Categories

WHO recommends groundbreaking malaria vaccine for children at risk

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

 
Categories

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

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.

 
Categories

Public consultation on Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations

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.  

 

 
Categories

Anvisa is reelected member of the ICH Management Committee

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

 

 
Categories

WHO: Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2

Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas

26 March 2021

Medical product alert
Geneva
Reading time: 2 min (443 words)

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:

  • The genuine manufacturer of COVID-19 Vaccine BNT162b2 confirmed they did not manufacture the product.
  • The batch number and expiry dates are falsified.
  • The glass vials and label are different from genuine COVID-19 Vaccine BNT162b2 vials.

 

Table 1: Products subject of WHO Medical Product Alert N°2/2021

Table 1. Falsified COVID-19 Vaccine details

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

Table 2. Falsified COVID-19 Vaccine images

 

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

Source: https://www.who.int/news/item/26-03-2021-medical-product-alert-n-2-2021-falsified-covid-19-vaccine-bnt162b2

 
Categories

31st edition of the RedETSA Webinars – Healthcare cost base

Dear all,

We are pleased to invite you to the 31st  edition of the RedETSA Webinars program, next Friday, March 19, at 2pm, Washington DC time.  

Alfredo Palacios, from the Institute for Clinical Effectiveness and Health Policy (IECS), Argentina,  will give a presentation on “Healthcare cost base.The session will take place in Spanish, without translation. 

The WebEx link that we will use is the following:

Please feel free to extend this invitation to all those who might be interested.

Best regards,

RedETSA Secretariat