As a member of the WHO Global Advisory Committee on Vaccine Safety (GACVS) Working Group on COVID-19 Vaccines Safety Preparedness, Dr Sonali Kochhar from Global Healthcare Consulting helped to develop the WHO Covid-19 vaccines: safety surveillance manual (https://www.who.int/publications/i/item/10665338400). This provides safety surveillance guidance for COVID-19 vaccine introduction for governments, global, regional and national staff from immunization programmes, regulatory authorities, ministries of health, pharmacovigilance centres and vaccine manufacturers. The manual is being utilized globally for COVID-19 vaccine deployment.
Author: admGHCC
For the UK Parliament, experts share concerns about COVID-19 and COVID-impacted areas
For the UK Parliament, experts shared their concerns about COVID-19 and COVID-impacted areas in the immediate and longer-term future. Researchers also shared what further data or information they would like to see the Government release to understand the decisions that underpin its approach. This information is available at – https://post.parliament.uk/covid-19-outbreak-what-are-experts-concerned-about/Bottom of Form
Dr Sonali Kochhar, Medical Director, GHC was one of the experts who contributed to the work https://post.parliament.uk/expert-aknowledgements/
COVID-19 Vaccines
.
As a member of the WHO Strategic Advisory Group of Experts on Immunization (SAGE) Working Group on COVID-19 vaccines, Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting helped to lead the drafting of the WHO SAGE Prioritization Roadmap for prioritizing uses of COVID-19 vaccines (that considers priority populations for vaccination based on epidemiologic setting and vaccine supply scenarios https://www.who.int/publications/m/item/who-sage-roadmap-for-prioritizing-uses-of-covid-19-vaccines-in-the-context-of-limited-supply) and the WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination (that offers guidance globally on the allocation of COVID-19 vaccines between countries, and guidance nationally on the prioritization of groups for vaccination within countries while supply is limited https://www.who.int/publications/i/item/who-sage-values-framework-for-the-allocation-and-prioritization-of-covid-19-vaccination).
She helped to develop the Critical Evidence Questions for COVID-19 Vaccines Policy Making (https://www.who.int/publications/m/item/critical-evidence-questions-for-covid-19-vaccines-policy-making) and is helping in the development of the COVID-19 vaccine recommendations for SAGE (https://apps.who.int/iris/bitstream/handle/10665/338484/WHO-2019-nCoV-vaccines-SAGE_recommendation-BNT162b2-2021.1-eng.pdf).
Standardized templates for the benefit-risk assessment of COVID-19 vaccine candidates endorsed by WHO Global Advisory Committee on Vaccine Safety (GACVS)
Global Healthcare Consulting led the development of standardized templates with key considerations for the benefit-risk assessment of COVID-19 vaccine. The templates have been developed for all the platforms being utilized for COVID-19 vaccines (including nucleic acid (RNA and DNA), protein, inactivated viral and live attenuated viral vaccines) and been published in Vaccine. (https://www.sciencedirect.com/science/article/pii/S0264410X20308306?via%3Dihub; https://www.sciencedirect.com/science/article/pii/S0264410X20309440?via%3Dihub; https://www.sciencedirect.com/science/article/pii/S0264410X20307891?via%3Dihub; https://www.sciencedirect.com/science/article/pii/S0264410X20310306, https://brightoncollaboration.us/bravato/).
The templates have been endorsed by the WHO Global Advisory Committee on Vaccine Safety (GACVS) and are being utilized by COVID-19 vaccine developers to evaluate and communicate the benefit-risk of COVID-19 vaccine candidates, pharmacovigilance and risk communication.
Pregnant Women and Vaccines against Emerging Epidemic Threats: Ethics Guidance on Preparedness, Research & Response.
Dr Sonali Kochhar from Global Healthcare Consulting was part of an international multi-disciplinary expert group worked on developing the “Pregnant Women & Vaccines against Emerging Epidemic Threats: Ethics Guidance on Preparedness, Research & Response”. This guidance provides concrete, actionable, consensus-driven ethics guidance on how to equitably include the interests of pregnant women and their offspring in the development and deployment of vaccines against epidemic threats. The guidance has been published in Vaccine. https://www.ncbi.nlm.nih.gov/pubmed/31060949. WHO’s Strategic Advisory Group of Experts (SAGE) found the guidance to be timely with regards to the R&D efforts for vaccines against emerging infectious diseases.
Webinar on Global Data Sharing
In order to help researchers create a good research proposal to conduct secondary research on clinical trial data, a global panel of experts from the data-sharing community participated in a Webinar on “Keys to Submitting a Quality Research Proposal to a Data Sharing Platform”. Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting was part of the panel. https://vivli.org/news/upcoming-webinar-keys-to-submitting-a-quality-research-proposal-to-a-data-sharing-platform/
Independent Review Panel for Vivli
Dr Sonali Kochhar was invited to be part of the Independent Review Panel for Vivli- the Centre for Global Clinical Research Data. https://vivli.org/independent-review-panel/
Stakeholder Meeting on Maternal Interventions Vigilance, WHO
Nov 20, 2017
Dr Sonali Kochhar was invited to make the opening presentation at the Stakeholder Meeting on Maternal Interventions Vigilance at World Health Organisation (WHO), Geneva on the need for Harmonized Vigilance Approaches for Pregnancy Interventions and Recent Initiatives- A Partner’s Perspective.
Maternal Immunization Safety Monitoring in Low- and Middle-Income Countries: A Roadmap for Program Development
Oct 16, 2017
Maternal immunization holds the promise of further reducing morbidity and mortality among pregnant women and infants, particularly in low- and middle-income countries where there is the greatest burden of vaccine-preventable disease. This report from a Bill and Melinda Gates Foundation (BMGF)-funded project, developed with input from a large, multidisciplinary group of experts, summarizes existing programs in pharmacovigilance and maternal, newborn, and child health surveillance in LMICs; identifies gaps and needs and outlines a roadmap for program development and implementation for monitoring the safety of maternal immunizations in LMICs. Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting was part of the Core Advisory Group for the project, and an Author and Reviewer for the report.
http://apps.who.int/medicinedocs/documents/s23275en/s23275en.pdf
Group B Step Support Medical Advisory Panel Member
Oct 6, 2017
Group B Strep Support (GBSS) invited Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting to join its International Medical Advisory Panel. GBSS is dedicated to working to stop group B Strep infections, including meningitis, in infants. Their goal is the eradication of group B Strep infections in infants.
https://gbss.org.uk/latest-news/new-medical-advisory-panel-member-joins-group-b-strep-support/