Vaccine News

Without a herpes preventive vaccine available in 2024, post-infection treatments offer patients their best option.

Over the past few years, an antiviral drug named Acyclovir has been used to slow the spreading and lessen the symptoms of the Herpes Simplex Virus 1 (HSV-1) virus.

However, Acyclovir will not cure herpes.

To address this need, Theralase® Technologies Inc. today announced that its lead drug formulation, Ruvidar™, could be more effective in destroying HSV-1 than Acyclovir.

Another important pre-clinical observation is that Acyclovir could not prevent HSV-1 replication if added one day after infection. However, Ruvidar prevented HSV-1 replication by ten million-fold when added one day after infection.

In other words, from a clinical perspective, if a patient has pre-existing HSV-1, then Acyclovir could not prevent the virus' replication; however, Ruvidar TM would be highly effective, the company wrote on September 3, 2024.

Roger DuMoulin-White, B.E.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase, stated in a press release, “This latest research continues to strengthen what we already know; Ruvidar is a very potent drug in the destruction of cancer, viruses, and bacteria on its own and is further enhanced by light, radiation, sound or drug activation."

"Based on this latest research, Theralase® plans to commence seeking a partner/licensing opportunity in the development of Ruvidar™ for both a topical and oral treatment for the prevention and treatment of herpes simplex.“

In previous research, Ruvidar was found effective at inactivating both enveloped and non-enveloped viruses.

Vaxcyte, Inc. today announced positive topline results from the Phase 1/2 study evaluating the safety, tolerability, and immunogenicity of VAX-31, the Company’s 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

In this Phase 1/2 study, VAX-31 was observed to be well tolerated and demonstrated a safety profile at all doses studied through the full six-month evaluation period similar to Prevnar 20® (PCV20).

The VAX-31 vaccine candidate showed robust opsonophagocytic activity (OPA) immune responses for all 31 serotypes at all doses studied.

At the middle and high doses, VAX-31 met or exceeded the OPA response non-inferiority criteria for all 20 serotypes common with PCV20.

At the VAX-31 high dose, average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio (GMR) greater than 1.0), with seven of these serotypes achieving statistically higher immune responses compared to PCV20.

At the middle dose, 13 of 20 serotypes had a GMR greater than 1.0, and five serotypes achieved statistically higher immune responses compared to PCV20. For all 11 incremental serotypes unique to VAX-31 and not in PCV20, all three doses met the superiority criteria.

Based on the strength of the results from this study, the Company has selected VAX-31 to advance to an adult Phase 3 program. The Company plans to select the VAX-31 dose before initiating the adult Phase 3 program.

Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte commented in a press release on September 3, 2024, “Based on the strength and clarity of these data, we have selected VAX-31 for the adult indication and plan to initiate the pivotal, non-inferiority Phase 3 study by mid-2025 and announce topline data in 2026."

"We intend to initiate the remaining VAX-31 Phase 3 studies in 2025 and 2026 and submit a Biologics License Application subject to the results of these studies.”

Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria, leading to thousands of hospitalizations yearly in the U.S.

The U.S. Centers for Disease Control and Prevention (CDC) has repeatedly stated that the majority of measles cases confirmed in the United States are linked to unvaccinated international travelers.

This assumption was reaffirmed in late August 2024 when the CDC reported that out of the 236 measles cases this year, 87% were in patients who were either unvaccinated or whose vaccination status was unknown, and most had contact with international travelers.

Various health agencies have recently updated their data to help determine where these measles viruses may have originated.

The Europen CDC recently reported that 30 EU/EEA Member States had reported a total of 17,949 measles cases of measles and 13 related deaths over the past year.

For example, in July 2024, Romania (382), Belgium (92), Italy (91), and Germany (84) reported the highest measles patient counts. Throughout 2024, Germany has reported 435 measles cases.

Other recent measles hot spots have been India, with about 24,000 measles cases over the past year. 

As of August 2024, 12,481 measles cases had been confirmed in the Region of the Americas.

The overall measles vaccination average in the Americas is about 85% coverage for the first MMR vaccine dose, indicating millions of unprotected people in the Americas.

While MMR vaccination is not a requirement to visit the U.S., the CDC recommends that all international travelers speak with a travel vaccine provider about their options to protect themselves from this highly transmittable virus.

OVAX Inc. is now emerging from stealth mode with an initial $10 million seed funding backed by its team, concerned parents, and mission-aligned investors. According to Pitchbook reporting, no enterprise valuation was disclosed.

OVAX is developing Fentanyl Armour nasal spray vaccine technology designed to stop fentanyl overdoses. Illicit fentanyl kills approximately 200 Americans daily.

Fentanyl is a synthetic opioid that is often added to illegal drugs, says the U.S. CDC.

The company offers a defense system that immediately neutralizes fentanyl upon exposure and blocks the euphoric effects, enabling the healthcare industry to prevent overdoses leading to death.

 On June 24, 2024, the company's media statement confirmed, 'Our vaccines (candidates) are designed to be taken a few times per year with several options in development, including a convenient nasal spray designed to be administered in the comfort of one's home, eliminating the requirement for a needle injection.'

The company licensed intellectual property from the University of Houston, Texas, which completed pre-clinical evaluations.

According to Ovax executives' comments, they plan to launch human clinical trials of Fentanyl Armour in 2025.

'We recognize that achieving our mission will require significant capital investment and a dedicated team. Additionally, OVAX will work alongside key collaborators at non-profits, governments, and communities dedicated to solving the fentanyl crisis,' wrote the company.

As of September 2024, there are no approved vaccines targeting fentanyl overdosing.

A new study from researchers at Wake Forest University School of Medicine sheds light on how the U.S. news media recently portrayed scientific evidence and the uncertainty surrounding unproven therapeutics.

The research team analyzed news reports on how scientific evidence, evidence details and limitations, safety, efficacy, and sources of authority were portrayed to the public.

“We found that 67% of news reports included scientific evidence, but only 24% mentioned scientific publications or journals,” said the study’s corresponding author in a press release on August 29, 2024.

 Zubin Master, Ph. D., associate professor of social sciences and health policy at Wake Forest University School of Medicine, commented, “This period of time (the recent pandemic) was when medical specialists and the general public were anxiously scrambling to learn as much as possible about prevention and treatments because there were yet no proven therapeutics or vaccines."

"This makes for an ideal case study to examine how the news media portrays scientific evidence.”

According to the American Press Institute, only 40% of the public read news articles beyond headlines or lead paragraphs.

“It’s crucial, especially with controversial science topics, that the evidence and uncertainty are featured more prominently,” Master said.

The study authors also noted that science can be strengthened by acknowledging limitations and by portraying science as a process that is constantly changing and being corrected as additional knowledge is gained.

These findings appear online in the Journal of Medical Internet Research Infodemiology.

The recently announced Africa Regional Polio Eradication Action Plan 2024-2025 outlines a new strategy for responding to polio outbreaks.

Released on August 19, 2024, the pre-publication version introduces a different approach by addressing all instances of poliomyelitis (polio) transmission, including outbreaks of circulating variant poliovirus, as if they were cases of wild poliovirus (WPV).

This action plan advocates for a more proactive strategy instead of following the previous two-round campaign response. It suggests that countries affected by polio should conduct between three and five vaccination campaign rounds based on their specific risk and population immunity.

The plan's authors wrote, 'By pursuing a new course of action defined by these priorities, the WHO African Region will end outbreaks and build the resilience required to achieve and maintain a polio-free Africa.'

Furthermore, this plan offers hope for the countries currently reporting poliovirus detections. On August 28, 2024, the Global Polio Eradication Initiative reported the following summary:

Afghanistan: four WPV1 cases,

Pakistan: two WPV1 cases and 16 positive environmental samples,

Chad: two cVDPV2 cases and two positive environmental samples,

Côte d’Ivoire: two cVDPV2 positive environmental samples,

DR Congo: one cVDPV2 case,

Niger: one cVDPV2 positive environmental sample,

Nigeria: three cVDPV2 cases and one positive environmental sample,

Palestinian territory: one cVDPV2 case,

South Sudan: one cVDPV2 case.

To alert international travelers to their potential polio risk, the U.S. CDC reconfirmed in August 2024 that before any of 37 countries, ensure you are up to date on your polio vaccines.

The GPEI previously launched its Polio Eradication Strategy 2022–2026. The GPEI strategy called for a rigorous review of its plan in 2023.

As of late August 2024, the type 2 novel oral polio (nOPV2) vaccine, produced by PT Biofarma, has been administered over one billion times in various countries. This vaccine was designed to improve phenotypic stability and make the poliovirus strains less prone to reversion to virulence.

The U.S. Food and Drug Administration today announced it granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating SARS-CoV-2 virus variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.

Novavax's updated COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3, formulated to target the JN.1 variant.

The updated monovalent, protein-based vaccine is authorized for individuals 12 and older.

This FDA approval helps protect Americans and their families during the U.S.'s biggest surge in COVID-19 cases since January 2022.

The FDA has determined that the updated Novavax COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, commented in a press release on August 30, 2024, “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Following the Center for Biologics Evaluation and Research's release of vaccine batches, Novacax vaccines will be available in thousands of locations, including retail and independent pharmacies and regional grocers.