October 6, 2023

The California Biotechnology Foundation is committed to keeping you up to date about COVID-19 testing, treatment and prevention advancements. The following resources track what progress has been made as of October 6, 2023. Notable advancements include:

• Two Hungarian-American scientists, Karikó and Weissman have won the Nobel Prize in medicine for work that enabled the creation of mRNA vaccines against COVID-19.
• The U.S. Food and Drug Administration has authorized the updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants.
• Moderna announced positive data from an early study of its experimental mRNA combination vaccine for both COVID-19 and influenza and plans to begin a Phase 3 study later this year.

Recent News

• Moderna claims positive results in early study for combo COVID-19, flu shot
  Biopharma Dive – October 5, 2023
  Moderna announced what it described as positive data from an early-stage study of its experimental messenger RNA-based combination vaccine for COVID-19 and influenza. Moderna said the vaccine spurred similar or stronger immune responses against all four influenza strains compared to one of two flu vaccines and to its Spikevax COVID-19 booster in older adults. Most side effects were mild in severity, the company said. The company plans to begin a Phase 3 study of the vaccine candidate later this year, and is targeting a regulatory approval in 2025.
• FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants
  FDA – October 3, 2023
  The U.S. Food and Drug Administration amended the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses. The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.
• Why you should wait a few days before taking an at-home COVID-19 test if you’re sick
  ABC News – October 2, 2023
  The best time to take an at-home COVID-19 test may be on the fourth day of having symptoms, according to a study published in the journal Clinical Infectious Diseases. Researchers looked at nearly 350 people and found that viral load peaked a few days after symptoms started. “Viral load just refers to the amount of virus that is replicating in your body, So the more virus that is replicating, the more chance of a test turning positive,” said John Brownstein, Ph.D., chief innovation officer at Boston Children’s Hospital and an ABC News Contributor.
• Karikó and Weissman win Nobel Prize in medicine for work that enabled mRNA vaccines against COVID-19
  AP News – October 2, 2023
  Two scientists won the Nobel Prize in medicine for discoveries that enabled the creation of mRNA vaccines against COVID-19 that were critical in slowing the pandemic — technology that’s also being studied to fight cancer and other diseases. Hungarian-American Katalin Karikó and American Drew Weissman were cited for contributing “to the unprecedented rate of vaccine development during one of the greatest threats to human health,” according to the panel that awarded the prize in Stockholm. The panel said the pair’s “groundbreaking findings … fundamentally changed our understanding of how mRNA interacts with our immune system.”
• An updated COVID-19 vaccine is here: What physicians need to know
  American Medical Association – October 2, 2023
  The Food and Drug Administration approved—and authorized—emergency use of an updated monovalent mRNA COVID-19 vaccine, which specifically offers protection against the XBB.1.5 strain. The authorization applies to vaccines for 2023–2024 manufactured by Moderna and Pfizer-BioNTech. An updated protein vaccine manufactured by Novavax is still under FDA review. Additionally, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends the updated vaccine for everyone 6 months or older to protect against COVID-19 this winter.
• Research Finds Paxlovid and Legevrio Reduced COVID-19 Hospitalization and Death
  Cleveland Clinic Newsroom – September 28, 2023
  New Cleveland Clinic-led research shows commonly used COVID-19 anti-viral drugs Paxlovid (nirmatrelvir) and Lagevrio (molnupiravir) reduce risk of hospitalization and death in high-risk patients with mild disease, even with Omicron subvariants. The observational study, published in JAMA Network Open, analyzed nearly 70,000 patients diagnosed with COVID-19 at Cleveland Clinic between April 2022 to February 2023. It found that nirmatrelvir lowered risk of death by 84% and molnupiravir by 77% compared to no treatment. Both drugs also reduced combined risk of hospitalization and death by over 40%. Importantly, the treatments were effective across all patient subgroups and against newer strains like BQ.1.1 and XBB.1.5.
• Does It Matter Which COVID-19 Booster Shot You Get?
  Time – September 26, 2023
  Now that it’s fall, it’s time to get updated on your COVID-19 vaccines if you want to stay protected throughout the winter, when infectious diseases flourish. But does it matter which shot you get? For now, there are only two options—both mRNA-based vaccines, made by Moderna and Pfizer-BioNTech. The U.S. Food and Drug Administration is still reviewing data from Novavax, which makes a different type of vaccine based on recombinant viral proteins. Both Moderna’s and Pfizer-BioNTech’s vaccines are approved for people 12 years and older, and have an emergency use authorization for children under 12. Practically speaking, if you’re eager to get your shot soon, you’ll get an mRNA vaccine, since these are the only ones approved so far.
• Scientists edge closer to finding a biomarker for long COVID-19, which could lead to better tests and treatments
  CNN – September 25, 2023
  People who have struggled to recover after COVID-19 often find that clinicians treat them like medical mysteries. Routine tests often don’t reveal that anything is amiss, so doctors sometimes wrongly assume that long COVID-19 might be a form of depression or anxiety or is otherwise all in a person’s head. Now, two small but very detailed studies are providing insights about the biology behind long COVID-19 and, if reproduced, could point to potential biomarkers for the chronic condition, which affects an estimated 6% of all American adults or more than 15 million people, according to the latest data from the US Centers for Disease Control and Prevention.
• One gene variant could be a shield against severe COVID-19 lung damage
  News Medical & Life Sciences – September 25, 2023
  Severe Acute Respiratory Syndrome COVID-19 has infected an estimated 770 million individuals globally, causing severe illnesses in a minority and approximately 7 million deaths. The host genetic background significantly influences susceptibility and outcomes of various infectious diseases, including COVID-19. Recent findings highlighted a relationship between severe COVID-19 and genetic variants influencing host defense and inflammation. Further research is essential to understand more precisely the impact of rs2204985 polymorphism and other genetic markers on COVID-19 severity and immune response, particularly in severe cases, which can lead to the identification of high-risk individuals across varying age groups and health conditions, enhancing strategies for prevention and treatment.

Rely on California Biotechnology Foundation to monitor breaking news and provide updates on the latest advancements in COVID-19 diagnostics, vaccines and treatments.

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