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Lucira Health, Inc. recently announced the nationwide launch of its Lucira COVID-19 & Flu Home Test in the United States.
The COVID-19 & Flu Home Test is the first and only combination COVID-19 & Flu test granted emergency use authorization by the U.S. Food and Drug Administration for use at home and other non-laboratory sites.
The Lucira COVID-19 & Flu Home Test is a molecular test, not an antigen test, that demonstrated similar performance for COVID-19 and Influenza compared to highly sensitive lab-based PCR tests in clinical trials.
The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab and as of March 28, 2023, can be purchased in the U.S. for $34.99 at www.lucirahealth.com/flu.
The Global Polio Eradication Initiative (GPEI) recently announced it had been two years since the novel oral polio vaccine type 2 (nOPV2) became available.
Approximately 590 million doses of nOPV2 have been administered across 28 countries under its WHO Emergency Use Listing (EUL) to date.
An additional 13 countries have met the EUL requirements for nOPV2 use in the event of a polio outbreak.
As of April 1, 2023, the nOPV2 vaccine is unavailable in the U.S.
GPEI’s nOPV Working Group leaders, Simona Zipursky (World Health Organization) and Ananda S. Bandyopadhyay (Bill & Melinda Gates Foundation), were interviewed on March 29, 2023, on the journey and the vaccine’s performance so far.
The unedited interview is posted at this link.
A recent study published in the peer-reviewed journal Science Advances indicates that the protease inhibitor Paxlovid could soon become less effective in treating COVID-19 infections.
This new research shows that simple single amino acid changes in SARS-CoV-2 coronavirus main protease could severely undermine the efficacy of antiviral drugs.
To lower the risk of resistance, the researchers say protease inhibitors must be carefully designed to avoid simple resistance mutations.
Announced on March 29, 2023, and conducted by the Midwest Antiviral Drug Discovery Center in Minnesota, this study shows that drug-resistant variants have appeared multiple times independently in different parts of the world, with regional clusters providing evidence for person-to-person transmission.
Further research will likely develop additional next-generation protease inhibitors with different resistance profiles and drugs targeting other viral processes, such as replication or cell entry.
A multi-drug approach—like existing therapies for HIV and Hepatitis C virus — could further help to protect against resistance and cure SARS-CoV-2-infected individuals, wrote these researchers.
The UK Health Security Agency Week #13 reported COVID-19 activity decreased across most indicators compared with the previous week.
As of March 30, 2023, through Respiratory Datamart, SARS-CoV-2 positivity decreased to 10% compared with 10.9% in the previous week.
Overall, COVID-19 hospitalizations decreased slightly in week #12 and were highest in the 85 and over age group.
Furthermore, the COVID-19 Autumn booster vaccination campaign commenced in September 2022.
By the end of week #10, about 65% of all people aged over 50 and living in England had been vaccinated with an Autumn booster dose.
The Region of the Americas has seen a significant surge in dengue cases and, in 2023, “is showing intense dengue transmission,” stated the World Health Organization on March 23, 2023.
By early March 2023, 342,243 dengue cases, including 86 deaths, were reported in the Americas.
At this pace, 2023 may easily eclipse the results seen in 2022.
In 2022, over 2.8 cases of dengue, including 1,290 deaths, representing a two-fold increase in patients compared with 2021.
Unfortunately, this trend is being realized in the state of Florida.
The Florida Health Department reported as of week #12, there had been 52 travel-associated dengue cases, and one locally acquired dengue case confirmed this year.
This compares with 903 travel-associated and 68 locally-acquired dengue cases reported in 2022, primarily in southern Florida.
The good news is that dengue is a vaccine-preventable disease, and two vaccines are becoming more available for international travelers in 2023.
Resistance to Paxlovid™ is already evident among viral SARS-CoV-2 variants currently circulating globally, indicating that this stand-alone antiviral, known as a protease inhibitor, could soon become less effective in treating COVID-19 patients.
Published on March 29, 2023, this study's conclusion was presented in the peer-reviewed journal Science Advances.
To lower the risk of resistance, the researchers say protease inhibitors must be carefully designed to avoid simple resistance mutations.
These researchers wrote that these results encourage the monitoring of resistance variants and the development of additional protease inhibitors and other antiviral drugs with different mechanisms of action and resistance profiles for combinatorial therapy.
"Despite Paxlovid's proven success in blunting COVID-19 symptoms, the long-term consequences of its widespread use in speeding up resistance are unknown," commented S. Arad Moghadasi, co-author of the study and a University of Minnesota Medical School graduate student in a press release.
The U.S. Centers for Disease Control and Prevention (CDC) today announced four additional influenza-associated pediatric fatalities have occurred during the 2022-2023 flu season in the United States.
A total of 138 pediatric flu deaths have been reported so far this flu season.
The good news is the CDC FluView week #12 report confirmed seasonal flu rates were low nationally last week, with outpatient respiratory illness below baseline, and eight of 10 HHS regions are below their respective baselines as of March 31, 2023.
Previously, the World Health Organization published Influenza Update N° 401 on March 20, 2023, stating most indicators of influenza activity decreased to levels similar to or below levels typically observed this time of year in the Northern Hemisphere.
The CDC suggests anyone traveling to the Southern Hemisphere in April 2023 speak with a healthcare provider about potentially getting an additional flu shot for protection.
Flu shots remain available for most people over six months at most clinics and pharmacies in the U.S.
As of March 4, 2023, about 173.37 million influenza vaccines had been distributed during the 2022-2023 flu season.
The European Medicines Agency human medicines committee today announced it recommended authorizing the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and older who have previously been vaccinated with an mRNA COVID-19 vaccine.
It is the eighth vaccine recommended in the European Union for protecting against COVID-19 and, together with the vaccines already authorized, will support vaccination campaigns in EU Member States during the pandemic.
An updated listing of COVID-19 vaccines is posted at Coronavirus Today.
NSW Health today announced a Western Sydney infant infectious with measles spent time in locations in Parramatta and Westmead on March 27, 2023.
The infant, too young to be vaccinated against measles, acquired the infection in India before returning to Sydney.
NSW Health also confirmed a local measles case in September 2022.
Dr. Christine Selvey, Director of Communicable Diseases, NSW Health, commented in a press release on March 29, 2023, "Measles is a highly contagious infection, and the most vulnerable are infants under 12 months, who are too young to be vaccinated against it, other members of the community who are not fully vaccinated and people with a weakened immune system."
Measles cases increased worldwide by about 80% during 2022 compared with 2021.
Measles is a vaccine-preventable disease that quickly spreads in the air through coughing or sneezing by someone unwell with the disease.
"It can take up to 18 days for symptoms to appear after an exposure, so it is essential to stay vigilant if you've been in the above locations, and if you develop symptoms, please call ahead to your GP to ensure you do not spend time in the waiting room with other patients," Dr. Selvey added.
The U.S. Food and Drug Administration (FDA) recently approved the intramuscular route of administration for M-M-R®II and ProQuad®. In addition, the FDA approved the Priorix vaccine for use in the U.S.
Measles outbreak news for 2023 is posted at Vax-Before-Travel.
The start-up company PathoVax LLC announced that the U.S. Food and Drug Administration had concluded that a Phase 1 clinical trial for its monovalent component- HPV16 RG1-VLP vaccine RGVax may proceed.
This first-in-human, global multicenter Phase 1 clinical study seeks to demonstrate RGVax's safety and immunogenicity responses to HPV16 RG1-VLP in healthy volunteers.
RGVax is a chimeric HPV virus-like particle platform that displays 360 copies of the highly conserved, neutralizing HPV epitope (RG1).
The foundational technology is based on research conducted at the Johns Hopkins University and Medical University Vienna.
Unlike existing HPV vaccines, the RGVax technology and formulation have been shown to provide comprehensive protection against at least 18 high-risk human papillomavirus (HPV) types with immunogenicity lasting over a year without additional boosts in head-to-head studies with existing approved HPV vaccines.
"The world needs more, and particularly broad-based, HPV vaccines. We look forward to globally supporting these efforts in parallel and beyond this Phase 1, especially in Asia-Pacific and other developing countries, where there is a high burden of HPV diseases," said Dr. Kevin Koh, Chairman of PathoVax, in a press release on March 29, 2023.
A National Cancer Institute PREVENT contract funds the initiation of the Phase 1 study.
As of March 31, 2023, there are various approved HPV vaccines and several vaccine candidates in development.
