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Novavax, Inc. today announced that partner SK bioscience had received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373), a protein-based booster for active immunization to prevent COVID-19 in adults aged 18 and older.

KFMDS previously approved Nuvaxovid as a primary series in adults aged 18 and older in January 2022 and as a primary series in adolescents aged 12 through 17 in August 2022.

"We are pleased to collaborate with SK bioscience to offer our protein-based vaccine, Nuvaxovid, for use as a booster in adults regardless of previous vaccine history," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release on January 18, 2-23.

"This is an important step in ensuring broad access to diversified vaccine options."

Novavax' COVID-19 vaccine is authorized as an adult booster in more than 35 countries.

In addition, several other countries have policy recommendations allowing the use of the vaccine as a booster dose.

Vaccine Treats:

COVID-19

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Staff Review

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Gaithersburg

Vaccine:

Novavax COVID-19 Vaccine

Avacc 11 Gonorrhea Vaccine

Avacc 11® Gonorrhea Vaccine 2023

Intravacc's Avacc 11® (NGoXIM) is the prophylactic intranasal gonorrhea candidate vaccine being developed in partnership with Therapyx Inc. This vaccine candidate consists of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) induced Th1-driven immunity, with circulating and genital antibodies to Neisseria gonorrhoeae, after intravaginal (i.vag.) administration.

Since intranasal immunization has previously been shown to induce antibody responses in both male and female genital tracts, the companies evaluated this route of immunization with gonococcal OMVs plus IL-12 ms. The administration is not a practical means of delivery. It is inapplicable to males and may not be acceptable to women. The Company's proprietary OMV platform-based gonorrhea vaccine candidate, combined with encapsulated IL-12, showed protection against subsequent infection with Neisseria gonorrhea (NG). Results were published in the peer-reviewed journal MSphere of the American Society of Microbiology on December 20, 2022.

In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. In December 2023, mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria Gonorrhea. And in January 2023, the Company announced preclinical data of Avacc 11® demonstrated protection against gonorrhea infection.

Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization for infectious diseases and therapeutic vaccines. Therapyx is a privately held pharmaceutical company headquartered in Buffalo, New York.

Avacc 11® Indication

Avacc 11 is being developed to prevent infection with NG (i.e., gonorrhea). Gonorrhea remains highly prevalent, with an estimated 87 million new infections yearly. In the United States, incidence increased by 66% from 2014 to 2018, exceeding 580,000 reported cases in 2018, although the actual incidence is believed to be even greater. N. gonorrhoeae is listed by the WHO as an "urgent threat" among human pathogens because of the emergence of resistance to currently available antibiotics, and cases of extreme resistance have been reported.

Avacc 11® Vaccine News 2023

January 16, 2023 - Dr. Jan Groen, Intravacc's CEO, says: "Together with our partner Therapyx, we are very pleased with the preclinical data of the intranasal candidate vaccine Avacc 11®. This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments.

October 5, 2022 – Intravacc announced that it had been awarded a contract with base and options that may total US$14.6 million from the US National Institute of Allergy and Infectious Diseases to develop a prophylactic intranasal vaccine against NG. Intravacc will develop a prophylactic vaccine based on its proprietary OMV platform technology.

Avacc 11® Clinical Trials

This candidate is currently being studied in mice. These study results show that i.n. immuImmunizationh gonococcal OMVs plus IL-12 ms as an adjuvant is at least as effective as i.vag. immunImmunization of the same vaccine in mice.

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Manufacturer:

Intravacc

Reviewer:

Robert Carlson, MD

Vaccine:

Avacc 11 Gonorrhea Vaccine

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PDF

Availability:

N/A

Generic:

NGoXIM

Drug Class:

Intransal Vaccine

Condition:

Gonorrhea

Last Reviewed:

Wednesday, June 28, 2023 - 07:50

Brand:

Avacc 11

Status:

Candidate

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Gonorrhea Vaccines

Gonorrhea Vaccines 2024

The WHO Global Health Sector Strategy on Sexually Transmitted Infections (STIs) set goals for reducing gonorrhea incidence by vaccination by 90% by 2030. As of September 2024, no gonorrhea vaccines have been approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) to prevent gonorrhea infection. However, the United Kingdom supports vaccinations to prevent gonorrhea. A systematic review of 12 studies published in 2024 evaluated the evidence of vaccine effectiveness (VE) of meningococcal B (MenB) outer membrane vesicle (OMV) vaccines against gonorrhea and a non-OMV-based vaccine (MenB-FHbp). This study concluded that 4CMenB and MenB-OMV vaccines show moderate effectiveness against gonorrhea infection.

Repurposed Vaccines Against Gonorrhea

On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) advised the government of a routine targeted vaccination program to prevent gonorrhea. The JCVI agreed that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection. In addition, a modeling study indicated that vaccinating at-risk people could prevent 110,000 gonorrhea cases in England. Meningococcal (MenB-4C, Bexsero) vaccination is recommended in France against Gonorrhea.

A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that the Outer Membrane Vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29. These results are consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea. Other STI vaccine news (herpes, HPV, mpox) is posted at this link.

On February 19, 2023, Mark Mascolini reported a meningococcal vaccine (4CMenB) continued to cut the risk of STIs in MSM using preexposure prophylaxis (PrEP) in the DOXYVAC trial. A study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection. Clinical studies (April 22) published in the Lancet Infectious Diseases reported that two doses of the 4CMenB vaccine were around 33% to 40% effective against gonorrhea in adolescents and young adults.

On July 17, 2017, a GSK-funded study concluded that exposure to MeNZB was associated with reduced rates of gonorrhea diagnosis. This is the first time a vaccine has shown any protection against gonorrhea. The results of this study provide proof of principle that can inform prospective vaccine development not only for gonorrhea but also for meningococcal vaccines.

Gonorrhea Vaccine Candidates

GSK announced on June 27, 2023, that the U.S. FDA had granted a Fast Track designation for its Neisseria gonorrhea (NgG) investigational vaccine. GSK is conducting a Phase I/II first-time in-human clinical study evaluating the vaccine candidate's safety and efficacy in individuals aged 18-50. Phase I of the study was a completed dose-escalation safety lead-in conducted in healthy adults; the Phase II segment of the study is ongoing and aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.

Intravacc's Avacc 11® is an experimental gonococcal vaccine consisting of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) that induces Th1-driven immunity. The prophylactic intranasal gonorrhea candidate vaccine is being developed in partnership with Therapyx Inc. Clinical study results were published in the journal MSphere of the American Society of Microbiology in December 2022. In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. On January 16, 2024, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator awarded $633k to Intravacc to develop a Neisseria gonorrhoeae preventive vaccine.

LimmaTech Biologics AG is advancing the development of its novel vaccine candidate targeted to prevent Neisseria gonorrhoeae infections.

UMass Chan Medical School received a U.S. National Institutes of Health (NIH) grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion. A report was published in the journal mBio in 2019.

Evaxion Biotech A/S EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate. The novel preclinical data for the mRNA-version of the vaccine substantiates that AI-Immunology™ identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities.

Gonorrhea Vaccine News

September 9, 2024 - Evaxion Biotech A/S announced new preclinical data demonstrating the ability of its novel EVX-B2 mRNA gonorrhea vaccine candidate to eliminate gonorrhea bacteria by triggering a targeted immune response.

March 28, 2024 - The U.S. CDC Morbidity and Mortality Weekly Reports confirmed the China Gonococcal Resistance Surveillance Program revealed that the prevalence of ceftriaxone-resistant Neisseria gonorrhoeae was 8.1% in 2022, nearly three times the 2.9% prevalence reported in 2017.

February 27, 2024 - "Resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. LimmaTech's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

January 16, 2024 - "Drug-resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. With an appropriate vaccination strategy, Intravacc's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

November 10, 2023—The U.K.'s Joint Committee on Vaccination and Immunisation published an Independent Report agreeing that a targeted program should be initiated using the 4CMenB vaccine to prevent gonorrhea in those at the highest risk of infection.

August 31, 2023 - Researchers with the Oregon Public Health Division suggest that the meningococcal group B vaccine may offer protection against gonorrhea infection.

June 27, 2023 - GSK plc announced today the US FDA has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine.

April 29, 2023 - Gonorrhea Risk Reduced with Oral Antibiotic.

April 11, 2023 - The U.S. CDC published - U.S. STI Epidemic Showed No Signs of Slowing in 2021 – Cases Continued to Escalate.

March 1, 2023 - Developing advanced vaccines for STI pathogens gains U.S. NIAID support.

February 17, 2023 - Promising gonorrhea vaccine may prevent 40% of cases.

January 16, 2023 - Intravacc announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed with Therapyx Inc. Dr. Jan Groen, Intravacc's CEO, commented, "This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments."

December 20, 2022 - mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria gonorrhoeae.

September 29, 2022 - The UMass Chan Medical School received a U.S. NIH grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion, a clinical-stage biotech company in Denmark.

July 27, 2022 - Aidsmap published: Taking antibiotic after sex cuts STIs by two-thirds, 'DoxyPEP' study finds.

April 12, 2022—The Lancet published effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea: a retrospective observational study. MenB-4C vaccination was associated with a reduced prevalence of gonorrhea and could offer cross-protection against Neisseria gonorrhoeae.

April 11, 2022 - The journal Frontiers published: Recent Progress Towards a Gonococcal Vaccine.

January 4, 2022 - The NEJM published Eliminating gonorrhea with a Vaccine?

Gonorrhea Test

On November 15, 2023, the U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test for use in adult patients ages 18. LetsGetChecked is the first OTC diagnostic test for gonorrhea with at-home sample collection to be granted marketing authorization. Before today's authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor's office.

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Reviewer:

Robert Carlson, MD

Last Reviewed:

Monday, September 9, 2024 - 11:25

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Vaccination offers protection from bacteria that causes gonorrhea.

Condition:

Gonorrhea

Vaccine:

Bexsero Meningitis B Vaccine

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Moderna, Inc. announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an mRNA vaccine candidate targeting respiratory syncytial virus (RSV) in older adults.

Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease as defined by two or more symptoms.

Based on these results, Moderna stated on January 17, 2023, it intends to submit for regulatory approval for mRNA-1345 in the first half of 2023.

"RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities," commented Abdullah Baqui, a principal investigator for the study sites in Bangladesh and Professor, Department of International Health, Director, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, in a related press release.

"This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas."

A concurrent review of available safety data was also conducted by the DSMB.

mRNA-1345 was well tolerated, with no safety concerns identified. To date, most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.

The overall rate of severe (Grade 3 or greater) solicited systemic adverse reactions was 4.0% for mRNA-1345 and 2.8% for placebo.

The overall rate of Grade 3 or greater solicited local adverse reactions was 3.2% for mRNA-1345 and 1.7% for placebo.

The study is ongoing, and an updated analysis of safety and tolerability will be provided at the time of regulatory submission.

Vaccine Treats:

Respiratory Syncytial Virus (RSV)

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from Pixabay

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Boston

Vaccine:

mRNA-1345 Respiratory Syncytial Virus (RSV) Vaccine

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Jefferson County Public Schools (JCPS) in Kentucky announced yesterday it would begin conducting measles vaccination clinics at local schools for about 10,000 unvaccinated students.

JCPS distributed notices to Louisville-area families whose school records show their students need to be protected against this vaccine-preventable disease.

Measles is highly contagious and often results in the hospitalization of those who contract the virus.

Beginning on January 17, 2023, JCPS students will be able to receive a Measles, Mumps, and Rubella (MMR) vaccine, as well as the COVID-19 and flu vaccines.

'We urge parents and guardians to ensure students are current with all required vaccines, including the MMR.

The U.S. CDC and the Kentucky Department of Public Health urge families to be aware of an ongoing measles outbreak near Columbus, Ohio.

As of January 17, 2023, the Columbus Health Department had confirmed 85 children had been infected with measles since June 2022. Most of these unvaccinated children are under ten years of age.

Previously, the CDC confirmed (118) measles patients in six jurisdictions in 2022. In 2021, a total of 49 measles cases were reported by five jurisdictions.

The CDC's top ten global measles outbreaks as of January 13, 2023, were led by India, with 12,271 cases, and Yemen, with 7,538.

In the U.S., various MMR vaccines are available at most clinics and pharmacies in 2023.

Vaccine Treats:

Measles

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by Likon Kom

Live Blog Update Author:

Don Hackett

Location Tags:

Louisville

Vaccine:

Priorix Vaccine

TB Vaccine Accelerator Council Announced

BCG vaccination reduces TB risks

January 17, 2023

Fact checked by Robert Carlson, MD

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During today's World Economic Forum Annual Meeting in Switzerland, Dr. Tedros Adhanom Ghebreyesus and others discuss what mechanisms can accelerate the development and deploy safe and effective tuberculosis (TB) vaccines.

The 'Ending Tuberculosis: How Do We Get There' live discussion is at this link.

While no new TB vaccine has been licensed in 100 years, the prospects for novel effective TB vaccines have improved recently, with at least 16 vaccine candidates under development.

According to the World Health Organization (WHO) 2022 Global TB report, more than 10 million people fell ill from TB, and 1.6 million died.

The WHO confirmed effective vaccines would undoubtedly be the best solution to prevent and potentially eradicate TB.

A recent WHO-commissioned study, An investment case for new TB vaccines, estimates that, over 25 years, a vaccine that is 50% effective in preventing disease among adolescents and adults could avert up to 76 million new TB cases and US$ 6.5 billion in costs.

The current century-old bacille Calmette-Guérin (BCG) vaccine continues offering disease protection.

According to a recent study funded by the U.S. NIH, BCG vaccination at birth effectively prevents TB in young children.

And on August 15, 2022, research published by Cell Reports Medicine suggested BCG protection against infectious diseases and vaccine efficacy takes 1-2 years to manifest, but the protection may last decades.

In the U.S., the BCG vaccine is a limited distributed product. BCG is only considered for people who meet specific criteria and are in consultation with a TB expert., says the U.S. CDC.

Vaccine Treats:

Tuberculosis

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by Anil Sharma

Live Blog Update Author:

Staff Review

Location Tags:

Davos

Vaccine:

Bacille Calmette-Guerin (BCG) Vaccine

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The Coalition for Epidemic Preparedness Innovations (CEPI) and Vaxxas today announced an agreement to advance the development of needle-free vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines.

CEPI confirmed on January 17, 2023, it would provide up to $4.3 million (AUD6.4 million) for preclinical testing of Vaxxas' platform, a needle-free, high-density microarray patch (HD-MAP) to assess its stability, safety, and immunogenicity.

And to evaluate its potential as a rapid-response technology for heat-stable, dried-formulation mRNA vaccines.

In addition to a Phase I clinical study of a COVID-19 vaccine candidate patch, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the U.S. government on pandemic vaccination solutions.

HD-MAPs comprise thousands of microscopic points attached to a small patch.

Each of these micro-projections contains a tiny dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells immediately below the skin surface.

HD-MAP vaccine delivery offers many advantages over more traditional vaccine administration methods.

For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations.

Vaxxas' HD-MAPs have proven safe and tolerable in hundreds of trial participants and have been shown to induce equal or greater immune responses to injected vaccines at lower doses.

Compared with needle and syringe systems, they are also much easier to administer and are likely to have greater acceptability.

Ultimately, HD-MAP patches could enable a future in which vaccine patches could be mailed directly to peoples' homes, workplaces, and schools, avoiding the delay and inconvenience of traditional needle-and-syringe vaccine scheduling and administration.

David Hoey, Vaxxas's CEO, commented in a related press release, "Earning this significant funding from one of the world leaders in vaccine development is a great honor and validates the benefits offered by Vaxxas' HD-MAP vaccine platform in the fight against global epidemic and pandemic threats."

"In addition to providing an opportunity to get life-saving vaccines for infectious diseases that have a disproportionate impact on the most vulnerable populations around the world, the advanced development of HD-MAP delivery of mRNA vaccines could also prove very beneficial for the development of Vaxxas' internal pipeline across several diseases, including Covid-19."

Vaxxas' core technology was initially developed at The University of Queensland in Australia. The private company was established as a start-up in 2011.

On December 5, 2022, Vaxxas announced it completed a financing round that raised US$23 million in new funds.

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched in 2017, to develop vaccines against future epidemics. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all needy people.

Vaccine Treats:

COVID-19

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Image Caption:

Vaxxas High Density Microarray Patch

Live Blog Update Author:

Don Hackett

Location Tags:

Brisbane

Vaccine:

Comirnaty COVID-19 Vaccine

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Pfizer Inc. today announced that it has significantly expanded its commitment to An Accord for a Healthier World to offer the full portfolio of medicines and vaccines for which it has global rights on a not-for-profit basis to enable greater health for 1.2 billion people living in 45 lower-income countries.

To better align with disease burden and unmet patient needs in these countries, Pfizer is expanding its offering under the Accord to include off-patent products, bringing the total offering to around 500 products.

Launched in May 2022, the Accord is a transformative initiative focused on reducing health inequities.

The Accord initially included a commitment from Pfizer for access to all its patented medicines and vaccines available in the U.S. or European Union on a not-for-profit basis to 45 lower-income countries.

The Accord portfolio offering now includes chemotherapies and oral cancer treatments that can potentially treat nearly one million new cancer cases in Accord countries each year.

It also includes a wide range of antibiotics that can help to address the rising morbidity, mortality, and costs associated with antimicrobial resistance.

As Pfizer launches new medicines and vaccines, those products will also be included in the Accord portfolio on a not-for-profit basis.

“We launched the Accord to help reduce the glaring health equity gap that exists in our world. Our hope is to empower country governments and co-create solutions with them and other multi-sector partners to break down many of the system-level barriers to better health. In the months since the Accord’s launch, we have heard resoundingly from these leaders that access to a broader and more immediate scope of consistent, high-quality products is needed for meaningful and sustainable transformation. We believe this expansion of our product offering, combined with continued efforts to help address the barriers that limit or prevent access, will help us to achieve and even expedite our vision of a world where all people have access to the medicines and vaccines they need to live longer and healthier lives,” said Pfizer Chairman and CEO Albert Bourla, in a press release on January 17, 2023.

Alongside governments and multi-sector partners, Pfizer is working to co-create scalable solutions that help address systemic barriers to better health focused on finding faster, more efficient pathways for the supply of medicines and vaccines as well as strengthening the resources, capabilities, and platforms that can enable quick and more sustainable access to those medicines.

This includes technical expertise, training, diagnostic capacity, innovative financing, and more.

“The Accord is an important step toward sustainable health security for Rwanda and the broader continent. The expanded portfolio offering and public health system strengthening efforts will further enhance our progress and offer valuable support to key national health initiatives that lead to positive health outcomes,” commented His Excellency Paul Kagame, President of Rwanda.

Further details about An Accord for a Healthier World are available at Pfizer.com/Accord.

Vaccine Treats:

Antimicrobial resistance

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