Group B Strep Vaccine for Pregnant Women on Fast Track for FDA Approval
Pfizer is conducting phase 2 trials for the development of a vaccine that will target pregnant women to prevent newborns from infection with Group B Streptococcal (GBS). The vaccine was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in September and the agency has indicated it will fast track the product’s path to approval.1
The FDA’s Breakthrough Therapy Designation, also known as “fast tracking” is specifically designed to expedite the development and review process of new drugs or biologics, which are addressing “unmet medical needs.” In 2017, the Group B strep vaccine was given Fast Track status by the FDA.”1
Upon FDA approval, the vaccine will be administered to pregnant women “for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.”1
Gates Foundation Grants $128 million for GBS and RSV Vaccines for Pregnant Women
In 2016, Pfizer received grants totaling $128 million from the Bill & Melinda Gates Foundation for the development and accessibility of the Group B Strep vaccine, as well as for an RSV vaccine. Over the past 15 years, the Gates Foundation has donated nearly $540 million to maternal immunization efforts. Keith Klugman, director at the Gates Foundation stated:
Maternal immunization—vaccinating pregnant women who can then pass on lifesaving protection to their babies—is a powerful way to reduce newborn and infant mortality. We are hopeful our investments in this promising pipeline of new maternal vaccines… will help infants in low-income settings have the best chance at life.2
Phase 2 Trials for GBS Vaccine Taking Place in U.S., Africa and U.K.
Pfizer has developed a genetically engineered six-valent polysaccharide Group B Strep conjugate vaccine that is currently in an ongoing Phase 2, placebo-controlled study taking place in Africa, the United Kingdom, and the U.S. The vaccine is known as the hexavalent anticapsular polysaccharide (CPS)/cross reactive material 197 glycoconjugate (GBS6). Pfizer’s GBS6 was also granted a similar “fast track” designation by the European Medicine’s Agency Committee for Medicinal Products for Human Use with the justification that it is a product that addresses an “unmet medical need.”1
FDA Has Fastest Drug and Biologicals Approval Process of All Regulation Agencyies in the World
Even without the Breakthrough Therapy Designation, the FDA has the fastest drug and biologics approval process of all pharmaceutical product safety regulating agencies in the world.3 Many health and public health policy authorities, including individuals who have worked for government health agencies, have voiced concern over the ethics of the FDA vaccine approval process.
Last year, two Pfizer senior officials resigned over the rushed Emergency Use Authorization (EUA) approval of COVID-19 booster shots. Over the years, many people have voiced concerns about the fact that Congress has allowed the FDA, which is supposed to be regulating the pharmaceutical industry, to get a large portion of its funding from drug companies for fast tracking drugs and vaccines to market.4
Serious Group B Strep Infection “Rare” According to ACOG
Group B Strep is a common type of bacteria found in the bowel, genital tract, urinary tract, throat, or respiratory tract of healthy men and women adults and is usually asymptomatic.5 Approximately one in four women are asymptomatically colonized with the bacteria, and colonization does not always lead to infection.6
GBS infection usually does not cause serious illness in adults and is not considered a sexually transmitted infection but, in some cases, the bacteria can be passed to the baby during labor. For babies, Group Strep B infection may lead to meningitis (brain inflammation), pneumonia, or sepsis (blood poisoning). According to the American College of Obstetrics and Gynecology, this transmission leading to serious disease “is rare and happens to 1 or 2 babies out of 100 when the mother does not receive treatment with antibiotics during labor.”7
When given antibiotics during labor to treat GBS infection, the baby’s risk of colonization is approximately 50 percent, while the risk of actually developing a serious GBS infection is one to two percent.6
The Group B Strep treatment protocol in the United States follows what is known as a “universal approach” that uses antibiotics and intravenous penicillin administered to any woman who tests positive for GBS during pregnancy or has had a history of GBS in prior pregnancies. Other countries like the U.K. take a more conservative approach and do not routinely screen for GBS and will only administer antibiotics if a women shows symptoms, such as running a fever during labor.8
Pfizer states that developing the Group B Strep vaccine will be “fulfilling a critical global health need” and that the development of maternal vaccines is critical for helping fight infection“ in newborns during the most vulnerable first months of life.”1
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