Coming Soon: More Moderna Boosters, More Monoclonal Antibody Treatments
The FDA has authorized five more batches of Moderna's updated covid shot to address shortages across the nation. And the Health and Human Services Department is buying 60,000 more doses of bebtelovimab.
Reuters:
U.S. FDA Clears Additional Lots Of Moderna's Covid Booster Amid Shortage
The U.S. Food and Drug Administration said on Monday it has authorized an additional five batches of Moderna Inc's updated Covid booster shots made at a Catalent facility in Indiana, after it deemed them safe for use. Last week, the health regulator had allowed use of ten batches of Moderna's updated booster shots made at the Bloomington, Indiana facility, owned by a unit of Catalent Inc, which is currently not a part of the company's emergency use authorization. (9/26)
Modern Healthcare:
COVID-19 Treatment Bebtelovimab Supplies For Uninsured Boosted
The Health and Human Services Department is purchasing 60,000 COVID-19 monoclonal antibody treatment doses as federal funding runs dry, the department announced Friday. (Berryman, 9/26)
Pfizer has requested an EUA for its updated covid booster in kids —
Axios:
Pfizer, BioNTech Ask FDA To Authorize New COVID Booster For Children
Pfizer and BioNTech announced Monday that they are seeking emergency use authorization from the FDA for its Omicron-specific COVID-19 booster for children ages 5-11. (Doherty and Bettelheim, 9/26)
AP:
Pfizer Seeks To Expand Omicron Booster To 5- To 11-Year-Olds
Pfizer and its partner BioNTech also announced a new study of the omicron-focused booster in even younger children, those ages 6 months through 4 years, to test different doses. (9/26)
More on the covid vaccine rollout —
CIDRAP:
Vaccines Protected Pregnant Women Against Severe COVID For 3 Months
Pregnant women who received two or three doses of an mRNA COVID-19 vaccine were well protected against Delta- and Omicron-related hospitalization and emergency department (ED) and urgent care (UC) visits for more than 3 months, but protection appeared to wane to zero by 4 months, shows a US test-negative case-control study published today in JAMA Network Open. (9/26)
The Wall Street Journal:
Covid-19 Vaccine Rollout Carries Lessons For Pharma Supply Chains, Says Pfizer Executive
The concentrated effort to develop, manufacture and distribute vaccines as the Covid-19 pandemic began to rage across the world highlighted the importance of the supply chain and helped set a model for how lifesaving medicines will be rolled out in the future, a Pfizer Inc. executive said. “Supply chain has probably done just as much, if not more” than the innovative science that Pfizer and other drug companies used to produce the new vaccines that have been distributed around the world, Jim Cafone, Pfizer’s senior vice president of global supply chain, told a supply-chain industry conference this week. (Young, 9/24)
