June 30, 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 June 30, 2023. Notable advancements include:

• A new study by researchers at the UNC School of Medicine have discovered that COVID-19 vaccines produce antibody responses in the lining of the nasal cavity, offering insights into future vaccine strategies.
• The U.S. Food and Drug Administration has advised Pfizer, Moderna and Novavax to manufacture single-strain vaccines targeting the omicron subvariant XBB.1.5.
• A new study finds children under the age of 12 are protected against severe illness from COVID-19 by mRNA vaccines.

Recent News

• COVID-19 Vaccines Produce Antibody Response in the Nasal Mucosa
  UNC School of Medicine – June 27, 2023
  A new study by researchers in the UNC School of Medicine, including Meghan Rebuli, PhD, Ilona Jaspers, PhD, and Kevin T. Cao, has found that SARS-CoV-2 mRNA vaccination produces a robust immune response in the nasal cavity. Respiratory viruses are known for their ability to enter the body through the eyes, nose, or mouth. Our bodies know that, too. The nasal cavity is well-equipped with sticky mucus that traps pathogens and serves as an important site for immune cell surveillance and signaling. It may also be our best ally in the fight against COVID-19.
• Study suggests vaccination plays role in making Omicron waves less severe
  CIDRAP – June 27, 2023
  For the first 2 years of the pandemic, Hong Kong was largely successful in suppressing mass infection with COVID-19. By the end of 2021, only 1% of the Hong Kong population had been infected with SARS-CoV-2, but 70% of the population aged 3 years or above had received at least two doses of vaccination. In March 2022, however, 1.1 million cases of the virus were confirmed when the Omicron variant caused mass infection in a largely immune-naïve population. To compare the severity between the Omicron and ancestral strains of the virus, researchers in Hong Kong looked at factors associated with mortality among hospitalized COVID-19 cases to quantify the overall patterns of COVID-19 severity.
• Household COVID-19 Omicron spread lower among vaccinated, study finds
  CIDRAP – June 26, 2023
  For the Vaccine Effectiveness, Networking, and University Safety (VENUS) study, Kyushu University researchers analyzed data on COVID-19 vaccination and infections and a resident registry in two municipalities in Japan and modeled the effect of vaccination on transmission. The evaluation included 7,326 households with a member infected by SARS-CoV-2 from January to April 2022 and 17,586 contacts. Households were categorized by whether they included children 11 years and younger, with 2,702 having children in that age-group (household group 1) and 4,624 with older children (household group 2).
• Invivyd, FDA agree on steps to emergency approval for COVID-19 monoclonal antibody
  Fierce Biotech – June 26, 2023
  Invivyd and the FDA have agreed on a path toward potential emergency use authorization of the biotech’s lead monoclonal antibody (mAb) and possible follow-on candidates designed to prevent symptomatic COVID-19. Currently, there aren’t any approved mAb treatments in the U.S. for the indication. Invivyd, which launched early in the pandemic under the name Adagio, recently shed its former focus— a mAb targeting COVID-19 and known as NVD200—in hopes that its third mAB will do the trick. Dubbed VYD222, the new pipeline star is made up of a component of the older treatment and was also engineered from the biotech’s original mAb adintrevimab. Now, the company says it has reached a “general alignment” with the FDA on a path to potential EUA for VYD222, which is currently being assessed in a phase 1 clinical trial.
• Study yields important findings about COVID-19 vaccination and previous infection in children younger than 12 years
  News Medical & Life Sciences – June 22, 2023
  In the present study, researchers characterized the effects of SARS-CoV-2 vaccination and prior COVID-19 on Omicron reinfection in children under 12. Two age groups of children, 0-4 and 5-11, were defined. The team used data from a surveillance system comprising positive test results for all COVID-19 cases and reinfections. Vaccination data were obtained from the COVID-19 Vaccination Management System until January 6, 2023.
• COVID-19 vaccines protective in children ages 0 to 11
  CIDRAP – June 20, 2023
  Children under the age of 12 are protected against severe illness from COVID-19 by mRNA vaccines, but the effectiveness decreases over time, as does immunity gained from previous infections. These findings and others are published in a new study in The Lancet Infectious Diseases. The study looked at the clinical outcomes seen in 1,368,721 North Carolina residents aged 11 years or younger from October 29, 2021 (October 29, 2021 for children aged 5 to 11 years and June 17, 2022 for children aged 0 to 4 years), to January 6, 2023.
• Pfizer, Moderna and Novavax gear up for fall COVID-19 vaccine rollout with an important head start
  CNBC – June 20, 2023
  The U.S. Food and Drug Administration’s COVID-19 strain selection for the next round of shots is a decisive win for Pfizer, Moderna and Novavax. The FDA advised the three pharmaceutical companies to manufacture single-strain vaccines targeting the omicron subvariant XBB.1.5. The agency’s decision puts the vaccine makers on track to deliver updated COVID-19 vaccines in time for the fall and winter. The timely delivery of new vaccines will position each pharmaceutical company to compete in the commercial market. The U.S. Food and Drug Administration’s COVID-19 strain selection for the next round of shots puts Pfizer, Moderna and Novavax on track to deliver new jabs in time for the fall – a decisive win for the vaccine makers as they gear up to compete against one another.
• FDA advisers endorse updating COVID-19 shots to match circulating virus strain
  Biopharma Dive – June 16, 2023
  Advisers to the Food and Drug Administration recommended updating COVID-19 vaccines to target one of the most common COVID-19 strains now circulating in the U.S. The panel, made up of independent vaccine and infectious disease experts, voted 21-0 in favor of modifying the vaccines to target a version of omicron known as XBB, rather than both the original and BA.1 omicron variants that the shots are currently aimed at. XBB and its related subvariants, particularly one dubbed XBB.1.5, now account for most new COVID-19 cases in the U.S., according to the Centers for Disease Control and Prevention.

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