Clinical Pfizer’s RSV vaccine given breakthrough therapy status by FDA

Pfizer’s RSV vaccine given breakthrough therapy status by FDA


Pfizer’s RSVpreF is for the prevention of respiratory syncytial virus(RSV) linked respiratory tract illness in infants through the vaccination of pregnant women.

RSVpreF is a developed vaccine under investigation, with the FDA granting the RSV vaccine breakthrough therapy designation. The vaccine developed by Pfizer aims to help protect against RSV A and B, while it consists of 2 preF proteins.

The RSV vaccine status was changed by the FDA after the results from RSVpreF’s Phase IIb clinical trial. The trial was a double-blinded and placebo controlled study for RSVpreF’s proof of concept.

The study’s results are not yet published for the public but the company indicated that they will be published later on.

The trial was based on the vaccine being administered to pregnant women in their 28 and 36 weeks of pregnancy. The participants were from 18 to 49 years of age at the time of the trial and the vaccine’s induced immune response, as well as its safety, was tested.

The developed RSV vaccine will help protect infants up to 6 months of age from lower respiratory tract problems due to the virus. The active vaccine will be given to women currently pregnant, for the protection of infants.

The company’s senior representative explained that this was an important step in gaining FDA approval for the RSV vaccine, to help pave the way for RSV treatment as well as reduction in the impact of the highly contagious virus and associated illness. 

FDA approval will allow for the vaccine to be the first of its kind providing needed immunity support to infants up to 6 months, helping them battle against the virus. Children are most vulnerable to the virus in this young stage.

The U.S. FDA granted Paxlovid, Pfizer’s oral antiviral drug, emergency use authorization last year. Paxlovid is an antiviral for COVID-19 treatment for people 12 years and above. The drug is a treatment for mild-to-moderate illness.

In 2018 the RSV vaccine was granted Fast Track status. 

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