Late preterm births, or births that occur between 34 and 36 weeks (approximately 4 to 6 weeks before the mother's due date), account for more than 70% of preterm births. Despite the large number of affected babies, many people are unaware of the serious health problems related to late preterm births. A new study and an accompanying editorial soon to be published in The Journal of Pediatrics investigate the serious neurological problems associated with late preterm births.
Dr. Joann Petrini of the March of Dimes and colleagues from institutions throughout the United States studied more than 140,000 babies born between 2000 and 2004, ranging from preterm (30-37 weeks) to full term (37-41 weeks). The researchers evaluated the babies' neurological development and found that late preterm babies were more than three times as likely to be diagnosed with cerebral palsy as full term babies. They also found that late preterm babies were at an increased risk for developmental delay or mental retardation.
Editorialist Dr. Michael Kramer of McGill University points out that the "rates of preterm births are increasing, especially in the United States, and the associated risks are a serious public health concern." He sees the increasing number of twins and induced labors as contributing factors in the rise of preterm births. "The rise in twins may be due to the use of fertility treatments like hormones and in-vitro fertilization," Dr. Kramer explains. However, he notes that the increased risks may not always come from early delivery itself, but from other underlying problems, such as gestational diabetes, that may lead to early delivery.
According to Dr. Petrini, "The negative outcomes of many babies born late preterm can no longer be described as temporary or benign." She suggests that late preterm babies may benefit from neuron-developmental assessments and stresses that elective delivery through cesarean section or induction should not be performed before 39 weeks unless medically necessary. Additionally, Dr. Kramer urges mothers and families to be aware of the risks when considering infertility treatments and induction of labor.
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Novavax's manufacturing process makes it possible to rapidly produce a vaccine that contains strains that are an exact genetic match to the strains circulating in the community causing influenza disease. Novavax's influenza VLPs are produced through recombinant technology in insect cell culture, utilizing a manufacturing process that will consist entirely of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than those of traditional egg-based or mammalian cell culture manufacturing. Because the Novavax process involves recombinant technology and does not require a live influenza virus, a matched vaccine for the first seasonal influenza clinical trial was manufactured within 12 weeks of identification of the Centers for Disease Control and Prevention ("CDC") released seasonal strains, or approximately half the time required to manufacture egg-based vaccines. The ability to rapidly respond to the identification of annual seasonal strains may be important in providing timely vaccine in advance of annual physicals for children before the school year.
Seasonal Influenza
The majority of individuals with influenza recover in less than two weeks; however, some may develop life-threatening complications such as pneumonia. In addition, influenza exacerbates the symptoms of chronic health conditions such as diabetes, asthma and congestive heart failure. The most severe disease occurs in infants and young children and adults older than 65 years of age. The CDC reports that 15 to 60 million people in the U.S. contract influenza each year leading to over 200,000 hospitalizations and 36,000 deaths. The Advisory Committee on Immunization Practices ("ACIP"), which has been expanding recommendations for seasonal influenza vaccination for the last several years, currently recommends seasonal influenza vaccination for children 6 months through 18 years of age, pregnant women, adults over 50 years of age, and individuals of any age with chronic health conditions or who are at high risk of influenza disease. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013.
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