Two new vaccines are cleared to hit the market following the U.S. FDA’s approval over the weekend for Vimkunya, a chikungunya vaccine from Bavarian Nordic A/S, and Penmenvy, a meningococcal vaccine from GSK plc.

With the FDA’s approval of Vimkunya, Bavarian Nordic is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older.

Copenhagen, Denmark-based Bavarian Nordic said the vaccine, which has virus-like particles to mimic the virus without infecting cells, replicating or prompting the virus, should be available in the U.S. sometime in the first half of 2025.

The vaccine already had made substantial progress in Europe. The EMA’s Committee for Medicinal Products for Human Use recommended granted a marketing authorization on Jan. 31 in the EU for Vimkunya for preventing disease caused by the chikungunya virus. The opinion went to the European Commission for a decision on an EU-wide marketing authorization. The single-dose vaccine would be the first in the EU for those ages 12 and older. Should the EMA gives its approval, the vaccine will be available in Europe sometime in the first half of 2025.

The priority BLA was accepted by the FDA in August 2024 and set a Feb. 14 PDUFA date. Bavarian Nordic announced the approval late in the day on that date. The agency also gave the company a priority review voucher.

Two phase III studies were at the heart of the approval. About 3,500 healthy participants ages 12 and older participated in the clinical trials, both of which hit their primary endpoints. The data showed 97.8% of the participants had neutralizing antibodies three weeks after vaccination.

The Bavarian Nordic approval trails a competitor. The FDA gave its blessing to Saint-Herblain, France-based Valneva’s Ixchiq, a single-dose, live attenuated vaccine in November 2023 for those 18 and older who are at increased risk of exposure to the virus. The company submitted a label extension application to the FDA in the latter part of 2024 to extend its use in adults to those ages 12 to 17.

Second pentavalent vaccine

The second pentavalent vaccine in preventing meningococcal disease approved by the FDA. GSK’s Penmenvy will now go to market against Pfizer Inc.’s Penbraya, which had a two-year head start into the market.

London-based GSK’s recombinant protein vaccine targets five groups of the bacteria Neisseria meningitidis (A, B, C, W and Y) to prevent meningococcal disease in those ages 10 through 25.

The new vaccine combines two separate GSK vaccines, Bexsero (meningococcal group B) and Menveo (meningococcal group ACWY), into a single dose. The aim is to lower the number of injections and deliver the same level of protection, improving coverage and compliance with a vaccination schedule, according to Clarivate’s Drugs to Watch 2025.

Penmenvy is one of 11 drugs on this year’s Drugs to Watch list that could become blockbusters or revolutionize treatment. The report anticipates the vaccine could generate $905 million in sales from the U.S. and four major EU markets in 2030.

The first pentavalent vaccine for meningococcal disease was approved a year and a half ago. The FDA cleared Pfizer’s Penbraya (meningococcal group ABCWY vaccine), the first pentavalent for the indication, in In October 2023. It was designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.

Although Penmenvy is second to market after Penbraya, GSK has the advantage of Bexsero’s approval in the EU for those ages 2 months and older, while Penbraya is limited by approval of Trumenba (meningococcal group B vaccine) for those starting at the age of 10 year, according to Drugs to Watch.  

The approval was based on two phase III studies that took in more than 4,800 healthy participants ages 10 to 25. One study evaluated the effectiveness of two or three doses of GSK's group B Bexsero vaccine and two doses of GSK-3536819A, which is now branded as Penmenvy.