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 After shaking the mixture to combine, the resulting solution is withdrawn and injected.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, vaccines and global health at GSK, said in a statement.
GSK evaluated the safety of the one-vial product in two clinical trials that gave a single dose to 1,337 people aged 10 years to 44 years. The studies found “no notable differences in frequency and severity of solicited adverse reactions within 7 days following vaccination” with the one- and two-vial products.
One of the studies compared the immunogenicity of the two products. The analysis showed the one-vial formulation is noninferior to its predecessor in terms of antibody levels 28 days after vaccination. Other endpoints delivered further evidence of the comparable immune responses triggered by the products.
GSK is providing the single-vial product with a pink cap, differentiating it from the gray and orange caps of the older two-vial formulation. The storage conditions are unchanged, with both versions of the GSK vaccine requiring refrigeration at 36 degrees Fahrenheit to 46 degrees Fahrenheit.