Travel Vaccine Breaking News

Vir Biotechnology, Inc. today announced it had achieved the target enrollment of approximately 3,000 participants in the Phase 2 PENINSULA clinical trial evaluating VIR-2482 for preventing illness due to influenza A.

The first participant was dosed in October 2022, and initial trial data are expected in mid-2023.

PENINSULA is the first Phase 2 outpatient trial to evaluate the role of a monoclonal antibody in the prevention of influenza A illness.

Phil Pang, M.D., Ph.D., EVP, chief medical officer and interim head of research at Vir Biotechnology, commented in a press release on December 21, 2022, "The rapid enrollment of the PENINSULA trial is a significant milestone that brings us one step closer to addressing the critical gap in preventing flu illness among those at high risk of serious illness."

VIR-2482 is an intramuscularly administered investigational monoclonal antibody that has demonstrated in vitro the ability to neutralize all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic.

Designed to be a prophylactic against both seasonal and pandemic influenza A, VIR-2482 has been engineered to have an extended half-life, providing the potential for protection throughout an entire flu season.

The U.S. CDC continues to encourage most people to get an annual flu shot, as it's never too late to be protected against influenza.

As of December 10, 2022, over 157 million influenza vaccines have been distributed in the U.S. These flu shots are offered at pharmacies throughout the U.S.

Other flu season 2022-2023 news is posted at PrecisionVaccinations.com/Flu.

Florida Health's latest Mosquito-Borne Disease Surveillance report indicates the dengue outbreak in south Florida continues to confirm new cases.

The Week #40 report disclosed four cases of locally acquired dengue were reported last week in Miami-Dade County.

In 2022, 59 cases of locally acquired dengue were reported in Florida.

Additionally, twenty-five cases of dengue were reported in Week #40 in persons that had confirmed international travel.

In 2022, 779 travel-associated dengue cases have been reported.

According to the U.S. Centers for Disease Control and Prevention (CDC) current report, the state of Florida has reported the most dengue cases in the U.S. during 2022.

Dengue is a vaccine-preventable disease, and the U.S. FDA has approved the Dengvaxia vaccine for selective administration in the U.S.

A newer dengue vaccine named Qdenga® was recently authorized for use in Europe.

Dengue vaccination information is generally available at travel clinics and pharmacies in the U.S.

Other dengue outbreak news is posted at Vax-Before-Travel.com/Dengue.

Note: As of Dec. 21, 2022, the CDC has not issued a travel advisory related to dengue outbreaks in Florida.

The Health Department of the City of Columbas, Ohio, reported on December 20, 2022, that since June 2022, there have been (81) confirmed measles cases in (76) unvaccinated people, of which (29) were hospitalized.

About 85% of these measles cases are in children less than five years of age.

As of December 15, 2022, the U.S. CDC reported 106 measles cases in five U.S. jurisdictions had been confirmed during 2022.

Furthermore, the CDC's top ten global measles outbreaks this year are led by India, with 11,055 cases.

Previously, the World Health Organization reported on November 23, 2022, that nearly forty million children are susceptible to the measles virus. 

The good news is that measles is a vaccine-preventable disease, and various vaccines are available at most clinics and pharmacies in the U.S.

Other measles outbreak news is posted at Vax-Before-Travel.com/Measles.

Note: The CDC data integrates Ohio's outbreak information.

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed the development of an effective vaccine against ricin toxin might act as a deterrent against the actual use of ricin.

And could be used to vaccinate military personnel and civilians who might be at high risk of potential exposure.

A study published in the journal njpVaccines on December 16, 2022, indicates a New Jersey-based biopharmaceutical company's vaccine may meet those requirements.

Soligenix, Inc. recently announced today the publication of preclinical immunogenicity challenge studies for RiVax® (heat stable ricin toxin vaccine) demonstrating statistically significant correlates of protection (100%) predicting survival after lethal aerosolized ricin challenge in non-human primates (NHPs).

"These published results identifying correlates of protection between NHPs and humans are essential to advancing RiVax® under the U.S. Food and Drug Administration (FDA) Animal Rule," stated Oreola Donini, Ph.D., Senior Vice President and Chief Scientific Officer of Soligenix, in a press release on December 19, 2022 

"This, and other ongoing work, has continued to corroborate the efficacy of RiVax® and will facilitate its potential approval (Animal Rule)."

RiVax is the Company's vaccine candidate for preventing death following exposure to a lethal dose of ricin toxin using a unique antigen completely devoid of ricin's toxic activity.

Ricin is a poison found naturally in castor beans. If castor beans are chewed and swallowed, the released ricin can cause injury. It can be in the form of a powder, a mist, or a pellet, or it can be dissolved in water or weak acid, says the CDC.

Since no antidote exists for a ricin infection, the most critical defense factor is avoiding ricin exposure in the first place.

In 2013, there was a ricin exposure situation in the U.S. 

Previously, RiVax received Orphan Drug and Fast Track designations from the FDA and, upon approval, has the potential to qualify for a biodefense Priority Review Voucher.

In addition, RiVax has received an Orphan Drug designation from the European Medicines Agency.

Indonesia's Ministry of Health notified World Health Organization (WHO) in November 2022 of a confirmed case of circulating vaccine-derived poliovirus type 2 (cVDPV2) with acute flaccid paralysis (AFP) from Pidie district in Aceh province.

There is low population immunity against all polioviruses in Indonesia but primarily type 2 in children born after the switch from the trivalent to the bivalent Oral Polio Vaccine (bOPV) in April 2016.

In response to this notification, Indonesia launched an immunization campaign for children under the age of 13 years in the affected areas on November 28, 2022.

The WHO announced on December 19, 2022, that it assesses the risk to be high at the national level due to low polio vaccination coverage in Aceh and other provinces in Indonesia.

Furthermore, the WHO's current international travel recommendations say that all travelers to polio-affected areas be fully vaccinated against polio.

Before the recent pandemic, millions of people visited Indonesia annually.

Previously, the U.S. Centers for Disease Control and Prevention (CDC) issued an Alert - Level 2, Practice Enhanced Precautions on November 30, 2022, increasing awareness of polio outbreaks in various countries, such as countries in Africa, Asia, Europe, India, Israel, and the United Kingdom.

The state of New York has been reporting the detection of poliovirus in wastewater samples (94) since April 2022.

The CDC also announced on November 30, 2022, that it would expand wastewater testing for poliovirus in select jurisdictions across the country outside of New York. 

It is essential that all countries, particularly those with frequent travel and contacts with polio-affected countries and areas, strengthen surveillance for AFP cases and commence any planned expansion of environmental surveillance to rapidly detect any new virus importation and facilitate a rapid response, says the WHO.

Polio is a highly infectious disease that primarily affects children under five years of age, causing permanent paralysis (approximately 1 in 200 infections) or death (2-10% of those paralyzed).

The virus is transmitted by person-to-person, mainly through the fecal-oral route or, less frequently, by a common vehicle (e.g., contaminated water or food) and multiplies in the intestine, from where it can invade the nervous system and cause paralysis.

Up to 90% of those infected are either asymptomatic or experience mild symptoms, and the disease usually goes unrecognized.

Vaccine-derived poliovirus is a well-documented strain of poliovirus mutated from the strain contained initially in OPV.

In rare instances, the vaccine-derived virus can genetically change into a form that can cause paralysis, as does the wild poliovirus.

This is what is known as a vaccine-derived poliovirus (VDPV).

The detection of VDPV in at least two different sources and at least two months apart that are genetically linked, showing evidence of transmission in the community, should be classified as 'circulating' vaccine-derived poliovirus type 2 (cVDPV2).

Circulating vaccine-derived poliovirus type 2 continues to affect different areas of the world, says the WHO.

Other polio outbreak news is posted at PrecisionVaccinations.com/Polio.

As if disruptions from the wet and cold weather triggered by a cyclone were not enough, a new threat in the form of vector-borne infection now hovers over Karnataka, India.

The Weather Channel India recently reported that Kamataka had confirmed its first Zika virus disease patient.

Previously, Zika cases were detected in Kerala, Maharashtra, and Uttar Pradesh.

Zika virus disease is now considered one of the significant public health concerns because of its impact on infants.

“It came to light when the serum was subjected to Dengue and Chikungunya tests. Usually, 10% of such samples are sent to Pune for a test, out of which this has come across as positive.” Karnataka’s Health Minister, Dr. K. Sudhakar, informed the media.

With various Indian health departments expressing caution, local residents must be aware of Zika symptoms and how to prevent its spread.

The Weather Channel listed answers to some frequently asked questions on the Zika virus at this link.

As of December 19, 2022, the U.S. CDC has not issued a travel advisory focused on Zika cases in India.

Pfizer Inc. and LianBio today announced that Pfizer had opted-in to the right to develop and commercialize sisunatovir, a respiratory syncytial virus (RSV) therapeutic candidate.

Sisunatovir (RV521) is an investigational, orally administered fusion inhibitor designed to block RSV replication by inhibiting F-mediated fusion with the host cell.

Sisunatovir is being evaluated for potentially treating RSV infection in pediatric and adult patients. In addition, it is being evaluated in a global phase 2 clinical study in children.

It has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

Pfizer will commercialize sisunatovir in Mainland China, Hong Kong, Macau, and Singapore pursuant to the companies’ existing strategic collaboration to expand patient access to novel therapeutics in Greater China.

In June 2022, Pfizer acquired ReViral Ltd. and its portfolio of RSV therapeutic candidates with the exception of development and commercialization rights for sisunatovir in Mainland China, Hong Kong, Macau, and Singapore, which LianBio had previously in-licensed from ReViral in March 2021.

“At Pfizer, we are committed to advancing potentially critical vaccines and therapies to help address a significant unmet need in infectious diseases around the world, including RSV, and we’re pleased that this ongoing collaboration with LianBio has the potential to provide more patients with access to a much-needed treatment,” said Jean-Christophe Pointeau, China President for Pfizer Global Biopharma Business, in a press release on December 19, 2022.

“We believe that, if clinically successful and approved, sisunatovir may help change the standard of care for patients with RSV disease, for whom treatment options are currently limited.”

Further clinical studies in adults and children are being planned and will be initiated following feedback from regulatory agencies.

As of December 19, the FDA has not approved an RSV vaccine candidate or antibody therapy.