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
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
How to monitor and report COVID-19 vaccine side effects : https://www.who.int/docs/default-source/coronaviruse/vaccine_safety_poster_final.pdf?sfvrsn=31614713_5
“We are still way behind where we should be as a Region”
Washington D.C. February 25 (PAHO) — The Director Carissa F. Etienne today briefed leaders of PROSUR, the Forum for the Progress and Development of South America, on COVID-19 vaccine supply and procurement advances, saying, “PAHO shares your great concerns for equity of access to vaccines particularly for middle and low-income countries and we continue to advocate strongly for the LAC countries.” (…)
For more information go to https://www.paho.org/en/news/25-2-2021-paho-director-briefs-prosur-leaders-vaccine-supply
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PRESS RELEASE WHO lists 2 additional COVID-19 vaccines for emergency use and COVAX roll-out AstraZeneca/Oxford-developed vaccines to reach countries in the coming weeks Geneva, 15 February 2021 – The World Health Organization (WHO) today listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India. WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. “Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.” The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites. In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under four weeks. The vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above. The AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S [recombinant]. It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements. WHO emergency use listing 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. 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. 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. WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020. See more on EUL Media contacts: |
USP is hosting a Global Seminar Series, Ensuring Quality Hand Sanitizer Production During COVID-19, to help ensure quality alcohol-based hand sanitizer production and support the safe use of alcohol-based hand sanitizer, February 25th, 2021.
For more information go to: USP Global Seminar Series: Ensuring Quality Hand Sanitizer Production During COVID-19 for Manufacturers and Healthcare Providers in Latin America – Event Summary | Online Registration by Cvent
PAHO published Questions and answers (Q&A) on regulatory matters related to the introduction and pharmacovigilance of vaccines against COVID-19, available at PAHOIMSHSSMTCOVID-19210001_eng.pdf
PAHO has published official Spanish version of the English original: WHO GLOBAL BENCHMARKING TOOL (GBT) FOR EVALUATION OF NATIONAL REGULATORY SYSTEMS OF MEDICINES AND VACCINES that is available at https://iris.paho.org/handle/10665.2/52851
The English version of the GBT, developed by WHO can be found at https://www.who.int/medicines/regulation/benchmarking_tool/en/
All queries related to GBT should be sent to WHO Regulatory Systems Strengthening Team at nra_admin@who.int
News and Public Information
News release
PAHO warns of potential blood shortages during the COVID-19 pandemic
Countries in the Americas should ensure continuity of donations and safety for donors
Washington, DC, April 10 2020 (PAHO/WHO) – The Pan American Health Organization (PAHO) today warned that countries in the Americas face potential shortages of blood for transfusions due to a significant reduction in voluntary blood donations during this time of the COVID-19 pandemic.
According to the latest available data, in 2017 more than 10.5 million units of blood were collected, through 1,800 blood donation centers in 37 countries and territories of the Americas. Given the current pandemic, health services are now running the risk of shortages in availability.
“We are concerned that blood bank reserves are being depleted, as this puts at risk the lives of many people who need transfusions,” said PAHO Director Carissa F. Etienne. People with cancer and leukemia, people needing transplant services, and women who suffer postpartum hemorrhage are among those who arrive at hospitals every day requiring transfusions. In addition, emergency services require continuous availability of blood to respond to trauma cases arising from road traffic accidents and other injuries..
Dr. Etienne called on governments to maintain adequate blood supplies even as they work to reduce the spread of COVID-19. This means ensuring that voluntary blood donors can continue to safely donate blood, platelets and plasma. “The need for blood is becoming critical,” said Dr. Etienne. “Health services must coordinate with donors to make appointments for blood donation, either within a health facility, or through mobile collection systems and health services.”
The risk of transmission of the new coronavirus through transfusion of blood and components is likely minimal. Respiratory viruses have never been reported to be transmitted through blood or blood components, and to date there have been no reports of COVID-19 infection in blood recipients.
“Stopping donations is not an acceptable action at this time. We must find ways to ensure that blood donations continue uninterrupted and are safe for both the donor and the recipient,” said Dr. Etienne.
She called on hospitals and blood banks to take precautionary measures to minimize any risk and prevent COVID-19 infection. This includes maintaining physical distancing and implementing adequate biosecurity practices to protect their personnel and donors.
Dr. Etienne urged countries to implement appointment systems, extend donor hours, use mobile collection systems, monitor emergency blood supplies, and reschedule elective surgeries.
She also called for ensuring the availability of critical supplies for blood collection, including personal protective equipment for health personnel, and urged health officials to inform the public about who can donate in the context of the pandemic and what measures they should take to ensure safe donation.
Who can donate blood during COVID-19?
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Links:
Maintaining a safe and adequate blood supply during the pandemic outbreak of COVID-19
https://www.who.int/publications-detail/maintaining-a-safe-and-adequate-blood-supply-during-the-pandemic-outbreak-of-coronavirus-disease-(covid-19)
Information on COVID-19
