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Streptococcus agalactiae, responsible for vaginal and urinary tract infections, neonatal infections including meningitis, and septicemia. Microscope view.
James Cavallini | BSIP | Global Image Collection | Getty Images
Pfizer On Wednesday he told her pilot Serum Targeting deadly bacterial diseases Group B Streptococcus He came back strong in the middle of the stage Clinical trial resultswhich is a promising step as the drug begins toward potential approval.
Pfizer is among several drugmakers racing to develop the world’s first shot targeting group B streptococcus disease, which is roughly associated with 150,000 deaths among children worldwide every year, especially in low-income countries.
Food and Drug Administration in September He was awarded the title of Breakthrough Therapy Pfizer’s vaccine, which aims to accelerate development and review of the shot.
Pfizer’s single-dose shot produced antibodies that may offer infants meaningful protection against disease, according to data Released Wednesday from a phase II clinical trial.
The punch is managed For expectant mothers who transfer vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus (RSV) uses the maternal vaccination method.
Encouraging results from Pfizer’s Phase 2 trial provide hope that vaccinating a mother against the disease, also known as GBS, can help prevent thousands of cases in babies.
The findings will also help the company plan its Phase 3 clinical trials for the shot, which are usually required before a drug can be approved by the Food and Drug Administration.
The Bill & Melinda Gates Foundation, which supported the second phase of the experiment, provided an additional program A grant of $100 million to Pfizer last year that will fund late-stage trials and help facilitate delivery of the shots to low-income countries after potential approval.
GBS risks
GBS disease is caused by A Common and usually harmless bacteria Which many adults carry in their bodies.
But an expectant mother can pass these bacteria to her newborn baby during labor and delivery, which can cause severe infections during the first few weeks or months of the baby’s life.
on 1 in 4 Women carry GBS bacteria, according to the Centers for Disease Control and Prevention.
Children with GBS infection can have symptoms that include fever and difficulty breathing.
Some children can have invasive GBS infection, which causes more serious complications such as pneumonia, infections of the bloodstream, meningitis, or inflammation of the tissues surrounding the brain and spinal cord.
There are 10 different GBS serotypes, which means the characteristic differences of the pathogenic bacteria. The Pfizer vaccine targets six of the most prominent serotypes, which together account for 98% of GBS cases worldwide.
Trial results and safety
Pfizer’s trial followed 360 healthy pregnant women in South Africa. Mothers were randomly assigned to receive a single injection at three different dose levels, with or without a specific adjuvant, or a placebo.
The trial found that the Pfizer shot produced strong antibodies against all six GBS serotypes in the mothers. These antibodies were “efficiently transferred” to the infants at rates between 0.4 and 1.3, depending on the dose.
This means that some babies received only a fraction of the antibodies from their mothers, while others received higher antibody levels than their mothers had.
Pfizer said these antibody transfer levels are associated with a lower risk of GBS. This conclusion was based on a parallel natural history conducted in South Africa.
The safety profile for both mothers and infants appeared to be similar between the vaccine group and the placebo groups, according to the trial results, indicating that the shot was generally well tolerated during the phase II trial.
Post-vaccination maternal reactions were generally mild or moderate and of short duration. Between 2% to 8% of the participants who received the vaccine reported a fever, compared to 5% in the placebo group, according to the results.
About 45% to 70% of pregnant women who received the vaccine experienced more adverse reactions such as headache and vomiting. But the placebo group wasn’t much different, with more than 60% of expectant mothers experiencing those adverse events.
About 62% to 75% of children in the vaccine group and 74% in the placebo group experienced adverse events, including upper respiratory tract infection. There were three infant deaths in the vaccine group and two in the placebo group.
The study authors determined that there were no adverse events or infant deaths associated with the vaccine.
The results come in as Pfizer parentheses for continuation Covid-related sales decline this year.
Pfizer is also facing a patent slope, or loss of market exclusivity, for several blockbuster drugs like cancer drugs Xtandi and Ibrance. That is expected to deal an additional blow to Pfizer’s annual revenue by 2030.
To counter the sharp decline in sales, the company is shifting its focus toward a new drug pipeline and mergers and acquisitions.
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