Pfizer Inc. received US clearance for a vaccine that protects infants from RSV by immunizing their pregnant mothers, positioning the drugmaker to enter a competitive new market for the common but dangerous virus in young children.
(Bloomberg) — Pfizer Inc. received US clearance for a vaccine that protects infants from RSV by immunizing their pregnant mothers, positioning the drugmaker to enter a competitive new market for the common but dangerous virus in young children.
The Food and Drug Administration gave the green light for Pfizer’s Abrysvo ahead of the RSV season, according to a statement. The Centers for Disease Control and Prevention must still determine how Pfizer’s shot will be used.
It’s taken 60 years for scientists to develop protection against RSV. After a series of failures, the race has intensified as concern about Covid-19 subsides. Some 2% to 3% of infants with RSV in the US are at risk of hospitalization, and 80,000 children under five end up being admitted each year due to complications related to the virus.
RSV prevention is quickly becoming a crowded market as global sales for both infant and older adult vaccines are expected to top $10 billion by 2032. Pfizer faces a rival preventive drug for infants from AstraZeneca Plc and Sanofi that gained CDC backing this month. Pfizer has already received FDA approval for its vaccines in people 60 and older, following GSK Plc’s entry into that market. Moderna Inc. is working on an injection for RSV using the same messenger RNA technology that powers its Covid vaccine.
“Abrysvo’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health,” Annaliesa Anderson, Pfizer’s head of vaccine research and development, said in a statement.
Pfizer is also studying the vaccine in high-risk children from 2 to 18 years old and in adults with underlying conditions like asthma and diabetes or who have weak immune systems.
Consensus estimates suggest an annual market of more than $2 billion for infant protection against RSV by 2032, according to Bloomberg Intelligence. Bloomberg Intelligence’s John Murphy said in a note that combined sales of Pfizer’s vaccine and the drug from Astra and Sanofi antibody will likely come in closer to $1.3 billion by that time.
“We see a slow uptake due to the need for major education and the challenge of incorporating an additional jab into the infant-vaccination schedule,” Murphy wrote.
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