Pfizer Inc. (NYSE: PFE) has announced that the U.S Food and Drug Administration (FDA) has given its vaccine candidate for the respiratory syncytial virus (RSV), RSVpreF, a Breakthrough Therapy Designation. The vaccine prevents lower respiratory tract disease associated with RSV in infants aged 0-6 months. The vaccine is given to pregnant women.
The FDA came to this decision after reviewing results from the international, placebo-controlled, double-blind study. This study evaluated the immunogenicity and safety of the drug in pregnant women between the ages of 18 and 49 and their infants.
President Biden offers free COVID-19 drug for at-risk groups
Meanwhile, U.S President Joe Biden has announced that hospitals will give patients at risk of severe COVID-19 infection free Pfizer antiviral drugs if they get infected. This is part of the Test to Treat initiative. It will involve giving at-risk groups who test positive for COVID-19 at clinics the free antiviral medication called Paxlovid.
Biden made this announcement at the State of the Union address. He explained that taking the antivirals made people at risk for severe infection, 90% more likely to survive. This news comes when the U.S still records many deaths and hospitalizations despite infections going down worldwide.
An official from the White House added that Paxlovid would be provided in several outlets, including Kroger, Walgreens, and CVS. The government will also make it available at community health centers.
Pfizer and BioNTech SE (NASDAQ: BNTX) receive positive booster review
Pfizer and BioNTech SE (NASDAQ: BNTX) have received a positive review from the Committee for Medicinal Products for Human Use (CHMP) on administering COMIRNATY COVID-19 booster in children aged 12-17.
The European Commission (EC) will review the CHMP’s opinion as it decides on a Conditional Market Authorization variation. If the EC chooses to grant the variation, it will apply to all members of the E.U. This move would make the booster legal for children aged 12 to 17 years in these countries.
The CHMP gave its opinion after investigating the booster’s efficacy and safety using results from clinical trials in people aged 16 and older. It also used data from its effect on young patients in Israel. As a result, the regulator concluded that the booster would yield a significant immune response in adolescents.
