Coronavirus Breaking News

VBI Vaccines Inc. today announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179), VBI's HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an HBV-targeting siRNA candidate, in chronically infected HBV patients.

The data, which will be featured in an oral presentation on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses when compared to BRII-835 alone.

Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or the lower limit of quantification (LLOQ) were achieved by Week 40, which were associated with robust HBV-specific antibody and T-cell responses.

Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI's Chief Medical Officer, commented in a press release on February 15, 2023, "Numerous studies have assessed the potential of siRNA candidates in hundreds of chronically infected HBV patients, but this is the first time we've seen data from the combination of an HBV siRNA with an HBV-specific immunomodulatory."

"Consistent with the known mechanism of action of VBI-2601 and its inclusion of the pre-S1 and pre-S2 antigens in addition to the S antigen, these interim data indicate that VBI-2601 may be able to break tolerance to the S antigen, achieving immune restoration."

"Additionally, the reduction of S antigen to at or below the LLOQ, as seen in the two patients, is a noteworthy achievement in this population."

"We are very encouraged by these interim data, which suggest that the combination of VBI-2601 and an HBV siRNA has the potential to be a meaningful part of a functional cure regimen."

"We look forward to additional data from this study, as well as data from the ongoing Phase 2 study of VBI-2601 as an 'add-on' to existing pegylated interferon and nucleos(t)ide reverse transcriptase inhibitor therapy in non-cirrhotic chronic HBV patients, both of which are expected later this year."

An abstract summarizing the interim data is available at this link.

Vaxart, Inc. today announced that it had dosed the first subject in a Phase 2 dose-ranging clinical trial of its oral tablet bivalent vaccine candidate.

Vaxart expects to report topline data from the Phase 2 study in mid-2023.

"Initiating the Phase 2 clinical trial of this candidate is an important achievement toward our goal of developing an oral tablet vaccine that may reduce the significant global health threat that norovirus poses to children and seniors," said Dr. James F. Cummings, MD, Chief Medical Officer at Vaxart, in a press release on February 14, 2023.

"Results from the Phase 1b clinical trial in healthy adults demonstrate that this candidate stimulates robust IgA antibody-secreting cells against the prevalent strains of two norovirus genotypes that cause most norovirus disease."

"Data from the Phase 2 trial will inform our further clinical development strategy for this promising vaccine candidate."

As previously reported, Vaxart's bivalent vaccine candidate demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain, with no interference observed.

Three Phase 1 studies of Vaxart's norovirus pill vaccine indicated it is well tolerated and generated systemic and local immune responses that are both robust and persistent. 

In the U.S., norovirus causes 21 million illnesses each year, infecting 15% of all children under the age of five years and resulting in illness — which frequently requires hospitalization — in 7.5% of people over 65 years.

Other norovirus vaccine candidate news is posted at PrecisionVaccinations.

Valneva SE today announced that it completed enrollment and vaccination for a Phase 3 clinical trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553.

This live-attenuated, investigational vaccine candidate targets the chikungunya virus and was designed by deleting a part of the chikungunya virus genome.

The initial results of this trial are expected in mid-2023, which are intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S.).

This adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the FDA in the U.S.

Furthermore, the adolescent trial is expected to supvaccine'svaccine's licensure in Europe and Brazil, which would be the first potential approval for use in these chikungunya endemic regions.

Previously, Valneva completed the rolling submission of the Biologics License Application (BLA) to the FDA for approval of VLA1553 in persons aged 18 years and above (adults) in December 2022. 

If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S.

The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination.

Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this pediatric study, commented in a press release on February 14, 2023, "Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur."

"The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licensed for use."

"Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate.

To make VLA1553 more accessible to Low- and Middle-Income Countries, Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing, and marketing of the chikungunya vaccine.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes.

A CHIKV infection leads to symptomatic disease in up to 97% of humans after three to seven days following the mosquito bite.

While mortality with CHIKV is low, morbidity is high.

Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia.

Additional chikungunya outbreak news at Vax-Before-Travel.

Jiangsu Recbio Technology Co., Ltd. today announced it has recently completed the first batch of subject enrollment for its novel adjuvanted recombinant vaccine, REC610, that prevents shingles caused by varicella zoster virus (VZV).

The study is a randomized, observer-blinded, active-controlled phase I clinical trial to evaluate the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above.

According to research data on shingles vaccines that have been marketed worldwide, the novel adjuvanted vaccine can provide stronger cellular immunity and protective efficacy compared to live attenuated vaccines.

This announcement is essential since about 2.5 million adults in China suffer from herpes zoster yearly, and most seniors in China carry the dormant herpes zoster virus.

REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies.

Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE-specific CD4+ T cell responses and IgG antibodies.

Its immune response is non-inferior to the controlled vaccine, Shingrix® says the Company.

Shingrix® is a non-live, adjuvanted recombinant vaccine consisting of the VZV glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes. 

Shingrix has been commercially available in the U.S. since 2017.

Additional shingles vaccine development is posted at PrecisionVaccinations.

In his opening address to the Executive Board, WHO Director-General Dr. Tedros Adhanom Ghebreyesus recently noted that no wild poliovirus cases had been reported anywhere since September 2022.

"We are in a much better situation now than we were previously. But the last mile is the hardest."

"There can be no room for complacency. Now is actually the moment to double down on our efforts. So let's continue to push on."

Experts noted the unique window of opportunity to succeed in 2023, the target year for stopping all remaining poliovirus transmission globally. 

The WHO also provided guidance to develop a new vision for the polio transition that will go beyond 2023, supported by tailored regional action plans to drive country progress.

AN updated list of At-Risk Countries was posted.

Following that WHO meeting, the Global Polio Eradication Initiative reported on February 8, 2023, a summary of new polioviruses detections and polio cases this week:

• Afghanistan: two WPV1-positive environmental samples
• Algeria: one cVDPV2 case
• Chad: two cVDPV2 cases
• DRC: eight cVDPV1 cases, 22 cVDPV2 cases and one cVDPV2 positive environmental sample
• Mali: one cVDPV2 case
• Nigeria: two cVDPV2-positive environmental samples

To alert international travelers of their potential health risk, the U.S. CDC updated its Alert - Level 2, Practice Enhanced Precautions notice regarding polio outbreaks in 2023.

Other polio outbreak news is posted at Vax-Before-Travel.

Since no U.S. Food and Drug Administration (FDA) vaccines are available to prevent Alzheimer's Disease (AD), can other vaccines reduce the risk of this old-age disease?

The Conversation published an article written by neurodegenerative disease experts on January 18, 2023, highlighting the potential value of existing FDA-approved vaccines to reduce AD aggravating factors from viral infections.

In previous studies, researchers identified that infections by varicella zoster (chickenpox and shingles) and influenza viruses could lead to a higher risk of AD.

However, researchers have been unable to consistently detect these suspect viruses in the brains of people who died of Alzheimer's. 

In other words, when researchers analyze AD patient brains, detectable viral components may have disappeared, and causation is difficult to establish.

The full unedited article published by The Conversation is posted at this link.

As of February 12, 2023, the FDA has not authorized any of the current Alzheimer's vaccine candidates.

According to research published in The Lancet Infectious Diseases by researchers at the University of Maryland School of Medicine (UMSOM), a monoclonal antibody (mAbs) treatment conferred protection in people against P falciparum (malaria) at low doses 

Published on January 25, 2023, this phase 1 clinical study found the mAbs CIS43LS protected 18 (82%) of 22 participants who received a dose. In addition, no participants developed parasitemia following dosing at 5 mg/kg intravenously or subcutaneously or at 10 mg/kg intravenously or subcutaneously.

All six control and four of seven participants dosed at 1 mg/kg intravenously developed parasitemia after controlled human malaria infection.

"The study demonstrates the feasibility of using mAbs therapies to help prevent malarial infection and holds promise for deployment to places where the disease is endemic," said Kirsten Lyke, MD, at UMSOM, in a related press release.

"This may allow us to revisit malaria eradication efforts."

According to the World Health Organization (WHO), malaria is a vaccine-preventable disease caused by a parasite. 

Vaccines like Mosquirix™ (RTS,S), and R21/Matrix-M™ have been reported to be effective at preventing disease in Africa and India.

As of February 11, 2023, the U.S. Food and Drug Administration (FDA) had not approved a malaria vaccine.

According to the 2021 World Malaria Report, about half the world's population lives in areas at risk of malaria transmission.

There were 241 million malaria cases and 627,000 deaths reported worldwide in 2020 alone, a 12% increase from 2019.

However, outbreaks of locally transmitted malaria cases in the U.S. have been limited and relatively isolated. The FDA has approved Artesunate to treat severe malaria in adult and pediatric patients.

Malaria outbreak news is posted at Vax-Before-Travel.com/MalariaOutbreasks.