Travel Vaccine Breaking News

Travel vaccine breaking news brought to you by Vax Before Travel.

Apr 18, 2023 • 8:55 am CDT
by Renate Köppel

SAB Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation to SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including those who have antiviral resistant strains.

SAB-176 is being developed for several influenza indications.

The FDA's Breakthrough Therapy designation confirms that the multi-epitope targeting modality of SAB-176 has a clear differentiation vs. monoclonal antibodies (mAbs) that bind to a single epitope.

And SAB's treatment can sustain its efficacy over viral mutations and prevent or reduce the risk of emerging treatment-resistant influenza strains.

Virus evolution driven by vaccines or treatments is a serious challenge, and the use of therapeutics can create "escape mutants" or versions of a virus that have changed to escape pressure on virus survival driven by antiviral treatment, whether it is a small molecule or mAbs modality, wrote the company.

SAB recently announced that the FDA had granted Fast Track designation to SAB-176.

The company had also received FDA guidance and regulatory alignment on advancing SAB-176 into the next development phase by initiating a Phase 2b clinical trial.

"Influenza continues to pose considerable health concerns in the U.S. and globally. This Breakthrough Therapy designation signifies an important step forward in our fight against this disease," said Eddie Sullivan, Ph.D., co-founder, President & CEO of SAB Biotherapeutics, in a press release on April 18, 2023.

"We are proud that based on generated preclinical and clinical evidence, SAB-176 has received both Breakthrough and Fast Track designations, a combination rarely seen."

The FDA's Breakthrough Therapy designation process is designed to expedite the development and reviewing a medicine intended to treat a serious or life-threatening condition. Preliminary clinical evidence indicates that the drug may substantially improve over current therapies on a clinically significant endpoint(s).

Products that qualify for Breakthrough Therapy designation receive more benefits than Fast Track products.

Precision Vaccinations post influenza vaccines news for April 2023.

Apr 18, 2023 • 8:17 am CDT
The Lancet state map COVID-19 impact March 2023

The Lancet recently published results from an analysis that assessed COVID-19 pandemic policies and behaviors in the U.S.

These researchers revealed where a person lived indicated COVID-19 risk.

Published on March 23, 2023, this analysis found nearly four-fold differences that existed across states in COVID-19 death rates, even when standardized for factors such as age and comorbidities, suggesting that lower death rates were achievable.

The states with the lowest standardized COVID-19 death rates were Hawaii, New Hampshire, Maine, Vermont, and Maryland, which are not confined to a single geographical region.

And the states and territories with the highest standardized cumulative death rates were Arizona (581 per 100 000 [509–672]), Washington, DC, New Mexico, Mississippi, and Colorado.

In summary, these researchers stated that the policy mandates and protective behaviors adopted during this pandemic effectively reduced SARS-CoV-2 infections.

Apr 18, 2023 • 7:07 am CDT
Annals of Internal Medicines April 2023

The Annals of Internal Medicine today published an opinion article that confirmed during the COVID-19 pandemic, the expanded use of facemasks as part of “universal masking” for healthcare personnel (HCP), patients, and visitors in healthcare settings was implemented to reduce the risk for morbidity and mortality associated with the spread of a novel virulent pathogen.

However, the context and conditions of the pandemic have changed dramatically, and evidence-based public health policy should also adapt in response.

The time has come to manage SARS-CoV-2 as we generally manage other endemic respiratory viruses in healthcare settings through correct and consistent application of Standard Precautions and Transmission-Based Precautions.

Moving away from universal masking policies should be accompanied by reconsidering other pandemic-era strategies, such as asymptomatic testing and resource-intensive contact tracing.

In conclusion, this article published on April 18, 2023, stated .... Interactions between humans and pathogens are inherently dynamic.

Therefore, they are constantly evolving, and we have achieved significant advancements in preventing and managing SARS-CoV-2 since the pathogen was initially identified in 2019.

In recognition of these achievements, the time has come to deimplement policies inappropriate for an endemic pathogen when the expected benefits of such policies are low.

Universal masking in health care is a policy whose time has come and gone ... for now.

Face mask research is posted by Coronavirus Today.

Apr 17, 2023 • 2:40 pm CDT
U.S. CDC Nigeria disease outbreaks 2023

Prof Mojisola Christianah Adeyeye, Director-General of the Federal Republic of Nogeria's National Agency for Food and Drug Administration And Control (NAFDAC), today announced it granted registration approval for the R21/Matrix-M™ vaccine.

The NAFDAC approval on April 17, 2023, is essential since the WHO African Region continues to carry a disproportionately high share of the global malaria burden.

For example, in 2021, the Region was home to about 95% of all malaria cases and 96% of deaths.

And malaria is transmitted throughout Nigeria, with 97% of the population at risk of malaria.

Furthermore, the prevalence of malaria parasitemia in Nigerian children under five is about 23%.

The R21 was created by the University of Oxford Jenner Institute in England, is manufactured by Serum Institute of India Pvt. Ltd., and includes Novavax AB proprietary saponin-based Matrix-M adjuvant.

In addition to malaria, the U.S. CDC has issued various Travel Advisories regarding disease outbreaks in Nigeria.

Vaccine-preventable diseases such as yellow fever, measles, and polio are health risks when visiting Nigeria in 2023.

Apr 17, 2023 • 2:19 pm CDT
WHO malaria map April 2023

The Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) today announced its approval for the R21/Matrix-M™ Malaria Vaccine manufactured by India's Serum Institute of India Pvt. Ltd.

The Marketing Authorization Holder is Fidson Healthcare Ltd.

During a press briefing on April 17, 2023, Prof Mojisola Christianah Adeyeye, Director-General NAFDAC, said malaria is transmitted throughout Nigeria, with 97% of the population at risk of malaria.

According to the 2021 World Malaria Report, Nigeria had the highest number of global malaria cases (27%) and the highest number of related fatalities (32%) in 2020

This is the second authorization for R21/Matrix-M this month, following the Republic of Ghana.

GSK's Mosquirix™ RTS,S recombinant malaria vaccine was authorized in 2020.

Additional malaria vaccine and outbreak news are posted at Vax-Before-Travel.

Apr 17, 2023 • 8:41 am CDT
U.S. CDC Ebola outbreak map April 2023

INOVIO today announced that Dr. Angela Huttner, Infectious Disease Consultant, Geneva University Hospitals presented data from a Phase 1b trial evaluating INO-4201, an Ebola booster vaccine candidate for rVSV-ZEBOV (Ervebo®).

"Preliminary data showed that INO-4201 was well tolerated and produced a strong immune response," stated Dr. Huttner in a press release on April 17, 2023.

"This suggests that a booster dose of IN0-4201 has the potential to extend protection against Ebola and could be an important tool in future Ebola Virus Disease prevention."

In February 2023, INOVIO announced positive initial results from the Phase 1b trial that evaluated INO-4201 as a booster in healthy adult participants who previously received a single injection of Ervebo.

These initial results showed that INO-4201 was well-tolerated and boosted humoral responses in 100% (36 of 36) of treated participants. In addition, data presented today included the assessment of binding antibodies showing that all 36 vaccine recipients responded to the boost.

The unedited press release is posted at this link.

Note: Merck's Ervebo® Vaccine is a live, recombinant, replication-competent vaccine approved by the U.S. FDA and by the European Medicines Agency.

Since 2019, approximately 300,000 persons have been vaccinated with the Ervebo vaccine in Africa.

Other Ebolavirus (Zaire and Sudan) vaccine and outbreak(s) news is posted at Vax-Before-Travel.

Apr 17, 2023 • 8:04 am CDT
by Niek Verlaan

Vaxcyte, Inc. today announced positive results from the VAX-24 Phase 2 study in adults aged 65 and older, as well as data from the full six-month safety assessment and prespecified pooled immunogenicity analyses from both the Phase 2 study in adults aged 65 and older and the prior Phase 1/2 study in adults aged 18-64.

VAX-24, the Company's lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate, is being studied to prevent invasive pneumococcal disease (IPD).

The Company says, 'The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD.'

"Based on the overall strength of our data and the well-established regulatory pathway, we look forward to meeting with regulators and advancing VAX-24 into a pivotal Phase 3 study for which we expect topline data in 2025," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte, in a press release on April 17, 2023.

"We developed VAX-24 to create a best-in-class PCV that provides broader coverage and better immune responses than standard-of-care vaccines."

"These data support that objective and demonstrate the potential of our PCV franchise, including VAX-31, our 31-valent PCV candidate."

In the Phase 2 study in adults aged 65 and older, VAX-24 demonstrated robust OPA immune responses for all 24 serotypes at all doses studied, confirming the prior adult study results.

The VAX-24 2.2mcg dose, which Vaxcyte plans to advance to Phase 3, showed an overall improvement in immune responses vs. PCV20 relative to the results from the prior Phase 2 study in adults aged 50-64.

And the six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.

The unedited announcement is posted at this link.

Other pneumococcal (PCV13, PCV15, PCV20, PCV24) vaccine news is posted at Precision Vaccinations.

Apr 17, 2023 • 6:08 am CDT
U.S. HHS

Gilead Sciences, Inc. today announced positive results from several COVID-19 clinical and real-world evidence studies being presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases.

For example, a Phase 3 clinical study demonstrated that Veklury® (remdesivir) was generally well tolerated in people with moderate to severe renal impairment.

Additional data includes a retrospective real-world study that demonstrated that Veklury treatment is associated with a lower risk of death from COVID-19 for people with cancer.

A separate real-world analysis demonstrated that Veklury is also associated with reduced hospital readmission risk in immunocompromised patients hospitalized with COVID-19.

"The breadth of clinical and real-world evidence data presented at ECCMID further support the strong efficacy and safety profile of Veklury," said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences, in a press release on April 16, 2023.

"Since the beginning of the (COVID-19) pandemic, Veklury has played a critical role in the treatment of hospitalized patients with COVID-19."

"The real-world data further demonstrates its role in reducing mortality and hospital readmission rates in vulnerable patient populations, including people living with cancer and other immunosuppressed conditions."

Additionally, results from a Phase 1 clinical study evaluating the safety, tolerability, and pharmacokinetics of obeldesivir, previously known as GS-5245, a novel investigational oral compound developed by Gilead for the treatment of SARS-CoV-2 infection, showed obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19.

Apr 17, 2023 • 4:55 am CDT
from Pixabay

Moderna, Inc. and Merck today announced the first presentation of detailed results from the Phase 2b clinical trial evaluating mRNA-4157 (V940).

In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) and reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.309-1.017]; one-sided p value=0.0266) compared with KEYTRUDA alone.

Dr. Kyle Holen, M.D. Moderna's Senior Vice President and Head of Development, Therapeutics, and Oncology commented in a press release on April 16, 2023, "The profound observed reduction in the risk of recurrence-free survival suggests this combination may be a novel means of potentially extending the lives of patients with high-risk melanoma."

"We look forward to starting the Phase 3 melanoma trial soon and expanding testing to lung cancer and beyond."

mRNA-4157 is a novel investigational mRNA-based individualized neoantigen therapy consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor.

Individualized neoantigen therapies prime the immune system so patients can generate a tailored antitumor response specific to their tumor mutation signature.

Apr 16, 2023 • 10:10 am CDT
WHO polio case map April 2023

The Global Polio Eradication Initiative recently announced two African countries reported new polio cases involving vaccine-derived types.

As of April 11, 2023, the Democratic Republic of the Congo reported six circulating vaccine-derived poliovirus type 2 (cVDPV2) cases from the Kasai Oriental, Haut Katanga, and Tshopo provinces. During 2023, there have been 14 cases. 

And in Benin, a second cVDPV2 case was confirmed in 2023.

Additionally, Burundi reported three cVDPV2-positive environmental samples, and Somalia confirmed one sample last week.

Previously, the World Health Organization (WHO) confirmed the spread of poliovirus remained a Public Health Emergency of International Concern.

Therefore, the WHO's International Travel and Health recommends travelers to polio-affected areas be fully vaccinated against polio.

Various polio vaccines are listed at Vax-Before-Travel.

Apr 15, 2023 • 7:41 am CDT
by Mirka P.

A meeting of the U.S. FDA's Peripheral and Central Nervous System Drugs Advisory Committee is scheduled for June 9, 2023.

This FDA Committee's digital presentation will discuss the supplemental biologics license application for LEQEMBI™ (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for treating early Alzheimer's disease (AD).

The Committee will discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement 4384-1, detailed on January 6, 2023, FDA approval letter.

Confirmatory studies verify and describe a product's clinical benefit after receiving an FDA accelerated approval. Accordingly, its application was granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.

As of April 15, 2023, the FDA has not approved any Alzheimer's vaccine candidate.

FDA advisory committees provide independent expert advice on topics or specific products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations.

The FDA generally follows these recommendations but is not legally bound to do so.

Apr 14, 2023 • 5:31 pm CDT
U.S. State Department map April 14, 2023

The U.S. Department of State reissued its Level 3: Reconsider Travel for the Independent State of Papua New Guinea.

On April 11, 2023, the State Department announced travelers should reconsider visiting Papua New Guinea due to crime, civil unrest, and piracy.

U.S. government employees must obtain authorization before traveling to areas of concern, including the southern part of Bougainville and the provinces of Southern Highlands, Western Highlands (excluding Mt. Hagen), Eastern Highlands (excluding Goroka), Hela, Enga, Jiwaka, and other areas of Papua New Guinea where one is unable to fly directly.

Additionally, the Travel Advisory says 'do not travel' to:

  • Southern Bougainville, particularly areas near the Panguna mine.
  • The Highlands region, other than the towns of Mt. Hagen and Goroka.

And there have been reports of criminals attacking resorts popular with foreign tourists to steal goods and money. And police presence is limited outside of the capital, Port Moresby.

Furthermore, piracy is active in the waters surrounding Papua New Guinea, located in the eastern area of New Guinea, the world's second-largest island. The western half of the island is part of Indonesia.

Travelers by boat should reconsider travel to the Bismarck and Solomon Seas along Papua New Guinea's north and eastern coasts. In 2021 and 2022, the Embassy was aware of at least three occasions in which sailboats operated by or carrying U.S. citizens were boarded by criminals and, in one incident, severely injured the captain.

From a health perspective, the U.S. CDC suggests various travel vaccines before visiting Papua New Guinea.

Apr 14, 2023 • 5:08 pm CDT
ECDC Influenza map April 14, 2023

The Weekly Influenza Surveillance Report #14, published today by the U.S. Centers for Disease Control and Prevention (CDC), indicates good news for the USA.

As of April 14, 2023, the CDC says seasonal influenza activity remains low nationally, with eight of 10 regions below their respective baselines.

However, the European CDC reported on April 14, 2023, there was a 15% influenza positivity for week 14/2023.

Of 41 countries and areas in Europe reporting on the spread of influenza viruses, 16 reported widespread activity across the Region.

The CDC continues to suggest anyone concerned about respiratory viruses should speak with a healthcare provider regarding their flu shot option.

Apr 14, 2023 • 1:13 pm CDT
U.S. HHS April 14, 2023

U.S. HHS Secretary Becerra today announced that in the coming weeks, he would issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19. 

In light of the significant impact of the PREP policy on the healthcare landscape and to provide further clarity, HHS offered additional information about key elements of its plan's flexibilities and protections on April 14, 2023, that will remain in place moving forward.

For example, extending protection coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests will be enhanced.

And PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines and COVID-19 tests, regardless of any USG agreement or emergency declaration.

In the month remaining before the end of the COVID-19 Public Health Emergency, HHS stated it would continue to work closely with its partners, including Governors, state, local, Tribal, and territorial agencies, industry, and advocates to ensure an orderly transition.

Additional, unedited information is posted at this HHS link.

Apr 14, 2023 • 10:00 am CDT
ECDC Influenza Update April 2023

The European Centre for Disease Prevention and Control (ECDC) recently published an influenza update for week #14, indicating flu positivity was about 15%.

Announced on April 14, 2023, the ECDC confirmed of the 41 countries and areas reporting data on influenza viruses:

  • 3 reported no activity (Georgia, Kazakhstan, and Kyrgyzstan),
  • 9 reported sporadic spread (eastern, northern, and southern Region),
  • 5 reported local spread (France, Malta, Serbia, Slovakia and Kosovo,
  • 8 reported regional spread (Albania, Austria, Bosnia and Herzegovina, Czechia, Lithuania, Republic of Moldova, Romania and Ukraine, and,
  • 16 reported widespread activity (across the Region).

The ECDC added seasonal influenza is a vaccine-preventable disease that annually infects over 10% of Europe's population.

When planning a European visit, the U.S. Centers for Disease Control and Prevention suggests discussing flu shot options with a healthcare provider.