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The World Health Organization (WHO) recently published Influenza Update N° 443, confirming after January 2023, worldwide activity increased with a higher proportion of influenza A(H1N1)pdm09 and B virus detections until a peak around week #10, after which detections decreased.

Currently, there are sporadic reports of the Southern Hemisphere flu season causing infections in Brazil and Peru.

And as of April 17, 2023, the WHO reported Respiratory Syncytial Virus (RSV) activity was generally low or decreasing except in Australia, New Zealand, South Africa, and a few countries in the Region of the Americas.

In South Africa, the RSV detection rate among children under five years of age in pneumonia surveillance reached a very high level.

And RSV remained elevated in Guatemala and Mexico and increased in the Plurinational State of Bolivia.

As of April 20, 2023, the U.S. FDA has not authorized any RSV vaccine candidate.

However, various countries have approved RSV monoclonal antibody therapies.

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WHO RSV and Influenza Report April 17, 2023
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The World Health Organization (WHO) today published Influenza Update N° 443, confirming flu detections decreased steeply in January 2023 after a peak in late 2022.

After the end of January 2023, global activity increased until a peak around week #10, after which detections decreased.

In the countries of North America, most indicators of influenza activity were at levels typically observed towards the end of the annual flu season.

And as of April 17, 2023, overall influenza detections in Europe decreased, and influenza positivity from sentinel sites decreased to 16% but remained above the epidemic threshold at the regional level.

Of 41 European countries, 13 reported moderate intensity, with the remainder reporting low or below baseline intensity.

Influenza activity was low last week in the Caribbean and Central American countries.

However, increases in influenza activity were reported in Belize and Guatemala, where activity was close to the moderate threshold.

And the tropical countries of South America, influenza remained low, except for Brazil, Peru, and the Plurinational State of Bolivia, which reported high activity.

Since spreading influenza is a year-round health risk, the WHO and the U.S. CDC recommend international travelers speak with a healthcare provider about flu shot options.

For example, the HEB Pharmacy at UT Health in Austin, Texas (78712), located near the Austin Bergstrom International Airport (AUS), offers pre-departure travel vaccination advice and services.

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by Rico P.
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The U.S. The Transportation Security Administration (TSA) has deployed various customer service resources and digital technologies to assist travelers in expediting the airport screening process.

These TSA services enable about 2.2 million air travelers to pass through airport security more effectively in April 2023.

According to the TSA's activity report on April 19, 2023, the number of air travelers recently exceeded 2019, before the pandemic curtailed travel.

And if you need a helping hand during screening, all you have to do is ask TSA.

Air travelers requiring special accommodations or concerned about the airport security screening process can ask TSA staff for a passenger support specialist, who provides on–the–spot assistance during the security screening process.

Furthermore, those with questions or concerns about traveling with a disability, medical condition, or other exceptional circumstances can contact the TSA Cares helpline 72 hours before traveling.

Travelers may provide the officer with the TSA notification card or other medical documentation to describe their condition.

TSA Cares answers questions about screening policies, procedures, and what to expect at the security checkpoint.

TSA Cares can also assist passengers with medical conditions and injured service members, veterans, and wounded warriors.

The TSA's layered approach to security gets air passengers quickly and safely to their destination.

For example, in Houston, Texas, Hobby Airport (HOU) TSA Security Wait Times are digitally displayed.

Before heading to the airport, be sure to check HOU Arrival and Departure Delays, or if you know your specific flight, use iFly's Flight Tracker.

TSA's screening procedures are intended to prevent prohibited items and other threats to transportation security from entering the sterile area of the airport

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U.S. TSA Cares April 2023
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TSA deploys computed tomography airport screening
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As the COVID-19 caseload recently accelerated in India, the global community is debating the cause of this upsurge. 

Medical experts have warned that the new XBB1.16 coronavirus variant can evade people's immune systems, regardless of vaccine or naturally induced immunity.

For example, India's Ministry of Health reported 12,591 new cases and 40 deaths on April 19, 2023. 

Dr. Randeep Guleria recently told ANI .... while the country was seeing a fresh surge in Covid-19 infections, the situation isn't one to induce panic.... the majority of the infections are mild.

And the rate of hospitalization hasn't gone up either.

In reaction to this new data, most states in India have reordered COVID-19 vaccines, such as CoviSheld, CorbeVax, and CovoVax™.

As of April 11, 2023, a total of 2,206,624,273 COVID-19 vaccine doses have been administered in India.

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BBC News April 2023
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New data collected by The Vaccine Confidence Project at the London School of Hygiene & Tropical Medicine and published today by UNICEF indicates a decrease in vaccine confidence in most countries.

As of April 20, 2023, people under 35 and women were more likely to report less confidence about vaccines for children after the start of the pandemic.

However, China, India, and Mexico were the only countries studied where the data suggests the perception of the importance of vaccines held firm or even improved.

In a related press release, Catherine Russell, UNICEF Executive Director, commented, "This data is a worrying warning signal. We cannot allow confidence in routine immunizations to become another victim of the pandemic."

"Otherwise, the next wave of deaths could be of more children with measles, diphtheria, or other preventable diseases."

Launched in 2015, the Vaccine Confidence Index™ (VCI) is a digital tool for gaining data-led insights into vaccine confidence at global, regional, and national levels.

In addition to measuring overall trust in vaccines, the VCI guides where to prioritize confidence building.

Data presented in this report comes from a large-scale retrospective study of changes in vaccine confidence between 2015 and November 2019 and since 2021. 

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World VCI map April 20, 2023
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According to recent data from the Republic of Costa Rica Health Surveillance Directorate of the Ministry of Health, a total of 105 positive cases of malaria have been identified in the Huerta Caribe region.

And 2,844 people treated from the communities of Finca 12, PCC, Medio Queso, Coquital, and San Gerardo, in the canton of Los Chiles, chose to prevent the spread of malaria, and 726 homes have been visited in which a total of 9,136 doses of chloroquine have been provided.

Most people detected as of April 13, 2023, were between 20 to 39 years of age.

It is essential to highlight that the Ministry of Health's goal is eliminating malaria by 2025.

To notify international travelers, the U.S. Centers for Disease Control and Prevention (CDC) issued an Alert - Level 2, Practice Enhanced Precautions on April 17, 2023, regarding Costa Rica's malaria outbreak.

The CDC warned malaria is a medical emergency, and appropriate treatment should not be delayed. And seek medical care if you develop fever, chills, sweats, headache, vomiting, or body aches. 

According to the World Health Organization Malaria Report released in December 2022, there were an estimated 619,000 malaria-related fatalities globally in 2021, with 568,000 deaths.

Additionally, the CDC stated if you are traveling to Limón or Alajuela Province, you should speak to your healthcare professional about how to prevent mosquito bites and which antimalarial drug is best.

Furthermore, as a prevention, you could take antimalarial drugs before travel. 

According to the CDC, malaria is a vaccine-preventable mosquito-borne disease. 

Vaccines such as RTS,S, and R21 have been approved in various countries and are reported to be effective at preventing disease.

Unfortunately, the U.S. Food and Drug Administration had not approved a malaria vaccine as of April 19, 2023.

This article was updated on April 20, 2023, with local links.

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U.S. CDC Map of malaria outbreak in Costa Rica April 2023
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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.

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U.S. CDC polio outbreak alert 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,

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U.S. CDC April 19, 2023
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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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Availability: 
N/A
Generic: 
VAX-24, VAX-31
Drug Class: 
Vaccine
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Last Reviewed: 
Friday, February 21, 2025 - 07:30
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FDA First In Class: 
Yes