A vaccine to prevent severe cases of the highly contagious respiratory syncytial virus in babies could be available as early as August.
Pharmaceutical giant Pfizer has developed an RSV vaccine to be given to expectant mothers to give their unborn babies up to six months of age antibody protection against serious disease.
RSV has been particularly acute this winter, afflicting infants and young children with severe lower respiratory tract infections.
Most children are exposed to RSV before they are two years old. Each year, between 58,000 and 80,000 babies are hospitalized with RSV and between 100 and 500 die.
The virus broke out last fall and sent thousands of children to hospitals. It was part of a “tripleemia,” a term coined by scientists to describe the nightmarish scenario of battling RSV on top of seasonal flu and Covid-19.
Pfizer’s RSV vaccine is poised to be the first available to expectant mothers to transfer antibodies to unborn babies. Clinical trials have shown that injection is 82 percent effective in preventing severe RSV disease in newborns during the first 90 days of life
The FDA will review Pfizer’s application to market its vaccine, called RSVpreF, to expectant mothers to protect their newborns from dangerous infections when they need it most.
Pfizer withdrew from the Phase 3 clinical trial of the injections last fall, concluding that they were safe and effective.
They were the first to demonstrate their ability to protect infants from severe RSV immediately after birth.
The vaccine was nearly 82 percent effective in preventing severe respiratory infections in infants in the first 90 days of life. In babies up to six months old, the injection was 70 percent effective in preventing hospitalization and assisted breathing.
Dr. Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development at Pfizer, said: “If RSVpreF is approved, it will help protect infants from the devastating effects of this infectious disease, although it is well known, with their first breath. , but is very clearly known in this RSV season.
“We look forward to continuing the review of Pfizer’s maternal RSV vaccine candidate with the FDA and other regulatory agencies, given its significant potential to make a positive contribution to global health in preventing RSV in infants.”
“Tripledemics” continue to falter with fewer flu and RSV cases
The Centers for Disease Control and Prevention (CDC) has expressed optimism about the declining number of flu and RSV cases and predicts a possible end to the triple dementia that scientists feared last year.
Almost all children are infected with RSV before the age of two. In most cases, RSV causes a relatively mild, cold-like illness with symptoms ranging from a runny nose and cough to a loss of appetite and difficulty breathing.
RSV is the leading cause of hospital admissions in infants. About two in 100 babies under six months with RSV require hospitalization.
Although there are currently four RSV vaccine candidates in the pipeline—most of them to protect older adults—there is no FDA-approved vaccine for the virus.
It is the most common cause of airway inflammation, also known as bronchiolitis, and pneumonia in children under the age of one.
The road to the development of a viable RSV vaccine was fraught with many flops. Most notable was the failed attempt in the 1960s to develop a shot that not only failed to protect children from disease, but actually worsened their later RSV infections.
About 80 percent of children who tried this vaccine were later hospitalized with RSV. Two vaccinated babies later died of lung problems.
It is unclear how much an RSV vaccination for expectant mothers will cost or whether health insurance companies will cover it.
The cost of producing vaccines is usually quite low. It is estimated that it costs Pfizer less than $2 to do its mRNA Covid injection. Still, profits from those recordings will generate $36.8 billion in revenue in 2021 and $37.8 billion in 2022.
The company expects sales to drop in 2023 as fewer people get the injections. The RSV vaccine would be given to far fewer people than the Covid-19 vaccine if approved, suggesting the gains would be much smaller.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
