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Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during COVID-19

Fernanda Lessa - 09:21, 9 de December de 20212,002

The ICMRA and WHO joint report on the implemented regulatory flexibilities in COVID-19 framework has been published

The report brings together different regulatory flexibilities/agilities that National Regulatory Authorities (NRAs) had implemented to ensure that there was continuity with regulatory oversight on routine functions while allowing for timely development and approvals of medical products for Covid-19.

The main objective of this report is to foster transparency and information sharing of practices among NRAs, besides providing models or examples of practices that other limited resourced NRAs could consider and potentially adopt and adapt to their regulatory systems within the respective national legal frameworks.

The authors inform that the report contains specific limitations on the scope of considered products, sources of information, period of review of flexibilities, context of application and effectiveness of these flexibilities.

 
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10th Conference of the Pan American Network for Drug Regulatory Harmonization

Fernanda Lessa - 15:13, 11 de November de 20211,959

The COVID-19 pandemic posed a challenge for health systems that had to take regulatory decisions to ensure timely access to medicines and other health technologies, including vaccines, blood and derivatives, medical devices, reagents and in vitro diagnostics that are quality, safe and effective to the population.

The 10th edition of the Conference of the Pan American Network for the Drug Regulatory Harmonization (PANDRH) provides a virtual space to discuss the contribution of regulatory systems in the response to the pandemic, as well as the lessons learned and post-COVID-19 regulatory challenges with PANDRH members and experts from the Region of the Americas and worldwide.

The Conference will take place entirely online on December 6, from 9:30 to noon, December 8 from 9 to 11am, and December 10, from 9 to 11:30am (Washington, D.C. time) and requires advance registration. Sessions will be held in English, Portuguese and Spanish, with the option of simultaneous translation in these languages, as well as in French.

Please register HERE

The quotas to participate in this Conference are limited, so PANDRH Secretariat will prioritize the registrations of representatives of the national regulatory authorities of the Americas region, representatives of the pharmaceutical industry members of ALIFAR and FIFARMA; of economic integration organizations such as CARICOM, MERCOSUR, NAFTA, ALADI, Andean Community; consumer groups; academics; representatives of regional professional associations; and from other groups interested in harmonization and regulatory convergence initiatives.

Note: quotas will be granted to representatives of pharmaceutical industries not affiliated to ALIFAR or FIFARMA as long as they remain vacant after the registration of those considered priority.

*Further information and agenda of the Conference, please click here

 
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WHO recommends groundbreaking malaria vaccine for children at risk

Fernanda Lessa - 11:07, 7 de October de 20212,148

Historic RTS,S/AS01 recommendation can reinvigorate the fight against malaria

 

The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing  tools to prevent malaria could save tens of thousands of young lives each year.”

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.

In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”

WHO recommendation for the RTS,S malaria vaccine

Based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria, the Organization recommends that:

WHO recommends that in the context of comprehensive malaria control the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO.  RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.

Summary of key findings of the malaria vaccine pilots

Key findings of the pilots informed the recommendation based on data and insights generated from two years of vaccination in child health clinics in the three pilot countries, implemented under the leadership of the Ministries of Health of Ghana, Kenya and Malawi. Findings include:

  • Feasible to deliver: Vaccine introduction is feasible, improves health and saves lives, with good and equitable coverage of RTS,S seen through routine immunization systems. This occurred even in the context of the COVID-19 pandemic.
  • Reaching the unreached: RTS,S increases equity in access to malaria prevention.
    • Data from the pilot programme showed that more than two-thirds of children in the 3 countries who are not sleeping under a bednet are benefitting from the RTS,S vaccine.
    • Layering the tools results in over 90% of children benefitting from at least one preventive intervention (insecticide treated bednets or the malaria vaccine).
  • Strong safety profile: To date, more than 2.3 million doses of the vaccine have been administered in 3 African countries – the vaccine has a favorable safety profile.
  • No negative impact on uptake of bednets, other childhood vaccinations, or health seeking behavior for febrile illness. In areas where the vaccine has been introduced, there has been no decrease in the use of insecticide-treated nets, uptake of other childhood vaccinations or health seeking behavior for febrile illness.
  • High impact in real-life childhood vaccination settings: Significant reduction (30%) in deadly severe malaria, even when introduced in areas where insecticide-treated nets are widely used and there is good access to diagnosis and treatment.
  • Highly cost-effective: Modelling estimates that the vaccine is cost effective in areas of moderate to high malaria transmission.

Next steps for the WHO-recommended malaria vaccine will include funding decisions from the global health community for broader rollout, and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.

Financial support

Financing for the pilot programme has been mobilized through an unprecedented collaboration among three key global health funding bodies: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.

Note to editors:

  • The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa.
  • The Malaria Vaccine Implementation Programme is generating evidence and experience on the feasibility, impact and safety of the RTS,S malaria vaccine in real-life, routine settings in selected areas of Ghana, Kenya and Malawi.
  • Pilot malaria vaccine introductions are led by the Ministries of Health of Ghana, Kenya and Malawi.
  • The pilot programme will continue in the 3 pilot countries to understand the added value of the 4th vaccine dose, and to measure longer-term impact on child deaths.
  • The Malaria Vaccine Implementation Programme is coordinated by WHO and supported by in-country and international partners, including PATH, UNICEF and GSK, which is donating up to 10 million doses of the vaccine for the pilot.
  • The RTS,S malaria vaccine is the result of 30 years of research and development by GSK and through a partnership with PATH, with support from a network of African research centres.
  • The Bill & Melinda Gates Foundation provided catalytic funding for late-stage development of RTS,S between 2001 and 2015.

 

Source: WHO https://www.who.int/news/item/06-10-2021-who-recommends-groundbreaking-malaria-vaccine-for-children-at-risk

 
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Deadline extension to ​​​​​​​15 October 2021

Fernanda Lessa - 10:10, 24 de September de 20211,105

Call for expression of interest to contribute to the value chain and supply of reagents for the sustainable manufacturing of a COVID-19 and other mRNA vaccines in the Americas [Deadline extension from 17 September to ​​​​​​​15 October 2021]

 

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:

  • Public or private manufactures of medical products (drugs, vaccines or drug substances) , and/or starting materials from the Region of the Americas, which could manufacture and supply one or more of the following:
    • DNAse 1,
    • T7 RNA Polymerase,
    • RNase inhibitor,
    • Guanyl Transferase,
    • Pyrophosphatase,
    • GTP,
    • s-adenosyl methionine, and
    • ribonucleotides.

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.

Deadline submission

Deadline extension from 17 September to 15 October 2021

This information must be sent to:

MT@paho.org

 

(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: https://www.paho.org/en/news/25-8-2021-call-expression-interest-contribute-value-chain-and-supply-reagents-sustainable

 
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PAHO selects centers in Argentina, Brazil to develop COVID-19 mRNA vaccines

Fernanda Lessa - 10:03, 23 de September de 20213,462

These are the Institute of Immunobiological Technology of the Oswaldo Cruz Foundation (Bio-Manguinhos / FIOCRUZ) and the biopharmaceutical company Sinergium Biotech

Washington DC, September 21, 2021 (PAHO) — The Pan American Health Organization (PAHO) announced the selection of two regional centers for the development and production of mRNA vaccines in Latin America in Argentina and Brazil, in order to address COVID-19 and future infectious disease challenges.

The Institute of Immunobiological Technology of the Oswaldo Cruz Foundation (Bio-Manguinhos / FIOCRUZ) was selected as a center in Brazil. It has a long history of vaccine manufacturing and has made promising progress in the development of an innovative mRNA vaccine against COVID-19.

Private sector biopharmaceutical company Sinergium Biotech has been selected as a hub in Argentina and will partner with biotech company mAbxience — belonging to the same group — to develop and manufacture the vaccine’s active ingredients. Both companies have extensive experience in the production and development of vaccines and other biotechnological medical products.

The announcement was made by Dr. Soumya Swaminathan, Chief Scientist of the World Health Organization (WHO), and Dr. Jarbas Barbosa, Deputy Director of PAHO, during a side event as part of the 59th Meeting of the Board of Directors of PAHO. The event “Technology Transfer for the Production of mRNA Vaccines in the Americas” brought together ministers of health and authorities from the countries of the region to discuss vaccine production.

“We congratulate the two selected centers,” said Dr. Barbosa, adding: “There is a hard job ahead, but we are moved by the conviction that this effort will result in timely and equitable access to vaccines in our region, which continues to be the most affected by this pandemic.”

The selection is the result of a call for expressions of interest promoted by WHO in April 2021 in which manufacturers and public and private research institutions were invited to contribute to the establishment of technology transfer centres for mRNA vaccines against COVID-19 in emerging economies. The initiative was supported by PAHO/WHO global partners, such as the Medicines Patent Pool.

The call attracted some thirty expressions of interest from Latin American companies and scientific institutions. To ensure sustainability and further increase regional capacity, PAHO launched a second call for expressions of interest in August 2021. This call was aimed especially at manufacturers interested in being part of a regional consortium to supply pharmaceutical-grade reagents and other inputs for the production of mRNA vaccines.

PAHO also recently presented the Regional Platform for Advancing the Production of Vaccines and Other Health Technologies for COVID-19 in the Americas, which will support collaboration among countries and agencies to apply existing regional biomanufacturing capacity to the production of COVID-19 vaccines and other medical technologies. The platform is based on the principle that pharmaceutical manufacturing should be regional in level and benefit the entire region, and that the distribution of vaccines will be carried out by the PAHO Revolving Fund to all countries.

“Delays in the production (of vaccines) have meant that many countries (in the region) are still waiting for the doses they bought months ago. The limitation of the supply of vaccines continues to delay” vaccination, said PAHO Director Carissa F. Etienne in her opening speech at the event. “This limited production and uneven distribution of vaccines in the face of staggering demand hamper our response to COVID-19 in the Americas. Mass vaccination is critical” to control the pandemic, he added.

The Americas has been the most affected by COVID-19 globally to date, with 87.6 million cases recorded and more than 2.16 million lives lost. The distribution of vaccines remains uneven and few countries in the region have reached the vaccination target of 40% of the population set by WHO.

CONTACTS:

Sebastián Oliel: +1 202 316-5679
Ashley Baldwin: + 1 202 340-4025
Daniel Epstein: +1 301 219-2105
Nancy Nusser: + 410 934-9588

mediateam@paho.org
www.paho.org

 
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Call for the sustainable manufacturing of COVID-19 and other mRNA vaccines in the Americas

Fernanda Lessa - 12:52, 8 de September de 20211,085

Call for expression of interest to contribute to the value chain and supply of reagents for the sustainable manufacturing of a COVID-19 and other mRNA vaccines in the Americas

 

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:

  • Public or private manufactures of medical products (drugs, vaccines or drug substances) , and/or starting materials from the Region of the Americas, which could manufacture and supply one or more of the following:
    • DNAse 1,
    • T7 RNA Polymerase,
    • RNase inhibitor,
    • Guanyl Transferase,
    • Pyrophosphatase,
    • GTP,
    • s-adenosyl methionine, and
    • ribonucleotides.

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.

Deadline submission: 17 September 2021

This information must be sent to: MT@paho.org

 

(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

 
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Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies

Fernanda Lessa - 14:36, 19 de July de 20211,823

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.

 
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