Exciting news for parents and healthcare professionals alike! A committee of independent expert advisors for the Food and Drug Administration has voted in favor of approving Pfizer’s vaccine for protecting infants from the common respiratory virus RSV. This virus can be deadly to infants, so the potential approval of the vaccine, provisionally dubbed Abrysvo, is a huge step forward in infant healthcare.
The vaccine is given to pregnant people between 24 and 36 weeks of pregnancy, allowing protective antibodies to develop and then cross the placenta to protect the fetus. In a phase III trial involving nearly 7,400 pregnant people in 18 countries, the vaccine was nearly 82 percent effective at preventing severe RSV disease in the first 90 days of a baby’s life. It was 69 percent effective at 180 days.
While the efficacy data looked good and suggested the vaccine would protect infants from RSV, the safety data gave some of the members pause. The vaccine appeared largely safe for pregnant people and infants compared with a placebo, but data from a phase II trial and the phase III trial included a faint signal suggesting the vaccination could increase the risk of pre-term birth.
Despite this concern, many advisors were enthusiastic about the vaccine’s potential. The efficacy is “very exciting,” said Amanda Cohn, director of the division of birth defects and infant disorders at the Centers for Disease Control and Prevention. In the US, RSV is among the leading causes of hospitalization for children under 5 years old, so the potential approval of this vaccine is a huge step forward in infant healthcare. The FDA will now decide whether to approve the vaccine, and if it does, the CDC will weigh in with recommendations for its use in the US.
On Tuesday, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to approve a new vaccine that is intended to protect infants from Respiratory Syncytial Virus (RSV). The vaccine, developed by pharmaceutical giant AstraZeneca, is the first and only such vaccine currently approved for use in the US.
RSV is a common virus that affects the respiratory system, and is particularly dangerous in very young children and infants. Approximately eight percent of all infants born in the US are hospitalized for RSV each year, and the disease is a leading cause of pneumonia in children under two years old. Treatment often requires hospitalization, and can lead to long-term respiratory problems.
The new vaccine, made with an adenovirus vector, is designed to protect infants against RSV infection by stimulating the body’s immune response to the virus. In clinical trials, the vaccine was found to be 70-94% effective in preventing severe RSV infection. Additionally, the vaccine had an excellent safety profile, with no increase in serious side effects reported.
The FDA’s decision to approve the vaccine is a major step forward in the medical community’s efforts to help protect vulnerable infants from RSV. The vaccine is expected to be available to the public sometime next year. Parents and healthcare providers are encouraged to keep an eye out for the new vaccine and discuss its use with a pediatrician. A successful preventative treatment against RSV could save thousands of lives in the US each year.
