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What is the history of Meningococcal vaccine use in America?
Meningococcal vaccine development in the United States began in the 1960s with the organization of a U.S. military meningococcal research group. Throughout both World Wars, meningococcal disease outbreaks occurred and often impacted new recruits within their first three months of service. While meningococcal disease death rates had decreased as result of the discovery and use of sulfonamides by the late 1930’s, sulfa-resistant meningococcal strains had begun to emerge in the 1940s, leading military scientists to begin research and develop a meningococcal vaccine.
The first polysaccharide vaccine targeting meningococcal serogroup C was developed by and tested on members of the U.S armed forces in early 1968. Military scientists also developed a meningococcal serogroup A polysaccharide vaccine; however, clinical trials of this vaccine took place in African communities where serogroup A meningococcal disease was endemic.
By October of 1971, all new U.S. Armed Forces recruits were required to receive the military’s meningococcal serogroup C vaccine, a vaccine not yet licensed for use by the FDA. It wasn’t until 1974 that the FDA licensed three meningococcal polysaccharide vaccines, but only for limited use. The first licensed vaccines included a monovalent meningococcal serogroup A vaccine, a monovalent meningococcal serogroup C vaccine, and a bivalent serogroup A and C vaccine. In 1975, the CDC’s Advisory Committee on Immunization Practices (ACIP) declined to routinely recommend the vaccines and stated that there was “insufficient data on their benefits.” The vaccines were, however, recommended for use in the event of a meningococcal serogroup A or C outbreak but permission for use was required by both the FDA and CDC. Additionally, the CDC stated that while travelers visiting countries where meningococcal disease was considered endemic might benefit from vaccination, they also noted that no cases of meningococcal disease had ever been reported among Americans visiting these high risk areas. The military continued to routinely administer meningococcal polysaccharide serogroup C vaccine to all new recruits until 1978 at which time it switched to the bivalent meningococcal serogroup A and C polysaccharide vaccine.
Menomune, the first tetravalent meningococcal polysaccharide vaccine targeting meningococcal serogroups A, C, Y and W-135 received FDA approval for use in 1981 and by 1982, the military began using this vaccine in place of the bivalent vaccine. In 1985, ACIP issued their first recommendations on use of the tetravalent vaccine and recommended the vaccine for individuals with terminal complement component deficiencies, functional or anatomical asplenia, or in the event of an outbreak of serogroup A, C, Y and W-135 meningococcal disease. In the spring of 2000, ACIP recommended college students, particularly college freshman living in dormitories, consider tetravalent meningococcal polysaccharide vaccination but chose not to recommend routine vaccination, stating that meningococcal disease rates were low and routine vaccination would not be cost effective.
The first meningococcal conjugate vaccine, Menactra, manufactured by Sanofi Pasteur, received FDA approval in January 2005 for use in persons ages 11 through 55 years. Menactra (MCV4 or MenACWY-D), a vaccine conjugating meningococcal serogroups A, C, Y and W-135 to a diphtheria toxoid, received FDA approval on the basis that it was not inferior in both safety and immunogenicity to the available tetravalent meningococcal polysaccharide vaccine, Menomune.
Later that year, in May of 2005, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that all 11-12-year olds receive the newly approved vaccine. In its recommendation, ACIP reported that a single vaccine dose would likely be effective for at least 22 years, and by vaccinating all 11-12-year olds, 21 cases and 3 deaths would be averted in the first year, and 270 cases and 36 deaths would be prevented over a period of 22 years. The committee also recommended the vaccine for use in persons between the ages of 11 and 55 with functional or anatomical asplenia and complement component deficiencies as well as for college freshmen living in dormitories, military recruits, microbiologists routinely working with N. meningitidis, and persons traveling to or residing in meningococcal disease endemic countries. When the recommendation was made, the vaccine had only been studied in approximately 5,000 health adolescents, and only one study of just over 1,000 teenagers had evaluated the safety and immunogenicity of the vaccine when administered concomitantly with the tetanus-diphtheria (Td) vaccine.
By September of 2005, the FDA and CDC issued a joint advisory warning of a potential association between Menactra vaccine and Guillain-Barre Syndrome (GBS). The vaccine product insert was updated to warn of the possible association of the vaccine to GBS and a previous history of GBS was listed as a contraindication to vaccination. The CDC, however, continued to recommend vaccination even as additional cases of GBS following Menactra vaccine administration were reported.
In May of 2006, the CDC issued a recommendation to defer vaccination of all 11-12 year olds in anticipation of a vaccine shortage, however, vaccination of all adolescents entering high school and all college freshman residing in dormitories continued to be recommended. Despite a meningococcal vaccine shortage, reports of GBS following Menactra vaccine administration continued to be submitted to the Vaccine Adverse Events Reporting System (VAERS). The CDC issued another update on the additional cases of GBS following Menactra vaccine in October 2006 but continued to recommend vaccination, reporting that GBS rarely occurred and data evaluation of a link would take years to determine.
In 2010, after a review of safety studies, ACIP voted to remove a personal history of GBS as a contraindication to meningococcal vaccination, and stated that the vaccine’s benefits outweighed the possible risk of developing a recurrent case of GBS. The Menactra product insert, however, continues to caution that a previous diagnosis of GBS may increase a person’s chance for recurrent illness and the decision to administer Menactra should carefully consider both the possible risks and potential benefits to vaccination.
By November 2006, the supply of Menactra vaccine had improved and routine vaccination of all 11-12-year olds was resumed along with continued vaccination of all high school freshman and college freshmen residing in dormitories. However, by November of 2006, additional vaccines targeting all 11-12-year olds had been both FDA approved and added to the CDC’s vaccine schedule by ACIP. The newly licensed tetanus, diphtheria, and acellular pertussis vaccine (Tdap) was added in March of 2006 and in June of 2006, Gardasil, Merck’s human papillomavirus vaccine (HPV4) received FDA approval for use in all 11-12 year old females. When ACIP published its recommendation on the HPV vaccine in March of 2007, it acknowledged that no evidence existed on the safety or effectiveness of administering the vaccine with Menactra or other newly recommended vaccines, however physicians were encouraged to simultaneously administer all recommended vaccines based on an assumption of safety. By August of 2007, ACIP recommended that all adolescents between the ages of 11 and 18 be vaccinated with the meningococcal conjugate vaccine at the earliest opportunity as the vaccine supply was believed to be sufficient enough to handle the increased demand for the product anticipated by this updated recommendation.
In October of 2007, the FDA approved Menactra (MCV4 or MenACWY-D) for use in children over the age of two. One week later, ACIP recommended that all children between the ages of two and ten years with functional or anatomical asplenia, complement component deficiencies, as well as children traveling to meningococcal disease endemic areas be vaccinated with MCV4. The vaccine was also recommended over the previously approved meningococcal polysaccharide vaccine despite any evidence that it was more effective than the previously recommended meningococcal polysaccharide vaccine. In February 2008, the committee, however, declined to decrease the recommended age of routine MCV4 vaccination to include children as young as two years of age, reporting that the current strategy of vaccinating all 11-12 year olds was likely to be most cost effective.
Menveo (MenACWY-CRM), a second meningococcal serogroup A, C, Y, and W-135 conjugate vaccine manufactured by Novartis Vaccine and Diagnostics (GlaxoSmithKline) received FDA approval in February of 2010 for use in persons aged 11 through 55 years. By March of 2010, ACIP announced that MenACWY-CRM could be used when vaccination with a meningococcal conjugate vaccine was indicated. Only one pre-licensing clinical trial of Menveo examined the safety and effectiveness of administering the vaccine concomitantly with both Tdap and HPV vaccine. The clinical trial involved 540 females between the ages of 11 and 18, however, trial results were not required by the FDA prior to the vaccine’s approval.
By October of 2010, public health officials had discovered that meningococcal conjugate vaccines were not as effective as previously thought. Meningococcal conjugate vaccines did not offer long-term vaccine acquired immunity and health officials reported that over 50 percent of teenagers vaccinated at age 11-12 years would likely not be protected against meningococcal disease when the risk of disease development was significantly higher, by age 16 through 21. As ACIP had previously determined age 11-12 to be a time when adolescents were noted to have a greater number of preventative care visits and that recommending the vaccine at this age would “strengthen the pre-adolescent vaccination platform,” a booster dose of meningococcal conjugate vaccine was recommended at age 16 in lieu of increasing the age recommendation to 16 years. The committee, however, stated that if the first dose of meningococcal conjugate vaccine was administered at age 16 or older, no additional booster dose would be required and that meningococcal vaccination of healthy individuals 21 years of age and older was not needed due to the low risk of meningococcal disease in this population.
In January of 2011, Menveo (MenACWY-CRM) received FDA approval for use in children age two through ten years and in April of 2011, Menactra (MenACWY-D) was approved for use in infants and young children between the ages of 9 and 23 months. Following FDA approval, ACIP voted to recommend Menactra (MenACWY-D) for use in infants and young children with complement component deficiencies, those traveling to areas where meningococcal disease was considered endemic, as well as those residing in an institution or community setting in the midst of a meningococcal outbreak. However, children with functional or anatomical asplenia, a population noted to be at greater risk for pneumococcal disease, were advised to wait until the age of two years before MenACWY-D vaccination. This recommendation was made as clinical trial data had noted that antibody levels decreased in three out of seven pneumococcal vaccine strains when MenACWY-D was administered at the same time as Prevnar 7 (PCV7) pneumococcal vaccine.
In June of 2012, the FDA approved the first meningococcal vaccine for use in infants as young as six weeks of age. MenHibrix (Hib-MenCY-TT), a meningococcal serogroup C and Y and Haemophilus b (HIB) tetanus toxoid conjugate vaccine manufactured by GlaxoSmithKline, received approval to be administered on a four dose schedule at 2, 4, 6, and 12 to 15 months of age. In response to FDA approval of MenHibrix (Hib-MenCY-TT), ACIP approved the vaccine for use in infants with complement component deficiencies or anatomical or functional asplenia and for use in the event of an outbreak of meningococcal serogroup C or Y. It was not, however, recommended for use in infants or young children traveling to sub-Saharian Africa as the vaccine would offer no protection against meningococcal serogroups A and W-135 disease, the two most common serogroups found within this region. Routine vaccination of infants and young children was not recommended as MenHibrix (Hib-MenCY-TT) offered no protection against meningococcal serogroup B, the serogroup responsible for approximately 60 percent of all invasive meningococcal disease in infants and children under the age of five years. Further, with infants under six months of age considered most at risk of infection, public health officials believed that one or possibly two doses of the vaccine administered before six months of age would likely not impact meningococcal disease rates. Citing low demand for the product, GlaxoSmithKline announced the discontinuation of MenHibrix in the United States in October of 2016.
In August of 2013, the FDA approved the use of Menveo (MenACWY-CRM) to be administered as a 4-dose series in infants at 2, 4, 6, and 12 to 15 months of age. Again, while routine vaccination of infants and young children was not recommended, the ACIP did, however, recommend the vaccine for use in infants and young children traveling to or residing in countries where meningococcal disease was considered endemic, during an outbreak of meningococcal disease for which the vaccine was indicated, in young children with complement component deficiencies, as well as for those with functional or anatomical asplenia. While simultaneous administration of Menactra (MenACWY-D) vaccine with Prevnar 7 (PCV7) vaccine was found to decrease pneumococcal antibody levels, this was not noted when Menveo (MenACWY-CRM) was administered concomitantly with PCV7 vaccine and therefore the vaccine was recommended for use in infants beginning at age two months who had received a diagnosis of functional or anatomical asplenia.
The first meningococcal serogroup B vaccine, TRUMENBA, manufactured by Wyeth (Pfizer) pharmaceuticals, received FDA approval for use in persons aged 10 through 25 years of age on October 29, 2014. Less than five months earlier, TRUMENBA was given Breakthrough Therapy designation by the FDA and as meningococcal serogroup was considered a significant health threat, the FDA’s Center for Biologics Evaluation and Research (CBER) to agree to review TRUMENBA under the accelerated approval regulation. Pre-licensing clinical trials of TRUMENBA involved less than 4,600 healthy individuals predominantly between the ages of 11 and 18 years and the vaccine was only studied for safety and immunogenicity when administered with HPV4 vaccine. Pre-licensing clinical studies did not evaluate safety or immunogenicity of administering TRUMENBA with Tdap, influenza, HPV9 or any licensed meningococcal conjugate vaccines.
BEXSERO, a second meningococcal serogroup B vaccine, manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline), received FDA approval for use on January 23, 2015. However, in late 2013 - early 2014, prior to FDA approval, the unlicensed vaccine was permitted by the CDC and FDA for use at both Princeton University and the University of California Santa Barbara (UCSB) where outbreaks of meningococcal serogroup B disease had been reported. At UCSB, where 51 percent of students received one vaccine dose and only 37 percent completed the recommended two dose series, no additional cases of meningococcal serogroup B disease were reported. At Princeton University, where 90 percent of students opted to receive 2 doses of the unlicensed vaccine, no further cases of meningococcal serogroup B disease were reported among vaccinated Princeton students but one additional case was reported in a student from another local university who had been in close contact with several Princeton University students. Vaccine researchers concluded that while the vaccine appeared effective at protecting vaccinated individuals, it likely had no impact on nasopharyngeal carriage and vaccinated individuals could still potentially spread the disease to others.
BEXSERO also received Breakthrough Therapy designation by the FDA, and through the accelerated approval designation, it was licensed within 10 months. At the time of FDA approval, no clinical studies had examined the safety or immunogenicity of BEXSERO when administered concomitantly with any other vaccine.
At the CDC’s February 2015 ACIP meeting, the two newly licensed meningococcal group B (MenB) vaccines were recommended for use in persons 10 years and older with functional or anatomical asplenia, complement component deficiencies, as well as individuals taking eculizumab (Soliris®) medication, microbiologists routinely exposed to Neisseria meningitidis, and in the event of a meningococcal serogroup B disease outbreak. At the June 2015 ACIP meeting, the committee declined to routinely recommend MenB vaccines but stated that they could be administered to adolescents and young adults between the ages of 16 and 23 years of age, with the preferred age considered between 16 and 18 years. Routine MenB vaccination was not considered cost effective as data suggested that overall, it would only prevent between 15 and 29 cases, and 2 to 5 deaths, and among college students, approximately 9 cases and 1 death.
In June 2016, HIV-positive individuals aged two months and older were added to the list of persons considered at high risk for meningococcal disease and recommended by ACIP to receive meningococcal conjugate vaccines (serogroup A, C, Y and W-135). At the time of this recommendation, committee members admitted that there had never been any safety or immunogenicity studies of the vaccine for use in HIV-positive children aged two months to two years or among HIV-positive adults 25 years of age and older. Further, this decision was made despite conflicting data on meningococcal disease case-fatality rates. Studies from South Africa had noted a high meningococcal disease death rate among HIV-positive persons whereas studies from New York City and the United Kingdom had found lower death rates among HIV-positive individuals in comparison to persons without HIV disease.
In February of 2017, Sanofi Pasteur announced the discontinuation of the Menomune tetravalent meningococcal polysaccharide vaccine. In response, the CDC announced that persons 56 years of age and older recommended to receive meningococcal vaccination could be administered a meningococcal conjugate vaccine. This recommendation was made despite acknowledging that neither available meningococcal conjugate vaccine was FDA approved for use in persons older than 55 years of age.
On April 23, 2018, Pfizer (Wyeth) announced that its TRUMENBA meningococcal group B vaccine had once again received Breakthrough Therapy designation by the FDA. The designation involved the use of TRUMENBA in children 12 months through 9 years of age. FDA approval for use of the vaccine in this population is still currently pending.
In April 2020, the FDA approved a third meningococcal conjugate vaccine, MenQuadfi (Sanofi Pasteur), targeting meningococcal serogroups A, C, Y, and W-135 for use in persons two years of age and older. Menactra was discontinued by Sanofi Pasteur in 2022.
In December 2022, Pfizer submitted data to support licensure of their experimental pentavalent meningococcal vaccine targeting serogroups A, B, C, Y, and W-135 in persons 10 through 25 years of age to the FDA. A decision on the application is expected by October 2023.
NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.