PAHO has launched a new platform to support regulatory processes for the introduction and the monitoring of COVID-19 vaccines safety, consolidating in a single tool information on the various components of the matter. New COVID-19 Vaccine Pharmacovigilance Dashboard is available in English and Spanish at: https://covid-19pharmacovigilance.paho.org/
For the successful establishment of mRNA vaccine manufacturing capacity globally, the World Health Organization (WHO) has launched a new initiative to support transfer of technology to produce mRNA vaccines in low- and middle-income countries (LMICs) (1). The initiative will ensure that all WHO regions will be able to produce vaccines as essential preparedness measure against future infectious threats.
Under this initiative, WHO and the Pan American Health Organization (PAHO) are working together to establish mRNA vaccine manufacturing capacities in LAC. Currently, there is a limited number of global manufacturers able to supply all necessary reagents and/or starting materials (2) needed for manufacturing mRNA vaccines. To ensure sustainability and independence of vaccine production in the Region, access to reagents that are critical to the value chain is fundamental. Hence PAHO/WHO is launching a call for expression of interest to manufacturers in the Region of the Americas that wish to become part of a regional consortium that will ensure that mRNA vaccines can be sourced from starting materials and preparations (including seed lots, cell banks and intermediates) to the finished product.
Through this new initiative, PAHO and WHO will facilitate the establishment of a Regional consortium and support of a comprehensive technology transfer. Ideally, the group of manufacturers that come together for this initiative will include representatives from different geographical areas in the Americas and work towards an integrated regional value chain that will provide sustainability and ease the dependence on imported vaccines from outside the Region.
To support this activity, we are seeking expressions of interest from:
Entities willing to be considered are invited to provide a brief summary that includes, at a minimum, the reagents and/or starting materials they wish to provide, a summary of their capacity, needs, and their interest in participating in this initiative.
(1). See Call for expression of interest to: Contribute to the establishment of a COVID-19 mRNA vaccine technology transfer hub (who.int)
(2). In accordance with WHO TRS Sixty-sixth report starting materials are: any substances of a defined quality used in the production of a pharmaceutical product but excluding packaging materials. In the context of biological products manufacturing, examples of starting materials may include cryo-protectants, feeder cells, reagents, growth media, buffers, serum, enzymes, cytokines, growth factors and amino acids
Source: PAHO
By unanimous decision of the Steering Committee, ANMAT became an Official Observer of the International Medical Device Regulators Forum (IMDRF)
Further information is available at ANMAT’s webpage: https://www.argentina.gob.ar/noticias/anmat-se-convierte-en-observador-oficial-de-imdrf
Join Launching of the Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas
➕ INFO: https://bit.ly/paho-platform
WHAT: Launching a collaborative Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas
WHEN: 27 August 2021 – 10:30 a.m. – 12:15 p.m. (EDT) Washington, D.C. Time
HOW: The event will be broadcast on PAHO’s YouTube channel https://www.youtube.com/PAHOTV
COVID-19 has shed light on the high dependence of Latin America and the Caribbean on imports of health technologies from outside the Region and the vulnerability of global supply. PAHO its Member States and regional partners have renewed the efforts to improve local production capacities in the region and, at the request of Member States, PAHO is launching a collaborative Platform that can convene public and private stakeholders to facilitate the expansion of vaccine and other health technology research, development, and manufacturing in the Region.
This first meeting of the Regional Platform will formalize the launch of this forum and will facilitate a high-level dialogue amongst Member States, development agencies and partners. Acting as a convener, PAHO will ensure that the public health perspective is central to the agenda and will be used to guide the construction of alliances that can accelerate vaccine and other critical health technology manufacturing in the Americas.
The platform will foster research and incentivize development and manufacturing of essential and strategic health technologies in the Americas, expanding manufacturing capacities to ensure access to safe, effective, and quality products, facilitate information exchange and foster cooperation between partners and countries.
In addition, a rational and coherent regional approach will include considerations for regulatory oversight, articulation with the PAHO Revolving Fund and contemplating all elements of the value chain to ensure that the region becomes less dependent on imports and, especially, self-sufficient during public health emergencies.
AGENDA
Moderator: Analía Porrás, Unit Chief, Medicines and Health Technologies, PAHO
Moderator: James Fitzgerald, Director, Health System and Services Department, PAHO
The document “Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies” is now published in IRIS at https://iris.paho.org/handle/10665.2/54516 .
The objective of this document is to identify the main gaps in readiness for the introduction of COVID-19 vaccines and to propose the regulatory procedures needed to manage and reduce these gaps, which were detected through a situation analysis of the emergency regulatory procedures implemented by national regulatory authorities (NRAs) in the Americas and based on the available information regarding existing regulatory frameworks in the Region. During emergency situations, the World Health Organization (WHO) recommends that NRAs adopt agile and efficient regulatory pathways to evaluate the quality, safety, and efficacy of new vaccines, which should be based on risk-benefit assessments. It also recommends that, for each authorized vaccine, pharmacovigilance activities should be implemented, based on risk management plans. Countries should have national emergency preparedness and response plans that include streamlined regulatory pathways that allow new vaccines to be introduced following legal and orderly processes. This regulatory preparedness is key to achieving a rapid response that does not obstruct or delay the availability of vaccines.
The document on Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations, is open for public comments on the WHO website: https://www.who.int/health-topics/biologicals#tab=tab_1 (scroll down to the right-hand you will find “Call for comments”.)
The direct link to the document is : https://cdn.who.int/media/docs/default-source/biologicals/call-for-comments/bs.2021.bs2402_who-regulatory-considerations-for-mrna-vaccines_final.pdf?sfvrsn=c8623b32_5.
Please use the WHO Comment Form to provide your comments: https://cdn.who.int/media/docs/default-source/biologicals/call-for-comments/comment_form_bs-2402_rna_2nd-pc_-9-july-2021-tz.doc?sfvrsn=65f0dc8d_5.
Comments should be sent to Dr. Tiequn Zhou at zhout@who.int no later than 17 September 2021.
Anvisa was reelected this Thursday morning (June 3), as a member of the Management Committee of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH . The decision was made by the ICH Assembly, with the presence of regulatory authorities and industrial associations from around the world.
The full article is available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-e-reeleita-como-do-membro-do-comite-gestor-do-ich
We invite you to review the working document “Guidelines on evaluation of similar biological products” that is under public consultation.
Please send your comments to Dr Hye na KANG (kangh@who.int) no later than 24 May.
PAHO report: COVID-19 highlights need for strengthening national regulatory authorities in Latin America and the Caribbean
Study draws lessons for the region from the six national regulatory authorities of reference in Argentina, Brazil, Chile, Colombia, Cuba, and Mexico.
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LINKS
“Regulatory System Strengthening in the Americas” (English)
“Fortalecimiento del systema regulatorio en las Américas” (Spanish)
Virtual launch of “Regulatory System Strengthening in the Americas” (Original audio)
Virtual launch of “Regulatory System Strengthening in the Americas” (English)
Lanzamiento virtual de “Fortalecimiento del sistema regulatorio en las Américas” (Spanish)
Alert Summary
This WHO Medical Product Alert refers to falsified COVID-19 Vaccine identified as “BNT162b2” detected in Mexico in February 2021 and recently confirmed as falsified to the WHO. The falsified product was supplied and administered to patients outside authorized vaccination programs.
This falsified COVID-19 Vaccine may still be in circulation in the region and may continue to be offered to patients outside authorized vaccination programs.
Laboratory analysis of the contents of the falsified products is pending and this Alert will be updated as soon as results are available.
Genuine COVID-19 Vaccine BNT162b2 is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 16 years of age and older. The use of genuine COVID-19 vaccines should be in accordance with official guidance from national regulatory authorities.
Falsified COVID-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems. It is important to identify and remove these from circulation.
The product identified in this alert is confirmed falsified on the basis that it deliberately/fraudulently misrepresents identity, composition, or source:
Table 1: Products subject of WHO Medical Product Alert N°2/2021
Advice to regulatory authorities and the public
WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies, and any other suppliers of medical products.
All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.
If you are in possession of the above products, please do not use them.
If you have used these products, or you suffered an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.
National regulatory/health authorities are advised to immediately notify WHO if these products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact the WHO Global Surveillance and Monitoring System via rapidalert@who.int
Table 2: Photographs of products subject of WHO Medical Product Alert N°2/2021
WHO Global Surveillance and Monitoring System
for Substandard and Falsified Medical Products
For more information, please visit the web pages of the WHO Global Surveillance and Monitoring System or Email: rapidalert@who.int
