Top of the morning to you, and a fine one it is. Although gray skies are hovering over the Pharmalot campus, our spirits remain sunny because, as the Morning Mayor taught us, “Every brand new day should be unwrapped like a precious gift.” We offer this reminder to folks who may remain apprehensive about what lies ahead. Meanwhile, there is work to be done. So time to get on with it and grab a cup of stimulation — our choice today is blueberry mountain. As always, feel free to join us. And now, here are some items of interest. Hope your day is manageable, and do stay in touch. …
Pfizer (PFE) and BioNTech (BNTX) have started a trial evaluating an adapted version of their Covid-19 vaccine targeting the Omicron variant of the coronavirus, The Wall Street Journal writes. The drug makers began enrolling adults ages 18 to 55 in the U.S. and South Africa to examine safety and tolerability and the immune response generated by the vaccine if it is given either as a primary series or as a booster dose. Initial study results are expected in the first half of the year, and Pfizer could ask U.S. regulators for authorization and begin distribution in March. However, STAT notes it is unclear what data regulators will want before authorizing use.
The U.S. Food and Drug Administration decided that Covid-19 antibody drugs from Regeneron Pharmaceuticals (REGN) and Eli Lilly (LLY) should no longer be used because they do not work against the Omicron variant that now accounts for nearly all U.S. infections, the Associated Press notes. The agency revoked emergency authorization for both drugs, which were purchased by the U.S. government and have been administered to millions of Americans with Covid-19. If the drugs prove effective against future variants, the FDA could reauthorize their use. The move was expected after the drugmakers said their infusion treatments are less able to target Omicron due to its mutations.
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