Coronavirus Breaking News

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

Jan 22, 2023 • 7:44 am CST
National Geographic Society Map 2023

The U.S. Department of State recently updated it's Level 2: Exercise Increased Caution for when visiting the southernmost continent of Antarctica.

As of January 19, 2023, the State Department announced travelers should be aware of environmental hazards posed by extreme and unpredictable weather and limited emergency services.

For travelers to Antarctica, severe low temperatures and high winds are the primary health hazards.

Temperature patterns vary widely because Antarctica is covered in continuous darkness during the winter and constant sunlight during the summer.

The sun's effects in Antarctica can damage the eyes and skin, and protective measures should be taken.

The U.S. Centers for Disease Control and Prevention (CDC) suggests various travel vaccinations, such as measles, before visiting Antarctica.

And if you travel to Antarctica, obtain comprehensive travel, medical, and medical evacuation insurance; see our webpage for more information on insurance providers for overseas coverage, says the State Department.

The U.S. government does not maintain an embassy or consulate in Antarctica.

If you need U.S. consular services when in Antarctica, contact the closest U.S Embassies/Consulates in Argentina, Australia, Chile, New Zealand, and South Africa. 

From outside the U.S., call 1-202-501-4444 to speak with a U.S. representative.

Furthermore, government resources in the Antarctic Region are committed to the Antarctic Program (USAP).

Private expeditions should be self-sufficient and are encouraged to carry adequate insurance coverage against the risk of incurring financial charges or material losses while in the Antarctic.

The National Science Foundation, as manager of the USAP, reserves the right to seek, in accordance with international and domestic law, recovery of all direct and indirect costs of any such emergency search and rescue.

The Antarctic also includes island territories within the Antarctic Convergence, says the National Geographic Society

Most of the islands and archipelagos of Lesser Antarctica are volcanic and heavily glaciated.

The islands of the Antarctic region are the South Orkney Islands, South Shetland Islands, South Georgia, and the South Sandwich Islands, all claimed by the United Kingdom.

Peter I Island and Bouvet Island, claimed by Norway.

Heard and McDonald islands, claimed by Australia.

And Scott Island and the Balleny Islands, claimed by New Zealand.

Jan 20, 2023 • 4:01 am CST
Google maps Jefferson County KY

In western Kentucky, the Jefferson County Public Schools (JCPS) began conducting measles vaccination clinics for about 10,000 students this week.

Students at Iroquois High School were offered the Measles, Mumps, and Rubella (MMR) vaccine and the COVID-19 and Flu vaccines.

On January 18, 2023, local media reported additional on-campus measles clinics at Marion C. Moore School on January 25, Newcomer Academy on January 31, and Fern Creek High School on February 7, 2023.

JCPS Health practitioner Angela Hayes informed WLKY, "The U.S. CDC has named Kentucky an at-risk state."

"At this point, we are not excluding students from classes if they are not up to date for their vaccinations," said Hayes.

"However, if there is an outbreak, those 10,000-plus students may have to be excluded from the school for a certain amount of time to help protect them and others."

Measles is an acute viral respiratory illness. It is characterized by a prodrome of fever (as high as 105°F), malaise, cough, coryza, and conjunctivitis, as reported by the Kentucky Board of Health.

Measles is one of the most contagious infectious diseases.

The virus is transmitted by direct contact with infectious droplets or by airborne spread when an infected person breathes, coughs, or sneezes.

The measles virus can remain in the air for up to two hours after an infected person leaves.

The Louisville-Jefferson County Metro Government publishes local measles information.

The JCPS's actions relate to the recent measles outbreak in the Columbus, Ohio, area, where about 85 children/students have contracted measles, with over 30 hospitalized.

Both Kentucky and Ohio require most students to be protected against measles before attending classes.

Nationwide, there were a total of 118 measles cases reported by six jurisdictions in 2022. This total increased from 2021 when only 49 measles cases were reported to the U.S. CDC.

Jan 19, 2023 • 5:09 pm CST
JYNNEOS Vaccine 1st and 2nd Doses

Since the Mpox outbreak began in May 2022, over 1.1 million doses of the Jynneos® vaccine have been administered in the United States (U.S.).

The city of Boston began offering Jynneos vaccinations to healthcare staff on May 24, 2022, followed by New York City (NYC). 

In September 2022, NYC Health began offering second doses of Jynneos to qualifying people.

As of January 17, 2023, 57 U.S. Jurisdictions have offered first and second doses to men and women at no charge.

From an effectiveness perspective, the U.S. Centers for Disease Control and Prevention (CDC) posted data on December 8, 2022, suggesting the effectiveness of a single dose of Jyennos was 87% protective.

Overall, the CDC has confirmed 30,026 Mpox cases and 23 related fatalities, a case-fatality rate of less than 1%.

Demetre Daskalakis, M.D., deputy coordinator of the CDC's pox response efforts in the U.S., recently posted on Twitter, 'Supply is there! We need to keep the drumbeat going for demand even as cases go down.'

'Getting vaccinated for #mpox now means protection in the future! Oh… that means two doses of the vaccine!

Find out where to obtain the Jynneos vaccine at http://mpoxvaxmap.org or your local/state health department.

Jan 19, 2023 • 10:57 am CST
ImmunityBio, Inc. 2023

ImmunityBio, Inc. today announced positive results in its fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88), showing that the overall survival (OS) rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy.

The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS.

In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS.

The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml.

In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

"We are encouraged by the positive results in these patients with 3rd, 4th, 5th, and even 7th line advanced pancreatic cancer and the considered and helpful feedback from the FDA," said Patrick Soon-Shiong, M.D., Executive Chairman, and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on January 19, 2023.

"Treatments for pancreatic cancer in the advanced setting remain an unmet need."

"We are committed to confirming our hypothesis that orchestrating the innate and adaptive immune system will advance the care of these patients."

This therapy is essential since pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. annually.

The QUILT 88 study results were presented at the American Society of Clinical Oncology Gastrointestinal conference on January 19-21, 2023.

ImmunityBio also announced that it held two productive Type B meetings with the U.S. FDA in December 2022. 

Jan 19, 2023 • 10:35 am CST
by Gerd Altmann

The Janssen Pharmaceutical Companies of Johnson & Johnson and a consortium of global partners announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen's investigational HIV vaccine regimen.

The study's independent Data and Safety Monitoring Board (DSMB) determined that the regimen was ineffective in preventing HIV infection compared to placebo.

In light of the DSMB's determination, the Mosaico clinical trial was discontinued.

Mosaico began in 2019 and completed vaccinations in October 2022.

The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the U.S.

"We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV," said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC., in a press release on January 18, 2023.

"We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine."

The Mosaico findings align with developments in the Phase 2b “Imbokodo” clinical trial, which tested a similar HIV vaccine regimen in women in sub-Saharan Africa. 

That DSMB determined in August 2021 that the experimental vaccine regimen was also ineffective in protecting against HIV acquisition.

As of January 19, 2023, the U.S. Food and Drug Administration had not approved an HIV vaccine candidate.

Jan 19, 2023 • 10:08 am CST
by Manuel Alvarez

LinKinVax and Gustave Roussy today announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with human papillomavirus (HPV).

LinKinVax develops CD40HVac based on an innovative technology directly targeting dendritic cells, which play a crucial role in the immune system by stimulating and regulating immune responses.

Although many HPV-induced tumors can be cured with modern multidisciplinary treatment approaches, it is essential to develop new and effective therapeutic vaccines against HPV-associated malignancies to better address the needs of patients, says LinkinVax.

The objectives of the study (EUCT n° 2022-502930-25-00), sponsored by Gustave Roussy, are to demonstrate the safety and immunogenicity of the CD40HVac vaccine candidate with the Poly-ICLC adjuvant (Hiltonol®) against oncogenic HPV in patients with head and neck cancer and to determine the recommended Phase 2 dose based on the safety profile of the vaccine candidate and its ability to induce immune responses.

Several exploratory objectives are also planned to estimate progression-free survival and overall survival.

Prof. Yves Levy, Chief Medical and Scientific Officer LinKinVax, commented in a press release on January 19, 2023, "This partnership ... represents a bridge between basic research and clinical research designed to accelerate innovation for the benefit of patients."

"Together with Gustave Roussy, we look forward to making what we hope will be a major contribution to treating HPV-related cancers."

A recent U.S. population-based study by the Centers for Disease Control and Prevention showed that 66% of cervical cancers, 55% of vaginal cancers, 79% of anal cancers, and 62% of oropharyngeal cancers are attributable to HPV 16 and 18.

LinKinVax's vaccine platform is built around a humanized monoclonal antibody fused with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells.

The results demonstrate this strategy's benefits due to the small number of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response.

The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years.

Jan 18, 2023 • 4:16 pm CST
from Pixabay

Evaxion Biotech A/S recently announced that the U.S. Food and Drug Administration (FDA) determined that the Company may proceed with its Phase 2b clinical trial of EVX-01 targeting malignant melanoma.

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia and in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®. 

The trial was first initiated in Australia with the enrollment of the first patient in September 2022.

In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial.

The Company anticipates a response from the FDA to the Fast Track designation submission in the first quarter of 2023.

“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,” says Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2023.

Jan 18, 2023 • 1:15 pm CST
from Pixabay

Novavax, Inc. today announced that partner SK bioscience had received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373), a protein-based booster for active immunization to prevent COVID-19 in adults aged 18 and older.

KFMDS previously approved Nuvaxovid as a primary series in adults aged 18 and older in January 2022 and as a primary series in adolescents aged 12 through 17 in August 2022.

"We are pleased to collaborate with SK bioscience to offer our protein-based vaccine, Nuvaxovid, for use as a booster in adults regardless of previous vaccine history," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release on January 18, 2-23. 

"This is an important step in ensuring broad access to diversified vaccine options."

Novavax' COVID-19 vaccine is authorized as an adult booster in more than 35 countries.

In addition, several other countries have policy recommendations allowing the use of the vaccine as a booster dose.

Jan 18, 2023 • 7:43 am CST
from Pixabay

Moderna, Inc. announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an mRNA vaccine candidate targeting respiratory syncytial virus (RSV) in older adults.

Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease as defined by two or more symptoms.

Based on these results, Moderna stated on January 17, 2023, it intends to submit for regulatory approval for mRNA-1345 in the first half of 2023.

"RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities," commented Abdullah Baqui, a principal investigator for the study sites in Bangladesh and Professor, Department of International Health, Director, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, in a related press release.

"This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas."

A concurrent review of available safety data was also conducted by the DSMB.

mRNA-1345 was well tolerated, with no safety concerns identified. To date, most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.

The overall rate of severe (Grade 3 or greater) solicited systemic adverse reactions was 4.0% for mRNA-1345 and 2.8% for placebo.

The overall rate of Grade 3 or greater solicited local adverse reactions was 3.2% for mRNA-1345 and 1.7% for placebo.

The study is ongoing, and an updated analysis of safety and tolerability will be provided at the time of regulatory submission.

Jan 17, 2023 • 3:15 pm CST
by Likon Kom

Jefferson County Public Schools (JCPS) in Kentucky announced yesterday it would begin conducting measles vaccination clinics at local schools for about 10,000 unvaccinated students. 

JCPS distributed notices to Louisville-area families whose school records show their students need to be protected against this vaccine-preventable disease.

Measles is highly contagious and often results in the hospitalization of those who contract the virus. 

Beginning on January 17, 2023, JCPS students will be able to receive a Measles, Mumps, and Rubella (MMR) vaccine, as well as the COVID-19 and flu vaccines.

'We urge parents and guardians to ensure students are current with all required vaccines, including the MMR. 

The U.S. CDC and the Kentucky Department of Public Health urge families to be aware of an ongoing measles outbreak near Columbus, Ohio.

As of January 17, 2023, the Columbus Health Department had confirmed 85 children had been infected with measles since June 2022. Most of these unvaccinated children are under ten years of age.

Previously, the CDC confirmed (118) measles patients in six jurisdictions in 2022. In 2021, a total of 49 measles cases were reported by five jurisdictions.

The CDC's top ten global measles outbreaks as of January 13, 2023, were led by India, with 12,271 cases, and Yemen, with 7,538. 

In the U.S., various MMR vaccines are available at most clinics and pharmacies in 2023.

Jan 17, 2023 • 10:04 am CST
by Anil Sharma

During today's World Economic Forum Annual Meeting in Switzerland, Dr. Tedros Adhanom Ghebreyesus and others discuss what mechanisms can accelerate the development and deploy safe and effective tuberculosis (TB) vaccines.

The 'Ending Tuberculosis: How Do We Get There' live discussion is at this link

While no new TB vaccine has been licensed in 100 years, the prospects for novel effective TB vaccines have improved recently, with at least 16 vaccine candidates under development.

According to the World Health Organization (WHO) 2022 Global TB report, more than 10 million people fell ill from TB, and 1.6 million died.

The WHO confirmed effective vaccines would undoubtedly be the best solution to prevent and potentially eradicate TB.

A recent WHO-commissioned study, An investment case for new TB vaccines, estimates that, over 25 years, a vaccine that is 50% effective in preventing disease among adolescents and adults could avert up to 76 million new TB cases and US$ 6.5 billion in costs.

The current century-old bacille Calmette-Guérin (BCG) vaccine continues offering disease protection.

According to a recent study funded by the U.S. NIH, BCG vaccination at birth effectively prevents TB in young children.

And on August 15, 2022, research published by Cell Reports Medicine suggested BCG protection against infectious diseases and vaccine efficacy takes 1-2 years to manifest, but the protection may last decades.

In the U.S., the BCG vaccine is a limited distributed product. BCG is only considered for people who meet specific criteria and are in consultation with a TB expert., says the U.S. CDC.

Jan 17, 2023 • 8:15 am CST
Vaxxas High Density Microarray Patch

The Coalition for Epidemic Preparedness Innovations (CEPI) and Vaxxas today announced an agreement to advance the development of needle-free vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines.

CEPI confirmed on January 17, 2023, it would provide up to $4.3 million (AUD6.4 million) for preclinical testing of Vaxxas' platform, a needle-free, high-density microarray patch (HD-MAP) to assess its stability, safety, and immunogenicity.

And to evaluate its potential as a rapid-response technology for heat-stable, dried-formulation mRNA vaccines.

In addition to a Phase I clinical study of a COVID-19 vaccine candidate patch, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the U.S. government on pandemic vaccination solutions.

HD-MAPs comprise thousands of microscopic points attached to a small patch.

Each of these micro-projections contains a tiny dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells immediately below the skin surface.

HD-MAP vaccine delivery offers many advantages over more traditional vaccine administration methods.

For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations.

Vaxxas' HD-MAPs have proven safe and tolerable in hundreds of trial participants and have been shown to induce equal or greater immune responses to injected vaccines at lower doses.

Compared with needle and syringe systems, they are also much easier to administer and are likely to have greater acceptability.

Ultimately, HD-MAP patches could enable a future in which vaccine patches could be mailed directly to peoples' homes, workplaces, and schools, avoiding the delay and inconvenience of traditional needle-and-syringe vaccine scheduling and administration.

David Hoey, Vaxxas's CEO, commented in a related press release, "Earning this significant funding from one of the world leaders in vaccine development is a great honor and validates the benefits offered by Vaxxas' HD-MAP vaccine platform in the fight against global epidemic and pandemic threats."

"In addition to providing an opportunity to get life-saving vaccines for infectious diseases that have a disproportionate impact on the most vulnerable populations around the world, the advanced development of HD-MAP delivery of mRNA vaccines could also prove very beneficial for the development of Vaxxas' internal pipeline across several diseases, including Covid-19."

Vaxxas' core technology was initially developed at The University of Queensland in Australia. The private company was established as a start-up in 2011.

On December 5, 2022, Vaxxas announced it completed a financing round that raised US$23 million in new funds. 

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched in 2017, to develop vaccines against future epidemics. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all needy people.

 

Jan 17, 2023 • 7:52 am CST
Pfizer Accord for a Healthier World 2023

Pfizer Inc. today announced that it has significantly expanded its commitment to An Accord for a Healthier World to offer the full portfolio of medicines and vaccines for which it has global rights on a not-for-profit basis to enable greater health for 1.2 billion people living in 45 lower-income countries.

To better align with disease burden and unmet patient needs in these countries, Pfizer is expanding its offering under the Accord to include off-patent products, bringing the total offering to around 500 products.

Launched in May 2022, the Accord is a transformative initiative focused on reducing health inequities.

The Accord initially included a commitment from Pfizer for access to all its patented medicines and vaccines available in the U.S. or European Union on a not-for-profit basis to 45 lower-income countries.

The Accord portfolio offering now includes chemotherapies and oral cancer treatments that can potentially treat nearly one million new cancer cases in Accord countries each year.

It also includes a wide range of antibiotics that can help to address the rising morbidity, mortality, and costs associated with antimicrobial resistance. 

As Pfizer launches new medicines and vaccines, those products will also be included in the Accord portfolio on a not-for-profit basis.

“We launched the Accord to help reduce the glaring health equity gap that exists in our world. Our hope is to empower country governments and co-create solutions with them and other multi-sector partners to break down many of the system-level barriers to better health. In the months since the Accord’s launch, we have heard resoundingly from these leaders that access to a broader and more immediate scope of consistent, high-quality products is needed for meaningful and sustainable transformation. We believe this expansion of our product offering, combined with continued efforts to help address the barriers that limit or prevent access, will help us to achieve and even expedite our vision of a world where all people have access to the medicines and vaccines they need to live longer and healthier lives,” said Pfizer Chairman and CEO Albert Bourla, in a press release on January 17, 2023.

Alongside governments and multi-sector partners, Pfizer is working to co-create scalable solutions that help address systemic barriers to better health focused on finding faster, more efficient pathways for the supply of medicines and vaccines as well as strengthening the resources, capabilities, and platforms that can enable quick and more sustainable access to those medicines.

This includes technical expertise, training, diagnostic capacity, innovative financing, and more.

“The Accord is an important step toward sustainable health security for Rwanda and the broader continent. The expanded portfolio offering and public health system strengthening efforts will further enhance our progress and offer valuable support to key national health initiatives that lead to positive health outcomes,” commented His Excellency Paul Kagame, President of Rwanda.

Further details about An Accord for a Healthier World are available at Pfizer.com/Accord.

Jan 16, 2023 • 5:21 pm CST
U.S. CDC Peru 2023

The U.S. Embassy in Peru recently confirmed the Government extended a 30-day State of Emergency in selected areas of Peru starting January 15, 2023.  The affected areas include the departments of Cusco, Puno, Lima, and the province of Callao.  

The province of Andahuaylas in the department of Apurimac, the provinces of Tambopata and Tahuamanu in the department of Madre de Dios, the district of Torata, and the province of Mariscal Nieto in the department of Moquegua are included.  

Some national highways are affected, including the Pan-American Highway as well as the Apurimac-Cusco-Arequipa roadway.

For additional details, please see the complete Supreme Decree.

The Embassy suggests U.S. citizens in Peru avoid crowds and demonstrations, comply with instructions from local authorities, and enroll in STEP to receive alerts and messaging from the U.S.  Embassy in Lima.

And for in-country assistance, visit the U.S. Embassy in Lima, Peru, at Avenida La Encalada cdra, 17 s/n, Santiago de Surco 15023, Lima , or contact +51-1-618-2000 and [email protected].

From a health perspective, the U.S. CDC says to check the vaccines and medicines list and visit your healthcare provider at least a month before your trip to Peru to get vaccines or medicines you may need.

Jan 16, 2023 • 3:44 pm CST
by Rudy Skitterians

The U. S. Centers for Disease Control and Prevention (CDC) recently announced it joined the Republic of Uganda in marking the end of the fifth Sudan Ebolavirus outbreak in Uganda.

The last Sudan Ebola outbreak in Uganda was in 2012.

In addition, entry screening and public health monitoring of travelers to the U.S. who have been in Uganda in the last 21 days ended on January 11, 2023.

“I commend the Government of Uganda, local health workers, and global public health partners who worked to end the country’s Ebola outbreak,” said CDC Director Rochelle P. Walensky, M.D., M.P.H., in a media statement.

The CDC confirmed it would continue supporting the Ugandan Ministry of Health in continuing surveillance, infection prevention and control, and response activities to help ensure rapid detection and response to future cases and outbreaks.

Since this outbreak declaration in September 2022, there were 164 cases with a case-fatality ratio was 47%.

Furthermore, three vaccine candidates launched human clinical trials for this type of Ebola in December 2022.