Vaccine News

60 Degrees Pharmaceuticals Inc. today announced that the Canadian Intellectual Property Office issued a patent on using novel tafenoquine regimens for malaria prevention in malaria-naive individuals, and it will remain valid until December 2, 2035.

The Company was issued a similar U.S. patent in 2019.

Tafenoquine is the active molecule in the Company's U.S. Food and Drug Administration-approved regimen for malaria prevention, ARAKODA®.

ARAKODA, an oral tablet containing 100 mg of tafenoquine base, is an anti-malarial indicated for malaria prevention in individuals 18 years and older.

As of July 31, 2023, travelers or individuals at risk of contracting malaria are prescribed 2 x 100 mg tablets once per day for three days (the loading phase) before travel, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

Travelers from, and residents of, Canada and the United States, are usually malaria naive because they have not previously contracted malaria and thus lack immunity to the disease.

During July 2023, malaria outbreaks have been reported in Florida and throughout Central America in countries such as Costa Rica. And numerous African countries have confirmed malaria outbreaks.

The bite of an infective female Anopheles mosquito spreads malaria. The disease can cause fever, chills, and flu-like illness. If it is not treated, it can cause severe complications and death, says the U.S. CDC.

Typically, about 2,000 malaria cases are diagnosed in the United States yearly.

In Africa, there are two malaria vaccines currently being administered.

And on April 26, 2023, the United States Patent and Trademark Office issued 60 Degrees a patent covering the use of tafenoquine as a treatment for COVID-19 disease. 

The World Health Organization (WHO) recently reported circulating vaccine-derived poliovirus type 2 (cVDPV2) cases in Africa.

The WHO confirmed on July 28, 2023, the United Republic of Tanzania reported the country's first cVDPV2 case and Kenya its first of 2023.

Tanzania's Ministry of Health notified the WHO the cVDPV2 virus was isolated from a case of acute flaccid paralysis (AFP) in the Rukwa region. Gene sequencing of the isolated virus has indicated close linkage with cVDPV2 currently circulating in South Kivu, Demographic Republic of the Congo.

According to the WHO-UNICEF estimates of national immunization coverage, the oral polio vaccine third dose (OPV3) and the inactivated polio vaccine first dose (IPV1) was 88% in Tanzania last year.

And on July 11, 2023, the WHO received an official report regarding detecting a cVDPV2 in two AFP cases and two asymptomatic healthy children community contacts in Kenya.

The genetic sequencing analyses showed that all four isolates are genetically linked to the cVDPV2 circulating in Banadir, Somalia.

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

OPV contains a live, weakened form of poliovirus that replicates in the intestine for a limited period, thereby developing immunity by building antibodies. On rare occasions, when replicating in the gastrointestinal tract, OPV strains genetically change and may spread in communities that are not fully vaccinated against polio, especially in areas with poor hygiene or overcrowding.

The lower the population's immunity, the longer this virus survives and the more genetic changes it undergoes.

In sporadic 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 is classified as cVDPV2.

In both countries, the WHO assesses the overall risk at the national level to be high due to the sub-optimal surveillance performance in some districts, sub-optimal vaccination coverage resulting in low population immunity, and the ongoing population movement across neighboring countries.

To alert international travelers, the U.S. CDC reissued its Level 2 - Practice Enhanced Precautions, Travel Health Advisory regarding the global polio outbreak on July 28, 2023.

The CDC says before any international travel, make sure you are up to date on your polio vaccines, and adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of polio vaccine.

The nOPV2 vaccine is offered in Africa in July 2023. Approximately 670 million doses have been administered in more than 31 countries worldwide.

In the U.S., various polio vaccines are available at health clinics and community pharmacies.

Dallas County Health and Human Services (DCHHS) today reported two new human cases of West Nile Virus (WNV) infection in Dallas County for 2023.

The patients are two male residents of the 75228 and 75204 zip codes in the City of Dallas. Both patients were diagnosed with West Nile Neuroinvasive Disease (WNND.)

Due to privacy and confidentiality reasons, DCHHS does not disclose additional information about the patient.

As of July 28, 2023, there are four total human cases this year. 

There were 42 cases of WNV in Texas and seven deaths in 2022. Over the last five years, Texas has had 485 cases and 65 deaths. 

"Mosquito activity continues in our community, and we're now reporting two additional human cases of West Nile Virus. WNV is transmitted to humans by the bite of an infected mosquito, and people should be careful when going out outside to enjoy outdoor activities," said Dr. Philip Huang, DCHHS Director. "Please follow the 4 Ds to do everything you can to avoid mosquito bites," in a press release.

As of July 28, 2023, there were seven new mosquito sample pools: in Dallas, 75218, 75241, and 75243 (2 pools); Mesquite, 75150 (3 pools).

WNV is transmitted through the bite of infected mosquitoes, says the Texas Department of State Health Services (DSHS).

Most people exposed to the virus don't get sick, but about 20% develop symptoms like headache, fever, muscle and joint aches, nausea, and fatigue.

In a tiny proportion, less than 1%, the virus affects the nervous system, leading to the more severe WNND that can cause neck stiffness, disorientation, tremors, convulsions, paralysis, and even death.

"It's important for people to be aware that there are many diseases transmitted by mosquitoes found in Texas," said DSHS Commissioner Jennifer Shuford, MD, MPH, in a press release on July 11, 2023.

 "Most of these diseases cause mild illness, but in rare instances, diseases like dengue or Zika can cause severe illness."

"We've even had a locally acquired malaria case in Texas this year, which underscores the importance of taking precautions to prevent mosquito bites."

As of July 2023, the U.S. FDA has not approved a WNV vaccine.

According to recent news from the World Health Organization (WHO), respiratory syncytial virus (RSV) outbreaks were found in a few countries in the Region of the Americas.

The WHO's Influenza Update N° 449, published on July 7, 2023, RSV activity was increasing in a few temperate South American countries. 

Separately, the U.S. Centers for Disease Control and Prevention (CDC) recently offered insights into when the U.S. could expect RSV to be detected in 2023.

The CDC's Morbidity and Mortality Weekly Report presented the seasonality of RSV in the U.S. from 2017–2023. The most recent RSV season onset occurred in June and peaked in November.

Across both prepandemic and pandemic years, RSV circulation in the U.S. began in Florida, then in the southeast, and later in the north and west regions. 

The CDC says Florida's RSV season is longer than the rest of the U.S.

For this reason, the Florida Department of Health segmented reports into five RSV regions, each with its own RSV season. As of July 22, 2023, there were no RSV outbreaks in Florida.

From a prevention perspective, the U.S. FDA recently approved RSV vaccines and a second monoclonal antibody therapy for children.

Merck today announced positive topline results from two Phase 3 trials evaluating V116, the company's investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals.

In both studies, V116 had a safety profile comparable to the comparator in the studies.

Results from the STRIDE-3 clinical trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination.

Positive immune responses were also observed for serotypes unique to V116.

Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year before the study.

If approved, V116 would be the first pneumococcal conjugate vaccine designed for adults, says Merck.

Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in a press release on July 27, 2023, "These results support the potential for V116 to become an important new preventative option for adults, regardless of prior pneumococcal vaccination status, by expanding coverage to include eight serotypes not currently included in any licensed vaccine."

According to pre-pandemic 2019 U.S. CDC data, the 21 serotypes covered by V116 are responsible for 85% of invasive pneumococcal disease in individuals 65 and older.

V116 includes eight serotypes not currently covered by approved pneumococcal vaccines.

Serotypes unique to V116 include 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older, based on pre-pandemic 2019 U.S. CDC data.

With several recent incidents reported in Irish media, the U.S. Embassy in Dublin reminded U.S. citizens on July 25, 2023, to exercise good personal security practices while traveling abroad.

For example, an older Buffalo, New York musician was abused last week during an unprovoked assault near Store Street Garda station.

The U.S. Embassy Dublin encourages all citizens to be aware of their surroundings, especially when traveling in unfamiliar places, crowded locations, empty streets, or at night in July 2023.

U.S. Embassy in Ireland can be contacted at +353 1 668-8777 or [email protected].

Furthermore, the U.S. Department of State reissued a Level 1: Exercise Normal Precautions travel advisory of Ireland on July 26, 2023.

The State Department says if you decide to travel to Ireland, visitors should participate in the Smart Traveler Enrollment Program to receive Alerts during an emergency.

From a health perspective, the U.S. CDC suggests speaking with a healthcare provider one month before visiting Ireland to ensure you are fully immunized against routine and travel diseases.