Travel Vaccine Breaking News

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.

The U.S. Embassy in Peru recently confirmed the Government extended a 30-day State of Emergency in selected areas of Peru starting January 15, 2023.  The affected areas include the departments of Cusco, Puno, Lima, and the province of Callao.  

The province of Andahuaylas in the department of Apurimac, the provinces of Tambopata and Tahuamanu in the department of Madre de Dios, the district of Torata, and the province of Mariscal Nieto in the department of Moquegua are included.  

Some national highways are affected, including the Pan-American Highway as well as the Apurimac-Cusco-Arequipa roadway.

For additional details, please see the complete Supreme Decree.

The Embassy suggests U.S. citizens in Peru avoid crowds and demonstrations, comply with instructions from local authorities, and enroll in STEP to receive alerts and messaging from the U.S.  Embassy in Lima.

And for in-country assistance, visit the U.S. Embassy in Lima, Peru, at Avenida La Encalada cdra, 17 s/n, Santiago de Surco 15023, Lima , or contact +51-1-618-2000 and [email protected].

From a health perspective, the U.S. CDC says to check the vaccines and medicines list and visit your healthcare provider at least a month before your trip to Peru to get vaccines or medicines you may need.

Global interest in developing vaccines against Neisseria gonorrhoeae (NG) has been sparked by the increasing threat of gonococcal antimicrobial resistance and the number of new infections.

And according to the U.S. Centers for Disease Control and Prevention (CDC), over 600,000 cases of gonorrhea were reported in 2020, making it the second most common sexually transmitted infection in the United States. 

And the disease is known to be contracted repeatedly without apparently developing protective immunity.

To address this extensive health need, Intravacc today announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed in partnership with Therapyx inc. 

The results of the candidate, a proprietary outer membrane vesicle (OMV) platform-based gonorrhea vaccine combined with encapsulated IL-12, showed protection against subsequent infection with NG.

In this study, mice were vaccinated via the intranasal route, and the results of this intranasal study were similar to the intravaginal vaccination route. Intranasal immunization resulted in high serum IgG, salivary IgA, and vaginal IgG and IgA anti-gonococcal antibodies when OMVs were administered with IL-12 ms.

The serum IgG and salivary IgA antibodies induced in male mice were similar to the response induced in female mice.

Gamma interferon (IFN-g) production by CD4 T cells from iliac lymph nodes was elevated after vaccination intranasally or intravaginally.

Female mice immunized with OMVs plus IL-12 ms by either route resisted challenge with NG to an equal extent, and resistance generated by intranasal immunization extended to heterologous strains of NG.

These results were published in the peer-reviewed journal MSphere of the American Society of Microbiology.

Dr. Jan Groen, Intravacc's CEO, commented in a press release on January 16, 2023, "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."

In October 2022, Intravacc was awarded a $14.6 Million U.S. NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further.

For the development of vaccines, Intravacc has designed and developed a platform based on outer membrane vesicles, spherical particles with intrinsic immune-stimulating properties.

The OMVs can be designed with immunogenic peptides and/or proteins that stimulate effective adaptive immunity.

The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens.

Intravacc has also developed genetic tools to increase the yield of the OMVs, reduce toxicity and achieve the desired antigenic composition.

Intravacc's OMV platform is scalable and allows rapid and efficient modification of the antigen composition, either through genetic modification of the bacterial host or by associating antigens with stored OMVs.

As of January 2023,  there is no effective gonorrhea vaccine available in the U.S.

As the new year began a few weeks ago, various scientists are focused on developing Human Immunodeficiency Virus (HIV) vaccines. And vaccine development has accelerated in 2023 with candidates utilizing innovative technologies such as mRNA.

Vaccines work by inducing the immune system to make antibodies that can neutralize a particular pathogen.

But doing so for HIV has been challenging because there are countless variants worldwide, wrote the U.S. National Institutes of Health (NIH) on December 13, 2022.

This challenge is why mRNA vaccines may become the solution.

Encouraging news was announced in 2022 when Moderna Inc., a global leader in mRNA vaccines, confirmed it was participating in the NIH's HVTN 302 study that examines the safety and immune responses of BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, and BG505 MD39.3 gp151 CD4KO vaccines.

Each of Moderna's vaccine candidates are designed to present the spike protein found on the surface of HIV that facilitates entry into human cells and encodes for different but highly related stabilized proteins.

While this early-stage, Phase 1 clinical trial was updated on October 3, 2022, it could be years from achieving U.S. Food and Drug Administration (FDA) approval.

As of January 15, 2023, the FDA had not approved any HIV prevention vaccine for use by people.

Unfortunately, the AIDS epidemic continues to impact people everywhere, specifically in Africa.

About 38 million people worldwide are living with HIV, and about 70% of them live in Africa.

However, over 28 million people were accessing antiretroviral therapy in 2022, a significant increase from 7.8 million in 2010.

And in 2023, these people have expanded treatment options.

Gilead Sciences, Inc. announced on December 22, 2022, that the FDA approved Sunlenca® for treating HIV-1 infections in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. 

And previously, the U.S. FDA-approved Apretude for use by at-risk adults and adolescents weighing at least 35 kilograms for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV on December 20, 2021.

Anthony S. Fauci, M.D., former director at the U.S. National Institute of Allergy and Infectious Diseases, recently commented about HIV vaccine development efforts in an Emerging and Reemerging Infectious Diseases Perspective: It Ain't Over Till It's Over…but It's Never Over. 

The State of Kentucky recently announced a panel of the Sixth Circuit U.S. Court of Appeals affirmed a lower court's ruling that said vaccine mandates were unconstitutional. The mandate requires workers contracting with the federal government to wear face masks and be vaccinated for COVID-19.

A federal judge in Louisville, Kentucky, blocked the U.S. government's rule in November 2021 for Kentucky, Tennessee, and Ohio.

"The Sixth Circuit's decision is a resounding victory against federal overreach into the personal medical decisions of Kentuckians," Kentucky Attorney General Daniel Cameron said in a statement on January 12, 2023.

The Fifth Circuit U.S. Court of Appeals issued a similar ruling for Indiana, Louisiana, and Mississippi in December 2022.

The U.S. Centers for Disease Control and Prevention (CDC) says certain workers are at risk for exposure to severe and sometimes fatal diseases.

If you work directly with patients or handle material that could spread infection, you should get appropriate vaccines to reduce the chance that you will get or spread vaccine-preventable diseases.

And protect yourself, your patients, and your family members by ensuring you are up-to-date with recommended vaccines, including COVID-19, says the CDC.

The World Health Organization (WHO) today called on countries to take urgent measures against measles outbreaks which are on the rise, with nearly nine million children having missed vaccination against the killer disease in the last two years.

Measles outbreaks are declared when the number of cases reported in an area is higher than expected.

"The strong political commitment, determination, focused and concerted efforts, and community support that marked our efforts for polio elimination are now urgently needed to stop and prevent measles outbreaks and accelerate efforts to eliminate the disease," said Dr. Poonam Khetrapal Singh, Regional Director, WHO South-East Asia, in a media release on January 13, 2023.

Measles and rubella elimination is a flagship priority program of the WHO South-East Asia Region. Both are vaccine-preventable.

Between 2014 and 2021, the Region recorded a 73% reduction in measles deaths and a 64% reduction in measles cases.

Five of the 11 countries in the South-East Asia Region – Bhutan, DPR Korea, Maldives, Sri Lanka, and Timor-Leste - have eliminated measles, and two countries - Maldives and Sri Lanka - have eliminated rubella as well.

In addition, governments have been administering two doses of measles vaccines as part of their childhood immunization program, and some are rolling out mass vaccination campaigns.

However, as the pandemic arrived, measles vaccination coverage, which had reached an all-time high of 94% coverage for the first dose and 83% coverage for the second dose by 2019, declined to 86% and 78%, respectively, in 2021.

This inaction left about nine million children unvaccinated for measles.

And around 5.3 million children are partially vaccinated against this highly infectious disease.

"The decline in vaccine coverage, and interruptions and delays in immunization and surveillance activities due to the pandemic, leaves the Region susceptible to large outbreaks and off track for the 2023 target of measles and rubella elimination," the Regional Director added.

"All countries have been taking several initiatives to revive and resume childhood immunization coverage and surveillance activities that were affected by the COVID-19 pandemic," Dr. Khetrapal Singh concluded.

The U.S. CDC says measles is highly contagious, with about 90% of people who are not protected will become following infected exposure to the measles virus. 

The CDC's Top 10 Measles Outbreak Country list was updated on January 13, 2023.

International travelers can check CDC's Travel Health Notices to search for measles or other issues that may affect travelers' health. During 2022, the CDC issued various measles-related travel alerts.

A recent study published by the peer-review journal Nature found that promoting the existence of vaccination incentives had no negative consequences, such as reduced follow-on vaccinations.

Announced on January 11, 2023, these researchers offered study participants in a randomized, controlled trial about $24 to receive a first COVID-19 vaccine dose within 30 days. 

They found the small payment increased vaccination uptake by 4% points 30 days after the study ended.

And they found that paying people an initial incentive didn't lower the likelihood of seeking the second or third vaccine dose.

To complement their study's evidence from Sweden with evidence on the effects of large-scale incentive programs implemented by US state governments during the early stages of the pandemic.

In a pre-registered study in the USA (n = 3,062), participants randomly assigned to the incentives condition received detailed information about their state's COVID-19 vaccine incentive program.

In line with the evidence from Sweden, they found no negative impacts of being informed about incentive programs on the willingness of participants to take further doses, morals, trust in the state government, safety and efficacy perceptions of vaccines, or intentions to donate blood or to receive a flu shot.

The authors identified no adverse effects of financial incentives.

A real-world example took place in New York City in May 2021.

Mayor Bill de Blasio announced incentives to encourage New Yorkers to get their COVID-19 vaccine, a free Shake Shack. The mayor 'chowed down' on a burger and fries as he introduced the promotion.

These researchers wrote, 'Despite its limitations, our study has a clear finding: offering modest financial incentives for vaccination has limited, if any, unintended negative consequences.'

'Contrary to prominent warnings in the academic literature and public debate, our work suggests that modest financial incentives for vaccination can be used without worries about grave unintended consequences.'

Disclosures: The Human Subjects Committee of the Faculty of Economics, Business Administration and Information Technology at the University of Zurich approved the study protocols (2022-045). Lund University provided open-access funding, and no industry conflicts were disclosed.