October 15, 2021

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 15, 2021. Notable advancements include:

• • Moderna’s booster shots for COVID-19 received emergency authorization after a unanimous recommendation from an Food and Drug Administration advisory panel, paving the way to sharply expand the number of people eligible for an additional shot in the United States.
  • AstraZeneca’s experimental COVID-19 antibody drug treatment succeeded in reducing severe disease or death in non-hospitalized patients in a late-stage study and reduced the risk of developing severe COVID-19 or death by 50% in patients who had been symptomatic for seven days or less.
  • Merck and Ridgeback Biotherapeutics have asked the Food and Drug Administration to authorize their oral drug for COVID-19 for adults with mild or moderate COVID-19 symptoms and who are at risk of poor health outcomes.

  ​Recent News

  • F.D.A. Panel Recommends Booster for Many Moderna Vaccine Recipients
    New York Times – October 15, 2021
    A panel of independent medical experts unanimously recommended Moderna booster shots for many of those who had received the company’s COVID-19 vaccine, paving the way to sharply expand the number of people eligible for an additional shot in the United States. The advisory panel to the Food and Drug Administration voted 19 to 0 in favor of emergency authorization of a half-dose booster, at least six months after the second dose.
  • What to expect from FDA panel on boosters for Moderna, Johnson & Johnson vaccines
    ABC News – October 14, 2021
    An independent FDA advisory panel is set to discuss and vote on whether to authorize Moderna and Johnson & Johnson COVID-19 vaccine boosters for those 18 and older. The outside experts will also consider new data from the National Institutes of Health on the potential benefits of mixing and matching vaccines for booster shots. Early results from the highly anticipated NIH study finds that boosting with a shot different from what people got the first time appears to be safe and effective.
  • New at-home rapid COVID-19 test will soon hit Bay Area stores. Here’s what we know about FlowFlex
    San Francisco Chronicle – October 13, 2021
    Another at-home COVID rapid testing kit will soon be on the way to store shelves, made by a California company — welcome news in the Bay Area, where the tests have been hard to find amid a nationwide supply crunch. The FlowFlex test, from San Diego-based Acon Laboratories, received emergency use authorization from the Food and Drug Administration.
  • FDA Grants EUAs for Cleveland Clinic COVID-19 PCR Test, Quest Diagnostics Sample Self-Collection Kit
    Genomeweb – October 13, 2021
    Two emergency use authorizations were granted separately by the FDA, first for the Cleveland Clinic’s PCR-based SelfCheck test. The second authorization was granted to ​Quest Diagnostics’ COVID-19 testing sample collection kit, developed for at-home specimen collection of anterior nasal swabs that will be sent for molecular testing to Quest-designated laboratories.
  • Pfizer Asks F.D.A. to Authorize Its COVID-19 Vaccine for Children 5 to 11
    New York Times – October 12, 2021
    Pfizer and BioNTech asked federal regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. The companies say they are submitting data supporting the change to the Food and Drug Administration.

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

Stay informed on the latest news and trends on the economic and health benefits of this industry by visiting the new CABiotech.org

If you have any questions about informational briefings contact California Biotechnology Foundation Executive Director Patty Cooper at (916)764-2434 or [email protected].