CDC Backs Pfizer’s Meningococcal Vaccine for Young People

Pfizer claims the vaccine demonstrated effective protection against five disease strains that may cause meningitis and sepsis.

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The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices announced its support of a new vaccine aimed at keeping young people safe from meningococcal disease.

Manufactured by Pfizer, Penbraya is an immunization designed to block life-threatening infections caused by the bacteria Neisseria meningitidis serogroups A, B, C, W, and Y, responsible for most meningococcal disease in teens and young adults ages 16 to 23 years old. The bacteria are spread through close personal contact, like living together or kissing.

“PENBRAYA, the first FDA approved 5-in-1 meningococcal vaccine, provides adolescents and young adults in the U.S. with the most comprehensive protection available against the leading causes of meningococcal disease,” said Luis Jodar, chief medical affairs officer of Vaccines/Antivirals and Evidence Generation at Pfizer, in a news release.

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The committee vote comes after Pfizer reported successful phase 3 clinical trial results in September 2022, followed by the U.S. Food and Drug Administration’s (FDA) December 2022 ruling to accept Penbraya’s Biologics License Application (BLA).

CDC Director Dr. Mandy Cohen must still review the committee’s recommendation and decide on its approval.

Penbraya Offers Same Protection in Fewer Doses

The phase 3 trial, sponsored by Pfizer, assessed over 2,400 participants between the ages of 10 and 25 from across the United States and Europe, randomized into two groups. One group was given two doses of Penbraya, while the other group received two doses of Trumenba plus a dose of Menveo—licensed vaccines designed to protect against meningococcal disease. Trumenba is only designed to protect against serogroup B, while Menveo protects against A, C, Y, and W. The current vaccine schedule calls for a combination of the two for a total of four shots.

According to Pfizer, Penbraya demonstrated noninferiority in protection against all meningococcal disease subgroups compared to the Trumenba and Menveo series. Moreover, Penbraya yielded a four-fold or greater immunity response against all disease serogroups compared to the currently licensed vaccines.

Penbraya is administered in two shots spaced six months apart.

“As a pioneer in vaccines, one of our goals is to deliver vaccines that evolve the paradigm and help simplify the standard of care in the U.S.,” said Annaliesa Anderson, senior vice president and head of Vaccine Research and Development at Pfizer, in a news release. “In a single vaccine, PENBRAYA has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”

Meningococcal Disease Symptoms

The two most common infections caused by meningococcal disease are meningitis and sepsis, bacterial blood poisoning. Symptoms vary based on the type of infection and may resemble the flu at first. According to the CDC, symptoms of meningococcal meningitis include fever, headache, stiff neck, nausea, vomiting, and confusion. Infection can also result in photophobia, a heightened sensitivity to light. Children and infants may show signs like physical inactivity, irritability, poor reflexes, or a bulge on the soft, uppermost part of their skull.

Meningococcal disease can lead to sepsis or death within just a few hours of infection if a person does not receive urgent medical treatment. Symptoms of sepsis include tiredness, vomiting, chills, severe aches and pain, cold hands and feet, fast breathing, and diarrhea. In later stages, a dark purple rash can appear.

Who Is at Risk?

While the risk of contracting meningococcal disease is low, anyone can get it. However, some are more at risk than others. A few groups that should be more cautious include:

• First-year college students living in dorms.
• People with a seriously damaged spleen or who’ve had it removed.
• Lab workers regularly exposed to the bacteria.
• Travelers to regions of sub-Saharan Africa and other areas of the world where the disease is widespread.
• U.S. military recruits.
• People in close contact with others who’ve contracted the disease.