Requirement for Proof of Negative COVID-19 Test or Recovery from COVID-19 for All Air Passengers Arriving in the United States
Scientists and health professionals worldwide have rarely been under as much pressure as they have been these past few months. This has led to unprecedented collaborative efforts using exceptional means on a global scale, including amongst world pharmacopoeias.
A pharmacopoeia is a legally-binding collection of standards and quality specifications for medical products. The World Health Organization (WHO) organizes official meetings entitled International Meeting of World Pharmacopoeias for participation of all WHO Member States' pharmacopoeias worldwide, be they national, regional or international. During these meetings, the pharmacopoeias share important news and strengthen their co-operation to improve public health outcomes for patients.
The 12th International Meeting of World Pharmacopoeias (IMWP) was hosted by WHO and met virtually from 22-24 February 2021. Sixty-one participants attended from 18 pharmacopoeias, representing 51 pharmacopoeias and pharmacopoeial authorities globally (out of the 60 listed in the Index of world pharmacopoeias and pharmacopoeial authorities compiled by WHO (Index of World Pharmacopoeias and Pharmacopoeial authorities). These pharmacopoeias work together to support the global public health response to the pandemic, providing support to manufacturers, regulators and stakeholders on medicines, all critical to the COVID-19 response. The availability and use of well-conceived international norms and standards - for performing clinical trials, producing a vaccine, a therapeutic, a medical device or diagnostics test or testing of their quality - are essential to ensure a successful outcome for a patient.
A major outcome of the collaboration is the global pharmacopoeial alert system initiated by the Brazilian, British, Chinese, European, Indian, International, Japanese, Mexican, United States and Vietnamese pharmacopoeias and other global pharmacopoeial partners. This has resulted in a dashboard listing of COVID-19 investigated medicines mapped to available monographs published in the various world pharmacopoeias. This listing is now available to allow easy identification of quality control specifications for therapeutics under consideration for COVID-19 treatment. Link: Health product and policy standard.
In addition, a number of world pharmacopoeias have increased the accessibility of supportive pharmacopoeial texts by making these freely available via their websites (these website addresses are included within the list).
The collaborative efforts of this group of world pharmacopoeias have brought forth the development of a new type of test specification under the umbrella of this IMWP. The pilot (the first specifications of this type) will be the IMWP monographs for Favipiravir. All related information will be made available on the WHO IMWP website. This will be an excellent initiative, making sure that test specifications are available and free of charge for those who need them during an emergency situation, such as the current pandemic. It will allow for quality checks and will be a tool to help prevent substandard and falsified products circulating.
In conclusion, the IMWP has again proven to be an invaluable forum and platform for world pharmacopoeias in their response to public health needs.
- Today, the governments of Côte d’Ivoire and Ghana began COVID-19 vaccination campaigns aimed at protecting healthcare workers
- This week’s first vaccinations happen as a further 11 million COVAX doses are expected to be delivered over the next seven days
- Publication of the allocation of the AstraZeneca/Oxford vaccine to 142 of COVAX’s participating economies, to be delivered between now and the end of May, is anticipated tomorrow
As the global rollout of COVAX vaccines accelerates, the first COVID-19 vaccination campaigns in Africa using COVAX doses began today in Ghana and Côte d'Ivoire. These campaigns are the among the first to use doses provided by the COVAX Facility’s Gavi COVAX Advanced Market Commitment (AMC).
The AMC is the COVAX Facility’s mechanism to provide donor-funded vaccines to lower-income countries.
The campaigns in Ghana and Côte d’Ivoire follow deliveries to both countries last week with Ghana taking delivery of 600,000 doses on February 24 and Côte d’Ivoire 504,000 doses two days later. Both countries received the AstraZeneca/Oxford vaccine licensed and manufactured by the Serum Institute of India (SII). The vaccine, branded COVISHIELD, was granted Emergency Use Listing (EUL) by the World Health Organization on 15 February.
H.E. Nana Akufo-Addo, President of the Republic of Ghana said: "COVID-19 has changed the world. It has cost lives, battered health systems, and damaged livelihoods. But, through these challenges, we have seen the best of humanity exemplified through strong multilateral cooperation. Ghana welcomes the arrival of the first doses of COVID-19 vaccines through the COVAX AMC as a pathway to ending the acute phase of the pandemic. To maximise the public health benefit of the vaccine, the first doses will be prioritized for health and essential workers, and other at-risk groups. This important milestone will allow Ghana to get back to business, and build back our economy even stronger than before."
The deliveries mark the start of what will be the largest, most rapid and complex global rollout of vaccines in history. In total, COVAX aims to deliver at least 2 billion doses of COVID-19 vaccines by the end of 2021, including at least 1.3 billion to the 92 economies eligible for support through the COVAX AMC.
Confirmation of first-round allocations, covering the majority of the COVAX Facility participants, will be published 2 March 2021. COVAX doses to date have been delivered by SII to India, Ghana, Cote d’Ivoire, while Pfizer-BioNTech has delivered doses to the Republic of Korea. More deliveries by these two manufacturers are planned in the coming days, with 11 million doses in total planned to be delivered over the next seven days. In addition, AstraZeneca is set to commence shipments this week.
COVAX, the overarching effort to accelerate development and access to COVID vaccines, is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization (WHO) working in partnership with UNICEF as well as the World Bank, manufacturers and civil society organizations, and others.
"This is a day many of us have been dreaming of and working for more than 12 months," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "It's gratifying to see the fruit of that labour. But success is still to come. This is only the beginning of what COVAX was set up to achieve. We have a lot left to do to realize our vision to start vaccination in all countries within the first 100 days of the year. There are just 40 days left."
“As vaccination begins in Côte D’Ivoire, less than a year after COVID-19 was characterized as a global pandemic, I am filled with confidence, and I am sure that through COVAX and international solidarity we will be able to reach the most at-risk everywhere. Global equitable access to life-saving vaccines is the surest way to save lives and rebuild economies. I would like to thank all donors and also the leadership of the G7 group of nations. Nowadays vaccine policy is the best economic policy,” said José Manuel Barroso, Chair of Gavi, the Vaccine Alliance.
“The last year has been a dark one for families all over the world, but the rapid development of COVID-19 vaccines provided a hopeful light at the end of the tunnel. Today, the COVAX Facility begins to make good on its promise to make sure that light shines for all,” said Henrietta Fore, UNICEF Executive Director. “This unprecedented global effort has rallied the international community behind identifying acceptable vaccines, raising funds to procure them, and laying the groundwork for the world’s largest immunization campaign in history. Now, these vaccines are quickly reaching people in low and middle-income countries, many of which would have been left behind without the Facility’s work. This proves what we can accomplish when we all – the private sector, UN and development agencies, governments, donors, and other partners – work as one.”
“This is a historic day in the global fight against COVID-19. Today’s vaccinations in Cote d’Ivoire and Ghana are among the first to be delivered through COVAX, which will protect many hundreds of millions of those most at risk from COVID-19, wherever they are in the world.” said Dr Richard Hatchett, CEO of CEPI. “In the coming days and weeks, COVAX will begin to redress the global imbalance in vaccine deployment, but there is still much to do. The spread of new COVID-19 variants means global access to vaccines is more important than ever before, and the global community must remain firmly focused on this goal if we are to bring the pandemic to an end.”
The start of Africa’s biggest immunization drive in history through the COVAX Facility marks a step forward in the continent’s fight against COVID-19. It is a welcome shift towards bringing African countries off the sidelines and back into the vaccination race, correcting the glaring inequity which has been an unfortunate hallmark of the global vaccine rollout to date. For months WHO teams in the region and partners have been supporting countries to plan and prepare for the complex challenges of such a massive vaccination campaign. We now look forward to seeing these plans put into action with an effective and efficient vaccine rollout,” Dr Matshidiso Moeti, WHO Regional Director for Africa.
“The first COVAX vaccine deliveries in West and Central Africa were a huge first step towards equity and a demonstration of global solidarity,” said UNICEF Regional Director for West and Central Africa Marie-Pierre Poirier. “A few days after the vaccine doses landed, we are already celebrating the first COVID-19 vaccination campaigns, starting today in Ghana and Cote d’Ivoire, aimed at protecting the most vulnerable. We are proud that countries in West and Central Africa were ready from the get-go. UNICEF is active on the ground, together with WHO and other partners, to support the roll-out of the vaccination campaigns until everyone is safe.“
Quotes from partners and donors
President Ursula von der Leyen, European Commission said: “To overcome coronavirus, vaccines must reach all corners of the planet, as soon as possible. I am delighted that we now have tangible results on the ground. I want to pay tribute to the tireless efforts of our partners, Gavi, CEPI, WHO and UNICEF. Team Europe is a proud supporter of COVAX and will continue to stand by the people of Africa."
Karina Gould, Minister of International Development, Government of Canada and Gavi COVAX AMC co-chair said: “Today is yet again proof of what can be achieved through international collaboration. We have reached another milestone in the global vaccination effort, with the first COVAX vaccines being administered in Cote d’Ivoire. Canada is committed to helping everyone, everywhere recover from the pandemic, and also, to strengthening health systems.”
Norwegian Minister of International Development and co-chair of ACT-A facilitation council Dag-Inge Ulstein said: “The progress on vaccines is impressive and, as a major funder to the ACT Accelerator, we believe in the need for the multilateral approach which is clearly working. As co-chair of the ACT Accelerator Facilitation Council, we urgently need to see the same traction in tests, treatments and health systems. Funding is needed to support this now; we have a small window of opportunity with the evolving context of the pandemic -new variants, limited vaccine supply, and underinvestment in global solutions means we cannot be complacent.”
HE Minister of Health in Saudi Arabia, Dr Tawfig AlRabiah said: “Saudi Arabia’s contribution to this historic moment reaffirms our commitment to the principles of ACT-A; equitable access to various pandemic tools, leaving no one behind.”
Adar Poonawalla, CEO, Serum Institute of India (SII) said: "We are delighted to play a part in vaccinating the world through COVAX. We will continue to work towards providing equitable access to vaccines."
Sai D. Prasad, President, Developing Countries Vaccine Manufacturer’s Network (DCVMN) said: “Developing Countries Vaccine Manufacturer’s Network has strongly stood with all stakeholders during this unprecedented time of COVID-19 pandemic and has strived hard to develop, manufacture and roll out COVID-19 vaccines in a record time span of 10-12 months as a part of global collaboration and solidarity. We stand together shoulder to shoulder in this endeavour.”
Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said: “Since the beginning of this pandemic, vaccine makers have spared no efforts to speed up development, production, registration, and equitable access to of high-quality vaccines. Pharmaceutical manufacturers are committed founding partners of ACT-Accelerator and COVAX, and we are excited that for the first time in the history of pandemics vaccines are rolled out in a coordinated manner quickly around the world. Another momentous effort, is the scaling up of the vaccine manufacturing from zero to millions in a matter of months. As producing vaccines is a complex process, so with such a scale up, there are inevitably going to be challenges ahead; we will continue working collaboratively to find solutions and join hands in making history.”
Notes to Editors
List of donor pledges to the Gavi COVAX AMC is available here.
COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance Gavi) and the World Health Organization (WHO) – working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.
CEPI is focused on the COVAX vaccine research and development portfolio: investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.
Gavi is focused on procurement and delivery for COVAX: coordinating the design, implementation and administration of the COVAX Facility and the Gavi COVAX AMC and working with its Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. The COVAX Facility is the global pooled procurement mechanism for COVID-19 vaccines through which COVAX will ensure fair and equitable access to vaccines for all 190 participating economies, using an allocation framework formulated by WHO. The COVAX Facility will do this by pooling buying power from participating economies and providing volume guarantees across a range of promising vaccine candidates. The Gavi COVAX AMC is the financing mechanism that will support the participation of 92 low- and middle-income countries in the Facility, enabling access to donor-funded doses of safe and effective vaccines. Gavi is fundraising for the COVAX AMC, and funding UNICEF procurement of vaccines as well as partners’ and governments work on readiness and delivery, including support cold chain equipment, technical assistance, syringes, vehicles, and other aspects of the vastly complex logistical operation for delivery. UNICEF and the Pan-American Health Organisation (PAHO) will be acting as procurement coordinators for the COVAX Facility, helping deliver vaccines to COVAX AMC participants and others.
WHO has multiple roles within COVAX: It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL) / prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. WHO leads, together with UNICEF, the Country Readiness and Delivery workstream, which provides support to countries as they prepare to receive and administer vaccines. Along with Gavi and numerous other partners working at the global, regional, and country-level, the CRD workstream provides tools, guidance, monitoring, and on the ground technical assistance for the planning and roll-out of the vaccines. Along with COVAX partners, WHO has developed a no-fault compensation scheme as part of the time-limited indemnification and liability commitments.
UNICEF is leveraging its experience as the largest single vaccine buyer in the world and working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as freight, logistics and storage. UNICEF already procures more than 2 billion doses of vaccines annually for routine immunization and outbreak response on behalf of nearly 100 countries. In collaboration with the PAHO Revolving Fund, UNICEF is leading efforts to procure and supply doses of COVID-19 vaccines for COVAX. In addition, UNICEF, Gavi and WHO are working with governments around the clock to ensure that countries are ready to receive the vaccines, with appropriate cold chain equipment in place and health workers trained to dispense them. UNICEF is also playing a lead role in efforts to foster trust in vaccines, delivering vaccine confidence communications and tracking and addressing misinformation around the world.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated ten partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.
Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 822 million children – and prevented more than 14 million deaths, helping to halve child mortality in 73 developing countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.
The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
For updates on COVID-19 and public health advice to protect yourself from coronavirus, visit www.who.int and follow WHO on Twitter, Facebook, Instagram, LinkedIn, TikTok, Pinterest, Snapchat, YouTube
UNICEF works in some of the world’s toughest places, to reach the world’s most disadvantaged children. Across 190 countries and territories, we work for every child, everywhere, to build a better world for everyone. For more information about UNICEF and its work for children, visit www.unicef.org. For more information about COVID-19, visit www.unicef.org/coronavirus . Find out more about UNICEF’s work on the COVID-19 vaccines here, or about UNICEF’s work on immunization here.
About the ACT-Accelerator
The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.
The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.
The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.