Meningococcal

Pentavalent Meningitis Vaccine Reduces Africa's Meningitis Belt

Karen McClorey Hackett — Mon, 23 Sep 2024 17:02:05 +0000

Reviewer:

Meningitis is one of the leading causes of mortality and morbidity, especially in the meningitis belt of sub-Saharan Africa. Recurrent meningitis outbreaks across the meningitis belt have resulted in significant mortality over decades.

Sub-Saharan Africa historically experienced major epidemics of meningococcal disease every 5 to 12 years. Meningitis is a severe infection of the thin membrane surrounding the brain and spinal cord that can cause severe brain damage and is fatal in up to 80% of cases if untreated.

The U.S. CDC reports that attack rates during epidemics in Africa can reach 1,000 cases per 100,000 population.

A recent paper examined the global burden of meningitis, 2.5 million cases, exploring its prevalence and impact across different regions.

This research further analyzed the evolution of meningitis vaccination strategies. Licensed vaccines against meningococcal disease have been available for more than 40 years. Over time, there have been significant improvements in strain coverage.

These researchers highlighted the recent development and introduction of the novel pentavalent Men5CV meningococcal conjugate vaccine.

The Men5CV vaccine has emerged as a remarkable advancement in the fight against meningitis. It is safe and effective against various serogroups, including the elusive serogroup X.

The vaccine results from a 13-year development collaboration between Serum Institute of India and PATH.

The Men5CV vaccine's pre-qualification by the World Health Organization (WHO) in July 2023 and subsequent recommendation for incorporation into routine immunization programs have opened a new era with the potential for meningitis eradication.

For example, Nigeria launched vaccinations in February 2024 and now sets a benchmark for other nations in the meningitis zone, becoming the first country in the world to roll out the new Men5CV vaccines.

Funding from organizations like Gavi highlights the importance of coordinated international efforts aligned with the WHO's roadmap for meningitis elimination by 2030.

Dr. Tokunbo Oshin, Director of High Impact Countries at Gavi, the Vaccine Alliance, commented in March 2024, "Thanks to vaccines, we have eliminated large and disruptive outbreaks of meningitis A in Africa: now we have a tool to respond to other meningococcal meningitis serogroups that still cause large outbreaks resulting in long-term disability and deaths."

The U.S. CDC says meningococcal vaccines are the best way to protect against meningococcal disease, but side effects can occur.

Three types of meningococcal vaccines are used in the U.S.: Meningococcal conjugate or MenACWY vaccines, Serogroup B meningococcal or MenB vaccines, and Pentavalent or MenABCWY vaccine.

These vaccines are offered at health clinics and pharmacies in the U.S.

The CDC recommends that travelers two months old or older get vaccinated before visiting areas part of the meningitis belt during the dry season when visiting countries such as Nigeria.

Sub Title:

Men5CV pentavalent meningitis vaccine is eliminating a leading cause of neurological disease and disability in Africa

References:

A perspective on the novel pentavalent Men5CV (NmCV-5) meningitis vaccine

Five things you need to know about the world’s latest weapon against bacterial meningitis

US CDC

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US CDC 2024

Meningococcal Cases Linked to Recent Travel

Donald Hackett — Mon, 20 May 2024 16:24:12 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The Centers for Disease Control and Prevention (CDC) today issued a Health Alert Network (HAN) Health Advisory to notify healthcare providers about cases of meningococcal disease associated with Umrah, which is conducted in the Kingdom of Saudi Arabia (KSA).

Meningococcal disease, caused by Neisseria meningitidis, is a rare but severe illness with a 10–15% case-fatality rate.

Since April 2024, 12 cases of meningococcal disease linked to travel to KSA for Umrah have been reported to national public health agencies in the United States (5 cases), France (4 cases), and the United Kingdom (3 cases).

Ten cases were in patients who traveled to KSA, and two were in patients who had close contact with travelers to KSA. Ten cases were caused by Neisseria meningitidis serogroup W (NmW), one U.S. case was caused by serogroup C, and the serogroup is unknown for one U.S. case.

The isolates from the one U.S. NmC case and two NmW cases (one U.S., one France) were resistant to ciprofloxacin; based on whole-genome sequencing, the remaining eight NmW isolates were all sensitive to penicillin and ciprofloxacin.

Nine of these patients were unvaccinated.

Umrah is an Islamic pilgrimage to Mecca, KSA, that can be performed at any time of the year, while the Hajj is an annual pilgrimage that will take place from June 14 to 19, 2024.

Meningococcal disease outbreaks have occurred previously in conjunction with mass gatherings, including the Hajj pilgrimage.

The most recent global outbreak of meningococcal disease associated with travel to KSA for Hajj was in 2000–2001, primarily caused by NmW.

Since 2002, KSA has required all travelers aged one year or older performing Hajj or Umrah to provide vaccination documentation. KSA's requirement aligns with the CDC's recommendations for revaccinating U.S. travelers to endemic areas.

MenACWY conjugate vaccination is routinely recommended for travelers to countries where meningococcal disease is hyperendemic or epidemic, including a booster dose of MenACWY if the last dose was administered 3–5 or more years previously (depending on the age at the most recent dose received).

In the U.S., various meningococcal vaccines are offered at pharmacies and travel vaccine clinics.

The unedited HAN CDCHAN-00508 is posted at this CDC link.

Sub Title:

Health Advisory alert issued for meningococcal cases linked to Umrah travel

Reference:

CDC HAN - CDCHAN-00508

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Most Meningococcal Disease Cases Confirmed Since 2014

Karen McClorey Hackett — Sun, 10 Mar 2024 20:18:23 +0000

Reviewer:

Robert Carlson, MD

Meningitis continues to be a major public health concern worldwide, with epidemics being reported in 2024.

In the U.S., the Centers for Disease Control and Prevention (CDC) recently reported a significant increase in meningococcal disease cases, which causes severe inflammation of the membranes surrounding the brain and spinal cord.

Based on preliminary data, as of March 8, 2024, there were 415 confirmed and probable cases of meningococcal disease in 2023 alone.

This is the highest number of cases reported in the U.S. since 2014.

Public health officials track all meningococcal disease cases in each state.

For example, the Department of State Health Services (DSHS) recently reported a statewide uptick in meningococcal disease in Texas. Of the 27 people infected since November 2023, 10 developed meningitis, and one unvaccinated person died.

In Houston, between November and February 2024, four adults and three children were infected with meningococcal disease.

This significant rise in cases is primarily driven by the N. meningitidis serogroup Y.

The bacterium N. meningitidis causes invasive meningococcal disease and spreads from person to person through respiratory or throat secretions (saliva or spit). Generally, it takes close and lengthy contact, such as kissing, sharing utensils, or staying in the same household, for spread to occur, says DSHS.

The bacteria can reside in the upper respiratory tract of asymptomatic individuals, who unknowingly can spread the disease. However, the bacteria are not distributed by simply breathing the air where a person with meningococcal disease has been.

Because of the risks of severe morbidity and death, effective antibiotics should be administered promptly to patients suspected of having meningococcal disease.

Meningococcal disease is vaccine-preventable, and several approved vaccines are available in the U.S. These vaccines are offered at most pharmacies.

In Texas, one dose of the MenACWY vaccine is required for students enrolling in 7th–12th grades.

Find more information on meningococcal meningitis at dshs.texas.gov/vaccine-preventable-diseases/meningococcal-invasive-disease.

Sub Title:

Houston reported seven recent meningococcal disease cases

References:

US CDC Cases of meningococcal disease 2024

Texas Health Advisory: Increase in Invasive Meningococcal Disease 2024

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US CDC meningococcal disease trends

Virginia's Deadly Meningococcal Disease Outbreak

Karen McClorey Hackett — Wed, 06 Sep 2023 16:41:26 +0000

Reviewer:

Robert Carlson, MD

The state of Virginia recently joined Florida in combating a multi-year meningococcal disease outbreak.

The Virginia Department of Health (VDH) announced on August 31, 2023, that twenty-seven cases of meningococcal disease have been reported in eastern, central, and southwest Virginia since June 2022.

Five patients have died from complications associated with this disease.

Most of the Virginia cases were in unvaccinated people and caused by the bacteria called Neisseria meningitidis type Y. This strain is known to be circulating widely in the United States.

Eastern Virginia (20 cases) is the most rural region of the state, with the smallest population and no cities. It's divided into three parts by the Chesapeake Bay: the Eastern Shore, Northern Neck, and Middle Peninsula.

Anyone can get meningococcal disease, regardless of gender, age, race, ethnicity, or sexual orientation. And keeping up to date with recommended vaccines is the best protection against meningococcal disease. says the VDH.

The meningococcal conjugate vaccine (MenACWY) can provide protection against Neisseria meningitidis type Y.

As of early September 2023, the VDH says the risk to Virginia's population remains low.

In Florida, the U.S. Centers for Disease Control and Prevention (CDC) and the Florida Department of Health announced in 2022 that they were investigating meningococcal disease among gay and bisexual men.

In 2023, 16 meningococcal disease cases were reported in 12 counties. The meningococcal disease rate was highest among those aged 12-18 years.

Six deaths among gay and bisexual men were previously reported.

In 2019, Florida reported 23 cases of meningococcal disease, which dropped to 17 cases in 2020 and then rose to 27 cases in 2021.

In response to the serogroup C meningococcal disease outbreak in Florida, the CDC encourages gay and bisexual men to get a MenACWY vaccine if they live in Florida and talk with their healthcare provider about getting a MenACWY vaccine if they are traveling to Florida.

In addition, the CDC says MenACWY vaccination is routinely recommended for all people with HIV in the U.S.

In the U.S., meningococcal disease rates have been declining since the 1990s and currently remain low, according to the CDC.

People spread meningococcal bacteria to others by sharing respiratory and throat secretions.

An infected person can spread the bacteria by kissing, coughing, or sneezing directly into the face of others or sharing cups, water bottles, eating utensils, cigarettes, lipstick, or toothbrushes.

People do not catch the bacteria through casual contact or breathing air where someone with meningococcal disease has been.

Most people exposed to this bacteria do not become ill. A small proportion of infected people can develop a severe illness, such as meningitis (inflammation of the lining of the brain and spinal cord) or a bloodstream infection (septicemia).

Invasive meningococcal disease (IMD) can exist as an endemic disease or as an epidemic. IMD incidence occurs mainly in infants under one year of age, teenagers, and young adults.

IMD can also affect older patients during severe outbreaks.

For additional help contacting your local health department in Virginia, call 877-VAX-IN-VA (877-829-4682, TTY users call 7-1-1). Assistance is available in English, Spanish, and over 100 other languages.

Sub Title:

Virginia and Florida report Meningococcal Disease deaths in 2023

References:

Meningococcal Disease Outbreak in Florida, 2021–23

Virginia Department of Health Announces Statewide Outbreak of Meningococcal Disease

VA Outbreak Cases by Region 2023

Cases of meningococcal disease in Florida

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Controlling Meningococcal Disease with Innovative Vaccines

Karen McClorey Hackett — Fri, 26 May 2023 14:24:13 +0000

Reviewer:

Robert Carlson, MD

The human pathogen Neisseria meningitidis has been feared worldwide for more than 215 years and has caused epidemics, pandemics, and sporadic cases of meningitis, fatal sepsis, and, less commonly, pneumonia, wrote David S. Stephens, M.D. in an Editorial published by the New England Journal of Medicine.

Although disease rates have decreased in many regions partly due to the introduction of highly effective vaccines, Neisseria meningitidis case fatality remains high at 10 to 20%.

"We are a step closer to worldwide control of meningococcal disease and the burden of meningitis with these (vaccine) efforts," added Stephens on May 25, 2023.

In 2019, there were estimated 2.5 million cases of meningitis worldwide, which resulted in more than 236,000 deaths.

The highest disease incidence across the African meningitis belt stretches from Gambia and Senegal in the west to Ethiopia in the east, where Neisseria meningitidis predominantly cause meningitis epidemics.

Although quadrivalent meningococcal ACWY conjugate vaccines have been licensed and prequalified by the WHO, their use in Africa has been limited.

Furthermore, there are currently no licensed vaccines against meningococcal serogroup X.

Thus, building on the success of the Meningitis Vaccine Project, the Serum Institute of India and PATH developed a pentavalent meningococcal ACWYX conjugate vaccine (NmCV-5) to eliminate meningococcal disease in sub-Saharan Africa.

In a NEJM Original Article, researchers report the results of a phase 3 trial of the NmCV-5 vaccine in participants 2 to 29 years of age in Mali and Gambia.

The trial aimed to show the safety and immunologic noninferiority of the NmCV-5 vaccine compared to a licensed, WHO-prequalified, quadrivalent meningococcal conjugate vaccine (Menactra).

In the NmCV-5 group, the percentage of participants with a seroresponse ranged from 70.5% (95% CI, 67.8 to 73.2) for serogroup A to 98.5% (95% CI, 97.6 to 99.2) for serogroup W; the percentage with a serogroup X response was 97.2% (95% CI, 96.0 to 98.1).

The overall difference between the two vaccines in seroresponse for the four shared serogroups ranged from 1.2 percentage points (96% CI, −0.3 to 3.1) for serogroup W to 20.5 percentage points (96% CI, 15.4 to 25.6) for serogroup A.

The overall GMT ratios for the four shared serogroups ranged from 1.7 (98.98% CI, 1.5 to 1.9) for serogroup A to 2.8 (98.98% CI, 2.3 to 3.5) for serogroup C.

The serogroup X component of the NmCV-5 vaccine generated seroresponses and GMTs that met the prespecified noninferiority criteria.

The incidence of systemic adverse events was similar in the two groups (11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group).

In conclusion, these researchers wrote all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine-elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine.

And NmCV-5 elicited immune responses to serogroup X, with no safety concerns evident.

This Serum Institute of India Pvt. Ltd. sponsored phase 3 clinical trial was intended to provide the required data for the licensure and WHO prequalification of the vaccine for future epidemic control.

The U.K. Foreign, Commonwealth, and Development Office and others funded this study, and no industry conflicts were disclosed.

Sub Title:

NmCV-5 is a pentavalent meningococcal ACWYX conjugate vaccine candidate

References:

Global Control of Meningococcal Disease

Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia

US CDC Meningococcal Vaccination

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U.S. CDC meningococcal disease map May 2023

Florida’s Meningococcal Outbreak Causes Six Fatalities

Karen McClorey Hackett — Thu, 23 Jun 2022 02:08:21 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The U.S. Centers for Disease Control and Prevention (CDC) announced today that a large, ongoing outbreak of serogroup C meningococcal disease had been confirmed in at least 24 cases, causing six related fatalities in Florida.

In response to this outbreak, the CDC is recommending gay, bisexual, and other men who have sex with men get a meningococcal vaccine (MenACWY) if they live in Florida or talk with their healthcare provider about getting vaccinated if they are traveling to Florida.

Anyone can spread meningococcal bacteria to others by sharing respiratory and throat secretions. Generally, it takes close or lengthy contact, such as kissing or being near someone coughing, to spread these bacteria, says the CDC.

The Florida Department of Health and the CDC also emphasized on June 22, 2022, the importance of routine MenACWY vaccination for people with HIV.

“Getting vaccinated against meningococcal disease is the best way to prevent this serious illness, which can quickly become deadly,” said José R. Romero, M.D., Director, National Center for Immunization and Respiratory Diseases, in a CDC press release.

“Because of the outbreak in Florida and the number of Pride events being held across the state in coming weeks, it’s important that gay and bisexual men who live in Florida get vaccinated with a MenACWY vaccine.”

In response to the serogroup B cluster in Florida, officials are recommending that college and university students in Leon County, FL, consider getting a MenB vaccine series.

People can find a meningococcal vaccine by contacting their doctor’s office, pharmacy, community health center, or local health department. 

Insurance providers should pay for meningococcal vaccination for those whom it is recommended for during an outbreak.

In Florida, anyone can get a MenACWY vaccine at no cost at any county health department during the outbreak.

Meningococcal symptoms can appear suddenly, including high fever, headache, stiff neck, nausea/vomiting, or a dark purple rash. Symptoms can first appear as a flu-like illness but can worsen very quickly. 

Meningococcal disease can be deadly and includes infections of the lining of the brain, spinal cord (meningitis), and bloodstream.

‘Keeping up to date with recommended vaccines is the best protection against meningococcal disease, says the CDC.

More information about the outbreak and vaccine is available at Meningococcal Disease in Florida, 2022 | CDC.  

PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership.

Sub Title:

CDC recommends the meningococcal vaccine MenACWY for various men in Florida

References:

CDC: Gay and bisexual men urged to get vaccinated if living in Florida, or talk with their healthcare provider about vaccination

Florida Department of Health Advises on Meningococcal Disease and Vaccines in Florida

Meningococcal Vaccines

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Late Stage Vaccine Updates Issued by Pfizer

Don Hackett — Mon, 22 Jun 2020 13:05:23 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Pfizer Inc. announced the initiation of four Phase 3 clinical trials within its current pipeline of investigational vaccines.

"The start of four Phase 3 studies across our portfolio of investigational vaccines is a testament to the talented and dedicated colleagues working throughout Pfizer, and the continued commitment to unlocking the potential promise and value that vaccines hold for our world,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc., in a June 22, 2020, press statement.

"If approved, all three vaccine candidates could help prevent serious, possibly deadly infectious diseases that negatively impact millions of people of all ages globally.”

Two studies (NCT04382326 and NCT04379713) of the 20-valent pneumococcal polysaccharide conjugate vaccine candidate, 20vPnC, evaluating a four-dose series in infants starting at 2 months of age. Both studies will expand the data on the safety and tolerability of the investigational vaccine in infants and include a control group of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). Study NCT04382326 has the goal of determining immunologic noninferiority between 20vPnC and Prevnar 13®, a critical requirement for vaccine licensure.

One study (NCT04424316) of the respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in pregnant women to evaluate the safety and efficacy of RSVpreF in infants born to immunized pregnant women as compared to placebo.

One study (NCT04440163) of the pentavalent meningococcal vaccine candidate, MenABCWY, in adolescents and young adults to assess the safety, tolerability, and immunogenicity of the MenABCWY vaccine candidate compared to licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.

Precision Vaccinations publishes investigational vaccine news.

Sub Title:

Pfizer announces pneumococcal, meningococcal and RSV clinical trials

Reference:

Pfizer Announces Start of Four Phase 3 Clinical Trials for Investigational Vaccines

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Invasive Meningococcal Disease Vaccine Approved

Don Hackett — Fri, 24 Apr 2020 20:21:21 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The U.S. Food and Drug Administration (FDA) announced its approval of a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.

This licensure on April 24, 2020, marks MenQuadfi as the only U.S. FDA-approved quadrivalent meningococcal vaccine indicated for persons 2 through 56 years of age and older.

And, MenQuadfi is the only quadrivalent meningococcal vaccine in the U.S. that uses tetanus toxoid as a protein carrier.

However, MenQuadfi does not prevent serogroup B disease.

David Loew, Executive Vice President, Sanofi Pasteur, said in a related press release, “Approval of this new vaccine in the U.S. represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease.”

“Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours.”

The ongoing Phase 3 trials are investigating use in infants as young as 6 weeks of age to better address the worldwide needs for meningococcal disease prevention throughout life.

The FDA approval is based on clinical data from 5 double-blind, randomized, multicenter Phase 2 and 3 trials that assessed the safety and immune responses following vaccination, with nearly 5,000 persons 2 years of age and older.

Based on study objectives, immune responses elicited by MenQuadfi achieved non-inferiority compared to those induced by licensed quadrivalent meningococcal vaccines.

Pivotal study results demonstrating MenQuadfi’s safety and effectiveness in inducing an immune response across all four serogroups have been published, including the performance of MenQuadfi in adolescents when the vaccine was co-administered with other routinely recommended vaccines, and its performance as a booster.

MenQuadfi is expected to be available to providers and pharmacies nationwide in the U.S. for immunization efforts in 2021.

In the U.S., the Centers for Disease Control and Prevention recommends vaccination against meningococcal disease at 11-12 years of age and a second dose at 16 years of age.

Despite strong public health recommendations, about half of teens have not received the recommended second dose of MenACWY vaccine by 17 years of age, leaving them vulnerable when they are at increased risk for the disease.

Hundreds of cases of vaccine-preventable meningococcal disease (caused by serogroups B, C, W, Y) still occur annually in the U.S. and, despite treatment, one in five survivors suffer from permanent complications such as hearing loss, organ damage, and limb amputations.

Around the world, meningococcal disease is highly unpredictable, and it varies widely across regions and ages.

MenQuadfi should not be given to people who have had a severe allergic reaction after a previous dose of MenQuadfi, any of its ingredients, or another vaccine that contains tetanus toxoid.

If MenQuadfi is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Please see the full Prescribing Information.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.

Precision Vaccinations publishes breaking vaccine development news.

Sub Title:

Sanofi MenQuadfi Meningococcal Conjugate Vaccine for the prevention of invasive meningococcal disease gains FDA approval

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FDA approves MenQuadfi, the latest innovation in meningococcal (MenACWY) vaccination

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Meningococcal Disease Outbreak Reported in the Republic of Benin

Danielle Reiter RN — Wed, 29 Jan 2020 14:41:35 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

An outbreak of meningococcal disease has been reported in the Banikora District of the Republic of Benin.

The US Centers for Disease Control and Prevention (CDC) issued a Level 1 Travel Alert on January 28, 2020, notifying visitors to the northwest border with Burkina Faso, which is located in west-central Africa.

This ‘Practice Usual Precaution’ Alert is important since illnesses related to the meningococcal disease are often severe and can be fatal.

Meningococcal disease includes infections of the lining of the brain and spinal cord (meningitis) and bloodstream infections. The bacteria that cause meningococcal disease is spread through respiratory secretions, such as saliva, says the CDC.

Most cases of meningococcal disease in this outbreak have been caused by Neisseria meningitidis serogroup C.

There is a vaccine available to travelers that can help prevent infection against meningococcal disease caused by Neisseria meningitidis serogroup C.

The CDC says health officials are reporting that a smaller number of cases in this outbreak have been caused by Neisseria meningitidis serogroup X.

Unfortunately, there are no vaccines available today that prevent infection against meningococcal disease caused by Neisseria meningitidis serogroup X.

Approximately 7–10 days before departure to Benin, the CDC suggests all travelers aged 2 months or older should be vaccinated with a single vaccine dose against Neisseria meningitidis serogroups A, C, W, and Y.

And, children younger than 2 years of age are recommended to receive 2–4 doses of serogroup A, C, W, Y vaccine before traveling, depending on age.

Since 2005, most adolescents in the United States receive vaccination against serogroups A, C, W, and Y. Protection from the serogroup A, C, W, Y vaccine only lasts for a few years.

Therefore, people who were vaccinated more than 3–5 years ago are recommended to receive an additional vaccine dose before traveling.

Vaccination against Neisseria meningitidis serogroup B (Bexsero or Trumenba) is not indicated for the outbreak in Benin.

There are 2 meningococcal vaccines available in the USA that protect against infection from serogroups A, C, W, and Y; Menactra and Menveo.

From a security perspective, the US Department of State issued a Level 1 Travel Advisory for Benin on May 23, 2019.

This ‘Exercise Normal Precautions’ Advisory includes specific security notices for ‘urban areas’ and for Park Pendjari, Park W and adjacent hunting zones, and other areas near Benin’s northern border with Burkina Faso, due to terrorism and kidnapping.

The CDC suggests international travelers who have vaccination questions to speak with a certified healthcare professional prior to departure.

Travel vaccine news published by Vax-Before-Travel.

Sub Title:

Vaccination against Neisseria meningitidis serogroups A, C, W, and Y suggested before visiting Benin Africa

References:

CDC: Meningococcal Disease in Benin

CDC: Meningococcal

US Department of State: Benin Travel Advisory

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MenB Vaccines Can Be More Target-Specific and Effective

Don Hackett — Sat, 21 Dec 2019 14:16:15 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

United Kingdom-based vaccine experts at the University of Nottingham say their new study ‘could have major implications for the meningococcal group B (menB) vaccines Trumenba and Bexsero.’

And, this new study highlights the importance of multivalent vaccine approaches.

According to these researchers, this new study’s findings could lead to an improved vaccine to protect people against the bacterium, Neisseria meningitides, that causes sepsis and meningitis, and may help to protect against mutated strains.

This is potentially important news published on December 19, 2019, since meningococcal infections are the most common cause of bacterial meningitis, and is a life-threatening disease that poses a continuing threat worldwide.

The new study, led by Dr. Ruth Griffin, Assistant Professor in Microbial Pathogenesis from the School of Life Sciences at the University of Nottingham, found that over 88 percent of invasive strains express the precursor version of FHbp- i.e. a larger, uncleaved protein that is not lipidated.

Therefore the antigen in the Trumenba vaccine is presented in a different manner to the native antigen produced by most strains.

This study said ‘it is unclear at the moment whether the altered presentation affects the ability of vaccine-elicited antibodies to kill these strains.’

“We analyzed the FHbp sequence of almost 2,000 isolates and experimentally tested 20 and saw a 100 percent correlation between mutations in the signal peptide sequence and inability to convert the precursor protein to the cleaved lipidated antigen, “said Dr. Griffin, in a related press release.

The test currently used to predict which meningococcal isolates will be targeted by Trumenba measures the abundance of FHbp on the cell surface since a critical amount is needed for antibodies to bind the cell and aid killing.

Dr. Griffin continued saying, “The data reported from these tests show that some strains with sufficient FHbp levels are surprisingly not susceptible to killing by Trumenba vaccine antibodies.”

“With our discovery that key mutations affect FHbp structure and abundance on the cell surface, this data can be re-evaluated and the MEASURE assay refined to include appropriate reference strains that express the precursor so that isolates can be benchmarked against typical strains.”

“Knowledge of the signal peptide sequence, (as well as “promoter” sequences which affect the amount of the protein made), can now be used to make predictions on FHbp structure and abundance and recognition by Trumenba.”

“Importantly, including the precursor form of FHbp in formulations, will no doubt increase the breadth of isolates that can be targeted.”

‘Our findings also bear relevance for Bexsero, although this vaccine is multivalent and thus less heavily reliant on the successful targeting of FHbp.’

“So, not only is improving target recognition of individual antigens important but increasing the number of antigens in a formulation is vital to overcome problems encountered by mutation,” concluded Dr. Ruth.

The US Centers for Disease Control and Prevention (CDC) says on its website as of April 15, 2019, the case-fatality ratio of meningococcal disease is up to 15 percent, even with appropriate antibiotic therapy.

And, the case-fatality ratio of meningococcemia is up to 40 percent.

As many as 20 percent of survivors have permanent injuries, such as hearing loss, neurologic damage, or loss of a limb.

Meningococcal disease is typically diagnosed by isolation of N. meningitidis from a normally sterile site. However, the sensitivity of bacterial culture may be low, particularly when performed after initiation of antibiotic therapy.

Meningococcal vaccination is recommended for persons at increased risk for meningococcal disease.

The CDC recommends routine vaccination with either MenACWY vaccine at 11 or 12 years of age, with a booster dose at 16 years of age.

The CDC says ‘first monovalent (serogroup C) polysaccharide vaccine was licensed in the United States in 1974.

A quadrivalent polysaccharide vaccine was licensed in 1981.

Monovalent serogroup C meningococcal conjugate vaccine has been licensed in the United Kingdom since 1999 and has had a major impact on the incidence of serogroup C meningococcal disease.

Quadrivalent conjugate vaccines were first licensed in the United States in 2005.

A bivalent conjugate combination vaccine (with Hib) was licensed in the United States in 2012, and two serogroup B recombinant vaccines were licensed in early 2015.

Both MenACWY and MPSV4 vaccines are recommended by the CDC for use in the control of meningococcal outbreaks caused by vaccine-preventable serogroups (A, C, W, Y).

Hib-MenCY-TT may be used for age-appropriate persons in outbreaks specifically caused by vaccine-preventable serogroups C and Y.

Furthermore, the CDC vaccine committee said people in an outbreak setting whom public health officials deem to be at risk should receive a 1-time booster at least a year after the primary series.

And, public health officials should consider a vaccination interval as short as 6-months. depending on the outbreak conditions, such as a college campus.

A study published in January 2019 found that students who were aged 18 to 24 were 3.5 times more likely to contract MenB than their peers who were not attending college classes.

Ten university-based MenB outbreaks occurred during 2013–2018, causing a total of 39 cases and 2 deaths, reports the CDC.

In 5 of these outbreaks, additional cases occurred 6–259 days following MenB vaccination initiation.

Moreover, the additional MenB cases occurred mainly among unvaccinated students.

Although it is difficult to predict outbreak trajectories and evaluate the effects of public health response measures, achieving high MenB vaccination coverage is crucial to help protect at-risk persons during outbreaks of meningococcal disease caused by this serogroup, says the CDC.

Both Bexsero® and Trumenba® have been licensed by the US Food and Drug Administration.

The University of Nottingham located in the UK is a research-intensive university with a proud heritage, consistently ranked among the world's top 100.

MenB vaccine news published by Precision Vaccinations

Sub Title:

University of Nottingham study could have implications for the meningococcal group B vaccines Trumenba and Bexsero

References:

Variant Signal Peptides of Vaccine Antigen, FHbp, Impair Processing Affecting Surface Localization and Antibody-Mediated Killing

New research uncovers improvements in vaccines against meningitis

CDC: Meningococcal Disease

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Featured:

Kansas Expands School Vaccine Requirements

Don Hackett — Sat, 20 Jul 2019 16:03:44 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

Two new vaccines will be required for school-age children to attend class in Kansas for the 2019-20 school year.

In a letter dated July 18, 2019, the Kansas Department of Health and Environment (KDHE) announced the following vaccine requirements for this academic year:

Vaccinations are required by August 2, 2019,
Students entering Kindergarten and Grade 1 now need two doses of the hepatitis A vaccine,
Students entering Grade 7 need one dose of the meningococcal ACWY vaccine,
Students entering Grade 11 need one dose of the meningococcal ACWY vaccine if not vaccinated prior to their 16th birthday. They will need two doses if their first dose was before their 16th birthday.

These vaccine requirements are in addition to the 2018-2019 Kansas school year schedule.

“We received many comments and input from all viewpoints,” KDHE Secretary Lee Norman said in a press release.

“We looked at the evidence. Both Meningitis and Hepatitis A illnesses are severe and preventable, and the safety profile of the vaccines is well-recognized. As an agency charged to establish policies that protect and improve the lives of Kansans, we felt the addition of the two vaccines was essential for the health and safety of our state.”

About these vaccines

Meningococcal ACWY Vaccine: The meningococcal ACWY vaccine protects against meningococcal disease, which has two common outcomes: meningitis (infection of the lining of the brain and spinal cord) and bloodstream infections. The bacteria that cause meningococcal disease spread through the exchange of nose and throat droplets, such as when coughing, sneezing, or kissing. Symptoms include sudden onset of fever, headache, and stiff neck. With bloodstream infection, symptoms also include a dark purple rash. About one of every 10 people who get the disease dies from it. Survivors of meningococcal disease may lose their arms or legs, become deaf, have problems with their nervous systems, become developmentally disabled, or suffer seizures or strokes. The Menactra vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.
Hepatitis A Vaccine: The hepatitis A vaccine protects against the hepatitis A virus. The virus is spread primarily person to person through the fecal-oral route. In other words, the virus is taken in by mouth from contact with objects, food, or drinks contaminated by the feces (stool) of an infected person. Symptoms can include fever, tiredness, poor appetite, vomiting, stomach pain and sometimes jaundice (when skin and eyes turn yellow). An infected person may have no symptoms, may have a mild illness for a week or two, may have a severe illness for several months, or may rarely develop liver failure and die from the infection. There are 3 HAV vaccines approved in the USA, Vaqta, Havrix, and Twinrix, which are available at pharmacies in most states.

Furthermore, in accordance with KSA 72-6262, legal alternatives to vaccination requirements include medical contraindications and religious beliefs. The medical exemptions signed by a medical clinician must be submitted on an annual basis by the family/guardian of the student.

Additionally, there could also be instances in which a person has a religious belief that prevents them from receiving a particular vaccination. The parent/guardian of the student must submit a written statement indicating they are adherent of a religious denomination whose religious teachings are opposed to such vaccination.

Local school boards or governing body for nonpublic schools are responsible for ensuring compliance with these vaccination regulations and statutes in Kansas.

Regarding the cost of these vaccines, the Vaccines For Children program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay.

And, for those who do not qualify for the Vaccines-For-Children program, financial support programs can be found at Vaccine Discounts.

Vaccines can cause side effects, which should be reported to a healthcare provider, or the CDC.

Sub Title:

Meningococcal and hepatitis A vaccinations now required for Kansas students

References:

Kansas Department of Health and Environment: Hep A and Meningococcal Vaccines to be required for 2019-20 School Year

State of Kansas: KANSAS SCHOOL IMMUNIZATION REQUIREMENT (Kindergarten-12 th Grade) 2018-2019 SCHOOL YEAR

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GoodRx Vaccine:

Havrix

Featured:

Meningococcal Vaccination Schedule Changes Pending

Don Hackett — Mon, 01 Jul 2019 13:12:05 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A Centers for Disease Control and Prevention (CDC) vaccine committee unanimously voted to recommend certain people at high-risk of serogroup B meningococcal disease get a ‘booster’ dose of the vaccine.

The CDC’s Advisory Committee on Immunization Practices (ACIP) says people with certain health conditions and those in an outbreak setting are at increased risk of serogroup B meningococcal disease (MenB).

Meningococcal disease is a serious illness caused by a type of bacteria called Neisseria meningitidis. It can lead to meningitis and infections of the blood, says the CDC.

The ACIP currently recommends MenB vaccinations for people 10 years of age and older with complement deficiency, complement inhibitor use or asplenia; microbiologists; and people exposed during an outbreak are vaccinated.

The ACIP recommendations suggest that individuals age 10 years or older at an elevated risk for serogroup B meningococcal disease get a MenB primary series and that teens and young adults ages 16 to 23 years may be vaccinated with a MenB primary series as determined by the physician through clinical decision making.

Since there is evidence that the MenB vaccine’s immunity protection wanes after 2 years, the ACIP approved a booster dose for people with the health issues listed above, reported the AAP.

These individuals should receive the MenB vaccine booster a year after the primary series and additional booster doses every 2 to 3 years, while the health risk is ongoing.

Furthermore, the ACIP committee said people in an outbreak setting whom public health officials deem to be at risk should receive a 1-time booster at least a year after the primary series.

And, public health officials should consider a vaccination interval as short as 6-months. depending on the outbreak conditions, such as a college campus.

A study published in January 2019 found that students who were aged 18 to 24 were 3.5 times more likely to contract MenB than their peers who were not attending college classes.

Ten university-based MenB outbreaks occurred in 7 states during 2013–2018, causing a total of 39 cases and 2 deaths, reports the CDC.

In 5 outbreaks, additional cases occurred 6–259 days following MenB vaccination initiation.

Moreover, the additional MenB cases occurred mainly among unvaccinated students.

All 10 universities implemented MenB vaccinations: 3 primarily used MenB-FHbp and 7 used MenB-4C.

Recent MenB news:

Regarding the CDC’s Vaccine-For-Children program’s meningococcal vaccines, the ACIP unanimously voted in favor of removing the conjugate vaccine HibMenCY from the list of currently available vaccines, and for new guidelines regarding serogroup B meningococcal vaccine booster doses.

Two serogroup B meningococcal vaccines — Bexsero® and Trumenba® — have been licensed by the US Food and Drug Administration.

MenB vaccines can help prevent meningococcal disease caused by serogroup B. Other meningococcal vaccines are recommended to help protect against serogroups A, C, W, and Y.

These vaccines are recommended routinely for people 10 years or older who are at increased risk for serogroup B meningococcal infections.

In conclusion, the ACIP said the same MenB vaccine should be used for all vaccination doses.

The ACIP provides advice and guidance to the Director of the CDC regarding the use of vaccines. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official recommendations in the Morbidity and Mortality Weekly Report.

Sub Title:

MenB vaccines Bexsero and Trumenba can help prevent meningococcal disease caused by serogroup B

References:

Meningococcal Vaccine Recommendations

Effectiveness and Duration of Protection of One Dose of a Meningococcal Conjugate Vaccine

Serogroup B Meningococcal (MenB) VIS

Vaccines for Children Program (VFC)

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Featured:

Niger Discovers ‘Fake’ Meningitis Vaccine Given to Children

Don Hackett — Fri, 15 Mar 2019 23:46:11 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Niger health authorities said today ‘they had found a fake version of a meningitis vaccine after launching a vaccination campaign to inoculate 5 million children against the disease.

The Ministry of Public Health Dr. Idi Illiassou Mainassara said on March 15, 2019, the bogus vaccine, Mencevax ACWY, had been discovered during a "routine inspection" in the Niger capital city of Niamey.

An investigation is underway to try to ascertain how many of the fake vaccines have been used, the spokesman said. The fake vaccine is marked as having been manufactured in December 2016, with an end-date for use by November 2021.

In a statement, Dr. Mainassara asked doctors to be vigilant over this "counterfeit" vaccine.

Niger is a country that lies in the so-called "meningitis belt" stretching from Senegal in West Africa to Ethiopia in the east.

The Meningitis Belt is where outbreaks of the disease are a regular occurrence, says the World Health Organization (WHO).

In December 2010, a new meningococcal A conjugate vaccine was introduced in Africa through mass campaigns targeting persons 1 to 29 years of age.

As of November 2017, more than 280 million persons have been vaccinated in 21 African belt countries.

The vaccine is remarkably safe and cheap. In addition, its thermostability allows its use under Controlled Temperature Chain (CTC) conditions.

Its impact on carriage and the reduction in disease and epidemics is significant: a 58% decline in meningitis incidence and a 60% decline in the risk of epidemics were described.

It is now introduced into routine infant immunization.

Maintaining high coverage is expected to eliminate meningococcal A epidemics from this region of Africa.

However, other meningococcal serogroups such as W, X, and C still cause epidemics and around 30 000 cases are reported each year in the meningitis belt.

WHO is committed to eliminating the meningococcal disease as a public health problem.

Meningococcal meningitis is a bacterial form of meningitis, a serious infection of the thin lining that surrounds the brain and spinal cord.

Meningococcal meningitis is associated with high fatality (up to 50% when untreated) and high frequency (more than 10%) of severe sequelae.

Early antibiotic treatment is the most important measure to save lives and reduce complications.

Previously, the US Centers for Disease Control and Prevention (CDC) had issued Travel Alerts for Polio in Niger on December 14, 2018. The CDC recommends that all travelers to Niger be fully vaccinated against the polio virus.

The CDC recommends vaccination with a meningococcal conjugate vaccine for all preteens and teens at 11 to 12 years old, with a booster dose at 16 years old. Teens and young adults (16 through 23-year-olds) also may be vaccinated with a serogroup B meningococcal vaccine.

Separately, on February 15, 2019, the US Department of State issued a Level 3 Travel Advisory, Reconsider Travel, regarding safety and security risks in Niger.

Sub Title:

Mencevax ACWY has been reported in Niger as a fake meningitis vaccine

References:

Niger's Health Minister warns of possible circulation of fake meningitis medications

WHO Update on the health situation in Niger

Meningococcal meningitis

Health Information for Travelers to Niger Traveler View

Reconsider travel to Niger due to crime and terrorism

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GoodRx Vaccine:

Bexsero

Are Colleges Prepared for a Meningococcal Disease Outbreak?

Don Hackett — Thu, 14 Mar 2019 18:26:20 +0000

Reviewer:

Robert Carlson, MD

John Paul Sanchez, PharmD

Kelley Lu, PharmD

Danielle Reiter, RN

New research says ‘achieving high MenB vaccination coverage is crucial to help protect at-risk persons during outbreaks of meningococcal disease caused by this serogroup.’

Moreover, 10 to 15 percent of meningitis B patients ultimately die from an infection, says the CDC.

This new study was published by the Centers for Disease Control and Prevention (CDC) in March 2019, it says ‘Although the incidence of meningococcal disease is low, university students are at increased risk of meningococcal disease caused by serogroup B outbreaks.’

This study reviewed outbreaks between 2013 and 2018 that included 39 cases and 2 deaths.

In some outbreaks, cases occurred over a prolonged period of time, as in a 2008–2010 Ohio outbreak, and the 2013–2014 New Jersey outbreak.

Half of the 10 studied outbreaks ended following implementation of MenB vaccination efforts, but additional cases occurred at the other 5 universities, mainly among unvaccinated students or close contacts.

College students are at risk for this disease since the MenB vaccine is not integrated into standard vaccination schedules, said this study.

A recent survey demonstrated that only 2 percent of universities require MenB vaccination for students prior to matriculation.

During 2013–2018, between 1 to 4 university-based MenB outbreaks occurred annually.

These outbreaks varied in size and duration and affected both small and large universities. All the outbreaks occurred at residential 4-year degree-granting universities.

Similar university-based disease outbreaks were reported in Canada in 2015, and the United Kingdom in 2017.

In 2017, partly on the basis of the experiences of these university outbreaks, the CDC revised its guidance for the evaluation and public health management of suspected outbreaks of meningococcal disease.

In the revised guidance, the outbreak threshold for vaccine decision-making in an organization-based outbreak, such as at a university, is defined as 2–3 outbreak-associated cases within an organization during a 3-month period.

“In most situations, 2 cases within an organization constitute an outbreak. However, in some situations, such as an outbreak within a large university where no identifiable subgroup at risk within the population can be identified, it may be reasonable to declare an outbreak after 3 cases,” said these researchers in a CDC statement.

The CDC says ‘decisions about whether, when, and how to offer MenB vaccine during an outbreak remain challenging and should be tailored to the unique epidemiology of each outbreak.’

Although the exact MenB vaccination coverage among young adults in the USA is unknown, the coverage of 1 dose of MenB vaccine among persons 17 years of age was estimated to be 14.5 percent in 2017.

Recently, on December 3rd, 2018, a New Jersey State committee approved Assembly Bill 1991 requiring residential students at 4-year colleges receive vaccinations that provide protection from meningitis serogroup B.

Currently, New Jersey is one of 37 states requiring college students to be vaccinated with the meningococcal conjugate vaccine, which delivers protection for meningitis serogroups A, C, W, and Y.

But, on December 19th, 2018, Johns Hopkins Medicine researchers said ‘that providing universal vaccination against the meningitis B infection to college students may be too costly to justify.’

Two serogroup B meningococcal vaccines — Bexsero® and Trumenba® — have been licensed by the US Food and Drug Administration.

These vaccines are recommended routinely for people 10 years or older who are at increased risk for serogroup B meningococcal infections.

Other meningococcal vaccines are recommended to help protect against serogroups A, C, W, and Y.

Meningococcal meningitis is a rare but serious bacterial infection. It causes the membranes that cover the brain and spinal cord to become inflamed.

Each year, approximately 1,000 people in the U.S. get meningococcal disease, which includes meningitis and septicemia, says the CDC.

Recent MenB vaccine news:

Dr. Soeters lead this new CDC study and is an epidemiologist in the Meningitis and Vaccine Preventable Diseases Branch, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, CDC.

The members of the Serogroup B Meningococcal Disease University Outbreak Group are: Kathleen Harriman and Kathleen Winter (California); Susan Lett, Ann Becker, and Kerry-Beth Garvey (Massachusetts); Barbara Montana and Elizabeth F. Zaremski (New Jersey); Tasha Poissant (Oregon); Perrianne Lurie and Elizabeth A. Negrón (Pennsylvania); Utpala Bandy (Rhode Island); and Susann Ahrabi-Fard (Wisconsin).

Sub Title:

Bexsero and Trumenba are serogroup B meningococcal vaccines licensed by the FDA

References:

University-Based Outbreaks of Meningococcal Disease Caused by Serogroup B, United States, 2013–2018

Meningococcal Disease

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Featured:

MenB May Linger on Campus After an Outbreak

Don Hackett — Fri, 15 Feb 2019 19:03:00 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

According to a new study, when dealing with university-based meningococcal serogroup B (MenB) outbreaks, it is difficult to predict if or when additional cases may occur.

In some MenB ‘outbreaks’ on campuses, cases occurred over a prolonged period of time.

According to this 10-campus study, outbreaks ranged from 0 to 376 days in duration.

And, additional MenB cases occurred mainly among unvaccinated students.

This study highlights the importance of MenB vaccination since 10 to 15 percent of meningitis B patients ultimately die from an infection.

This study’s authors identify under-vaccinations as a cause of not developing ‘herd protection’ following an outbreak.

‘Decisions about whether, when, and how to offer a MenB vaccine during an outbreak remain challenging and should be tailored to the unique epidemiology of each outbreak.’

‘At the same time as vaccination discussions begin, appropriate chemoprophylaxis, enhanced case detection, and communication efforts should be promptly initiated.’

‘Efforts are underway to better understand MenB vaccine effectiveness and duration of protection, MenB vaccine strain coverage, and current risk factors for meningococcal disease among university students.'

‘This information, along with lessons learned when implementing MenB vaccination campaigns, could help guide and improve university responses to future outbreaks.’

These researchers said ‘it is difficult to determine whether university-based outbreaks have increased in frequency in recent years, as reporting of outbreaks to CDC has historically been incomplete and disease surveillance began collecting data only in 2015.'

The good news is outbreaks of meningococcal disease are rare in the United States. In fact, only about 2 to 3 out of every 100 cases are related to outbreaks, says the CDC.

Meningococcal disease is found worldwide, with the highest incidence of disease found in the ‘meningitis belt’ of sub-Saharan Africa. In this region, major epidemics occur every 5 to 12 years with attack rates reaching 1,000 cases per 100,000 population.

In the meningitis belt, serogroup A has historically accounted for 90% of meningococcal disease cases and the majority of large-scale epidemics.

Separately, a January 2019 analysis confirmed long-standing fears about meningitis B outbreaks at a university.

These investigators found that students who were aged between 18 to 24 were 3.5 times more likely to contract MenB than their peers who were not attending college.

This is important news since ‘one-third of meningitis infections occur among young Americans aged 16 to 23’, says the Centers for Disease Control and Prevention (CDC).

The CDC reported during 2016, there was a total of about 370 cases of all forms of meningococcal disease across all age groups in the United States.

Two serogroup B meningococcal vaccines — Bexsero® and Trumenba® — have been licensed by the US Food and Drug Administration.

MenB vaccines can help prevent meningococcal disease caused by serogroup B. Other meningococcal vaccines are recommended to help protect against serogroups A, C, W, and Y.

These vaccines are recommended routinely for people 10 years or older who are at increased risk for serogroup B meningococcal infections.

All 10 universities in this study used MenB-FHbp and 7 or MenB-4C vaccines.

Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia. No conflicts of interest were reported.

Sub Title:

Meningococcal serogroup B under-vaccinations limit herd immunity protection

References:

https://wwwnc.cdc.gov/eid/article/25/3/18-1574_article

Meningococcal Disease Among College-Aged Young Adults: 2014–2016

Meningococcal Disease in Other Countries

College Students Are 3.5 Times More At Risk for MenB Disease

Meningococcal carriage among a university student population - United States, 2015

MENINGOCOCCAL CARRIAGE