Pfizer awarded grant to evaluate vaccine to protect newborns against group B Streptococcus infection

PfizerPfizer Inc. (NYSE:PFE) today announced an award of a grant from the Bill & Melinda Gates Foundation to conduct a Phase 1/2 clinical trial of Pfizer's vaccine candidate against group B Streptococcus(group B strep or GBS) infection, a leading cause of neonatal sepsis, a serious life-threatening blood infection. (1) The investigational vaccine is designed to protect newborns via maternal immunization.

There is an urgent global health need for a vaccine that could protect pregnant women and their infants against GBS, particularly in developing countries where prophylactic administration of antibiotics is not routine. A pregnant woman has the ability to transfer protective antibodies to her unborn child through the placenta; if successful, the vaccine could help augment this protective effect for the newborn baby.

"The first few days and weeks of a baby's life are the most dangerous by far," said Keith Klugman, Director for Pneumonia at the Bill & Melinda Gates Foundation. "The clinical development of a group B streptococcal vaccine would be an important landmark in the story of vaccine development to protect newborns from this disease through the immunization of their mothers."

Neonatal GBS infection is a debilitating and often fatal disease with mortality rates of around 6% to 14% of those infected in industrialized countries(2) and approximately 14% to 38% of those infected in parts of the developing world.(3) The estimated incidence of invasive GBS disease is among the highest in South Africa, with 2.38 cases per 1,000 live births.(4)

"The health benefits of maternal immunization to protect pregnant mothers and their babies against flu, tetanus and pertussis are well-documented," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "We are looking to determine whether our investigational vaccine could generate levels of protective antibodies in the mother that, when passed to her unborn baby, will protect the baby against deadly GBS infection during a time when the infant is most vulnerable to infection."

GBS bacteria have the potential to cause severe disease, particularly in newborn infants who have an immature immune system that is still adapting to the environment outside the womb. Some of the most common complications caused by GBS impact the blood, lungs, lining of the brain, and spinal cord in the form of sepsis, pneumonia or meningitis. It is estimated that more than 40% of survivors remain impaired during childhood.(5) Current preventative care in the developed world consists of prophylactic treatment with intravenous antibiotics before delivery of the baby, which is an uncommon practice in the developing world as it presents multiple challenges to implementation in countries lacking a robust health care infrastructure.

Research has shown that a potential conjugate vaccine that incorporates at least five serotypes of GBS could prevent approximately 95% of group B streptococcal disease in infants younger than three months.(6)

Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. 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. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

1. Thigpen MC, et al. Bacterial Meningitis in the United States, 1998–2007. N Engl J Med. 2011: 364:2016-2025.
2. Edwards MS, Gonik B, "Preventing the broad spectrum of perinatal morbidity and mortality through group B streptococcal vaccination." Accessed 24 June 2016. Available at http://www.ncbi.nlm.nih.gov/pubmed/23200934
3. Johri AK, Lata H, et al., "Epidemiology of Group B Streptococcus in developing countries." Accessed 24 June 2016. Available athttp://www.ncbi.nlm.nih.gov/pubmed/23973346
4. Dangor Z, Lala SG, et al., "Burden of Invasive Group B Streptococcus Disease and Early Neurological Sequelae in South African Infants." Accessed 13 October 2016. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123014#sec014
5. Libster R, Edwards KM, et al., "Long-term outcomes of group B streptococcal meningitis." Accessed 24 June 2016. Available athttp://www.ncbi.nlm.nih.gov/pubmed/22689869
6. Le Doare K, Heath PT, "An overview of global GBS epidemiology." Vaccine. 2013; D7– D12. Accessed October 10 2016. Available athttp://www.sciencedirect.com/science/article/pii/S0264410X13000285

Most Popular Now

Cannabis extract helps reset brain function in psy…

Research from King's College London has found that a single dose of the cannabis extract cannabidiol can help reduce brain function abnormalities seen in people with psyc...

New cancer treatment uses enzymes to boost immune …

Researchers at The University of Texas at Austin have developed a new approach to treating cancer using enzyme therapy. The enzyme, PEG-KYNase, does not directly kill can...

Bayer accelerates six new startups

Changing the experience of health: that's the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year. The young companies fr...

Novartis receives European Commission approval of …

Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pe...

Antioxidant reduces risk for second heart attack, …

Doctors have long known that in the months after a heart attack or stroke, patients are more likely to have another attack or stroke. Now, a paper in the Journal of the A...

Shire completes sale of oncology franchise

Shire plc (LSE: SHP, NASDAQ: SHPG) announces today that it has completed the sale of its Oncology franchise to Servier S.A.S. for $2.4 billion. The franchise includes the...

Novartis to divest the Sandoz US dermatology busin…

Novartis today announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids po...

Tezepelumab granted Breakthrough Therapy Designati…

AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab...

Pfizer terminates domagrozumab (PF-06252616) clini…

Pfizer Inc. (NYSE: PFE) announced that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrop...

New tablet production facility in Ingelheim: Cente…

Boehringer Ingelheim held a groundbreaking ceremony for the construction of a new production facility for innovative drugs. This new Solids Launch facility will focus on ...

Study links widely-used drug azathioprine to skin …

A drug used to treat inflammatory bowel disease, arthritis and vasculitis as well as to prevent organ rejection in transplant patients has been identified as an important...

Pfizer and Astellas amend clinical research protoc…

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced amendments to the protocols for two registratio...