Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Apr 24, 2024 • 10:49 am CDT
PharmaJet Tropis ID 2024

PharmaJet® today announced that the journal Nature published results from Gennova Biopharmaceutical's Phase 2/3 clinical trial. The trial was conducted to evaluate the safety and immunogenicity of its novel samRNA-based Covid-19 vaccine booster.

The study's results demonstrated that GEMCOVAC-OM, administered exclusively with Tropis®, is well-tolerated with no related serious adverse events and significantly boosts immune responses against the Omicron variant.

GEMCOVAC®-OM samRNA vaccine low dose was licensed under emergency use authorization in 2023.

This new study is the first time a samRNA vaccine has been developed with a lipid nano-emulsion, and the data show that intradermal administration of this vaccine is safe and well-tolerated.

Furthermore, the April 18, 2024 publication cited that the self-amplifying, thermostable mRNA platform delivered intradermally with Tropis provides a framework for next-generation vaccines that can improve accessibility and global equity.

PharmaJet has partnered with Gennova to improve the performance and outcomes of their samRNA platform with PharmaJet's breakthrough delivery technology. 

The PharmaJet pioneering technology unlocks the rich potential of the human dermis, paving the way for enhanced immune responses.

Chris Cappello, President and Chief Executive Officer, PharmaJet, commented in a press release on April 24, 2024, "This new data adds to the evidence base indicating Tropis needle-free ID administration is an enabler for vaccine platforms."

Tropis intradermal administration and Stratis® SC/IM (for intramuscular and subcutaneous administration) are the only commercially scaled needle-free technologies that enhance the performance of several vaccines and therapeutics.

Since its launch, Tropis has performed over 10 million vaccinations in several countries.

Apr 24, 2024 • 9:54 am CDT
US CDC 2024

According to data from the Czech State Health Institute (SZU), the number of pertussis cases in 2024 has exceeded 7,888.

Local media (Xinhua) reported that this outbreak is the most severe in decades.

Pertussis is a highly infectious bacterial disease involving the respiratory tract. It is caused by a bacterium (Bordetella pertussis or Bordetella parapertussis) found in an infected person's mouth, nose, and throat. It is also known as whooping cough, said the European Centre for Disease Prevention and Control (ECDC) on April 22, 2024.

In 2022, the ECDC reported that EU/EEA countries had only 2,623 cases of pertussis. Germany and Poland accounted for 60% of all reported cases.

In the five years between 2018 and 2022, pertussis case numbers peaked in spring 2020 but decreased to a very low level until the end of 2022.

Furthermore, SZU recently indicated that about 5,800 cases had been vaccinated, suggesting a decrease in vaccine efficacy.

More than 45,000 people have been revaccinated to address this concern in 2024, compared to about 24,000 last year.

According to the U.S. CDC, international travel generally doesn't put people at a higher risk of getting pertussis (Whooping Cough). However, travelers are more likely to get infected if they have close contact with people with the disease. 

The CDC recommends that adults who have never been vaccinated speak with a travel vaccine advisor about pertussis vaccine options and other vaccinations one month before visiting a pertussis outbreak area.

Apr 24, 2024 • 8:22 am CDT
by Gerd Altmann

Moderna, Inc. and OpenAI today announced their ongoing collaboration to co-innovate with a shared vision of AI's transformative potential in the future of business and healthcare.

Moderna is a digital-first company that has leveraged the power of machine learning since its beginnings.

This strong data foundation and its robust learning culture position the Company to responsibly and seamlessly integrate generative AI into its operations and capitalize on next-generation AI innovation.

The organizations began their collaboration in early 2023 by launching Moderna's instance of ChatGPT, called mChat, internally built on top of OpenAI's API.

With more than 80% internal adoption since its debut, this initial success accelerated an AI culture that led to the deployment of ChatGPT Enterprise and its enhanced capabilities such as Advanced Analytics, Image Generation and GPTs.

These GPTs are now embedded across Moderna's business functions - from legal, to research, to manufacturing, to commercial - and are purpose-built as assistants that work beside Moderna's employees, augmenting their roles through personalized support.

With these tools serving as an extension to Moderna's team, the Company can advance its mission to deliver the greatest possible impact to people through mRNA medicines.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a press release on April 24, 2024, "Moderna has an ambitious plan to launch multiple products over the next few years, and collaborations with companies like OpenAI are critical to our ability to scale and maximize our impact on patients."

Apr 24, 2024 • 7:54 am CDT
by Ingela Skullman

CureVac N.V. today announced the start of the Phase 1 part of a combined Phase 1/2 clinical trial of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK.

In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control. The study will be conducted in the United States.

The monovalent vaccine candidate is based on CureVac's proprietary second-generation messenger ribonucleic acid (mRNA) backbone and encodes an influenza A H5-antigen.

Dr. Myriam Mendila, CureVac's Chief Develop­ment Officer, commented in a press release on April 24, 2024, "This clinical milestone, in collaboration with GSK, expands the application of our mRNA technology into an additional indication in infectious diseases and addresses the need to be prepared for potential future pandemics."

The H5N1 avian influenza virus is considered a potential pandemic threat. It is known to sporadically cross-species from its original bird host to other animal hosts, such as bears, cows, foxes, and humans worldwide.

The combined Phase 1/2 study will evaluate the safety, reactogenicity, and immunogenicity of an investigational influenza A (H5N1) pre-pandemic vaccine candidate in healthy younger and older adults.

The broad CureVac-GSK infectious disease collaboration was first announced in July 2020.

As of April 2024, the U.S. government has approved a bird flu vaccine (Audenz) and invested hundreds of millions in preparing avian influenza vaccine candidates.

Apr 23, 2024 • 2:06 pm CDT
PAHO Dengue Case Trend Report Week #13 April 2024

Since the first dengue-like epidemic was suspected in 1635 in the Caribbean Islands, this mosquito-transmitted disease has impacted the health of millions of people throughout the Region of the Americas.

According to new data, the year 2024 may set an all-time record. 

The Pan American Health Organization (PAHO) recently issued Situation Report No. 14 confirming that 4,820,955 suspected cases of Dengue (an increase
of 260% from 2023) and 1,733 deaths have been registered as of mid-April 2024.

As of April 23, 2024, Brazil has reported the most Dengue cases this year.

To alert international travelers, the U.S. Centers for Disease Control and Prevention (CDC) reissued its Level 1 Travel Health Advisory for the Americas on April 18, 2024. The countries listed have reported higher-than-usual dengue cases.

The CDC says travelers to these Caribbean, Central, and South American countries may be at increased risk.

Within the U.S., the CDC reported that 37 jurisdictions have reported 929 dengue cases as of April 2024.

The unfortunate leader is Puerto Rico, which has 644 dengue cases, followed by the state of Florida, which has 106 travel-associated cases and five locally acquired dengue cases this year.

From a prevention perspective, two dengue vaccines have been approved. To learn about vaccination options, the CDC says travelers should speak with a vaccine advisor at least one month before traveling abroad.

As of April 23, 2024, travel vaccines are offered at specialty clinics and certified pharmacies in the U.S.

Apr 23, 2024 • 7:56 am CDT
US FDA April 2024

ImmunityBio, Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved ANKTIVA® (N-803) plus Bacillus Calmette-Guérin (BCG) vaccine for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

This treatment is essential as bladder cancer is the 10th most commonly diagnosed cancer globally, and the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in the U.S. in 2024.

"The FDA's approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on April 22, 2024.

"ANKTIVA not only proliferates and activates the patient's own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. 

ANKTIVA is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4, and CD8 T cells.

ANKTIVA is expected to be available in the United States by mid-May 2024, as well as ImmunityBio's Patient Assistance Program.

Merck's TICE® BCG vaccine is used in this therapy.

Apr 22, 2024 • 5:56 pm CDT
by Peter Kraayvanger

The Florida Department of Health published Arbovirus Surveillance Update #15, which discloses various mosquito-borne diseases reported this year.

As of April 13, 2024, countries in southern Florida confirmed these mosquito-transmitted diseases:

  • Chikungunya - Three cases of chikungunya that began in 2024 have been reported in individuals with a travel history to Brazil, and four cases were confirmed in 2023.
  • Dengue Fever - In 2024, 106 travel-associated dengue cases have been reported, mainly by visitors from Cuba. In 2023, 609 travel-associated dengue cases were reported, primarily in people arriving from Brazil and Cuba. Five cases of locally acquired dengue were reported from Miami-Dade (4) and Pasco counties in 2024. 
  • Malaria - In 2024, nineteen cases of malaria with onset in 2024 have been reported in individuals with a travel history to malaria-endemic areas in Africa. In 2023, 78 malaria cases were reported.

To learn where these diseases are spreading, the U.S. CDC issued Travel Health Notices to inform travelers about global health risks.

While the U.S. FDA recently approved an innovative chikungunya vaccine, its availability in Florida is pending. Access to the approved dengue vaccine has specific requirements.

Furthermore, two approved malaria vaccines are unavailable in the U.S.

Visit a local travel clinic, such as Passport Health USA Tampa, to learn more about these and other travel vaccine options.

Apr 22, 2024 • 7:49 am CDT
by Gerd Altmann

Moderna, Inc. today announced a contract with Brazil's Ministry of Health (Ministério da Saúde) to supply its monovalent mRNA COVID-19 vaccine.

Under the new contract, 12.5 million doses of Moderna's mRNA COVID-19 vaccine (SpikeVax) are anticipated for delivery in the second quarter of 2024.

This contract follows the Brazilian Health Regulatory Agency's approval of Moderna's COVID-19 vaccine (XBB.1.5 sublineage) in March 2024 to prevent COVID-19 in children from six months of age and adults.

"We are proud to partner with the Ministry of Health to provide our mRNA COVID-19 vaccine for the first time in Brazil as part of the national vaccination campaign," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on April 22, 2024.

"This agreement underscores our commitment to global health and our role in supporting Brazil's efforts to protect its citizens against COVID-19."

"We look forward to working with the Ministry of Health to help maintain health security in Brazil."

Previously, Moderna generated preclinical and clinical data of its monovalent XBB.1.5 vaccine candidate, which showed an immune response against XBB sublineages and currently circulating strains of the SARS-CoV-2 virus, including JN.1.

Apr 22, 2024 • 7:33 am CDT
ACTG is the largest HIV clinical trials network

Although antiretroviral treatment (ART) can help manage the impact of the Human Immunodeficiency Virus (HIV), it is not a cure. People living with HIV need to take the treatment for their entire lives to suppress viral replication and protect their immune systems.

To address this clinical need, ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of A5374, a phase 1/2a study evaluating the safety, tolerability, and antiviral effect of a novel combination regimen that includes therapeutic T-cell vaccines, two broadly neutralizing antibodies (3BNC117-LS, 10-1074-LS), and an immune-system boosting treatment among people living with HIV who started ART during acute HIV infection.

This study hypothesizes that this combination regimen will be safe and result in a more extended period of viral control during a closely monitored pause in ART (known as an analytic treatment interruption) compared to placebo.

The approach being studied in A5374 is part of a potential path toward enabling the immune system to manage HIV in the absence of ART for weeks or months.

“We expect that controlling HIV in the absence of ART will require a combination of novel treatments to decrease the number of cells harboring HIV and simultaneously stimulate the immune system to keep the virus from replicating,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles in a press release.

“A5374 is a pivotal trial, and we hope it will provide us with important insights into how to boost the immune system to control HIV.”

ACTG says carefully monitored analytic treatment interruptions are an essential part of HIV cure clinical trials. They can help determine whether a research intervention can reduce latent HIV (HIV that is “hidden” in different cells and tissues but not replicating) or increase immune function and delay or prevent latent HIV from actively replicating.

While there are no U.S. FDA-approved HIV prevention vaccines today, clinical development accelerated in 2023, with vaccine candidates utilizing innovative technologies such as mRNA.

Apr 20, 2024 • 11:24 am CDT
US CDC influenza area map April 19, 2024

The U.S. CDC FluView report for week #15 stated seasonal influenza activity continues to decline in most areas of the United States.

Nationally, the number of weekly flu hospital admissions has been decreasing since January 2024.

Unfortunately, four influenza-associated pediatric deaths occurring during the 2023-2024 season were reported to the CDC last week, bringing the flu season total to 142 pediatric deaths.

As of April 19, 2024, the CDC recommends that everyone six months and older get an annual flu vaccine as long as influenza viruses spread.

Flu shots (egg, cell, nasal-based) can still provide benefits this season.

Apr 20, 2024 • 10:03 am CDT
Nationally Notifiable Infectious Diseases and Conditions, United States: Weekly Tables - April 13, 2024

According to the recent Nationally Notifiable Infectious Diseases and Conditions weekly report, the number of mpox cases in the United States has more than doubled compared to Week #15 in 2023.

As of April 13, 2024, 750 mpox cases had been reported, compared to 336 cases at the same time last year.

The U.S. CDC highlights New York City (151), California (72), and Texas (55) as mpox case leaders.

The U.S. Health and Human Services (HHS) was initially charged with coordinating the federal response to the mpox outbreak. According to the General Accountability report issued on April 18, 2024, HHS is recommended to adopt a coordinated, department-wide program that incorporates input from external stakeholders to identify and resolve challenges.

In the United States, Bavarian Nordic's JYNNEOS® vaccine was initially offered to healthcare staff in Boston on May 24, 2022.

Since then, over 1.2 million (1-dose: 38.8% and 2-dose: 24.3%) JYNNEOS doses have been administered in U.S. Jurisdictions. 

As of April 2024, JYNNEOS remains the only FDA-approved non-replicating smallpox and mpox vaccine for military and non-military use and has recently become commercially available at U.S. pharmacies.

Apr 19, 2024 • 3:52 pm CDT
GPEI polio case map April 16, 2024

The WHO Director-General convened the thirty-eighth meeting of the Emergency Committee on the international spread of poliovirus in late March 2024. 

The Committee unanimously agreed that the risk of the international spread of poliovirus remains a Public Health Emergency of International Concern and recommended the extension of Temporary Recommendations for a further three months until July 2024.

Regarding a weekly update, the Global Polio Eradication Initiative reported on April 17, 2024, that three African countries reported wild poliovirus (WPV1) and circulating vaccine-derived polioviruses (cVDPV) cases last week.

Chad reported one cVDPV2 case in Mandoul, making it the first in 2024. The number of 2023 cases remains 55.

The Democratic Republic of the Congo reported one cVDPV1 case in Haut-Katanga, the first this year. The number of polio cases in 2023 remains at 106, and 117 cases of cVDPV2 in 2023.

Nigeria confirmed one cVDPV2 case last week in Kebbi, the eighth this year. There have been 87 cases reported in 2023.

The U.S. CDC publishes travel advisories for countries reporting active polio cases and recommends fully vaccinating people before visiting these countries.

To understand polio vaccination options, including booster doses, the CDC suggests speaking with a travel vaccine advisor one month before traveling abroad.

Apr 19, 2024 • 12:39 pm CDT
by Gerd Altmann

Various media sources reported Merck would only supply 18.8 million HPV vaccine doses to Gavi-supported countries in 2024. Merck had previously promised to supply 29.6 million doses.

According to the Peoples Gazette, on April 19, 2024, Merck spokesman Patrick Ryan said the company "experienced a manufacturing disruption," requiring it to hold and check numerous doses manually.

Ryan disclosed that Burundi, Tajikistan, Mozambique, Sierra Leone, Ivory Coast, and Burkina Faso will not receive HPV vaccines in 2024.

By the end of 2022, 32 countries had successfully launched their HPV vaccine national program with Gavi support, fully immunizing more than 16.3 million girls since 2014.

GAVI says HPV vaccination is critical to reducing cervical cancer, especially in lower-income countries with a high disease burden and less developed cervical cancer screening and treatment programs.

On March 13, 2024, Merck announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types.

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of the GARDASIL®9 vaccine compared to the approved three-dose regimen.

"Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health," said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, in a press release.

"These significant investments build upon our leadership and, importantly, provide the opportunity to further impact the global burden of certain HPV-related cancers and diseases."

The latest addition to Merck's pipeline employs the company's proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV-type coverage.

This includes several types known to have a greater impact on African and Asian populations and individuals of African and Asian descent. First-in-human phase 1 clinical studies are scheduled to start in the fourth quarter of 2024.

In the U.S., HPV vaccines remain available at clinics and pharmacies in 2024.

Apr 19, 2024 • 10:41 am CDT
from Pixabay

For many years, oral vaccines have proven to be the quickest intervention for preventing, limiting, and controlling cholera outbreaks.

However, the supply of these vaccines was at an all-time low in 2024, especially in 23 countries, including Comoros, the Democratic Republic of the Congo, Ethiopia, Mozambique, Somalia, Zambia, and Zimbabwe.

To help relieve this inventory shortage, the World Health Organization (WHO) issued a new oral cholera vaccine (OCV) prequalification.

On April 12, 2024, EuBiologicals Co., Ltd.'s inactivated oral vaccine, Euvichol-S, which has similar efficacy to existing vaccines but a simplified formulation, was announced.

This authorization creates new opportunities to increase OCV production capacity rapidly.

"The new vaccine is the third product of the same family of cholera vaccines on our WHO prequalification list," said Dr Rogerio Gaspar, Director of the WHO Department for Regulation and Prequalification, in a press release on April 18, 2024.

The WHO's OCV prequalification list already includes Euvichol, Euvichol-Plus, Vaxchora®, Dukoral®, and Shanchol™.

When visiting countries with cholera outbreaks in 2024, the U.S. Centers for Disease Control and Prevention recommends OCV vaccination one month before traveling.

Apr 18, 2024 • 5:20 pm CDT
UKHSA measles case trend 2023

While measles outbreaks have been reported in dozens of countries in 2024, recent attention has focused on the cities of Chicago and London.

The U.K. Health Security Agency (UKHSA) published an updated epidemiological overview on April 18, 2024, stating that an additional 86 cases of measles were confirmed in England last week.

This data brings the total number of confirmed cases since October 2023 to 1,109.

About 39% of the U.K.'s measles cases (76 of 191) were in London during the last four weeks.

In a press release, Dr. Vanessa Saliba, UKHSA Consultant Epidemiologist, commented, "We know some communities in London have very low measles-mumps-rubella (MMR) vaccination rates. The MMR jab offers the best protection against measles."

The effective Priorx MMR vaccine is generally available at clinics and pharmacies in England. However, no measles-only vaccines are offered in England.

In the U.S., the Centers for Disease Control and Prevention (CDC) reported 121 measles cases in eighteen jurisdictions in 2024.

Most of these cases (61) have been reported by the Chicago Department of Public Health over the past two months.

The U.S. CDC republished a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice in March 2024, alerting international travelers of potential health risks and identifying measles outbreaks in 49 countries.

The CDC recommends speaking with a travel vaccine consultant one month before traveling abroad to any outbreak countries.