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UNICEF recently confirmed that more than 550,000 doses of a World Health Organization (WHO)-recommended malaria vaccines arrived in the Republic of Sierra Leone.
Malaria burden is significant in Sierra Leone as it accounts for over two million hospital visits per year, of which children under five years of age account for one million of these cases.
This vaccine-preventable disease accounts for about 25% of child deaths in this West African country.
These vaccinations are essential as exposure to malaria parasites does not confer lifelong protection, unlike other mosquito-transmitted diseases.
Announced on December 15, 2023, this shipment, worth $ 5.5 million, follows the shipment of over 330,000 doses to Cameroon. These shipments signal the scale-up of vaccination against malaria across the highest-risk areas on the African continent.
As of December 24, the WHO and the European Medicines Agency recommended the Mosquirix™ (RTS,S/AS01) and R21 / Matrix-M™ malaria vaccines. These vaccines have been added to the WHO's list of prequalified vaccines.
These malaria vaccines are not yet available in the Region of the Americas, which includes the United States.
First identified in Germany in 1967, Marburg virus (MARV) outbreaks have been reported more than a dozen times over the past 56 years.
A Marburg virus (MARV) vaccine tested at Texas Biomedical Research Institute is progressing in clinical trials, moving a step closer to becoming the world’s first vaccine against the deadly virus.
The Sabin Vaccine Institute recently announced it launched Phase 2 clinical trials of its single-dose vaccine candidate ChAd3-MARV.
Early tests demonstrating the vaccine’s efficacy, safety, and optimal dosage were completed at Texas Biomed.
This announcement is essential since there are no approved Marburg vaccines or treatments.
“We have been partnering with Sabin since 2019 and are very excited to see their Marburg vaccine candidate move into Phase 2 clinical trials,” says Ricardo Carrion, Jr., Ph.D., the Director of Maximum Containment Contract Research at Texas Biomed, in a press release on December 7, 2023.
“An effective vaccine is critical to protect people from this deadly virus, especially as we see the frequency of outbreaks increasing in more places.”
The Phase 2 clinical trial will build on promising results from preclinical studies and a smaller Phase 1 clinical trial.
Texas Biomed continues to partner with Sabin to gather more detailed information that can only be gained through tightly controlled animal studies, including how soon protection is induced after vaccination.
Marburg virus is a part of the same filovirus family as Ebola virus and causes severe hemorrhagic fever. It is incredibly deadly, with up to a 90% fatality rate.
Recent MARV outbreaks that occurred in Equatorial Guinea killed 12 out of 17 confirmed cases, with another 23 probable deaths, according to the World Health Organization.
Tanzania also saw its first-ever Marburg outbreak, which killed six out of eight confirmed cases.
Texas Biomed has conducted similar work on Sabin’s closely related Sudan ebolavirus vaccine as part of a World Health Organization-coordinated outbreak response.
As of December 24, 2023, several Ebola vaccines, therapies, and vaccine candidates are conducting research studies. Ebola vaccines are not generally available in the U.S.
Most scientists say that having two independent data points empowers better decisions. This philosophy can be applied when determining the local health risk during the 2023-2024 flu season.
As of late December 2023, the U.S. Centers for Disease Control and Prevention (CDC) and Walgreens published updated maps and data identifying where influenza is being detected.
The CDC's FluView Updates for Week #50, ending December 16, 2023, reported seasonal influenza activity was elevated and continues to increase in most parts of the country.
And outpatient respiratory illness is above baseline for the 7th consecutive week and is above baseline in all 10 HHS Regions.
Previously, the Walgreens Flu Index® reported state and market-specific information regarding flu activity, which is compiled using retail prescription data for antiviral medications used to treat influenza across Walgreens locations nationwide.
As of December 16, 2023, Walgreens identified the top ten states:
- Louisiana
- Mississippi
- Alabama
- Texas
- North Carolina
- Tennessee
- South Carolina
- New Mexico
- Wyoming
- Nevada
The good news from the CDC is that as of December 2023, over 153 million influenza vaccines were distributed this season, available today at most pharmacies in the U.S.
Following the discovery of Human Immunodeficiency Virus (HIV) as a causative agent of AIDS, multiple vaccine-candidate clinical trials have been conducted over the past 35 years.
According to the authors of a new study published in the journal Science, future HIV vaccine candidates may be more successful if they include additional doses or persist longer in the body to stimulate the immune system further.
These researchers wrote on December 14, 2023, that the potential of an HIV vaccine might be better judged by measuring how it affects CD8+ T-cell function and sensitivity in addition to just assessing the number of CD8+ T cells generated, which has been the usual practice.
These findings build on decades of research by the HIV-Specific Immunity Section of NIAID’s Laboratory of Immunoregulation to better understand the immune response to HIV.
The insights from this study may help guide future preventive and therapeutic HIV vaccine design and development and HIV immunotherapy approaches.
Mark Connors, M.D., chief of the HIV-Specific Immunity Section of NIAID’s Laboratory of Immunoregulation, is available to discuss this research via e-mail at [email protected].
As of December 23, 2023, there are no approved HIV vaccines.
While malaria vaccines have become more available in Africa during 2023, they are not available in the Region of the Americas, where they are needed to protect children.
As disease-carrying mosquitos expand their range, tourists in vacation hot-spots such as the Republic of Costa Rica's breaches are left unprotected against this disease.
The Central American country of Costa Rica confirmed in December 2023 that there have been 544 malaria cases this year.
In 2022, Costa Rica's Health Ministry reported 406 locally-acquired malaria cases.
Globally, there were an estimated 249 million malaria cases and 426,000 deaths in 2022.
This year, the U.S. CDC recommends travelers visiting Costa Rica take prescription medicine to prevent malaria, but it can't suggest vaccinations yet.
As of October 2023, the World Health Organization (WHO) recommends two malaria vaccines for children: RTS,S/AS01, and R21/Matrix-M™.
The WHO expects these vaccines to have a positive public health impact.
And on December 21, 2023, WHO announced that it prequalified the R21/Matrix-M malaria vaccine. Prequalification status enables United Nations agencies to procure the vaccine for eligible countries.
Since most malaria cases in the United States are travel-related, the CDC may not expedite its approval for these new vaccines.
However, during 2023, local malaria cases have been confirmed in Florida, Maryland, and Texas.
Barinthus Biotherapeutics plc today announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of the VTP-500 vaccine candidate for the prevention of Middle East Respiratory Syndrome (MERS) Coronavirus (CoV).
This new project intends to take this MERS vaccine through Phase II clinical trials and, if successful, on into the development of an investigational ready reserve of 100,000 doses.
The three-way partnership has awarded up to $34.8 million to Barinthus Bio in addition to funds previously committed to the University of Oxford.
VTP-500 has already completed Phase I clinical trials in Britain and Saudi Arabia, and the University of Oxford is now conducting a Phase Ib trial in the UK to assess vaccination of older adults, the age group most in need of this vaccine.
The VTP-500 development program was awarded PRIME designation in December 2023 by the European Medicines Agency.
This program is essential, as no vaccines targeting MERS have been licensed.
“We are thrilled to be working with the University of Oxford and CEPI on developing this important vaccine candidate,” commented Bill Enright, Barinthus Bio’s Chief Executive Officer, in a December 21, 2023 press release.
MERS is a severe respiratory infection caused by MERS-CoV, a coronavirus first identified in 2012 in Saudi Arabia. It has caused more than 2,600 human infections in at least 27 countries. MERS has a case-fatality rate of more than 35%.
The World Health Organization wrote on August 29, 2023, that it expects additional MERS-CoV cases to be reported from the Middle East and/or other countries where MERS-CoV is circulating in dromedaries.
Barinthus Bio, formerly Vaccitech plc, is a clinical-stage biopharmaceutical company developing novel T-cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
HOOKIPA Pharma Inc. today announced that Gilead Sciences has purchased 15 million shares of the company's common stock for approximately $21.25 million, for $1.4167 per share.
This transaction closed on December 20, 2023, indicating Gilead's total ownership in HOOKIPA's Common Stock is approximately 19.4%.
In addition, HOOKIPA has other transaction rights.
Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on December 21, 2023. "Together, we have made meaningful progress in finding a potential functional cure for Human Immunodeficiency Virus (HIV)."
"Most recently, we received clearance from the U.S. Food and Drug Administration of our Investigational New Drug application for HB-500 and are excited to begin our Phase 1 trial in the first half of 2024."
HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine that is being evaluated as part of a potential curative regimen for HIV.
One vector is based on lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.
Both encode the same HIV antigens.
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter.
As of December 22, 2023, there are several HIV vaccine candidates conducting research, but none have been approved. According to the U.S. National Institutes of Health, HIV vaccine candidates can not cause an HIV infection.
In Canada, most influenza surveillance indicators are increasing but remain within expected levels typical of this time of year.
From August 27, 2023, to December 9, 2023, 163 laboratory-confirmed influenza outbreaks have been reported in Canada.
From an age-group perspective, adults 65 and older have accounted for 42% of recent flu-related hospitalizations.
On December 21, 2023, Canada confirmed its recommendation for seniors to get a flu shot for the 2023-2024 season.
Canada's National Advisory Committee on Immunization (NACI) preferentially recommends adults 65 years of age and older preferentially receive an enhanced influenza vaccine, which includes adjuvanted, high-dose, and recombinant vaccines.
This included CSL Seqirus's FLUAD® Influenza vaccine (surface antigen, inactivated, adjuvanted with MF59®).
"The 2022/23 influenza season was especially challenging for Canadians and added to the already significant strain being experienced by our healthcare systems," said Bertrand Roy, Ph.D., Country Head Medical Affairs Canada at CSL Seqirus, in a press release on December 21, 2023.
The NACI's new recommendation is based on data from studies showing that all approved enhanced influenza vaccines effectively reduce the risk of influenza-related hospitalization and medical encounters.
Influenza causes an average of 12,200 hospitalizations and approximately 3,500 deaths each year in Canada, with the majority occurring in adults over 65 years of age.
Canadians over 65 accounted for 76% of the reported influenza-associated deaths during the 2022/23 flu season.
Vaxart, Inc. today announced that it has completed enrollment and dosing in the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate focused on lactating mothers.
There is no U.S. Food and Drug Administration-approved vaccine against norovirus.
Outbreaks sickens approximately 21 million people in the United States annually, and 15% of children under age five contract norovirus annually.
Approximately 3 million sets of parents are forced by this virus to miss work, 2.2 days on average, to care for their children. The annual disease burden from norovirus is $10.6 billion in the U.S. alone.
“This is an important step forward as we drive toward a vaccine candidate that may make it possible for mothers to protect their children against this highly contagious – and potentially lethal -- virus. We look forward to announcing topline data from this study by the end of 2024,” commented Dr. James F. Cummings, Vaxart’s Chief Medical Officer, in a press release on December 21, 2023.
“We are very proud of our clinical team for completing enrollment of this trial within our planned timeline.”
The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study (VXA-NVV-108) is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age.
As of late December 2023, several norovirus vaccine candidates are conducting clinical research.
