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Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.
Pfizer announced on March 2, 2022 that it has received Breakthrough Therapy Designation from FDA for its respiratory syncytial virus (RSV) vaccine candidate (RSVpreF). The vaccine candidate is for the prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.
RSV is a common cause of respiratory illness and can be potentially life-threatening for infants. There is currently no vaccine to prevent RSV and no direct treatment other than supportive care.
FDA’s Breakthrough Therapy Designation allows for the review and development of new drugs and vaccines to be expedited in order to treat or prevent serious conditions on a faster basis. The Breakthrough Therapy Designation was granted after the results of the safety and immunogenicity of RSVpreF were assessed through a double-blinded, placebo-controlled study. The study involved healthy pregnant women ages 18 through 49 years old who were vaccinated between 28 and 36 weeks of gestation. Pfizer will publish the outcomes of the study at a future date.
“Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants,” said Kathrin U. Jansen, PhD, senior vice president and head of vaccine research & development at Pfizer, in a press release. “If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus. We look forward to our ongoing dialogue with the FDA to accelerate the development of our maternal RSV vaccine candidate.”