Search API

0 min read

GSK plc announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) AREXVY™ vaccine to adults aged 50-59 who are at increased risk for RSV disease.

A European regulatory decision is anticipated in the second half of 2024.

If accepted, AREXVY would be the first vaccine available to help protect this population. 

GSK recently estimated that nearly 80 million adults in the U.S. could receive an RSV shot for the first time. 

GSK announced on November 1, 2023, that AREXVY's third-quarter 2023 sales were approximately $850 million. 

As of January 30, 2024, AREXVY is approved in Europe, Japan, the United States, and several other countries for adults aged 60 and over to prevent lower respiratory tract disease caused by RSV.

Image: 
Image Caption: 
by Bryan Dilts
Live Blog Update Author: 
Location Tags: 
Include in VBT newsletter: 

Gonorrhea Treatments

Gonorrhea Treatments 2024

Gonorrhea can be treated with antibiotics; however, the bacteria have developed resistance to some treatments, and treatment will not repair any permanent damage done by the disease, says the U.S. Centers for Disease Control and Prevention (CDC). The WHO announced on July 24, 2023, that the spread of a Neisseria gonorrhea clone highly resistant to ceftriaxone is increasingly being reported in various countries. 

Gonorrhea Treatment Candidates

GSK plc announced on April 17, 2024, positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin (GSK2140944). Gepotidacin achieved a 92.6% microbiological success rate and was non-inferior to the leading combination treatment. Gepotidacin is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action and binding site and, for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most strains of target uropathogens (such as E. coli and S. saprophyticus) and N. gonorrhoeae, including isolates resistant to several antibiotics. Due to the well-balanced inhibition of two enzymes, gepotidacin target-specific mutations are needed to affect gepotidacin susceptibility significantly. EAGLE-2 and EAGLE-3 were phase 3 studies that found that Gepotidacin is an efficacious oral antibiotic with acceptable safety and tolerability profiles.

On November 1, 2023, the journal Nature published an article: The potential new super gonorrhea treatment, called zoliflodacin, developed initially by drug firm AstraZeneca and later by its spin-off Entasis Therapeutics, targets an essential bacterial enzyme that untangles DNA during cell replication. Zoliflodacin has a unique mechanism of action that inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.

The NEJM journal published Original Research on April 6, 2023, which found that gonorrhea incidence was low with doxycycline postexposure prophylaxis. The Lancet Infectious Disease wrote on June 12, 2023, that there is increasing evidence that doxycycline post-exposure prophylaxis (doxy-PEP) effectively prevents sexually transmitted infections among high-risk patients, particularly in patients using HIV preexposure prophylaxis. Overall, the risk of selecting dual-resistant strains and increasing N gonorrhea ceftriaxone resistance must be carefully balanced against the benefits of using doxy-PEP to prevent and treat sexually transmitted infections. The randomized phase of the DOXYVAC clinical study was stopped in August 2022 when DoxyPEP, a U.S. study presented at the International AIDS Conference, found that doxycycline PEP cut the risk of gonorrhea by 55%. In California, doxy-PEP is recommended for certain people.

Gonorrhea Tests

CARB-X announced on April 18, 2024, that it will award up to $1 million to diagnostics and health tech company Scout to demonstrate proof-of-concept and feasibility ahead of developing a new point-of-care test, STI Scout. The test will detect and differentiate between Neisseria gonorrhoeae and Chlamydia trachomatis.

3 min read
Last Reviewed: 
Friday, April 19, 2024 - 10:45
Description: 
Gonorrhea Treatments are available in 2024
Condition: 
0 min read

The Pan American Health Organization (PAHO) recently stated, 'Despite a global reduction in Zika cases since 2017, the circulation of this mosquito-borne virus has been confirmed in 89 countries around the world.'

The PAHO's data dashboard was updated on January 30, 2024, identifying 24 Zika virus cases in the Region of the Americas in 2024.

The PAHO listed Columbia (21) and Peru (3).

In 2023, the PAHO reported 35,549 Zika cases in the Americas, led by Brazil, with 33,863 cases.

In the United States, Puerto Rico reported 46 Zika cases last year.

"Most infections with this virus are asymptomatic or mild, making their detection by healthcare systems quite challenging," commented María Van Kerkhove, Head of the Emerging Diseases and Zoonoses Unit at the World Health Organization (WHO) in September 2023.

With regard to complications from a Zika infection, the WHO warns that pregnant women are particularly susceptible to its effects since it can lead to congenital malformations, such as microcephaly, as well as an increased likelihood of preterm births or spontaneous abortions.

From a protection perspective, no specific antiviral treatment is available for Zika virus disease, nor has a Zika vaccine candidate been approved in 2024.

Vaccine Treats: 
Image: 
Image Caption: 
WHO / Frontiers Zika map
Live Blog Update Author: 
Location Tags: 
Include in VBT newsletter: 

Precision Vaccinations Business

Ownership

Precision Vax, LLC is a 100% woman-owned private enterprise founded in 2016. Karen McClorey Hackett, Precision Vax's president, is committed to transparency in our ownership structure and revenue sources. Karen launched her career with IBM and has invested in digital health enterprises since 1997. Here is Karen's LinkedIn profile. 

Revenues

PVax's primary revenues come from advertisers. Our editorial team has no relationship or communications with any advertiser. Our dominant digital advertiser is Google Adsense. Please note that advertising networks such as Adsense integrate user-tracking capabilities that may not be obvious to users. Google Ads Terms & Conditions are published at this link. PVax also integrates lead-generation business agreements for clinical trials, diagnostic tests, and vaccine appointments.

Brands

InstantRx™ trademark is owned by Precision Vax LLC.

Note: PVax was a customer of GoodRx Inc. until 2019. On Feb. 1, 2023 - FTC Enforcement Action to Bar GoodRx from Sharing Consumers' Sensitive Health Info for Advertising. Under the proposed FTC order, GoodRx will pay a $1.5 million civil penalty for failing to report its unauthorized disclosure of consumer health data to Facebook, Google, and other companies. GoodRx Inc. published a response.

1 min read
Last Reviewed: 
Thursday, September 12, 2024 - 10:10
Description: 
PVax ownership, revenues, and brands
0 min read

Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC, PREVNAR 20®, APEXXNAR®) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.

The CHMP’s positive opinion will now be reviewed by the European Commission (EC) to decide whether to approve the vaccine.

This EC decision is expected in the coming weeks and will apply to all 27 EU member states plus Iceland, Liechtenstein, and Norway.

“Pfizer has a longstanding history of developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life-threatening infections,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on January 26, 2024.

“Today’s CHMP positive opinion represents a significant step forward in our continued efforts and, if approved, 20vPnC has the potential to cover more disease burden than any other available pediatric pneumococcal conjugate vaccine in the EU.”

In April 2023, the U.S. Food and Drug Administration approved PREVNAR 20® for most infants and children.

In February 2022, the EC Decision was adopted for APEXXNAR® (20vPnC) to prevent invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes in the vaccine in adults.

The unedited Pfizer press release is available at this link.

Vaccine Treats: 
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Location Tags: 
Include in VBT newsletter: 
0 min read

According to the U.S. CDC Yellow Book 2024, an international traveler's risk for acquiring Yellow Fever virus is determined by their immunization status and destination-specific and travel-associated factors. 

Since about thirty countries require proof of a pre-arrival yellow fever vaccination, many travelers have questions about the vaccine's long-term efficacy.

On January 22, 2024, the Lancet Global Health recently published results from a systematic review aimed at assessing the necessity of a booster vaccination based on the long-term (10+ years) immunogenicity of primary yellow fever vaccination in travelers and in residents of yellow fever-endemic areas, as well as in specific populations, including children and immunocompromised individuals.

The gathered evidence suggested that a single dose of yellow fever vaccine provides lifelong protection (overall seroprotection rate 94%) in travelers.

However, in people living with HIV and young children (<2 years), booster doses might still be required because lower proportions of vaccinees were seroprotected ten or more years post-vaccination.

The pooled seroprotection rate was 47% in children and 61% in people living with HIV. 

Lower observed seroprotection rates among residents of yellow fever endemic areas were partly explained by the use of a higher cutoff for seroprotection that was applied in Brazil. No conclusions could be drawn for the sub-Saharan Africa region.

The CDC says most people infected with yellow fever do not get sick or have only mild symptoms. People who get sick will start having symptoms 3–6 days after infection.

According to the CDC, about 12% of people with symptoms develop serious illnesses.

The study was registered with PROSPERO, CRD42023384087. No industry conflicts of interest were disclosed.

Vaccine Treats: 
Image: 
Image Caption: 
US CDC Yellow Book 2024
Live Blog Update Author: 
Location Tags: 
Include in VBT newsletter: 
0 min read

The journal Clinical Microbiology and Infection published the results from a post-hoc analysis regarding the relative effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) against recurrent hospitalizations for seniors.

Published on January 27, 2024, this analysis found that among 12,477 randomly assigned participants, receiving QIV-HD was associated with lower incidence rates of hospitalisations for pneumonia or influenza (10 vs. 33 events, IRR 0.30 [95% CI 0.14-0.64], p=0.002).

And all-cause hospitalisations (647 vs. 742 events, IRR 0.87 [95% CI 0.76-0.99], p=0.032) compared with QIV-SD.

These researchers wrote, 'Our exploratory results correspond to a number needed to treat 65 (95% CI 35-840) persons vaccinated with QIV-HD compared with QIV-SD to prevent one additional all-cause hospitalization per season.'

'Further research is needed to confirm these hypothesis-generating findings.'

As of January 29, 2024, over 156 million cell, egg, and nasal-based influenza vaccines were distributed in the U.S. during the 2023-2024 flu season.

Vaccine Treats: 
Image: 
Image Caption: 
US CDC flu shots 2024
Live Blog Update Author: 
Location Tags: 
Include in VBT newsletter: 
Chikungunya
Coalition for Epidemic Preparedness Innovations funds Houston Methodist Research Institute vaccinology team
measles
Wastewater surveillance can identify measles and polio viruses.
0 min read

Anyone can get pneumococcal disease, but some people are at increased risk. To better protect children and seniors from disease, innovative vaccine candidates are conducting clinical trials in 2024.

Currently, two kinds of pneumococcal vaccines are recommended in the U.S. - Pneumococcal conjugate vaccines (PCVs, specifically PCV15 and PCV20) and Pneumococcal polysaccharide vaccine (PPSV23).

However, even with U.S. FDA-approved vaccines broadly available, approximately 5,000 deaths are related to pneumococcal disease each year in the U.S.

To address this health issue, Vaxcyte, Inc. today announced the completion of enrollment in its Phase 1/2 clinical study evaluating VAX-31, a next-generation 31-valent PCV and the broadest-spectrum pneumococcal vaccine candidate in the clinic today. 

This vaccine candidate is designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte expects to announce topline safety, tolerability, and immunogenicity data from the Phase 1/2 study in the third quarter of 2024.

"Completing the enrollment of the VAX-31 study with more than one thousand adults 50 years and older is a significant step for our PCV franchise, and we look forward to announcing topline safety, tolerability, and immunogenicity data in the third quarter of this year," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release.

"VAX-31, the broadest-spectrum PCV in the clinic, has the potential to address a significant public health need by covering approximately 95% of IPD circulating in the U.S. adult population while maintaining coverage of previously circulating strains that are currently contained via ongoing vaccination."

Vaxcyte's unedited press release is posted here.

Vaccine Treats: 
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Location Tags: 
Include in VBT newsletter: