Scientists tackle vaccine safety, efficacy and access at global R&D forum

More than 2,800 scientists from 130 countries gathered on Friday (January 15) in a virtual forum hosted by the World Health Organization (WHO) to identify knowledge gaps and set research priorities for vaccines against SARS-CoV-2, the virus that causes COVID-19.

They discussed the safety and efficacy of existing vaccines and new candidates, ways to optimize limited supply, and the need for additional safety studies.

“The development and approval of several safe and effective vaccines less than a year after this virus was isolated and sequenced is an astounding scientific accomplishment,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in his opening remarks. “The approval of the first few vaccines does not mean the job is done. Far from it. More vaccines are in the pipeline, which must be evaluated to ensure we have enough doses to vaccinate everyone.”

More than 30 million vaccine doses have already been administered in 47 mostly high-income countries.

 

But the global vaccine rollout has exposed glaring inequalities in access to this life-saving tool. 

“The spirit of collaboration has to prevail in these challenging times as we seek to understand this virus,” said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention. “We have to be mindful of the inequalities and we must deliberately promote investment in regional capacities to level the playing field and have meaningful collaboration to begin to address some of the challenges.”

Experts agreed the need for critical research on administering vaccines in different target populations, as well as on vaccination delivery strategies and schedules. This includes trials, modelling and observational studies, all of which would help to inform policy.

They discussed the impact of emerging SARS-CoV-2 variants on the efficacy of vaccines, the impact of vaccines on transmission of infection, and the need to develop the next generation of vaccine platforms.

 

“The world needs multiple vaccines that work in different populations in order to meet global demand and end the COVID-19 outbreak. Ideally, those will be single-dose vaccines that do not require cold chain, could be delivered without a needle and syringe and are amenable to large-scale manufacture,” said Professor Mike Levine, Director of the Center for Vaccine Development at the University of Maryland.

The meeting concluded with agreement to establish a WHO-hosted platform for global sharing and coordination of emerging vaccine research information on efficacy and safety. The forum would enable scientists to share and discuss unpublished and published data and research protocols to further our collective understanding of SARS-CoV-2 vaccines.

“The WHO will regularly convene experts from around the world, promote collaborative research, provide standard protocols and develop a platform for sharing the latest knowledge in the field,” said Dr Soumya Swaminathan, WHO Chief Scientist.

More than 2,800 scientists from 130 countries gathered on Friday (January 15) in a virtual forum hosted by the World Health Organization (WHO) to identify knowledge gaps and set research priorities for vaccines against SARS-CoV-2, the virus that causes COVID-19.

They discussed the safety and efficacy of existing vaccines and new candidates, ways to optimize limited supply, and the need for additional safety studies.

“The development and approval of several safe and effective vaccines less than a year after this virus was isolated and sequenced is an astounding scientific accomplishment,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in his opening remarks. “The approval of the first few vaccines does not mean the job is done. Far from it. More vaccines are in the pipeline, which must be evaluated to ensure we have enough doses to vaccinate everyone.”

More than 30 million vaccine doses have already been administered in 47 mostly high-income countries.

 

But the global vaccine rollout has exposed glaring inequalities in access to this life-saving tool. 

“The spirit of collaboration has to prevail in these challenging times as we seek to understand this virus,” said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention. “We have to be mindful of the inequalities and we must deliberately promote investment in regional capacities to level the playing field and have meaningful collaboration to begin to address some of the challenges.”

Experts agreed the need for critical research on administering vaccines in different target populations, as well as on vaccination delivery strategies and schedules. This includes trials, modelling and observational studies, all of which would help to inform policy.

They discussed the impact of emerging SARS-CoV-2 variants on the efficacy of vaccines, the impact of vaccines on transmission of infection, and the need to develop the next generation of vaccine platforms.

 

“The world needs multiple vaccines that work in different populations in order to meet global demand and end the COVID-19 outbreak. Ideally, those will be single-dose vaccines that do not require cold chain, could be delivered without a needle and syringe and are amenable to large-scale manufacture,” said Professor Mike Levine, Director of the Center for Vaccine Development at the University of Maryland.

The meeting concluded with agreement to establish a WHO-hosted platform for global sharing and coordination of emerging vaccine research information on efficacy and safety. The forum would enable scientists to share and discuss unpublished and published data and research protocols to further our collective understanding of SARS-CoV-2 vaccines.

“The WHO will regularly convene experts from around the world, promote collaborative research, provide standard protocols and develop a platform for sharing the latest knowledge in the field,” said Dr Soumya Swaminathan, WHO Chief Scientist.

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Statement to the 148th Executive Board by the Chair of the Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response

Kam Jan 21 , 2021
<p>Honorable Chair, Excellencies, Director-General, Ladies and Gentlemen<br></p> <p>Thank you once again for the opportunity to provide you with an update on the work of the Review Committee on the Functioning of the International Health Regulations (2005) during COVID-19.<br></p> <p>As you know, this Committee was convened by the Director-General on 8 September 2020, in line with World Health Assembly Resolution WHA73.1. The Committee is composed of experts with a wide range of expertise and with adequate gender and geographical representation. I have the honour to be the Chair of this Committee and am ably supported by our Vice-Chair, Professor Lucille Blumberg of South Africa and our Rapporteur, Professor Preben Aavitsland, from Norway.<br></p> <p>Our mandate is to review the functioning of the International Health Regulations (2005) during the COVID-19 response and the status of implementation of the relevant recommendations of previous IHR Review Committees and to make technical recommendations to the Director-General, including any potential amendments.<br></p> <p>We convened for 16 closed meetings so far, and we continue to work through three sub-groups: preparedness, alert, and response. I take this opportunity to reiterate my thanks to our three subgroup leads. We also convened 5 open meetings, when we provided updates on our work and listened to the submissions and questions raised by Member States, international agencies and non-governmental organizations in official relation to WHO. These open meetings continue to be attended by numerous designated representatives.<br></p> <p>I reported on our progress to the 73rd World Health Assembly on 9 November 2020. And I continue to interact regularly with the Co-Chairs of the Independent Panel for Pandemic Preparedness and Response and the Chair of the Independent Oversight Advisory Committee.<br></p> <p>Let me now turn to the substance of our work. I invite you to read our Interim Progress Report, document EB148/19. It details our preliminary findings as of December 2020, which were reached following numerous interviews, discussions and the review of a wealth of documentation.<br></p> <p>Let me point out the most important ones:<br></p> <ol><li>Member States and experts overwhelmingly support the IHR as a cornerstone of international public health and health security law, but several areas need improving if we are to be better prepared for the next pandemic. While we have not finalized our article-by-article assessment, there is a growing belief in the Committee that most of the necessary improvements can be achieved through more effective implementation of the existing provisions of the IHR, and do not require at this point changes to the design of the IHR.<p> </p></li><li>National IHR Focal Points need to be further empowered, including where necessary through national legislation. National Focal Points play a critical role in the timely sharing of information, but their limited authority and status often lead to delays in notification. The Committee noted that effective IHR implementation requires many functions that are not within the narrow mandate of the national IHR focal points, such as multisectoral coordination for preparedness and response and collaborative risk assessment. The absence of a dedicated national entity with sufficient authority and a clear mandate to take ownership and leadership is considered a significant limitation to effective implementation of the IHR at national and subnational levels. At country level, national IHR focal points need to be integrated in the national emergency plan as well as the national health committee or similar body.<p> </p></li><li>The possible need for an intermediate level of alert before a Public Health Emergency of International Concern (PHEIC) is declared, is also under consideration. The previous review committee on the Ebola response recommended such an intermediate level, but this recommendation was not taken up. The 5th open meeting of the Committee on 12 January 2021 discussed issues surrounding the possible introduction of a grading system. The different views expressed by Member States and the advantages and potential disadvantages of a new system will be further studied by the Committee. It is clear, that global preparedness, alert and response actions need to start much earlier and more decisively than they did during COVID-19. But it is far from certain, that introducing an intermediate level of alert would result in such earlier action. The Committee is considering how regular global and regional risk assessments can be used better to drive earlier and more targeted response measures at all levels. The aim, the Committee feels, should be to react early and strongly enough so as to prevent the need to declare a PHEIC.<p> </p></li><li>Compliance with IHR provisions remains a challenge in several areas, from setting up core capacities to implementing travel measures during health emergencies. The Committee is mindful of the lack of teeth in the IHR. We are therefore looking at new ways to monitoring and evaluating adherence to the IHR – both in preparedness and response – and to strengthen existing tools without overburdening countries. Considering a peer-review mechanism similar to the Universal Periodic Review used by the Human Rights Council, may be useful in improving preparedness and response. For example, the Universal Periodic Review has been shown to foster intersectoral coordination and whole-of-government approaches, to encourage good practices, and to link implementation of its recommendations with other government agendas – all of which are vital to strengthening IHR implementation. It is in this context that the Director-General has proposed the Universal Health and Preparedness Review initiative which is currently being pilot tested. <p> </p></li><li>Last but far from least, political support and resources for IHR implementation remain insufficient and irregular at all levels. In this context, the Committee is awaiting further detailed information on the funding mechanisms for IHR implementation.<br></li></ol> <p>I would like to clearly state my conviction that we need more meaningful cooperation during and in-between health emergencies; more transparency, more regular detailed exchange of real-time data and experiences at all levels, more reliability of interaction, and greater speed in sharing data and samples. Fortunately, digital technology supporting such developments is increasingly becoming available, from data mining to find disease outbreaks early, to next generation sequencing to follow a pathogen around the globe, to virtual conferencing that makes human interaction easier.<br></p> <p>To come to the conclusion, the deadline for our final report is the 74th World Health Assembly in May 2021. However, as we all know, the COVID-19 pandemic will be far from over in 4 months’ time, and therefore our findings and recommendations will not necessarily be complete. Further deliberations may be needed later.<br></p> <p>Let me reiterate what I said in November 2020 on the occasion of the 73rd Health Assembly: The IHR are your instrument, our instrument, of international public health law. Making them work requires giving WHO the tools and the resources it needs to better prepare and protect humanity against public health risks, through an effective, coordinated, multisectoral and evidence-based public health response.</p><br>Thank you again for the opportunity to speak to you today and let me also thank the Director-General for the excellent support provided by the WHO Secretariat to this Review Committee.<p> </p>