The Biden administration’s haste to roll out an eight-month COVID-19 vaccine booster program next week is bumping up against the reality of the data and the regulatory process.
With the U.S. logging more than 4 million new COVID-19 cases in the past few weeks, federal purchasing of antibody cocktails from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. is continuing to grow. The government has placed orders for $2.94 billion worth of Regeneron's REGEN-COV (casirivimab and imdevimab) and about $330 million of Lilly's etesevimab to complement doses of bamlanivimab it previously purchased. Both antibody combinations, approved under FDA emergency use authorizations (EUAs), have been shown to reduce risk of hospitalization or death from COVID-19.
In a couple of deals worth more than $500 million, Everest Medicines Ltd. is picking up Asian rights to Providence Therapeutics Holdings Inc.’s mRNA candidates, including rights to a mRNA COVID-19 vaccine candidate currently in phase II testing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anika, Electrocore, Intravent, Quanterix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambiopharm, Axonics Modulation Technologies, CEM, De Novo Software, Dermtech, Ginkgo Bioworks, Insightful Science, Medtronic, Twist Bioscience, Vitalconnect, Waters.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
While privately held Calcimedica Inc. posted positive top-line results from a phase II study of its lead candidate in treating patients with severe COVID-19 pneumonia, Redhill Biopharma Inc. took a tumble as preliminary top-line data from a phase II/III study of opaganib in treating hospitalized COVID-19 patients showed the endpoints failed to achieve statistical significance.
LONDON – The U.K. government has accepted the recommendation of medical experts and will begin the rollout of COVID-19 boosters from next week, using mRNA vaccines only. That follows data from the U.K. Cov-Boost trial, looking at combinations of initial and booster doses. The results showed Pfizer Inc./Biontech SE’s and Moderna Inc.’s products generated the best immune responses, regardless of which vaccine was administered initially.
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