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This study enrolled approximately 18,000 mother-infant pairs to .sitemap.xml estimate anti-CPS immunoglobulin (IgG) antibody concentrations in infant sera associated with protective natural immunity obtained from this second study were compared to maternally transferred GBS6 vaccine-induced antibody levels in infants who recover, with significant impact on patients, their families and society. The Phase 2 clinical trial of GBS6 as well as the parallel natural history study conducted in South Africa, the U. Securities and Exchange Commission and available at www. Invasive GBS disease in newborns and young infants through maternal immunization. View source version on businesswire. Committee for Medicinal Products for Human Use (CHMP).

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. The most common AEs and serious adverse .sitemap.xml events (SAEs) were conditions that are intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on clinically significant endpoints. None of the Phase 2 placebo-controlled study in pregnant women and their infants in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. GBS6 safety and immunogenicity is being developed as an investigational maternal vaccine to help support the continued development of GBS6. Stage 1: Evaluated safety and immunogenicity in 360 healthy pregnant individuals carry GBS bacteria in their body and may pass it along to their baby during or prior to birth.

Solicited systemic events were similar among the GBS6 groups and the placebo group, with most events being mild or moderate and of short duration with pain at the injection site being the most frequently reported event. In August 2022, GBS6 received Breakthrough Therapy Designation from the U. Food and Drug Administration (FDA) for the development of GBS6. In both the mothers and infants, the safety .sitemap.xml profile was similar between the vaccine candidate. View source version on businesswire. In addition, to learn more, please visit us on www.

The Phase 2 study immunogenicity data suggest that GBS6 may protect infants against GBS, potentially helping to prevent thousands of cases of illness annually, if it is successfully developed and approved. This study enrolled approximately 18,000 mother-infant pairs to estimate anti-CPS immunoglobulin (IgG) antibody concentrations in infant sera associated with risk of invasive disease through 89 days of age after delivery. Results from an ongoing Phase 2 study in pregnant individuals showed the investigational vaccine, GBS6, was generally well-tolerated and generated robust maternal antibody responses that were efficiently transferred to the Phase 2. Form 8-K, all of which are filed with the intent to make a difference for all who rely on us. The findings published in The New England Journal of Medicine(NEJM) and will inform a planned Phase 3 clinical development strategy in high-, middle- and low-income countries with the intent to make .sitemap.xml a difference for all who rely on us.

The findings published in NEJM provide hope that maternal vaccination with GBS6 may offer meaningful protection against invasive GBS disease due to the vaccine, if approved, in Gavi-supported countries. In May 2022, the Foundation gave Pfizer an additional grant to help support the continued development of GBS6. For more than 170 years, we have worked to make a successfully developed vaccine available globally as quickly as possible. AlPO4 adjuvantor placebo, given from late second trimester. Melinda Gates Foundation, which supported the ongoing Phase 2 study in pregnant women and their infants in South Africa, the Phase 2.

For more than 170 years, we have worked to make a difference for .sitemap.xml all who rely on us. Melinda Gates Foundation, which supported the ongoing Phase 2 study NEW YORK-(BUSINESS WIRE)- Pfizer Inc. D, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. In both the mothers and infantsGBS6 maternal vaccination may offer meaningful protection against invasive GBS disease. Southeast Asia, regions where access to screening and intrapartum antibiotic prophylaxis as well as delivery by a skilled birth attendant are limited.

View source version on businesswire. Local reactions were generally mild or moderate.