January 28, 2022

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 January 28, 2022. Notable advancements include:

• Moderna announced that a first participant has received a dose in its Phase 2 clinical trial of a COVID-19 vaccine booster shot that is specific to the Omicron variant.
• Gilead‘s COVID-19 drug Veklury has received broadened approval from The Food and Drug Administration to include people who have not yet been hospitalized, a move meant to help increase the supply of drugs available to counter the Omicron variant.
• Pfizer is enrolling healthy adults to test a reformulated COVID-19 vaccine that matches the contagious Omicron variant.

Recent News

• Pfizer Gets Nod From EU Regulator for COVID-19 Drug Paxlovid
  Bloomberg – January 27, 2022
  Pfizer Inc.’s COVID-19 pill received backing from the European Union’s drugs regulator, offering a tool to manage COVID-19 infections at home and ease the burden on hospitals. The European Medicines Agency’s expert committee recommended granting authorization for the antiviral, called Paxlovid, for adults with COVID-19 who don’t require supplemental oxygen and are at risk of developing severe disease, the regulator said.
• Moderna begins next phase of Omicron-specific booster trial
  CNN – January 26, 2022 
  Moderna announced that the first participant has been dosed in the company’s Phase 2 clinical trial of a COVID-19 vaccine booster shot that is specific to the Omicron variant. Moderna is advancing the trial into its next phase as research published Wednesday in the New England Journal of Medicine found that a booster dose of the vaccine remained durable against the Omicron variant but did show signs of waning antibody protection.
• Fauci says children younger than 4 will get three doses of COVID-19 vaccines
  New York Post – January 26, 2022
  The White House said that the COVID-19 vaccine regime for kids younger than 4 years old will likely be three doses when it’s approved — and vowed to make millions more hard-to-find Pfizer anti-viral pills available in coming months. White House officials promised to release millions more Pfizer antiviral pills by June, amid reports that the medicine has been difficult to find in recent weeks.
• Moderna Booster May Wane After 6 Months, Company Says
  Time – January 26, 2022
  Moderna reported the first data on how well its authorized vaccine and booster hold up against the Omicron variant, which quickly dominated new infections around the world. The company also announced that it is starting to study its Omicron-specific vaccine. Antibody levels generated by Moderna’s primary two-dose regimen continued to neutralize Omicron in lab tests, but these levels were 35 times lower against Omicron than the original SARS-CoV-2, against which the vaccine was designed.
• Blood test could help detect who will get long COVID-19, study shows
  New York Post – January 26, 2022
  Lower levels of a certain antibody that can be detected through a blood test might be able to indicate whether a person is more likely to get long COVID-19, according to a new study. The study published in the journal Nature Communications found that people who develop long-term symptoms of the virus have lower levels of two immunoglobulins shortly after being infected with the virus.
• Results of NIH mix-and-match COVID-19 booster trial published
  Healio – January 26, 2022 
  The New England Journal of Medicine published data from the ongoing NIH-sponsored trial that led the FDA last fall to authorize the mix-and-match strategy for COVID-19 vaccine boosters. The NIH said more data from the phase 1/2 trial are expected to be available “in the coming months.” The FDA authorized the mix-and-match strategy in October and the CDC endorsed the approach in federal guidelines, allowing vaccinated Americans to choose their own booster shot.
• Pfizer begins testing omicron-matched COVID-19 shots in adults
  AP News – January 25, 2022
  Pfizer is enrolling healthy adults to test a reformulated COVID-19 vaccine that matches the hugely contag ious Omicron variant, to see how it compares with the original shots. COVID-19 vaccine-makers have been updating their shots to better match omicron in case global health authorities decide the change is needed.
• COVID is less severe with Omicron than Delta, U.S. study suggests
  Reuters – January 25, 2022
  The Omicron variant appears to result in less severe COVID-19 than seen during previous periods of high coronavirus transmission including the Delta wave, with shorter hospital stays, less need for intensive care and fewer deaths, according to a new U.S. study.
• US turns to Gilead’s COVID-19 drug to help counter Omicron
  BioPharma Dive – January 24, 2022
  The Food and Drug Administration broadened its approval of Gilead’s COVID-19 drug Veklury to include people who haven’t yet been hospitalized, a move meant to help bolster the supply of drugs available to counter the Omicron variant. The new approval makes Veklury an option for those with mild or moderate symptoms as well.

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