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Since the approval of Respiratory Syncytial Virus (RSV) vaccines and an enhanced monoclonal antibody in 2023, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have received reports of RSV vaccines being administered in error to young children and pregnant women.
A Clinician Outreach and Communication Activity COCA Now email issued today says the number of reports received by the Vaccine Adverse Event Reporting System (VAERS) as of January 17, 2024, suggests that these types of errors are uncommon in young children less than two years of age (25 reports) and pregnant women (128 reports).
The CDC stated this is a relatively small amount of errors compared to the estimated one million infants protected from RSV either through infant receipt of Beyfortus™ (nirsevimab) or by pregnant women being vaccinated.
According to the CDC, most of these administration error reports described no adverse event. When an adverse event was concurrently reported to VAERS, most reports were classified as nonserious.
The CDC, FDA, and other federal agencies said they continue to monitor the safety of RSV vaccines and reports of vaccine administration errors and will share information with the public as it becomes available.
On January 22, 2024, the CDC published Recommendations for Healthcare Providers who Have Administered Incorrect RSV Vaccine Products to Their Patients.
The U.S. Centers for Disease Control and Prevention (CDC) recent influenza vaccination coverage estimates indicate a continued decrease among pregnant women since 2020.
Based on data from January 13, 2024, the CDC reported last Friday that flu vaccination coverage among pregnant Women as of December 2023 is about 3% lower compared to the end of December 2022 (36% Vs. 39%),
And about 6% lower compared to the end of December 2021 (36% Vs. 42%) and 17% points lower than at the end of December 2020 (36% Vs. 53%).
With the 2023-2024 flu season ongoing in the United States and numerous countries, the CDC recommends flu vaccination and early antiviral treatment for certain people.
There’s still time to benefit from the protection vaccination offers this flu season, says the CDC.
Various flu shots remain available at health clinics and pharmacies in the U.S.
As the world awaits the approval of a Human Immunodeficiency Virus (HIV) vaccine, a novel candidate based on Gorilla adenoviral vector (GRAd-HIV) technology was recently funded by The Bill & Melinda Gates Foundation.
Over the past few decades, various HIV vaccine candidates have not succeeded in human clinical trials.
Announced on January 22, 2024, ReiThera Srl, the Ragon Institute of Mass General, MIT, Harvard, and IAVI confirmed a collaboration to develop a novel HIV vaccine candidate that will be composed of ReiThera’s GRAd vector and HIV T-cell epitopes.
ReiThera’s vaccine platform uses a novel proprietary GRAd vector belonging to species C adenoviruses that are considered among the most potent vaccine carriers for the induction of CD8 T-cell responses to the encoded antigens and having a low seroprevalence in humans.
Prior findings by the Ragon Institute have shown that mutation of residues at important network positions disproportionately impaired viral replication and occurred with high frequency in epitopes presented by protective human leukocyte antigen (HLA) class I alleles.
Moreover, CD8+ T-cell targeting of highly networked epitopes distinguished individuals who naturally control HIV, even in the absence of protective HLA alleles.
“We are thrilled to have the opportunity to collaborate with ReiThera and IAVI, with the support of the Bill & Melinda Gates Foundation, to advance the GRAd-HIV highly networked T-cell vaccine candidate towards clinical evaluation,” said Gaurav Gaiha, Ragon faculty member, in a press release.
“We are particularly pleased that this takes place with partners in sub-Saharan Africa, given the immense need for new solutions to curtail the ongoing HIV epidemic.”
Key partners in this program include researchers at the Africa Health Research Institute, the National Institute for Communicable Diseases in South Africa, Mutala Trust, and Charles River Medical Group in Zimbabwe.
IAVI is the sponsor and will execute a phase I clinical trial.
The Global Polio Eradication Initiative (GPEI) recently reported 20 circulating vaccine-derived poliovirus type 1 or type 2 (cVDPV2) cases were reported in six African countries in late 2023.
Chad, the Democratic Republic of the Congo, Ivory Coast, Mozambique, Nigeria, and South Sudan reported new polio cases.
Since March 2021, the GPEI has helped administer nearly 1 billion doses of novel oral polio vaccine type 2 (nOPV2) across 35 countries, primarily in Africa.
After nearly three years of use, estimates show that nOPV2 is 80% less likely to seed new variant polio outbreaks, making it the tool of choice to stop these outbreaks for good, says the GPEI.
The World Health Organization (WHO) confirmed in December 2023 that the spread of the poliovirus (31 countries) remained a Public Health Emergency of International Concern.
The WHO Director-General, Dr Tedros Adhanom Ghebreyesus, commented on January 9, 2024, "nOPV2 has blazed a trail for other new vaccines that address critical health emergencies."
In late December 2023, the WHO issued its first-ever prequalification approval for a vaccine, nOPV2, being used under its Emergency Use Listing regulatory pathway.
As of early January 2024, 325 cases of cVDPV2 had been reported in 2023, compared to 689 cases in 2022.
In the United States, following the detection of poliovirus in New York, the U.S. CDC selected jurisdictions to strategically expand wastewater testing for poliovirus in counties with potentially low polio vaccination coverage.
Last year, the World Health Organization (WHO) confirmed the first known case of Western Equine Encephalitis (WEE) in more than two decades in Argentina.
Since then, and until January 9, 2024, 21 human cases in Argentina have been confirmed by the WHO/PAHO.
To alert international travelers to this WEE health risk, the U.S. CDC issued a Level 1 - Practice Usual Precautions, Travel Health Notice on January 12, 2024.
WEE is a rare, mosquito-borne viral disease that affects equines and humans. Most human cases are associated with epidemics in birds or horses.
The CDC says travelers to these regions of Argentina should avoid mosquito bites, which can transmit the Eastern Equine Encephalitis Virus (EEEV).
EEEV transmission is most common in and around freshwater hardwood swamps in the Atlantic and Gulf Coast states and the Great Lakes region in the U.S.
Only about 4-5% of human EEEV infections result in EEE.
In the United States, an average of 11 human cases of EEE are reported annually, according to the CDC. There were 7 EEEV neuroinvasive disease cases in 2023, reported by four states.
From 2012-2021, most cases of EEE have been reported from Massachusetts, Michigan, Florida, Georgia, and North Carolina.
As of 2024, the CDC says no vaccine prevents EEE virus infection.
However, the U.S. Army Medical Research Institute of Infectious Diseases developed a human vaccine for EEE in the mid-1980s, but it has never been approved for public use.
The U.S. government recently invested in a vaccine against western, eastern, and Venezuelan equine encephalitis viruses.
MVA-BN® WEV has completed Phase 1 clinical development demonstrating potential for broad, and long-term protection, with a Phase 2 study planned for 2024.
According to various news sources, Indian Immunologicals Ltd (IIL) launched Havisure, the 'first' indigenously developed two-dose Hepatitis A vaccine.
"Currently, Hepatitis A vaccines are imported into our country, and as a true meaning of Atma Nirbhar Bharat, IIL has tirelessly put in efforts and developed India's 1st vaccine for Hepatitis A," said K Anand Kumar, Managing Director, IIL, told newspersons such as Businessline on January 19, 2024.
Priced at ₹2,150 ($25) per dose, the vaccine is recommended for individuals at risk of exposure or travel to regions with high hepatitis A prevalence. In addition to this, people with occupational risk of infection and suffering from chronic liver diseases also need Hepatitis A vaccination.
According to the U.S. CDC, Hepatitis A is a severe liver disease. It is usually spread through close, personal contact with an infected person or when a person unknowingly ingests the virus from objects, food, or drinks contaminated by small amounts of stool from an infected person.
Hepatitis A vaccinations (Havrix, Twinrix, VAQTA) have made this disease much less common in the United States.
However, outbreaks of hepatitis A among unvaccinated people still happen. Since hepatitis A outbreaks were first identified in 2016, the World Health Organization estimates that 7,134 persons have died from hepatitis A worldwide.
In the U.S., 37 states have publicly reported the following cases as of January 12, 2024:
Cases: 44,947
Hospitalizations: 27,469 (61%)
Deaths: 424
In response to all hepatitis outbreaks, the CDC provides ongoing epidemiology and laboratory support and support on vaccine supply and vaccine policy development.
The Costa Rica Ministry of Health today announced it confirmed a measles case near the capital city of San Jose.
This new measles patient was detected on January 11, 2024. In 2023, one measles patient was also confirmed.
Given this new measles case, the Costa Rica health authorities conducted all follow-up efforts to address the situation. Currently, this person is in good health.
An active community search for cases in San Josecito de San Rafael de Heredia was conducted on January 18, 2024. As a result of the search, no additional measles cases were found, as most of the people approached had completed vaccination schedules. A total of 408 houses were visited.
After the WHO Region of the Americas was declared measles-free in September 2016, a steady increase in imported measles cases from other WHO Regions and between countries within the Region of the Americas was observed.
For example, several states in the eastern United States have reported measles cases in early 2024.
Last year, the Pan American Health Organization / World Health Organization (PAHO/WHO) urged Member States to continue activities to increase and maintain adequate vaccination coverage against measles, rubella, and mumps (MMR).
Globally, the WHO has reported significant measles outbreaks throughout 2023.
In addition to measles, Costa Rica confronted an expansion of Dengue and Zika cases in 2023.
Vaxart, Inc. today announced that the United States Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company $9.27 million to fund preparation for a 10,000-subject Phase 2b clinical study evaluating Vaxart's oral pill XBB COVID-19 vaccine candidate against an approved mRNA vaccine comparator.
Vaxart's oral pill vaccine platform provides many of the features desired by BARDA, such as generating mucosal immunity and providing a cross-reactive response to many COVID variants.
"We believe we have the chance to improve on existing vaccines in two important ways," said Dr. James F. Cummings, Vaxart's Chief Medical Officer, in a press release on January 19, 2024.
"First, a thermostable pill vaccine such as Vaxart's offers the chance to overcome needle-phobia, a documented obstacle to vaccination, and offers the potential to make it easier to vaccinate more people faster than traditional injected vaccines."
"Second, our previous research on other vaccine constructs found Vaxart's oral pill vaccine to be cross-reactive against all tested SARS-CoV-2 variants and to trigger long-lasting immune responses, potentially offering broader, longer protection than the current first-generation vaccines."
"We believe our vaccine does this by triggering both a systemic and mucosal response."
This oral vaccine development project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS). Project NextGen is a $5 billion initiative by HHS to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19 than the first-generation COVID vaccines and medicines.
Project NextGen is separate but similar to the Disease X initiative.
