Travel Vaccine Breaking News

Travel vaccine breaking news brought to you by Vax Before Travel.

Jan 2, 2024 • 9:49 am CST
from Pixabay

ImmunityBio, Inc. announced today a recent capital raise that provides significant financial resources to accelerate the Company's commercialization efforts and expand its pipeline within the broader urological cancer space.

The Company's pipeline is based on broad immunotherapy and cell therapy platforms designed to attack cancer and infectious pathogens by activating the innate and adaptive branches of the immune system in an orchestrated manner.

On January 2, 2023, the Company confirmed up to $320 million royalty financing and equity investment by Oberland Capital, with $210 million of gross proceeds received at closing on December 29, 2023.

The proceeds will also fund ongoing business operations and clinical trials expanding Anktiva® (N-803) indications into multiple solid tumors.

ImmunityBio's commercialization efforts are in anticipation of potential U.S. Food and Drug Administration ("FDA") approval of Anktiva in combination with Merck's Bacillus Calmette-Guérin (BCG) vaccine for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 disease.

The Company announced on March 26, 2023, that the FDA had set a user fee goal date for Anktiva's Biologics License Application resubmission of April 23, 2024. 

Anktiva® (N-803) is an investigational therapy, and no safety or efficacy has been established by any Health Authority or Agency, including the FDA.

"This transaction raises significant capital for the Company to support important growth plans, yet with limited equity dilution and with a cap on total payments tied to the initial investment," said Richard Adcock, Chief Executive Officer and President of ImmunityBio, in a press release.

"Besides providing a capital source at a key inflection point for ImmunityBio, this investment demonstrates strong confidence by Oberland Capital in our future, and in particular in the potential value of Anktiva in bladder cancer, as well as the direction of our clinical pipeline."

In aggregate, $850 million in capital was raised in 2023, with $320 million from institutional investors and $530 million from its founder, Patrick Soon-Shiong, M.D.

The investment from Oberland Capital takes the form of a $300 million Revenue Interest Purchase Agreement ("RIPA") that is non-dilutive to current investors, of which $200 million was funded at closing, and $100 million is to be funded contingent upon FDA approval of the Company's BLA for Anktiva in combination with BCG for NMIBC, and subject to other terms and conditions as outlined in the RIPA. 

Under the terms of the RIPA, Oberland Capital will have a right to receive initially tiered single-digit royalty payments on net sales of the Company's products, which are capped at a multiple of their investment. In addition, the Company has entered into a purchase agreement with Oberland Capital for the private placement of 2,432,894 shares issued at closing, representing $10 million of gross proceeds based on the trailing 30-trading days VWAP. Oberland Capital can also purchase an additional $10 million of common stock at a future date.

In connection with the RIPA, the Company and Nant Capital entered into amendments to extend the maturity dates of certain existing promissory notes with an aggregate principal amount of approximately $505 million from December 31, 2024, to December 31, 2025, and to allow Nant Capital to convert up to an aggregate of $380 million of principal, plus accrued and unpaid interest, into shares of common stock at a price per share equal to a 75% premium to the closing market price on January 3, 2024. Nant Capital and the RIPA Purchaser Agent also concurrently entered into a Subordination Agreement, pursuant to which the Notes were subordinated to the Company's obligaCompany'sthe Purchasers under the RIPA.

Jan 2, 2024 • 7:37 am CST
US CDC Marburg outbreak map 2024

The journal Vaccine recently published a manuscript entitled "Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection."

This publication describes the preclinical efficacy of a novel, single-vial, bivalent thermostabilized vaccine providing 100% protection in the most rigorous non-human primate challenge models against Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections.

Recent outbreaks have occurred in Africa, with increased frequency in 2023.

There are currently no approved vaccines or therapeutics for either SUDV or MARV infections.

However, vaccines are available for Zaire ebolavirus (EBOV) infections in 2024, but they provide no protection against SUDV or MARV infection.

"Filoviruses such as EBOV, SUDV, and MARV are some of the most lethal viruses known, and they are endemic in areas of the world where the power supply and distribution network can be uncertain, says the World Health Organization.

A thermostabilized vaccine in a single vial format would significantly enhance any public health response to a new outbreak, at its source," stated Axel Lehrer, Ph.D., Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, University of Hawaiʻi at Mānoa, in a press release.

"Our work to date has demonstrated the feasibility of rapid and efficient manufacturing, as well as the ability to thermostabilize multiple antigens that can then be stored for extended times at temperatures exceeding 100 degrees Fahrenheit."

"The use of a bivalent vaccine has the potential to both prevent future infections with these pathogens and potentially mitigate future outbreak events, potentially using an accelerated dosing regimen."

The thermostabilized filovirus vaccine program continues to advance with the support of a National Institute of Health grant and a Small Business Innovation Research grant awarded to Soligenix, Inc.

Jan 2, 2024 • 6:57 am CST
by L. Ordmok

Inventprise Inc. today announced the completion of vaccination in their Phase 2 dose-ranging study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in young adults.

On January 2, 2023, the company stated that this Phase 2 study is essential in developing an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV). This vaccine candidate is designed to help prevent pneumococcal disease caused by serotypes not covered in the current PCVs.

“PCVs are the world’s most complex vaccines, and increasing the number of serotypes (25) and manufacturing capacity has been challenging since conjugate vaccines were first developed,” commented Yves Leurquin, President & CEO of Inventprise, in a press release.

As of 2024, several approved PCVs and vaccine candidates are conducting research. However, some do not include critical disease-causing serotypes.

“This study was designed to evaluate safety and antibody responses following single doses of three different formulations of IVT PCV-25 in young adults to pave the way for future studies in infants and older adults. In Canada, as well as elsewhere in the world, there continues to be significant rates of disease due to serotypes not covered in licensed vaccines so we are very interested in the potential for broader coverage,” says Dr. Joanne Langley, the study’s principal investigator at the Canadian Center for Vaccinology.

As a leading cause of deadly childhood pneumonia, sepsis, meningitis, and debilitating middle-ear infections, the pneumococcus bacterium is responsible for an estimated 300,000 deaths per year in children less than five years of age worldwide.

Inventprise is producing the IVT PCV-25 vaccine at its automated manufacturing facilities in Washington State. Funding for the development of IVT PCV-25 has been achieved with support from the Bill & Melinda Gates Foundation.

Dec 31, 2023 • 11:55 am CST
by Светлана

The Alaska Department of Environmental Conservation recently reported a polar bear was found dead after being infected with the highly pathogenic avian influenza (HAPI).

The polar bear was found on October 1, 2023, near Utqiagvik, a North Slope community in the United States. Following HAPI sample testing, the bear's death was confirmed on December 6, 2023.

This was also the first Endangered Species Act-listed animal in Alaska known to fall victim to HAPI.

There has been a global increase in HPAI outbreaks due to the genetic diversity of circulating virus strains, which rapidly spread in birds.

This World Organisation for Animal Health report issued in October 2023 provides an update on the HPAI situation.

Since people can become infected by the HAPI virus, the U.S. government has been preparing vaccines for an outbreak. 

According to the Centers for Disease Control and Prevention, about 20 million H5N1 and 12 million H7N9 vaccines were available in the U.S. National Strategic Stockpile in 2023.

Dec 31, 2023 • 9:42 am CST
US CDC polio travel map 2023

The last report of the Polio Eradication Initiative (GPEI) confirmed additional vaccine-derived poliovirus type 2 (cVDPV2) cases.

The west African country of the Islamic Republic of Mauritania confirmed its first cVDPV2 case in Nouakchott Nord, the first one in 2023.

And Indonesia's confirmed one cVDPV2 case was reported this week in Jawa Tengah. There have been four cVDPV2 cases this year and one case in 2022.

Indonesia Ministry of Health previously completed two rounds of immunization for children below five years of age with the nOPV2 vaccine, regardless of their prior vaccination status. The first round was implemented in April 2023.

The nOPV2 vaccine is a modified version of the type 2 monovalent OPV and is genetically more stable.

The administrative coverage of the bivalent oral polio vaccine between 2018 and 2022 in West Java ranged from 88% to 102%, while coverage of inactivated polio vaccine ranged from 26% to 106%. 

Vaccine-derived poliovirus is a strain mutated from the strain initially contained in the oral polio vaccine (OPV).

OPV vaccines contain a live, weakened form of poliovirus that replicates in the intestine for a limited period, thereby developing immunity by building up antibodies, says the World Health Organization (WHO).

On rare occasions, when replicating in the gastrointestinal tract, OPV strains genetically change and may spread in communities not fully vaccinated against polio.

According to the GPEI's data, as of December 31, 2023, about 1 billion nOPV2 vaccinations have been completed globally.

WHO's International Travel recommendations include .... that all travelers to the 35 polio-affected areas should be fully vaccinated against polio.

Dec 31, 2023 • 9:11 am CST
by Gerd Altmann

Novotech recently released the latest global clinical trial landscape report on HIV, a condition now affecting more than 39 million people.

According to the HIV Global Clinical Trial Landscape report published on December 18, 2023, the biopharma industry has initiated over 1,000 HIV clinical trials worldwide since 2018.

The distribution of the trials is as follows: Asia-Pacific accounts for 29% of trials, Europe at 28%, and North America at 26%, while the Rest of the World contributes a moderate share of 17%.

The report delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

It begins by elucidating HIV's progression, from its attack on the immune system to the potential development of AIDS. In the United States, there were 1.2 million HIV cases, leading to 19,986 deaths in 2022.

At the report's core lies the worldwide strategy articulated by organizations such as WHO, the Global Fund, and UNAIDS to eradicate the HIV epidemic by 2030.

Moreover, the report explores cutting-edge research, including long-acting injectables, HIV vaccines, and gene editing, underscoring the potential to find an HIV cure.

As of December 31, 2023, there are no approved HIV vaccines available, but several vaccine candidates are conducting studies.

Novotech's research analyst team provides these expert reports every month, free of charge.

Dec 30, 2023 • 12:51 pm CST
US CDC Mexico disease map 2024

Mexico's president recently announced a "super pharmacy" that will help patients nationwide access medicines and vaccines.

According to VOA reporting on December 29, 2023, President Andrés Manuel López Obrador's solution is a centralized warehouse on the outskirts of Mexico City intended to complement local health facilities.

If a patient can't get needed medications at a local hospital, the patient's doctor or pharmacist could have it delivered from the 40,000-square-meter warehouse.

"The pharmacy is going to be big, big, big, and it is going to have all the medications used in the health system," López Obrador said.

The question is whether Mexico can overcome its history of being bad at regulating the pharmaceutical industry, buying medicines, storing them, and distributing them. Extreme centralization also hasn't helped Mexico much in the past in many areas, wrote VOA/AP.

The U.S. Centers for Disease Control and Prevention (CDC) recently updated its Mexico Yellow Book for 2024, identifying numerous endemic diseases such as dengue, varicella, and measles.

And the CDC issues Travel Health Alerts regarding specific disease outbreaks in Mexico and advises that all travelers should be updated on their routine immunizations and travel vaccinations.

Dec 30, 2023 • 10:01 am CST
US CDC Thailand map 2024

Thailand is a geographically diverse country, a little smaller than Texas, and a trendy destination for millions of tourists.

As New Year's Eve 2023 approaches, the U.S. Centers for Disease Control and Prevention (CDC) recently stated transmission of the Zika virus is a health risk in Thailand.

And the Hong Kong Centre for Health Protection (CHP) of the Department of Health confirmed it is aware of the recent Zika outbreaks in Thailand.

According to Thailand's Bureau of Epidemiology, 742 Zika cases have been recorded in 2023, which is much higher than in the past three years.

Among the recent Zika cases, 160 were recorded in Bangkok, which has about 11 million residents.

Given the Zika cases in Thailand this year, the CHP specifically reminded members of the public, especially pregnant women and women preparing for pregnancy, that they must adopt necessary precautions against mosquito-borne diseases.

Furthermore, the U.S. Embassy in Thailand recently informed U.S. citizens that the CDC says that if you decide to travel, prevent mosquito bites and sexual exposure to Zika during and after travel, and wait two months after returning before becoming pregnant.

From a prevention perspective, there are no approved Zika vaccines as of December 30, 2023. However, several vaccine candidates are conducting clinical research.

Dec 30, 2023 • 8:47 am CST
US CDC FluView data Dec. 23, 2023

As the 2023 flu season draws to a close, the U.S. Centers for Disease Control and Prevention (CDC) announced today that seasonal influenza activity is elevated and above baseline in all 10 HHS Regions.

And outpatient respiratory illness is above baseline nationally for the eighth consecutive week.

As of December 29, 2023, the CDC confirmed a total of 20 pediatric deaths have occurred during the 2023-2024 season.

Last flu season, the CDC reported 183 pediatric deaths.

The CDC also estimated that there have been at least a total of 4,500 deaths from flu so far this season.

To reduce the health risks from the flu, the CDC recommends that everyone six months and older get an annual flu vaccine as long as influenza viruses are spreading. 

Vaccination in late December 2023 can still provide benefits into 2024.

The good news is that over 155 million flu shots have been distributed in the U.S. this season. These egg, cell, and nasal-based flu shots remain available at most pharmacies. 

Dec 29, 2023 • 10:33 am CST
from Pixabay

Jiangsu Recbio Technology Co., Ltd. today announced that the novel adjuvanted recombinant shingles vaccine candidate REC610 recently achieved positive results in the interim analysis of the first-in-human clinical trial in the Philippines.

Published on December 29, 2023, the Interim Analysis results showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses.

REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and peaked 30 days after the second vaccination.

The humoral and cellular immune responses were comparable between REC610 and the Shingrix® vaccine comparison group, and the immune response level in the REC610 group was numerically higher than that in the Shingrix group.

REC610 is intended to prevent shingles in adults aged 40 and above. It is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies.

REC610 received a drug clinical trial approval notice issued by the National Medical Products Administration in October 2023. It is approved as a preventive 3.3 biological product in its Phase I and III clinical trials in China.

The Company will soon adopt a randomized, double-blind, parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China to evaluate the safety, tolerability, and immunogenicity of REC610.

According to statistics, China's population aged 40 and above is approximately 700 million, and about 6 million new shingles cases occur each year in China.

Furthermore, the incidence of shingles has gradually become younger in recent years. 

Only Shingrix is on the market in China, and there is a strong demand for import substitution, according to Jiangsu Recbio Technology's press release.

Beginning in January 2024, Chongqing Zhifei Biological Products will have exclusive rights to import and distribute Shingrix in China.

Dec 28, 2023 • 3:53 pm CST
US CDC mpox case map Dec. 2023

The World Health Organization (WHO) recently published its External Situation Report #31 regarding the ongoing, multi-country outbreak of mpox.

Based on the data reported on December 22, 2023, the mpox outbreak continues in most WHO regions, while more extensive transmission has been observed in the European Region and the Region of the Americas.

A total of 906 additional mpox cases were reported in November 2023, representing a 26% increase compared to October.

The United States of America (299 vs. 135) reported the most significant increase in the Americas. The states of California, New York, and Texas have reported the most mpox cases.

Around half (52%) of cases with available information in this outbreak are reported to be in persons living with HIV. 

The U.S. CDC's Advisory Committee on Immunization Practices voted on October 25, 2023, to recommend the routine use of the JYNNEOS® vaccine for people at risk of mpox infection.

However, only 23% of the at-risk population has been fully vaccinated nationally as of December 2023.

On December 7, 2023, the CDC published an advisory stating the JYNNEOS is expected to be effective for both Clade I and Clade II MPXV infections. However, real-world data is lacking, reported the European CDC.

According to the CDC, approximately 1.2 million JYNNEOS vaccine doses have been administered in the U.S. since the mpox outbreak began in May 2022.

Dec 27, 2023 • 3:13 pm CST
PAHO Zika data dashboard Dec. 27, 2023

Despite a global reduction in Zika cases since a peak in 2017, the Pan American Health Organization (PAHO) recently confirmed the circulation of this mosquito-borne virus in 89 countries worldwide.

However, Zika outbreaks escalated in certain countries in the Region of the Americas in 2023.

The PAHO's data dashboard indicates there have been 35,538 confirmed Zika cases this year.

Ten countries, led by Brazil, have accounted for about 89% of Zika cases recorded over the past decade.

This year, Brazil has reported over 33,000 Zika cases.

In the United States, the Centers for Disease Control and Prevention (CDC) says mosquitoes continue to spread Zika throughout Puerto Rico.

About 25% of infected people develop Zika symptoms, and the illness is usually mild, lasting between two and seven days. 

Moreover, Congenital Zika-associated syndrome is a set of anomalies, such as microcephaly, seen in infants born to mothers with a history of gestational Zika fever, says the CDC.

The PAHO and other health agencies have stated that vaccination is the best option to prevent further infections.

But, as 2024 approaches, no Zika vaccine has been approved by any health authority.

Clinical trials involving DNA, modified vaccinia Ankara vector platform, and purified inactivated virus vaccine candidates have shown they can induce neutralizing antibodies.

Since 2016, about $350 million of funding has been allocated for Zika vaccine candidates.

Dec 26, 2023 • 3:30 pm CST
by Nicolas DeBray

According to local media, Brazil's Ministry of Health announced it would integrate the Qdenga® tetravalent vaccine into its Unified Health System (SUS).

The two-dose, 0.5 mL each, three months apart, Qdenga vaccinations are scheduled to launch in February 2024.

About 5 million vaccinations in 2024 will be focused on specific audiences and priority regions without pre-administration testing.

"The Ministry of Health assessed the cost-benefit relationship and the issue of access, as in a country like Brazil, it is necessary to have an adequate quantity of vaccines for the size of our population. Following the favorable opinion of Conitec, we will be the first country to provide public access to this vaccine as an immunizer under SUS," said Health Minister Nísia Trindade, reported Folha de Paulo on December 22, 2023.

The World Health Organization recently confirmed dengue is endemic in about 125 countries. 

During 2023, the most significant number of dengue outbreaks were reported in Brazil, with over 2.5 million patients.

Qdenga was initially authorized in Indonesia, followed by Argentina, Denmark, Germany, Portugal, and Thailand. This dengue vaccine is not approved in the U.S.

Note: This article was updated for clinical accuracy on January 10, 2024. 

Dec 26, 2023 • 2:54 pm CST
US TSA airport screening Dec. 25, 2023

Based on last week's airport screening activity, the U.S. Transportation Security Administration (TSA) is expecting a busy end-of-year holiday season.

As of December 25, 2023, the number of air travelers screened exceeded the volume last seen in 20219.

And to keep the wait times down, about 99% of TSA PreCheck® passengers waited less than 10 minutes passing through security lines in early December 2023.

Travelers can also help keep screening wait times down by remembering to bring an acceptable ID, including a digital wallet.

In collaboration with the State of Arizona and Samsung, the TSA is now accepting, for limited testing and evaluation purposes, Arizona-issued mobile driver's licenses and identification cards in Samsung Wallet on Samsung mobile devices at select TSA airport security checkpoints.

Passengers can use this new feature at checkpoints for identity verification at 27 participating airports.

TSA introduced the concept of the mobile driver's license in April 2021. Since then, Google and Apple digital wallets have also been accepted at various airports in the U.S.

This is one of TSA's many steps to transform airport security experiences.

From a health perspective, the U.S. CDC recently issued Travel Health Notices regarding dengue virus outbreaks in numberious countries.

The CDC says that getting vaccinated against infectious diseases is one of the most effective ways to protect your health while traveling abroad.

Travel vaccines can prevent dengue and other infectious diseases and are generally available at travel clinics and pharmacies in the U.S.

Dec 26, 2023 • 7:29 am CST
US CDC flu detections Dec. 22, 2023

The U.S. Centers for Disease Control and Prevention (CDC) reported on December 22, 2023, the updated percentage of people who have received COVID-19, influenza, and/or Respiratory syncytial  virus (RSV) vaccines in 2023.

Influenza, the SARS-CoV-2 coronavirus, and RSV have been circulating during the fall through early spring for the past few years, causing respiratory illness, says the CDC.

Alaska recently reported particularly low vaccination rates for the three illnesses that typically send hundreds of Alaskans to the hospital yearly.

Dr. Joe McLaughlin, Alaska’s state epidemiologist, informed Anchorage Daily News fewer than 20% of Alaskans had gotten a flu shot, and just 13% of eligible Alaskans were up-to-date on their COVID-19 vaccinations.

“I’m always concerned about vaccination rates,” McLaughlin said, noting that Alaska often has one of the lower vaccination rates in the country for flu and other illnesses.

“This year, our coverage rates are below even what they have been in recent years.”

Regarding the new COVID-19 vaccines, the CDC reported that 7.6% (95% confidence interval: 6.7-8.4) of children and 18.5% (17.8-19.2) of adults have been vaccinated.

The percent of the population reporting receipt of a flu vaccine is about 43%

The percentage of adults 60+ reported receiving an RSV vaccine is 17% (15.9-18.1).

These respiratory vaccines remain available at most pharmacies in the U.S.

In late 2023, the CDC confirmed partnering with community-based organizations, healthcare providers, and other trusted messengers to build vaccine confidence and awareness. 

Since egg, cell, and nasal-based flu shots are available, consumers have ample choice to select which vaccine is best for them.