FDA Grants Breakthrough Therapy to Pfizer RSVpreF Vaccine: Maternal Immunity Protects Infants!
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FDA Grants Breakthrough Therapy to Pfizer RSVpreF Vaccine: Maternal Immunity Protects Infants!
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FDA Grants Breakthrough Therapy to Pfizer RSVpreF Vaccine: Maternal Immunity Protects Infants!
Pfizer announced today that the U.S. FDA has granted a bivalent prefusion F subunit vaccine (RSVpreF) for respiratory syncytial virus (RSV) with Breakthrough Therapy Designation (BTD): for use in pregnant women, for active Immunization to prevent RSV-related lower respiratory tract disease (LRTI) in infants from birth to 6 months of age.
In November 2018, the FDA granted Fast Track designation (FTD) for RSVpreF: prevention of RSV-related LRTI in infants through active immunization of pregnant women.
BTD is the FDA’s new drug review channel designed to expedite the development and review of new drugs for the treatment of serious or life-threatening diseases that have preliminary clinical evidence that they can substantially improve the disease compared to existing treatments.
Drugs that receive BTD receive closer guidance, including senior FDA officials, during development, and are eligible for rolling review and potential priority review during review to ensure that new treatment options are available to patients in the shortest time possible.
The FDA granted RSVpreF BTD based on the results of a Phase 2b proof-of-concept study (NCT04032093). This is a global, double-blind, placebo-controlled study in healthy pregnant women 18-49 years of age who received RSVpreF between 28-36 weeks of gestation.
This study evaluated the safety and immunogenicity of RSVpreF in these healthy pregnant women and their infants, with the aim of conferring protection against RSV-associated lower respiratory tract disease (LRTI) in infants through maternal immunity. Pfizer will announce the results of this clinical study in the future.
“Today’s FDA decision is a critical next step on the road to regulation of our maternal RSV vaccine candidate and our efforts to help address the harmful effects of RSV disease on infants,” said Kathrin U. A major milestone in the development of the new mother-to-child immunity.
If approved by the FDA, this mother-to-child immunization has the potential to be the first vaccine to help protect vulnerable infants from the disease caused by this highly contagious virus in the first few months of life.
We look forward to Continued dialogue with the FDA to expedite the development of a mother-to-child RSV vaccine candidate.”
Respiratory syncytial virus (RSV) is a common and prevalent cause of acute respiratory disease. The virus is highly contagious and affects the lungs and respiratory tract.
RSV infection occurs in people of all ages and is like the common cold for most young people, but it can be life-threatening in infants, the immunocompromised and the elderly.
Currently, there is no vaccine to prevent RSV, and the medical community is limited to providing supportive care to patients.
RSVpreF, an RSV vaccine candidate being developed by Pfizer, builds on basic science discoveries, including those from the National Institutes of Health (NIH), which detail a method RSV uses to attack human cells Crystal structures of key forms of viral proteins.
The NIH study showed that antibodies that protect humans from RSV infection target a form of the viral protein.
Applying insights from this important work, Pfizer developed and tested a number of vaccine candidates and identified in preclinical evaluation those that elicited a strong antiviral immune response, resulting in the vaccine candidate that Pfizer is evaluating in human trials RSVpreF.
RSVpreF consists of 2 preF proteins designed to optimize protection against RSV types A and B and is currently undergoing Phase 3 human clinical trials .
Reference：
Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women
FDA Grants Breakthrough Therapy to Pfizer RSVpreF Vaccine: Maternal Immunity Protects Infants!
(source:internet, reference only)
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