GSK has won FDA approval for a single-vial formulation of its meningococcal disease vaccine Menveo, thereby ending the need for reconstitution that has existed since the product came to market in 2010.
The original two-vial presentation of Menveo must be reconstituted in a three-step process before the intramuscular injection can be administered. The liquid from the first vial is removed and mixed with the contents of the second vial. After shaking the mixture to combine, the resulting solution is withdrawn and injected.
Now, the FDA has approved a single-vial, ready-to-use version of Menveo in people aged 10 years to 55 years. The two-vial version, which is approved for use in children as young as 2 months, remains on the market. GSK is pitching the one-vial product as being more convenient to healthcare providers.
“Outbreaks of this dangerous disease continue to occur, impacting families, health systems and society. This FDA approval of Menveo one-vial presentation offers greater convenience to healthcare providers to help prevent this disease in at-risk populations in the United States,” Roger Connor, president, of vaccines and global health at GSK, said in a statement.