Clinical Development and Operations - Maternal Immuni...

SWAT Team Description: The Clinical Development and Operations SWAT team collaborates on initiatives related to clinical operations (incl.  supporting trial site readiness and setting up a clinical trial site network, providing information on COVID-19 CTA and EC requirements for specific regions), vaccine safety (incl. AESIs / case definitions, post roll-out vaccine safety surveillance), vaccine science (incl. development of strategic documents on key topics such as standard CT elements, adaptive trial design, Correlate of Protection, alternative/supportive evidence, optimization options) and maternal immunization. 

Co-Leads: Peter Dull (BMGF), Jakob Cramer (CEPI)

Clinical Trials

Stay informed about the latest clinical trials and studies on maternal immunization

MI Vaccine Safety

Learn more about vaccine safety
for pregnant mothers and newborns

Policies and guidelines

Find out about policy, regulations and guidelines on maternal immunization wordwide

Publications

Explore our selection of relevant publications on COVID-19 maternal immunization

Clinical Trials

 Stay informed about the latest clinical trials and studies on maternal immunization

Policies and guidelines

 

Find out about policy, regulations and guidelines on maternal immunization.

Publications

 Explore our selection of relevant publications on COVID-19 maternal immunization

Working Group Details

Objectives  Workstreams

Working Group Outputs

Key Deliverables  Reports  Past Workshops

Upcoming Workshops:

At the moment there are no upcoming workshops! Please check back soon as we update this page with our latest events

Objectives:

1. describe approaches for the evaluation of COVID-19 vaccine candidates for use in pregnant women and their infants, from pre-licensure clinical studies to the post-licensure period;
2. create an evaluation framework for COVID-19 vaccine candidates for use in pregnant and lactating women; and
3. describe the necessary data and studies to close the availability and access gap to safe and effective COVID-19 vaccination and prevention strategies for pregnant and lactating women.

WORKSTREAM 1

Vaccine Candidate Mapping / Key Characteristics
Lead: Dr Emily Erbelding, US NIH

WORKSTREAM 2

Pre-Clinical / Clinical Data
Lead: Prof Beate Kampmann, LSHTM

WORKSTREAM 3

Vaccine Safety Monitoring
Leads: Prof Andy Stergachis, Univ. of Washington; Dr Steve Anderson, US FDA

Key Deliverables

V.1 Vaccine candidate mapping, key characteristics, and development timelines

COVID-19 Vaccines prioritized by COVAX  | Vaccine Candidate Mapping  | Target Product Profile  

V2. Key questions for the evaluation of COVID-19 vaccine candidates in pregnant and lactating women 

V.3 Key Questions for the post-licensure safety evaluation of COVID-19 vaccine candidates in pregnant and lactating women.

Reports

The MIWG regularly issues reports summarizing its activities in the respective period. These can be accessed from the below links.

COVAX Maternal Immunization Working Group Project Report | March 2021

COVAX Maternal Immunization Working Group Executive Summary Report | January 2021

Workshops

THE MIWG is holding workshops on pertinent topics as and when needed. They are typically announced in the SWAT Teams newsletter. Workshop material and reports are available below.

Challenges of vaccinating pregnant and lactating women during the COVID-19 pandemic | 13 Apr 2021 | Workshop Material

VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT)

FREQUENTLY ASKED QUESTIONS (FAQ) on Thrombosis with Thrombocytopenia Syndrome (TTS) and WHO Emergency Use Listed (EUL) Adenovirus-Vectored COVID-19 Vaccines During Pregnancy | 15 Sep 2021

CDC Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients | 30 Apr2021 

COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets  | 20 Apr 2021

ACOG Statement on the Johnson & Johnson COVID-19 Vaccine | 13 Apr 2021

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine  | 13 Apr 21

MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots  |  7 Apr 2021

Workstream 1. Vaccine Candidate Mapping / Key Characteristics - Lead: Dr. Emily Erbelding, US NIH

• Review of COVID-19 vaccine candidates
• Expert consultations
• Summary of key characteristics of COVAX supported COVID-19 vaccine candidates and data mapping as pertinent to maternal immunization 

 Emily Erbelding (Lead), Director, Divison of Microbiology and Infectious Diseases NIH - ACTIV; US
 Ajoke Sobanjo-ter Meulen, Senior Program Officer, Bill & Melinda Gates Foundation; US
 Karin Bok, Senior Advisor Vaccine Development, VRC, NIAID, NIH; US
 Anh Wartel, Associate Director General of Clinical Development, IVI, South Korea
 Angela Gentile, Head, Department of Epidemiology, Ricardo Gutiérrez Children's Hospital; Argentina
 Gerald Voss, Scientific Director of the TuBerculosis Vaccine Initiative/CEPI; Belgium
 Johan Vekemans, SARS-CoV-2 vaccine Global Clinical Head, AstraZeneca; Belgium
 Titilope Oduyebo, CDC; US, ACOG, IIFPHPEWG

Workstream 2. Pre-clinical / Clinical Data - Lead: Prof. Beate Kampmann, LSHTM

• Identification of key questions and date needs for the pre-clinical and clinical assessment of vaccine candidates for maternal immunization.
• Discussion forum with invited presentations and expert consultations to inform the working group on various topics including burden and impact of COVID-19 in pregnancy, placental physiology, the fetus and newborn, clinical development, ethics, and regulatory considerations.
• Survey of working group members on key questions with collection and evaluation of responses.
• Discussion and consensus among the full working group.

Beate Kampmann (Lead), Professor of Paediatric Infection & Immunity, Director of the Vaccine Centre; London School of Health and Tropical Medicine; UK
Flor Munoz-Rivas, Associate Professor, Pediatrics-Infectious Disease; Baylor College of Medicine; US
Geeta Swamy, Associate Professor of Obstetrics and Gynecology, Duke University School of Medicine; US
Clare Cutland, Lecturer, University og the Witwatersand; South Africa
Asma Khalil, Professor, Consultant obstetrician at St George's Hospital; UK
Helen Marshall, Medicail Director VIRTU & A-Prof Vaccinology / Affiliate Lecturer, Women's and Children's Health/Public Health, University of Adelaide; Australia
Chrissie Jones, Associate Professor in Paediatric Infectious Diseases and Immunology, University of Southampton; UK
Sylvanus Okogbenin, Professor, Consultant Obstetitrican, Irrua Specialist Teaching Hospital; Nigeria
Judith Absalon, Senior Director, Vaccines Clinical Research, Pfizer; US

Workstream 3. Vaccine Safety - Leads: Prof. Andy Stergachis, University of Washington; Dr. Steve Anderson, US FDA

• Identification of pregnancy safety considerations for four vaccine development scenarios:
• Pregnant women not included in pre-licensure clinical trials, i.e. excluded from clinical trials.
• Pregnanct women included in pre-licensure clinical trials.
• Separate pre- (or post-) licensure clinical trial specifically designed for pregnant women.
• Post-licensure safety surveillance. 
• Review and consideration of key regulatory and WHO guidance documents pertaining to pregnancy safety studies.
• Development and administration of a survey of the Advisory Board members of the project, "Sentinel Site Readiness for Maternal Immunization Active Safety Surveillance in LMICs (Lead: Prof. Pierre Buekens, Tulane University)," with collection and evaluation of written responses. 

Cross-cutting Workstreams:

• Review and input from ethics and regulatory experts across all workstreams.

Cross-cutting advisors

Marion Gruber (Regulatory), Director, CEnter for Biologics Evaluation and Research (CBER) FDA; US
Helen Rees (Regulatory), Professor, Wits Reproductive Health and HIV Institute, Board Chair SAHPRA; South Africa
Ruth Karron (Ethics), Professor, John Hopkins Bloomberg School of Public Health; US
Carleigh Krubiner (Ethics), Policy Fellow, Center for Global Development, Johns Hopkins University; US
Daniel Brasseur (Regulatory/CEPI), Former CHMP-PDCO-VWP chair at EMA, CEPI consultant; EU