World-first vaccine could be rolled out in MONTHS for baby killer winter bug RSV — which hospitalizes 50,000 children and kills 500 per year

A vaccine to prevent severe cases of the highly contagious respiratory syncytial virus in babies could be coming as soon as August.

Pharmaceutical behemoth Pfizer has developed an RSV vaccine that is administered to expectant mothers to confer antibody protection from severe disease to their unborn babies through six months of age. 

RSV has been especially acute this winter, plaguing infants and young children with severe lower respiratory infections. 

Most children are exposed to RSV before the age of two. Between 58,000 and 80,000 infants are hospitalized with RSV each year and between 100 to 500 will die. 

The virus exploded last fall, sending thousands of children to hospitals. It constituted one part of a ‘tripledemic,’ a term dubbed by scientists to describe the nightmarish scenario of contending with RSV, on top of seasonal flu, and Covid-19.

The FDA will consider Pfizer’s application to market its vaccine, called RSVpreF, to expectant mothers, endowing their newborns with protection against dangerous infection when they most need it.

Pfizer stopped its Phase 3 clinical trial of the shots last fall, concluding that they were both safe and effective. 

Theirs was the first to demonstrate that it can protect infants against severe RSV immediately after birth.

The vaccine was nearly 82 percent effective at preventing severe respiratory infection in infants through their first 90 days of life. In infants through six months old, the shot was 70 percent effective at preventing hospitalization and assisted breathing.

Dr Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Vaccine Research & Development at Pfizer said: ‘If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season.

‘We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.’

Virtually all children become infected with RSV before the age of two. In most cases, RSV causes a relatively mild cold-like illness with symptoms ranging from runny nose and coughing to loss of appetite and trouble breathing.

RSV is the leading cause of hospitalizations of infants. About two in 100 babies under six months with RSV must be hospitalized.

While four RSV vaccine candidates are in the pipeline currently – most of which are aimed at protecting older adults – there is no FDA-approved vaccine for the virus. 

It is the most common cause of inflammation of the airways, also known as bronchiolitis, and pneumonia in children under one-year-old.

The journey to develop a viable RSV vaccine has been fraught with many flops. Most notable among them was the failed attempt in the 1960s to make a shot that not only did not lend children any protection from illness, but in fact made their subsequent RSV infections worse.

Roughly 80 percent of the children who tried that vaccine were later hospitalized with RSV. Two vaccinated babies later died of lung issues.

It is unclear how much an RSV vaccine for expectant mothers would cost or whether health insurance plans would cover it. 

The cost of making vaccines is usually pretty low. It is estimated that it costs Pfizer less than $2 to make its mRNA Covid shot. Yet, profits from those shots generating revenue of $36.8 billion in 2021 and $37.8 billion in 2022.

The company projects sales will plummet in 2023 as fewer people get the shots. The RSV vaccine, if approved, would be administered to far fewer people than the Covid-19 vaccine, suggesting that profits would be far lower.