Common Questions About Vaccines (for Parents)

meningococcal vaccine recommendation :: Article Creator

GSK Trails After Pfizer In 5-in-1 Meningococcal Vaccine Race

The FDA has started a review of GSK's five-in-one meningococcal vaccine, cueing up a decision in mid-February next year, as it tries to chase down a rival candidate from Pfizer cleared last year.

The new vaccine is a combination of GSK's already-approved vaccines Bexsero and Menveo and is designed to protect against meningitis and blood poisoning caused by the A, B, C, W, and Y serogroups (MenABCWY) of the bacteria Neisseria meningitidis.

MenABCWY covers five of the six serogroups that cause most disease worldwide, with the B, C, and Y strains responsible for most cases of invasive meningococcal disease (IMD) encountered in the US.

GSK is currently the market leader in the meningococcal vaccine market, racking up sales of £1.26 billion (almost $1.6 billion) last year across the Bexsero and Menveo brands, but is having to play catch-up to Pfizer in the MenABCWY combination category after the FDA cleared the latter's Penbraya in October.

Penbraya also combines elements from Pfizer's meningococcal vaccines Trumenba and Nimenrix, which together made around $300 million in 2023, and started shipping in the US earlier this year.

Also active in the category is Sanofi, which sells MenACWY vaccines Menactra and MenQuadfi, lacking coverage of the B serogroup considered the most common cause of meningococcal disease in the US. Sanofi is working on a MenABCWY shot codenamed SP0230, which is currently in mid-stage clinical development.

The companies see potential for their new vaccines in simplifying immunisation schedules and reducing the number of injections needed – four across two products before Penbraya's launch – as well as potentially enhancing uptake and reducing costs.

They argue that the current need to use multiple meningococcal vaccines to provide coverage across all meningococcal strains has resulted in confusion among consumers and doctors, leading to poor compliance and restricting sales.

In the US, while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunisation rates for IMD have remained low overall.

With the FDA review now underway, GSK is hoping for a positive verdict for its shot by the action date of 14th February.

"IMD is an unpredictable but serious illness that can cause life-threatening complications," said GSK in a statement. "Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours. One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems."

USFDA Accepts For Review GSK 5-in-1 Meningococcal ABCWY Vaccine Candidate

London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025.GSK's 5-in-1 MenABCWY vaccine candidate combines...

GSK's 5-in-1 MenABCWY vaccine candidate combines the antigenic components of its two well-established meningococcal vaccines with demonstrated efficacy and safety profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). The MenABCWY combination will target the five groups of the bacteria Neisseria meningitidis (Men A, B, C, W and Y) that cause most invasive meningococcal disease (IMD) cases globally.

According to the Company, combining the protection offered by these vaccines into fewer shots aims to reduce the number of injections, simplifying immunisation. This can help increase series completion and vaccination coverage and help reduce the overall burden of IMD, with unvaccinated adolescents being at particular risk of infection and potential outbreaks.

IMD is an unpredictable but serious illness that can cause life-threatening complications. Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours. One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss and nervous system problems. Although anyone can get IMD, those who are in their late teens and early adulthood are amongst the groups at higher risk of contracting it.

In the US, while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunisation rates for IMD have remained low overall, due in part to a complex schedule. MenB is the most common group of IMD-causing bacteria in US adolescents and young adults, accounting for more than half of the IMD cases among this age group in the US from 2017-2021. For protection against MenB, which is subject to the shared clinical decision-making recommendation of the CDC, just under 12% of US adolescents have had the two required doses.

In the phase III trial , all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK's Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the US) as compared to two doses of GSK's Meningococcal Group B Vaccine. The vaccine was well tolerated with a safety profile consistent with both vaccines.

Read also: CDSCO Panel grants GSK's Updated Prescribing Information for Antibiotic FDC of Amoxicillin, Clavulanic acid

GSK Announces FDA Acceptance Of New Meningococcal Jab BLA

GSK plc GSK announced that the FDA has accepted its biologics license application (BLA) seeking approval of its 5-in-1 meningococcal ABCWY vaccine candidate, MenABCWY. The FDA has granted a standard review to the BLA and is expected to give its decision on Feb 14, 2025.

The MenABCWY vaccine candidate combines the antigenic components of GSK's two popular licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). The MenABCWY combination targets the five serogroups of the bacteria Neisseria meningitides (A, B, C, W, and Y), which is primarily responsible for most invasive meningococcal disease cases globally.

Per GSK, a potential approval of this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and lead to a simplified immunization schedule. The 5-in-1 meningitis vaccine candidate has the potential to reduce the number of injections compared to current FDA-approved meningitis vaccines, as it has been designed to protect against all five vaccine-preventable serogroups with one combined product.

The BLA was based on data from a pivotal phase III study. The study met all its primary endpoints, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups compared to Bexsero and Menveo in terms of an immune response.

GSK's stock has risen 6.9% in the past year against a decline of 17.6% for the industry.

Zacks Investment Research

Image Source: Zacks Investment Research

GSK boasts a broad vaccine portfolio that targets infectious diseases like meningitis, shingles, flu, polio and many more. GSK has more than 20 marketed vaccines in its portfolio. The company achieved strong vaccine growth of 25% at CER in 2023, driven by strong sales for its shingles vaccine, Shingrix and meningitis portfolio and exceptional contribution from the new respiratory syncytial virus (RSV) vaccine, Arexvy.

The company expects continued strong sales of Shingrix in 2024, primarily driven by outside U.S. Markets. The vaccine is now approved in 39 countries. Arexvy sales are expected to be strong in 2024, driven by further penetration in the U.S. Market as well as early adoption from international launches. Over time, GSK expects Arexvy to generate more than £3 billion in annual sales.

GSK is also focusing on accelerating the vaccines pipeline, particularly the expanded use of the RSV vaccine, pentavalent vaccine and MenABCWY to drive long-term growth. It has a leading suite of vaccine platform technologies, including next-generation mRNA, multiple antigens presenting systems, as well as adjuvant systems.

Story continues

Zacks Rank & Stocks to Consider

GSK currently has a Zacks Rank #3 (Hold).

GSK PLC Sponsored ADR Price and Consensus

GSK PLC Sponsored ADR price-consensus-chartGSK PLC Sponsored ADR Quote

Some better-ranked stocks in the healthcare sector are ANI Pharmaceuticals (ANIP), Entera Bio (ENTX) and ADMA Biologics (ADMA), sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today's Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for ANI Pharmaceuticals have improved from $4.06 per share to $4.43 per share. For 2025, earnings estimates have improved from $4.80 per share to $5.04 per share in the past 60 days. In the past year, shares of ANIP have risen 69.4%.

Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 109.06 %.

In the past 60 days, the consensus estimate for Entera Bio's 2024 loss has narrowed from 75 cents per share to 25 cents per share. In the past year, shares of ENTX have risen 168.5%.

ENTX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 10.66%.

In the past 60 days, estimates for ADMA Biologics' 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 84.5%.

Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Bubonic Plague Symptoms