US FDA approves Pfizer's vaccine for meningococcal disease

[October 21, 2023]  (Reuters) -The U.S. Food and Drug Administration (FDA) has approved Pfizer's vaccine Penbraya, making it the first shot to protect against five groups of a deadly bacteria that can cause meningitis and blood poisoning, the company said on Friday.

Meningococcal diseases are rare bacterial infections that commonly affect the brain, spinal cord and bloodstream, and can be deadly in a matter of hours.

The pentavalent vaccine protects against five meningococcal bacteria groups - A, B, C, W and Y - which are known to commonly cause the disease.

Pfizer currently sells two vaccines to protect against the disease, with Trumenba targeting the B group and Nimenrix protecting against the other four bacteria groups.

Penbraya combines components from those two vaccines and is approved for use in individuals 10 through 25 years of age. It is administered as a two-dose series given six months apart.

After the FDA approval, the Centers for Disease Control and Prevention's advisers are scheduled to meet on Oct. 25 to discuss use of the vaccine, the company said.

The FDA's decision is based on data from mid- and late-stage studies where Penbraya was shown to be non-inferior in providing immunity against the bacteria compared with a combination of Pfizer's Trumenba and GSK's vaccine Menveo, which is similar to Nimenrix.

A vial and sryinge are seen in front of a displayed Pfizer logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

Pfizer's Trumenba had sales of $123 million last year, while Nimenrix generated $268 million, according to the company's annual report.

Cantor Fitzgerald analyst Louise Chen said in a note in September that if Pfizer's pentavalent vaccine is approved, it could have more uptake than Nimenrix and Trumenba as it will offer more comprehensive protection against the disease.

In 2021, there were about 210 total cases of meningococcal disease reported in the United States, according to CDC data.

GSK is also developing a pentavalent vaccine against meningococcal disease, which combines the components of its B-strain-targeting Bexsero and Menveo.

(Reporting by Leroy Leo, Khushi Mandowara and Christy Santhosh in Bengaluru; Editing by Devika Syamnath)

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