COVID-19 Vaccines

Dr Sonali Kochhar is serving on theWHO Strategic Advisory Group of Experts (SAGE) Working Group on COVID-19 vaccines; WHO Global Advisory Committee on Vaccine Safety (GACVS) Working Group on COVID-19 Vaccines Safety Preparedness; COVID-19 Outbreak Expert groups for the UK Parliament, and the UK Government.

The WHO Working Group on COVID-19 vaccines provides policy advice to SAGE on the evidence on candidate vaccines, guidance for the development of prediction models to determine the optimal age groups and target populations for vaccine introduction and guide vaccine introduction for optimal impact, updates the target product profiles and provides guidance on accelerated use of vaccines, equitable access to vaccination and vaccine safety.

Standardized templates for the benefit-risk assessment of COVID-19 vaccine candidates endorsed by WHO Global Advisory Committee on Vaccine Safety (GACVS)

Dr Sonali Kochhar led the development of standardized templates with key considerations for the benefit-risk assessment of COVID-19 vaccine candidates has been led by. 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.

The templates were presented to WHO SAGE and Global Advisory Committee on Vaccine Safety (GACVS) members, and at its May 27-28, 2020 meeting, GACVS recommended that “any review of the safety of new vaccines be based on the appropriate Brighton Collaboration standardized templates for benefit-risk assessment of vaccines (by technology platforms) when available and approved, which offer a structured approach to evaluating safety. GACVS advised that templates be pilot-tested in a number of scenarios and then adapted accordingly.”

 The templates are currently being utilized by vaccine developers, including those funded by  Coalition for Epidemic Preparedness Innovations (CEPI), to evaluate and communicate the benefit-risk of COVID-19 vaccine candidates.

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 thePregnant 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/

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/

Impatient Optimists, Bill and Melinda Gates Foundation

The Bill and Melinda Gates Foundation (BMGF) invited Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting to write on Safety Monitoring for Immunization in Pregnancy – The GAIA Project for their blog, Impatient Optimists. GHC co-led the scientific coordination of the international project along with BCF.

For more information, please visit- http://www.impatientoptimists.org/Posts/2017/03/Harmonized-Safety-Monitoring-of-Immunization-in-Pregnancy-the-Global-Alignment-of-Immunization-Safety-Assessment-in-Pregnancy-GAIA-project

Special Issue of Vaccine Published

Global Healthcare Consulting co-led the scientific coordination of the international Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project with the Brighton Collaboration Foundation. The multi-year Bill and Melinda Gates Foundation (BMGF) funded GAIA project consisted of 13 partners from 8 countries (including the National Institute of Health, WHO, Erasmus University Medical Centre, St George’s University of London, Baylor College of Medicine etc). The GAIA project outputs are being utilized in Interventional and Observational studies and AEFI surveillance for Vaccines and Maternal and Child Health Research for adverse maternal and perinatal birth outcomes assessments globally. They include a core set of over 21 globally standardized case definitions of selected key obstetric and neonatal terms, a glossary of enabling terms critical to these obstetric and neonatal case definitions (e.g., an algorithm for the determination of gestational age) to support stakeholders using the definitions, guidelines for the standardized conduct of clinical trials of vaccines in pregnant women (including a landscape analysis of regulatory guidance available for immunization in pregnancy from the Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conference on Harmonization) and guidance on study design and the standardization of data collection etc. These have been published in a special issue of Vaccine (http://www.sciencedirect.com/science/journal/0264410X/34/49). A standardized approach to safety data collection and reporting is likely to improve the acceptability and implementation of immunizations in pregnancy and subsequently help reduce illness and death among pregnant women and young infants globally.