Daily Newsletter

22 August 2023

Daily Newsletter

22 August 2023

FDA grants approval for Pfizer’s RSV vaccine

The vaccine is administered to pregnant people to prevent RSV-related lower respiratory tract disease and severe LRTD in infants.

Vishnu Priyan August 22 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, for use in pregnant women to offer protection for their babies.

The bivalent RSV prefusion F (RSVpreF) vaccine is administered between 32 and 36 weeks of gestation. It is indicated to prevent RSV-caused lower respiratory tract disease (LRTD) and severe LRTD in infants from birth until the age of six months.

Based on findings from the Phase III MATISSE clinical trial in 7,000 pregnant individuals and their infants, the regulatory agency granted the approval.

The trial analysed the safety, efficacy and immunogenicity of the vaccine in infants born to healthy people who were inoculated during the gestation period.

The company obtained FDA approval in May 2023 for the vaccine indicated to prevent LRTD in those aged 60 years and above.

Pfizer Vaccine research and development senior vice-president and chief scientific officer Annaliesa Anderson stated: “Abrysvo’s approval as the first and only maternal immunisation to help protect newborns immediately at birth through to six months from RSV marks a significant milestone for the scientific community and for public health.

“We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available.

“Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger – when they are at greatest risk of possible serious consequences from RSV – has been achieved.”

The company has also commenced two trials of Abrysvo for RSV in children aged two to 17 years and adults aged 18 to 60 years.

Multiple Myeloma (MM) pipeline is dominated by CAR-T cells

The success of CAR-Ts in MM has fueled R&D investment into this class of therapy, with more CAR-Ts in development than all other cell and gene therapy classes combined. The approval of the autologous CAR-T cell therapies Abecma and Carvykti sees the CAR-T pipeline mostly constituted of autologous drugs. However, there are also multiple allogeneic CAR-Ts in the pipeline, with these therapies having an “off-the-shelf” advantage over autologous therapies.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close