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The journal ScienceDirect recently published a study on vaccine-derived poliovirus serotype 2 outbreaks and response in the Democratic Republic of the Congo (DRC) 2017–2021.

Published on April 6, 2023, this study revealed previous VDPV serotype 2 outbreaks (cVDPV2) documented outbreaks in the DRC since 2005.

The nine cVDPV2 outbreaks detected during 2005–2012 resulted in 73 paralysis cases.

And from January 2017–December 31, 2021, 19 cVDPV2 outbreaks were detected in DRC, resulting in 235 paralysis cases in 18 of DRC's 26 provinces.

Moreover, the DRC-KAS-3 cVDPV2 outbreak that circulated during 2019–2021 resulted in 101 paralysis cases in 10 provinces and was the largest recorded in DRC.

To notify visitors to the DRC, the U.S. Centers for Disease Control and Prevention (CDC) reissued a Global Polio Alert - Level 2, Practice Enhanced Precautions on March 22, 2023.

This CDC Travel Alert included the DRC.

Before traveling to any destination listed, the CDC suggests that adults who previously completed the entire polio vaccine series receive a single, lifetime booster dose of the polio vaccine.

In the U.S., various polio vaccines are available at health clinics and pharmacies, such as United and Market Street in Lubbock, Texas.

Vaccine Treats: 
Polio
Image: 
Image Caption: 
U.S. CDC polio outbreak alert March 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Kinshasa
Vaccine: 
nOPV2 Polio Vaccine March 2023
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The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) conducted a digital meeting today led by Dr. Grace Lee focused on the U.S. FDA's updated COVID-19 vaccine emergency use authorizations (EUAs).

The EUAs were structured by the FDA on April 18, 2023, to simplify the use of bivalent mRNA vaccines for all doses and indications administered to individuals ages six months and older and additional mRNA dose(s) for specific populations.

These changes did not impact the Novavax protein-based COVID-19 vaccine (Nuvaxovid™, CovoVax™).

The ACIP also reviewed the following presentations on April 19, 2023:

  • Vaccine safety updates,
  • Vaccine effectiveness data updates,
  • Epidemiology and hospitalization data,
  • Benefit-risk analysis,
  • Considerations for transition to bivalent primary series,
  • Future directions of COVID-19 vaccines, including updates to vaccine policy.

Both the CDC and FDA staff confirmed today that a meeting in June 2023 would offer additional clarity before any Fall 2023 COVID-19 vaccination program,

Vaccine Treats: 
COVID-19
Image: 
Image Caption: 
U.S. CDC April 19, 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Atlanta
Vaccine: 
Novavax COVID-19 Vaccine

Vaxcyte Pneumococcal Vaccines

Vaxcyte Pneumococcal Vaccines Clinical Trials, Indication, Side Effects

Vaxcyte Inc.'s carrier-sparing Pneumococcal Vaccine (PCV) franchise candidates, VAX-24, a 24-valent PCV, and VAX-31, a 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease (IPD). Both VAX-24 and VAX-31 are designed to improve upon the standard-of-care PCVs for children and adults by covering the serotypes responsible for a significant portion of IPD in circulation and are associated with high case-fatality rates, antibiotic resistance, and meningitis while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.

Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company's system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficient create and deliver high-fidelity vaccines with enhanced immunological benefits disease (PD) is an infection caused by Streptococcus pneumonia  (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis. 

Grant Pickering, CEO and Co-founder of Vaxcyte, commented in a press release on November 6, 2024: "We believe the recent topline results for VAX-31 in adults demonstrate its potential as a best-in-class PCV to provide protection against both currently circulating and historically prevalent strains while setting a new standard for immunogenicity. In addition, we plan to initiate the VAX-31 infant Phase 2 study in the first quarter of 2025, subject to IND application clearance by the end of this year."

Vaxcyte (Nasdaq: PCVX) is a vaccine innovation company that engineers high-fidelity vaccines to protect humans from the consequences of bacterial diseases. On September 4, 2024, Vaxcyte announced that it had commenced an underwritten public offering of $1.4 billion of its common stock and pre-funded warrants.

VAX-24 Vaccine

VAX-24 is an investigational 24-valent PCV candidate designed to prevent IPD, which can be most serious for infants, young children, older adults, and those with immune deficiencies or certain chronic health conditions. In July 2024, the VAX-24 Phase 2 study results in adults aged 65 and older were published in the journal Vaccine. The study evaluated the safety, tolerability, and immunogenicity of Vaxcyte's investigational 24-valent, carrier-sparing PCV compared to Prevnar 20® (PCV20) for preventing invasive pneumococcal disease (IPD) in healthy adults. The results showed that VAX-24 demonstrated a safety and tolerability profile comparable to PCV20 across all ages and doses studied. The VAX-24 2.2mcg dose showed an overall improvement in immune responses compared to PCV20 relative to the prior Phase 2 study results in adults aged 50-64. The U.S. FDA awarded VAX-24 Breakthrough Therapy Designation on January 5, 2023, and cleared the Company's infant Investigational New Drug application for VAX-24 on February 21, 2023. 

VAX-31 Vaccine

VAX-31 is a next-generation PVC vaccine and is the broadest-spectrum PCV candidate in the clinic today. As of February 5, 2025, Vaxcyte announced that the first study participants had been dosed in the second and final stage of the ongoing Phase 2 study of VAX-31 in healthy infants. Advancement to Stage 2 follows a blinded assessment of the Stage 1 safety and tolerability data per the study protocol. The Company expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later.

Vaxcyte Inc. Vaccine News

February 5, 2025 - “Advancing to Stage 2 of the VAX-31 infant Phase 2 study represents a significant step forward in evaluating the broadest vaccine candidate in the clinic today for this vulnerable population,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte.

December 3, 2024 - “The initiation of the VAX-31 Phase 2 infant study marks a significant milestone as we continue advancing our PCV clinical programs, which also include the fully enrolled, ongoing VAX-24 Phase 2 infant study,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.

September 3, 2024 - The Company presented topline results from the Phase 1/2 study evaluating the safety, tolerability, and immunogenicity of VAX-31 in healthy adults aged 50 and older.

August 6, 2024 - The Company announced it had cash, cash equivalents, and investments of $1,851.9 million as of June 30, 2024, compared to $1,242.9 million as of December 31, 2023.

January 4, 2024 - Mr. Grant Pickering commented in a press release, "We also received encouraging feedback from the FDA regarding the licensure requirements for VAX-24 in adults. We are fortunate to be afforded these ongoing discussions, given the Breakthrough Therapy designation granted to VAX-24, and expect to seek additional CMC-focused input from regulators as we prepare for and conduct the adult Phase 3 program, which will comprise several studies. With VAX-24 and VAX-31, we are confident in our plans to build a best-in-class PCV franchise that delivers the broadest spectrum of coverage against invasive pneumococcal disease."

July 11, 2023 - Vaxcyte, Inc. announced that the ongoing Phase 2 study of VAX-24 in healthy infants is advancing to the second and final stage of the study. 

Vaxcyte Vaccine Clinical Trials

VAX-24 Infant Phase 2 Study - The VAX-24 infant Phase 2 clinical study, which is now fully enrolled with 802 healthy infants, is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability, and immunogenicity of VAX-24. The Stage 1 portion of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels (low dose/1.1mcg, middle dose/2.2mcg, mixed dose/2.2mcg or 4.4mcg) and compared to VAXNEUVANCE™ (PCV15), which was the broadest-spectrum PCV at the time of study initiation, in 48 infants. The Stage 2 portion evaluates the safety, tolerability, and immunogenicity of VAX-24 at the same three dose levels and compared to Prevnar 20® (PCV20), currently the broadest-spectrum PCV recommended by the Advisory Committee on Immunization Practices (ACIP), in 754 infants. Participants who received VAX-24 in Stage 1 will continue the standard dosing regimen as part of Stage 2 and will be included in the study's safety, tolerability, and immunogenicity analysis.

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Manufacturer: 
Vaxcyte, Inc
Reviewer: 
Robert Carlson, MD
Vaccine: 
Vaxcyte Pneumococcal Vaccines
VIS: 
PDF
Availability: 
N/A
Generic: 
VAX-24, VAX-31
Drug Class: 
Vaccine
Clinical Trial Phase I: 
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults
Clinical Trial Phase II: 
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
Condition: 
Pneumococcal
Last Reviewed: 
Friday, February 21, 2025 - 07:30
Status: 
Candidate
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
0 min read

The journal Nature recently published a news article focused on an innovative tactic to reduce the number of dengue cases in Brazil.

This program aims to protect up to 70 million Brazilians from diseases such as dengue.

The non-profit World Mosquito Program announced it would release about five billion bacteria-infected mosquitoes annually in many of Brazil’s urban areas over the next ten years.

Researchers have tested the release of this type of mosquito, which carries a Wolbachia bacterium that stops mosquitoes from transmitting viruses. Wolbachia naturally infects about half of all insect species.

In Brazil, previous test results have been modest. For example, in Niterói, the intervention was associated with a 69% decrease in dengue cases, while in Rio de Janeiro, the reduction was 38%.

But this will be the first time that the technology is dispersed nationwide.

Nature posts the unedited article as of April 14, 2023.

In the U.S., the state of Florida launched a similar program in May 2021.

Florida continues to report the most travel-related and locally acquired dengue cases in the U.S. during 2023.

Globally, two dengue vaccines have been authorized.

Vaccine Treats: 
Dengue
Image: 
Image Caption: 
by Gabriela Piwowarska
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Brazil
Vaccine: 
QDENGA (TAK-003) Dengue Vaccine
0 min read

The Nigeria Centre for Disease Control and Prevention (NCDC) has reported an unprecedented negative trend in confirmed cases of Lassa Fever.

The NCDC recently confirmed a total of 869 confirmed Lassa Fever cases and 151 related fatalities from 26 states and 101 local government areas.

Cumulatively for 2023, the case fatality rate (CFR) of 17.4%.

As of April 9, 2023, for week #14 , the number of new confirmed cases is 23 from Bauchi, Ondo, Edo, Taraba, Lagos, and Enugu Niergian States.

Lassa fever is an acute viral hemorrhagic fever with a natural reservoir in the Mastomys natalensis rodent (African rat).

As of early March 2023, the U.S. CDC's Watch - Level 1, Practice Usual Precautions notice alerts visitors to Nirgeria of the health risk.

As of April 19, 2023, the U.S. FDA had not approved a Lassa fever vaccine.

Vaccine Treats: 
Lassa Fever
Image: 
Image Caption: 
U.S. CDC Nigeria Lassa fever Travel Notice March 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Lagos
Vaccine: 
INO-4500 Lassa Fever Vaccine
Dengue outbreaks April 2023

Dengue Travel Alert for the Americas Reissued

Dengue vaccines are authorized in various countries
April 19, 2023
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AstraZeneca recently highlighted new data at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), reinforcing its ambition to provide long-lasting immunity for millions globally. 

For example, data featuring AZD3152, AstraZeneca’s investigational long-acting COVID-19 antibody, shows the investigational COVID-19 long-acting antibody neutralizes all known variants of concern identified to date.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, stated in a press release on April 14, 2023, “Our first in vitro data from our next generation long-acting antibody, AZD3152, shows its potential to protect the immunocompromised from all known COVID-19 variants of concern to date.”

Last updated on April 3, 2023, the aim of the phase I/III clinical study is to evaluate the safety and neutralizing activity of AZD3152 compared with AZD7442 for pre-exposure prophylaxis of COVID-19 and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Other COVID-19 antibody news is posted by CoronavirusToday.com.

Vaccine Treats: 
COVID-19
Image: 
Image Caption: 
by Bruno G.
Live Blog Update Author: 
Don Hackett
Location Tags: 
London
Vaccine: 
EvuSheld Long-Acting Antibody 2023
0 min read

According to the U.S. government, pharmacies are the leading distribution outlet for COVID-19 vaccines. During the 2022-2023 season, available data show that more than two-thirds of adult COVID-19 vaccinations were administered at pharmacies.

Announced on April 18, 2023, the U.S. Department of Health & Human Services (HHS) announced the ‘HHS Bridge Access Program For COVID-19 Vaccines and Treatments Program (“Program”) to maintain broad access to COVID-19 vaccines for millions of uninsured Americans.

The program will create a unique $1.1 billion public-private partnership to help maintain uninsured individuals’ access to COVID-19 care at local pharmacies.

HHS wrote pharmacies had been a critical partner in the Administration’s response to COVID-19 and a vital access point for millions of Americans in receiving convenient and timely COVID-19 vaccines, treatments, and tests.

In the future, HHS aims to ensure that the pharmacy setting remains a place of access for the uninsured.

In building the Program, CDC will establish contracts with pharmacies to enable them to continue offering COVID-19 vaccines and designated treatments with no out-of-pocket costs to uninsured individuals, maintaining this critical access point for this population.

And pharmacies will also be expected to conduct outreach regarding the availability of the COVID-19 vaccine, including through community partnerships focusing on underserved populations. 

Together, these efforts will create a unique public-private partnership that will help maintain uninsured individuals’ access to COVID-19 care at their local pharmacies, local health centers, and public health infrastructure. 

Vaccine Treats: 
COVID-19
Image: 
Image Caption: 
U.S. HHS Secretary Becerra April 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Washington DC
Vaccine: 
Novavax COVID-19 Vaccine
0 min read

The journal ScienceDirect recently published results from an early-stage, innovative Zika virus vaccine candidate, OraPro-Zika.

On April 6, 2023, this study addressed several challenging features attributed to vaccinology.

First, developing a thermostable vaccine negates the need for a "cold chain." And second, the potential to deliver the vaccine orally.

Having demonstrated that iosBio's OraPro-Zika vaccine provided a measurable efficacy in the murine models, they performed a challenge study in NHP to investigate the potential clinical utility.

In this setting, enteric-coated capsules were given orally, negating the need for stomach acid neutralization.

Upon vaccination, a significant rise in anti-Zika IgG was evident after the first dose concordant with our murine model.

Furthermore, the level of IgG was similar to that in convalescent serum from NHP previously infected with the Zika virus.

Most strikingly, in challenge studies, convalescent and OraPro-Zika vaccinated animals showed no evidence of replicative Zika virus. In contrast, the placebo-vaccinated cohort showed full-blown infection, which modeled the disease pathology as it was rectified by day 8 of the study.

While we hypothesize the immune protection in our model systems is potential via a mucosal root, our study is limited and does not define cellular mechanisms or sIgA.

Nonetheless, IgG and challenge studies remain the gold standard for vaccine efficacy.

In summary, these researchers showed that an orally administered Ad5- vaccine encoding genes for the Zika envelope (Env) and NS1 proteins induced a specific immune response that reduced Zika infection in both murine and NHP models and remained thermally stable for over 109 days at 25 °C.

This preliminary study with OraPro-Zika suggests oral administration of a non-replicating adenovirus vector protects against challenge and warrants further investigation to establish a mode of action.

These authors declared various industry relationships, and Innovate UK supported the study.

Updated May 10, 2023 - Reassigned domain.

Vaccine Treats: 
Zika
Image: 
Image Caption: 
by Michal Jarmoluk
Live Blog Update Author: 
Don Hackett
Location Tags: 
United Kingdom
0 min read

The U.S. Centers for Disease Control and Prevention (CDC) today reissued its Watch - Level 1, Practice Usual Precautions regarding dengue outbreaks in Asia and the Pacific Islands.

The CDC stated that on April 17, 2023, the listed countries reported higher-than-usual dengue cases, and travelers visiting these countries may be at increased risk.

Because Dengue is a severe disease spread by mosquito bites, all travelers to risk areas should prevent mosquito bites by using an EPA-registered insect repellent, wearing long-sleeved shirts and long pants outdoors, and sleeping in an air-conditioned room or room with window screens or under an insecticide-treated bed net.

The CDC says Dengue can take up to 2 weeks to develop, generally lasting less than a week.

Additionally, visitors to these countries should speak with a healthcare provider regarding dengue vaccines, such as Dengvaxia and Takeda's QDENGA®.

Vax-Before-Travel posts other dengue outbreak news.

Vaccine Treats: 
Dengue
Image: 
Image Caption: 
U.S. CDC dengue map April 17, 2023
Live Blog Update Author: 
Don Hackett
Vaccine: 
QDENG (TAK-003) Dengue Vaccine