Travel Vaccine Breaking News

Florida Health's latest Mosquito-Borne Disease Surveillance report indicates the recent malaria outbreak in the Sarasota area has continued into the summer of 2023.

As of July 15, 2023, Florida Health'w week #28 reported confirmed the seventh locally-acquired malaria case in the Sarasota area since May 2023. The Plasmodium species reported were Plasmodium vivax.

And state-wide, there have been 26 travel-related malaria cases reported in Broward (5), Duval, Hillsborough (4), Lee, Leon (2), Miami-Dade (5), Orange (2), Osceola, Pinellas (3), Sarasota, and Volusia counties this year.

The majority of travel-associated malaria cases in Florida were in people who had recently visited Africa.

Malaria still threatens international travelers, military personnel, and U.S. citizens living and working abroad, says the Centers for Disease Control and Prevention (CDC).

According to the World Health Organization World Malaria Report, the global number of malaria outbreaks reached about 240 million cases, with over 600,000 related fatalities in 2021. 

As of July 18, 2023, the U.S. CDC says 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.

The CDC has issued malaria alerts for malaria-endemic countries, including Costa Rica, but not Florida.

Various antimalarial treatments are approved by the CDC in 2023, but not no malaria vaccines.

As of July 5, 2023, twelve African countries are set to receive 18 million doses of GSK's Mosquirix recombinant vaccine over the next two years. 

Vaxxinity, Inc. today announced new data from an early-stage clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson's disease, UB-312, slows the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients as demonstrated using multiple target engagement assays.

These data signify that UB-312 has established clear target engagement in Parkinson's disease (PD) patient CSF.

Jean-Cosme Dodart, Ph.D., SVP of Research at Vaxxinity, commented in an email, “The more data we see from our UB-312 program, the more excited I get for the future of this vaccine and its potential positive impacts for patients with PD or other a-synucleopathies."

"Demonstrating target engagement in PD patients immunized with UB-312 is an exciting milestone which encourages us to push this program further into clinical development.”

UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies.

"Our candidate has shown target engagement of the toxic species of alpha-synuclein in patients, demonstrating not only proof of our technology platform but also proof of the mechanism of our vaccine-derived antibodies specifically engaging with the toxic target in vivo," said Mei Mei Hu, CEO of Vaxxinity, in a press release on July 17, 2023.

"Showing target engagement has always been a key challenge to overcome in neurodegeneration and is of critical importance when demonstrated – a milestone worth celebrating."

"It is beyond our expectation to see this in our Phase 1 clinical trial."

"We are endlessly grateful to the patients who participated and to The Michael J. Fox Foundation and our collaborators for their work on these cutting-edge assays that supported this breakthrough."

Last month, Vaxxinity announced clinical data from Part B of its Phase 1 clinical trial of UB-312 demonstrating that UB-312 was well-tolerated and induced anti-aSyn antibody responses in participants with early PD and that antibodies were detectable in the CSF.

As part of this trial, The Michael J. Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients and to conduct exploratory research to characterize the anti-aSyn antibodies produced after UB-312 administration and assess target engagement.

Mark Frasier, Ph.D., Chief Scientific Officer of MJFF, commented, "Integration of critical biomarker insight into therapeutic development programs is essential for building confidence in the treatment approach and designing informative trials. We're pleased to support efforts of this kind that can have a major impact for people with Parkinson's disease."

Invivyd, Inc. today announced additional positive initial data from its ongoing Phase 1 healthy volunteer clinical trial of its lead investigational monoclonal antibody (mAb) candidate, VYD222.

The results announced today add to the positive initial Phase 1 data reported by Invivyd in June 2023.

VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.

"We are pleased to see a favorable safety and tolerability profile as well as robust serum neutralizing titers against Omicron XBB.1.5 for all the VYD222 dose levels tested in our ongoing Phase 1 clinical trial," said Dave Hering, chief executive officer of Invivyd, in a press release on July 17, 2023.

"We believe these high neutralizing titer values and fold increases at this early timepoint are extremely encouraging as they indicate the potential for VYD222 to protect longer between doses and to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves."

The Phase 1 clinical trial of VYD222 enrolled 30 healthy volunteers across three dosing cohorts. In each cohort, participants were randomized 8:2 to VYD222 or placebo.

The initial Phase 1 data showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested, with no serious adverse events (SAEs) reported to date. At the middle VYD222 dose tested (2500 mg), geometric mean serum neutralizing titers were 9647.0 (95% CI: 6115.4, 15218.0) against Omicron XBB.1.5 at Day 7, with a geometric mean 92.82-fold rise (95% CI: 21.2, 406.6) from baseline to Day 7.

At the highest VYD222 dose tested (4500 mg), geometric mean serum neutralizing titers were 16864.7 (95% CI: 12825.5, 22176.1) against Omicron XBB.1.5 at Day 7, with a geometric mean 120.97-fold rise (95% CI: 31.4, 466.2) from baseline to Day 7.

The higher VYD222 dose levels tested in the Phase 1 clinical trial are designed to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves.

Analysis of the serum-neutralizing activity from samples collected at different time points across all dose cohorts in Phase 1 clinical trial is ongoing, as is detailed pharmacokinetic analysis and modeling.

Invivyd intends to use these analyses, combined with published clinical outcome data from prior clinical trials of vaccines and mAbs for the prevention of symptomatic COVID-19, including data from its Phase 2/3 clinical trial of adintrevimab for the prevention of COVID-19 (EVADE), to inform its VYD222 dosing strategy further.

Mr. Hering continued, "As a point of reference, we find it encouraging to observe that even our lowest VYD222 dose tested in our Phase 1 clinical trial resulted in higher titers against Omicron XBB.1.5 than the maximum titers against XBB.1.5 from investigational XBB-containing mRNA vaccines tested in humans that were shared at the FDA's recent vaccines advisory committee meeting."

"Higher VYD222 doses tested in our Phase 1 clinical trial have resulted, as expected, in higher titer levels that were well above those reported mRNA COVID-19 vaccine titer levels."

"We believe these initial Phase 1 clinical trial results support the potential for VYD222 to provide safe, meaningful, durable protection for vulnerable populations, such as immunocompromised people who may not generate adequate protection from COVID-19 vaccines, and we look forward to advancing VYD222 as fast as possible in collaboration with global regulators, starting with the FDA."

As of July 2023, mAbs targeting COVID-19 are in use globally.

Since the last World Health Organization (WHO) situation report published in late June 2023, about seventeen countries have reported 316 new mpox cases and two new deaths have been reported by the WHO.

As of July 14, 2023, the WHO says there is a significant increase in mpox cases in the South-East Asia Region, driven by sustained community transmission in Thailand.

Available information on these Thailand cases shows that all patients are male, most from Bangkok without a travel history abroad in the 21 days before symptom onset. Around half of the new cases are among people living with HIV.

The U.S. CDC says the association of mpox cases with HIV infection highlights the need for a syndemic approach to care for HIV, sexually transmitted infections, and mpox in the context of comprehensive sexual health care.

However, mpox virus transmission continues at a low level in most countries reporting cases, and the main epidemiological and clinical characteristics of patients have remained stable over time, says the WHO.

From January 2022 through July 11, 2023, a cumulative total of 88,288 laboratory-confirmed cases of mpox, including 149 deaths, have been reported to WHO from 112 countries/territories/areas in all six WHO Regions.

And in the U.S., 1,243,378 mpox vaccine doses have been administered in 57 U.S. Jurisdictions.

As of July 15, 2023, Sexually Transmitted Disease vaccine news is posted by Precision Vaccinations.

The Houston Health Department recently reported a syphilis outbreak has significantly impacted women in eastern Texas and continues to expand in 2023.

As of July 13, 2023, there has been a 128% increase in syphilis cases among women and a nine-fold rise in congenital syphilis in Harris County.

In response to the syphilis outbreak, Houston's Health department is waving all clinical fees for sexually transmitted infections at its health centers. Untreated syphilis during pregnancy can result in a stillbirth or a baby's death soon after birth.

Syphilis testing is recommended in Texas at a woman's first prenatal visit, during the third trimester, and at delivery.

"It is crucial for pregnant women to seek prenatal care and syphilis testing to protect themselves from an infection that could result in the deaths of their babies," said Marlene McNeese Ward, deputy assistant director in the department's Bureau of HIV/STI and Viral Hepatitis Prevention, in a related press release.

"A pregnant woman needs to get tested for syphilis three times during pregnancy."

Statistics from the department indicate new syphilis infections rose from 1,845 in 2019 to 2,905 in 2022, a 57% increase.

Cases among women totaled 674 cases in 2022, up from 295 cases in 2019.

And congenital syphilis soared from 16 cases in 2016 to 151 cases in 2021.

Since reaching a historic low in 2001, the rate of syphilis has increased almost every year in the U.S., increasing 28.6% from 2020 to 2021. 

Nationwide, men account for the most cases of syphilis.

In most cases, syphilis goes undetected because the signs and symptoms are misinterpreted or unnoticed.

If untreated, Treponema Pallidum, the bacterium that causes syphilis, remains in the body and begins to damage the internal organs, including the brain, nerves, eyes, heart, blood vessels, liver, bones, and joints, says the U.S. CDC.

As of July 15, 2023, the U.S. FDA has not approved a syphilis vaccine.

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.

With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease.

This is essential news since more than 37 million people in the U.S. are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19-related morbidity and mortality.

The FDA approval follows the European Commission's decision to extend the approved use of Veklury on June 26, 2023.

"Patients with advanced CKD and end-stage kidney disease (ESKD) are at high risk for severe COVID-19 with hospitalization and mortality rates remaining high, even for those who are vaccinated. With limited clinical trial information for COVID-19 patients with advanced CKD and ESKD, few antiviral treatment options currently exist for this population," said Meghan Sise, MD, Department of Nephrology at Massachusetts General Hospital, in a press release on July 14, 2023.

"This latest update to the prescribing information for remdesivir now includes patients with advanced CKD and ESKD, and this is an important advance for a population that remains highly vulnerable to the impacts of COVID-19."

The updated prescribing information for Veklury announced today does not require dose adjustments for renal-impaired patients and removes the requirement for eGFR testing before or during treatment with Veklury.