Corporate news releases, statements, and notes for media issued by the World Health Organization.
The World Health Organization (WHO) today listed the Comirnaty, COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago.
<p>The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago.</p><p>The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.</p><p>“This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.” </p><p>Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.</p><p>The vaccine is also under policy review. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on 5 January, 2021, to formulate vaccine specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritization <a href="https://www.who.int/publications/i/item/who-sage-values-framework-for-the-allocation-and-prioritization-of-covid-19-vaccination">recommendations</a> for COVID-19 vaccines in general, issued in September 2020.</p><p>The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.</p><p><strong>How the emergency use listing works</strong></p><p>The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.</p><p>The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.</p><p>Experts from individual national authorities are invited to participate in the EUL review. Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.</p><p>In addition to the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with prioritization specified for the earliest use. Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL.</p><p>As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.</p><p><strong>More information: </strong></p><ul><li><a href="https://extranet.who.int/pqweb/vaccines/who-recommendation-covid-19-mrna-vaccine-nucleoside-modified-comirnaty%C2%AE">Listing for COVID-19 mRNA vaccine (nucleoside modified) - COMIRNATY®</a><br /><a href="https://extranet.who.int/pqweb/vaccines/who-recommendation-covid-19-mrna-vaccine-nucleoside-modified-comirnaty%C2%AE"></a></li><li><a href="https://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=37">Prequalification of AD syringes for vaccine<br /></a></li><li><a href="https://www.youtube.com/watch?v=WvomdZFF__A&t=1s">More on EUL</a></li></ul><p> </p>
In his end of year message for 2020, WHO Director-General says there is light at the end of the tunnel in the fight against COVID-19. But going into 2021, he urges countries and communities to work together, in solidarity, to overcome this and future health challenges.
<hr /><p><iframe width="860" height="450" src="https://www.youtube.com/embed/Beoo9NvI_zc" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture"></iframe><br /><em>Dr Tedros Adhanom Ghebreyesus, WHO Director-General</em></p><hr /><p> </p><p>As people around the world celebrated New Year's Eve 12 months ago, a new global threat emerged. <br /></p><p>Since that moment, the COVID-19 pandemic has taken so many lives and caused massive disruption to families, societies and economies all over the world. <br /></p><p>But it also triggered the fastest and most wide-reaching response to a global health emergency in human history. <br /></p><p>The hallmarks of this response have been an unparalleled mobilization of science, a search for solutions and a commitment to global solidarity. <br /></p><p>Acts of generosity, large and small, equipped hospitals with the tools that health workers needed to stay safe and care for their patients. <br /></p><p>Outpourings of kindness have helped society’s most vulnerable through troubled times. <br /></p><p>Vaccines, therapeutics and diagnostics have been developed and rolled out, at record speed, thanks to collaborations including the Access to COVID-19 Tools Accelerator. <br /></p><p>Equity is the essence of the ACT Accelerator, and its vaccine arm, COVAX, which has secured access to 2 billion doses of promising vaccine candidates. <br /></p><p>Vaccines offer great hope to turn the tide of the pandemic. <br /></p><p>But to protect the world, we must ensure that all people at risk everywhere – not just in countries who can afford vaccines – are immunized. <br /></p><p>To do this, COVAX needs just over 4 billion US dollars urgently to buy vaccines for low- and lower-middle income countries. <br /></p><p>This is the challenge we must rise to in the new year. <br /></p><p>My brothers and sisters, the events of 2020 have provided telling lessons, and reminders, for us all to take into 2021. <br /></p><p>First and foremost, 2020 has shown that governments must increase investment in public health, from funding access to COVID vaccines for all people, to making our systems better prepared to prevent and respond to the next, inevitable, pandemic. <br /></p><p>At the heart of this is investing in universal health coverage to make health for all a reality. <br /></p><p>Second, as it will take time to vaccinate everyone against COVID, we must keep adhering to tried and tested measures that keep each and all of us safe. <br /></p><p>This means maintaining physical distance, wearing face masks, practicing hand and respiratory hygiene, avoiding crowded indoor places and meeting people outside. <br /></p><p>These simple, yet effective measures will save lives and reduce the suffering that so many people encountered in 2020. <br /></p><p>Third, and above all, we must commit to working together in solidarity, as a global community, to promote and protect health today, and in the future. <br /></p><p>We have seen how divisions in politics and communities feed the virus and foment the crisis. <br /></p><p>But collaboration and partnership save lives and safeguard societies. <br /></p><p>In 2020, a health crisis of historic proportions showed us just how closely connected we all are. <br /></p><p>We saw how acts of kindness and care helped neighbors through times of great struggle. <br /></p><p>But we also witnessed how acts of malice, and misinformation, caused avoidable harm. <br /></p><p>Going into 2021, we have a simple, yet profound, choice to make: <br /></p><p>Do we ignore the lessons of 2020 and allow insular, partisan approaches, conspiracy theories and attacks on science to prevail, resulting in unnecessary suffering to people’s health and society at large? <br /></p><p>Or do we walk the last miles of this crisis together, helping each other along the way, from sharing vaccines fairly, to offering accurate advice, compassion and care to all who need, as one global family. <br /></p><p>The choice is easy. <br /></p><p>There is light at the end of the tunnel, and we will get there by taking the path together. <br /></p><p>WHO stands with you – We Are Family and we are In This Together. </p><p>I wish you and your loved ones a peaceful, safe and healthy new year. </p><p> </p><p> </p>