Streptococcus agalactiae, which causes vaginal and urinary tract infections and neonatal infections, including meningitis and sepsis. Optical microscope view.
Cavallini James | BSIP | Universal Image Group | Getty Images
Pfizer Wednesday said its experimental vaccine Targeting Potentially Deadly Bacterial Diseases Group B Streptococcus Mid-term strong comeback clinical trial resultsa promising step forward as the drug progresses toward potential approval.
Pfizer is one of several drugmakers racing to develop the world’s first vaccine against group B strep, a disease closely related to 150,000 infant deaths worldwide, especially in low-income countries.
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Food and Drug Administration September Awarded Breakthrough Therapy Designation Pfizer’s vaccine, which aims to expedite the development and review of vaccines.
Pfizer’s single-dose injection produced antibodies that conferred meaningful protection against the disease in infants, according to the agency. data A phase 2 clinical trial was released on Wednesday.
injection is managed Pregnant women, who pass on vaccine-induced antibodies to their fetuses. One of the company’s vaccines against respiratory syncytial virus also uses this maternal vaccination approach.
Encouraging results from a phase 2 trial by Pfizer raised hopes that maternal vaccination against the disease, also known as GBS, could help prevent thousands of cases in infants.
The results will also help the company plan Phase 3 clinical trials for its injectables, which are typically required before the FDA approves a drug.
The Bill & Melinda Gates Foundation, which supported the Phase 2 trial, provided additional $100 million in grants The money given to Pfizer last year will fund late-stage trials and help boost the availability of the vaccine to low-income countries after possible approval.
GBS disease is caused by common and usually harmless bacteria Many adults have this stuff in their bodies.
But expectant mothers can pass the bacteria to their newborns during labor, which can lead to serious infections in the baby’s first weeks or months after birth.
about 1 in 4 people According to the U.S. Centers for Disease Control and Prevention, women carry the GBS bacteria.
Babies infected with GBS may develop symptoms such as fever and difficulty breathing.
Some babies may experience an invasive GBS infection that can lead to more serious complications such as pneumonia, blood infection, meningitis, or inflammation of the tissues surrounding the brain and spinal cord.
There are 10 different GBS serotype, implying a distinct variation in the disease-causing bacteria. Pfizer’s vaccine targets the six most important serotypes, which collectively account for 98% of GBS disease cases worldwide.
Trial Results and Safety
The Pfizer trial followed 360 healthy pregnant women in South Africa. The mothers were randomly assigned to receive a single injection at three different dose levels, with or without a specific adjuvant or a placebo.
Trials found that Pfizer’s injection produced potent antibodies against six GBS serotypes in mothers. These antibodies are “effectively transferred” to the infant in a ratio between 0.4 and 1.3, depending on the dose.
This means that some babies get only a fraction of the antibodies from their mothers, while others get higher levels of antibodies than their mothers.
These levels of antibody transfer were associated with a reduced risk of GBS disease, Pfizer said. This conclusion is based on parallel natural history research conducted in South Africa.
According to the trial results, the safety profile for mothers and babies in the vaccine and placebo groups appeared to be similar, suggesting that the shot was generally well tolerated in the phase 2 trial.
Maternal reactions to vaccination were generally mild or moderate and short-lived. The results showed that between 2% and 8% of the participants who received the injection reported a fever, compared with 5% of the placebo group.
About 45% to 70% of pregnant women who received the vaccine had more adverse effects, such as headaches and vomiting. But there wasn’t much difference in the placebo group, with more than 60 percent of expecting mothers experiencing these adverse events.
Adverse events, including upper respiratory infections, were experienced by about 62% to 75% of infants in the vaccine group and about 74% in the placebo group. Three infants in the vaccine group died and two infants in the placebo group died.
The study authors determined that no adverse events or deaths among the infants were related to the vaccine.
The results come as Pfizer prepares to continue Sales related to COVID-19 are down this year.
Pfizer also faces a patent cliff, the loss of market exclusivity for several blockbuster drugs such as cancer drugs Xtandi and Ibrance. This is expected to be an additional hit to Pfizer’s annual revenue through 2030.
To offset the sharp decline in sales, the company is shifting its focus to a new drug pipeline and mergers and acquisitions.