CDC Pushes Pfizer’s Pentavalent Meningococcal Vaccine

• by Marco Cáceres

• Published April 7, 2024
• Opinion

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On Oct. 20, 2023, Pfizer, Inc. announced that the U.S. Food and Drug Administration (FDA) approved its new pentavalent meningococcal vaccine, Penbraya, which targets five meningococcal serogroups (A, B, C, W and Y) that most commonly cause meningococcal disease in adolescents and young adults 10-25 years old. Penbraya, is recommended to be given in two doses six months apart and combines components from Pfizer’s two other meningococcal vaccines, Trumenba and Nimenrix. Trumenba targets meningococcal serogroup B, while Nimenrix targets meningococcal serogroups A, C, W-135 and Y.^{1 2 3 4}

Today marks an important step forward in the prevention of meningococcal disease in the U.S. 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.^{1 2}

Meningococcal disease, which most often presents as meningitis, is caused by bacteria called Neisseria meningitidis. In rare cases it can lead to invasive disease that involves a serious blood infection and inflammation of the spinal cord and meninges of the brain, which can lead to death within 24 hours.^{1 5}

The first meningococcal conjugate vaccine (MCV4) that included serogroups A, C, W and Y was

licensed in the U.S. in 2005 and recommended for 11-12 year olds, and a booster dose is given today at age 16. In 2014, a meningococcal vaccine targeting serogroup B was licensed and recommended for individuals 10 to 25 years old.^6 7

CDC Issues Health Alert About Rise in Meningococcal Disease Cases

There were 375 cases of meningococcal disease reported in the U.S. in 2019. Despite the relatively low number of meningococcal disease cases usually reported in the U.S. every year, the U.S. Centers for Disease Control and Prevention (CDC) has grown concerned about the apparent upsurge in the disease, especially cases involving serotype Y.^{8 9}

The agency reported 422 meningococcal disease cases in 2023—the most since 2014. During the first three months of 2024, the CDC reported 143 meningococcal disease cases, suggesting that cases this year may well surpass those reported last year.

On Mar. 28, 2024, the CDC, through its CDC Health Alert Network (HAN), issued an alert to doctors recommending that they maintain a “heightened suspicion for invasive meningococcal disease and start immediate antibiotic treatment for persons with suspected meningococcal disease.”^{10 11 12}

The alert also recommends to the public:

Talk to your healthcare provider about meningococcal vaccines that may be recommended for you and your household or family members, including any recommended booster doses.¹⁰

Given the introduction of Penbraya into the market last year, it is likely that this vaccine may be widely recommended by doctors to combat the current spike in meningococcal disease cases. Following the FDA’s approval of Penbraya,  pediatric infectious disease physician Jana Shaw, MD of Upstate Golisano Children’s Hospital in Syracuse, New York said:

Nearly nine out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups. For the first time, we have a single vaccine that helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.²

Side Effects of Penbraya and Lack of Key Safety Studies a Concern About the Vaccine

A few safety concerns worth noting about Penbraya…

The vaccine (like all vaccines) has the potential to cause numerous “side effects.” The most common of these are injection site reactions (pain, redness and swelling), fatigue, headache, muscle and joint pain, and chills. Serious side effects can include:

– Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
– Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
– Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.¹³

Penbraya can cause allergic reactions, including life-threatening anaphylaxis. It can cause syncope (fainting).¹³

Additionally, there is little or no data that shows Penbraya is safe for certain individuals. For example, no clinical studies have been done involving the use of Penbraya in pregnant woman. According to the vaccine’s package insert:

Available human data on Penbraya administered to pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy. There were no developmental toxicity studies performed with Penbraya.¹³

There are no data available to assess the effects of Penbraya on the breastfed infant or on milk production/excretion.¹³

No studies have been performed on the relationship of age to the effects of Penbraya in children younger than 10 years old or in adults over 65 years of age. The package insert states: “Safety and efficacy have not been established.” Penbraya has also not been evaluated for the “potential to cause carcinogenicity, genotoxicity, or impairment of fertility.”¹³

Finally, while there is no evidence yet that Penbraya is associated with the polio-like disease Guillain-Barré syndrome (GBS), Pfizer acknowledges that GBS has been reported following administration of other meningococcal vaccines. In its package insert for Penbraya, the company recommends people ask their health care provider about the risks and benefits of Penbraya if they have a history of GBS.^{2 13}

That’s a lot to consider in weighing whether to take this new vaccine. Particularly given the rarity of the disease it targets.

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