. RS is the former Secretary
set a bold vision for the capacities that are needed both of the Department of Biotechnology at the Indian Ministry of Science and
globally and regionally, as well as a clear framework for Technology. J-FT is the Head of Research and Development at Sanofi Vaccines;
owns shares from Sanofi; and received shares from GlaxoSmithKline until January,
how those capacities might be operationalised in a timely 2021, as a former employee. NSW is the Founder and Chief Executive Officer of
and inclusive manner. Once these elements are agreed, Vaccines for All and is a consultant to Africa CDC for the Partnership for Africa
Vaccine Manufacturing initiative at CEPI India.
governments, organisations, companies, and experts will
be ready to work together to deliver this bold vision. Victor Dzau, Soumya Swaminathan,
*Charlotte Baker, Rick A Bright, Jose Castillo,
As STEG members, we advocate for actions that bring
Tan Chorh Chuan, Ruxandra Draghia-Akli,
us closer to realising the 100 Days Mission by tracking Ranna Eardley-Patel, George F Gao, Ken Ishii,
progress and publishing annual reports and scorecards Yenew Kebede Tebeje, Teresa Lambe, Shingai Machingaidze,
on the state of pandemic preparedness,15 which set John-Arne Røttingen, Umesh Shaligram, Mariângela Simão,
goals for all involved partners to work towards reducing Renu Swarup, Jean-Francois Toussaint, Niteen S Wairagkar
[email protected]
deficits in research and development; making the
International Pandemic Preparedness Secretariat, London NW1 2BE, UK (CB);
exceptional collaboration seen during the COVID-19 US National Academy of Medicine, Washington, DC, USA (VD); M S Swaminathan
pandemic routine (eg, accelerated regulatory pathways Research Foundation, Chennai, India (SS); Foundation for Innovative New
Diagnostics, Geneva, Switzerland (RAB); Univercells, Nivelles, Belgium (JC);
and preagreed clinical trial protocols); and ensuring that Singapore Ministry of Health, Singapore (TCC); Johnson & Johnson,
pre-negotiated guidance on good practice for all relevant New Brunswick, NJ, USA (RD-A); Coalition of Epidemic Preparedness Innovations,
London, UK (RE-P); Savaid Medical School, University of Chinese Academy of
stakeholders in a pandemic15 is established before the next Sciences, Beijing, China (GFG); Institute of Medical Science, University of Tokyo,
pandemic. We see great potential for the global medical- Tokyo, Japan (KI); Africa Centres for Disease Control and Prevention, African Union
Commission, Addis Ababa, Ethiopia (YKT, SM, NSW); Medical Sciences Divison,
countermeasures network, especially if underpinned by University of Oxford, Oxford, UK (TL); Norwegian Foreign Ministry, Oslo, Norway
clearly defined roles and responsibilities, and with groups (J-AR); Serum Institute of India, Pune, India (US); Instituto Todos Pela Saúde,
São Paulo, Brazil (MS); Department of Biotechnology, Ministry of Science and
from all sectors taking ownership. We are ready to work Technology, Government of India, New Delhi, India (RS); Sanofi Vaccines, Gentilly,
with all who want to join us on the 100 Days Mission. France (J-FT)

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Retraction: The first tissue-engineered airway transplantation:

5-year follow-up results
1 The Editors of The Lancet. Expression of concern: The first tissue-engineered
Further to the two Expressions of concern The Lancet airway transplantation: 5-year follow-up results. Lancet 2023; 401: 536.
issued in February, 20231,2 for the Article presenting the 2 The Editors of The Lancet. Expression of concern: Clinical transplantation of a
tissue-engineered airway. Lancet 2023; 401: 536.
5-year follow-up results3 of the case of tissue-engineered 3 Gonfiotti A, Jaus MO, Barale D, et al. The first tissue-engineered airway
transplantation,4 the Swedish National Board for Assessment transplantation: 5-year follow-up results. Lancet 2014; 383: 238–44.
4 Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-
of Research Misconduct5 has concluded in an investigation engineered airway. Lancet 2008; 372: 2023–30.
into this paper that it “contains fabrication and falsification 5 Swedish National Board for Assessment of Research Misconduct. Decision
regarding research misconduct. Ref 3.2-22/0092. Sept 20, 2023. https://npof.
in several places, and three falsified figures (4, 5 and 6C)”. We se/wp-content/uploads/2023/10/Decision-in-case-3.2-22-0092_web.pdf
(accessed Oct 20, 2023).
are therefore now retracting this Article3 together with the
6 The Editors of The Lancet. Retraction: Clinical transplantation of a tissue-
original description of this case.6 engineered airway. Lancet 2023; 402: 1510.

The Editors of The Lancet

The Lancet, London EC2Y 5AS, UK

Retraction: Clinical transplantation of a tissue-engineered

airway
After The Lancet issued two Expressions of concern in mechanical properties at 4 months” would also constitute
February, 20231,2 for the original case description3 and the falsification.5 We are, therefore, also retracting the Article of
5-year follow-up Article,4 the investigation by the Swedish the original case description.
National Board for Assessment of Research Misconduct5 into The Editors of The Lancet
the 5-year follow-up paper has led us to retract this paper.6 The Lancet, London EC2Y 5AS, UK
During that investigation, it was confirmed that a stent was 1 The Editors of The Lancet. Expression of concern: The first tissue-engineered
airway transplantation: 5-year follow-up results. Lancet 2023; 401: 536.
inserted in the patient’s trachea less than 4 months after
2 The Editors of The Lancet. Expression of concern: Clinical transplantation of a
the operation. The Swedish National Board for Assessment tissue-engineered airway. Lancet 2023; 401: 536.
of Research Misconduct5 found that the statement made 3 Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-
engineered airway. Lancet 2008; 372: 2023–30.
in that Article4 that a “4-month follow-up showed no 4 Gonfiotti A, Jaus MO, Barale D, et al. The first tissue-engineered airway
transplantation: 5-year follow-up results. Lancet 2014; 383: 238–44.
complications” and that omitting information that a
5 Swedish National Board for Assessment of Research Misconduct. Decision
stent was inserted constitutes falsification. Similarly, the regarding research misconduct. Ref 3.2-22/0092. Sept 20, 2023. https://npof.
se/wp-content/uploads/2023/10/Decision-in-case-3.2-22-0092_web.pdf
statement in the original report3 that “the graft immediately (accessed Oct 20, 2023).
provided the recipient with a functional airway, improved 6 The Editors of The Lancet. Retraction: The first tissue-engineered airway
transplantation: 5-year follow-up results. Lancet 2023; 402: 1510.
her quality of life, and had a normal appearance and

1510 www.thelancet.com Vol 402 October 28, 2023