A new vaccine from Pfizer has been approved by the Food and Drug Administration as the first shot of its kind to address multiple strains of meningococcal disease, the company said Oct. 20.
After receiving FDA approval, the vaccine is now waiting for the Centers for Disease Control and Prevention to release their recommendations, which would allow the shot to reach consumers.
Meningococcal disease, the cause of meningitis and other severe illnesses, has been on the decline since vaccines were introduced as part of a child’s regular shot regimen, according to data from the CDC.
But what has long been a multi-dose care plan may now come down to a single shot.
Here’s what you need to know.
What is meningococcal disease?
Meningococcal diseases include a group of illnesses that are caused by a type of bacteria known as Neisseria meningitidis.
The bacteria is so common that about one in every 10 people have the bacteria in their nose and throat, but may not get sick, according to the CDC.
When the bacteria is able to enter the body, it most commonly causes one of two illnesses, either meningococcal meningitis or meningococcal septicemia.
The first, known commonly as meningitis, can cause a fever, headache and stiff neck, or progress to more severe symptoms like nausea, vomiting, light sensitivity and mental confusion.
The symptoms are caused by the bacteria entering the lining of the brain and the spinal cord, causing the lining to swell and increase pressure, the CDC says.
In extreme cases of meningitis or if the bacterial infection is left untreated, it can cause difficulty breathing, low blood pressure, necrotic tissue, nerve and brain damage, or death, according to the CDC.
About 10% to 15% of people who develop a meningococcal disease die from the illness, and of those who survive, one in five are left with long-term medical complications like limb amputations, deafness, nervous system problems or brain damage.
The second most common illness from the bacteria, meningococcal septicemia, may begin with similar symptoms like fever and nausea.
However, septicemia occurs when the meningococcal bacteria enters the bloodstream instead of the nervous system, traveling through the walls of the bloodstream and blood vessels to the skin and organs, according to the CDC.
Symptoms include cold hands and feet, muscle and joint aches and pains, rapid breathing, diarrhea and a dark purple rash.
Left untreated, septicemia can have similar severe negative effects as meningitis, the CDC says.
Most meningococcal diseases fall under six different serogroups or serotypes, an identifiable strain of the bacteria.
Neisseria meningitidis has serotypes A, B, C, W, X and Y, and the most common serotypes seen in the United States are B, C and Y, according to the CDC.
Is there already a vaccine for meningococcal disease?
Due to the potentially extreme symptoms of meningococcal diseases, there are two vaccines already available as part of a child’s regular vaccine regimen.
The first is a meningococcal conjugate vaccine, or MenACWY vaccine that addresses four of the six serotypes.
The second is specific to serotype B, known as a MenB vaccine.
Most kids will only receive the first vaccine during their preteen years and then a booster at age 16, but some children with preexisting conditions or heightened risk factors will also take the second vaccine.
Now, the FDA has approved a new vaccine called Penbraya, and it addresses five of the six serogroups, the first vaccine of its kind.
“Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” Jana Shaw, a pediatric infectious disease specialist at Upstate Golisano Children’s Hospital said in an Oct. 20 news release. “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.”
Who should get a vaccine?
The CDC currently recommends the existing MenACWY for all children ages 11 and 12. This includes three approved shots – Menactra, Menveo and MenQuadfi. These shots are given as two doses, the first at age 11 or 12 and the second as a booster at age 16.
A meningococcal disease vaccine is required by most states for students in public education, according to the CDC.
Health officials also recommend that teens should get the second vaccine MenB, to increase their protection.
This includes the two-dose vaccine Bexsero given to people ages 16 to 23, or the two-dose vaccine Trumenba given to the same age group. Trumenba has an additional dose for those at an increased risk.
These recommendations may change with the introduction of a single vaccine to combat all five serogroups, but those changes won’t be made until the CDC advisory committee meets.
The CDC Advisory Committee on Immunization Practices will meet Oct. 25 to discuss changes to meningococcal vaccine recommendations to include Penbraya, according to an Oct. 20 release from Pfizer, the vaccine developer.
If they did not receive the vaccine during their teen years, adults can get one of the existing vaccines if they have preexisting conditions or an increased risk of the disease such as living in a college dormitory, working internationally or being a member of the military.
Pregnant women should not receive a meningococcal vaccine while pregnant unless they are at an increased risk for the disease and have discussed the potential risks with a doctor, the CDC says.
In all situations, it’s important to discuss your vaccine options with a primary care physician or health care provider.
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