Moderna's COVID-19 vaccine wins approval in Switzerland | EMA to launch accelerated review for AZ COVID-19 vaccine | Bangledesh company reaches COVID-19 vaccine deal
January 14, 2021
News on diagnostic and therapeutic innovations and regulatory science
Swissmedic, Switzerland's drug regulator, has approved Moderna's COVID-19 vaccine, the second vaccine authorized for emergency use after the Pfizer/BioNTech vaccine. The approval will allow for the delivery of up to 1.5 million doses from both companies through February.
AstraZeneca and partner Oxford University are seeking
conditional marketing authorization for their COVID-19 vaccine, and the European Medicines Agency is about to initiate an accelerated review of its application. An opinion on the CMA could be issued by the agency by Jan. 29.
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The Serum Institute of India will sell three million doses of AstraZeneca's COVID-19 vaccine to Bangladesh's Beximco Pharmaceuticals to be used on the private market. The vaccine could be delivered as soon as next month, according to a Beximco official.
Merck's application for V114, its 15-valent pneumococcal conjugate vaccine, was granted priority review status by the FDA, according to a company announcement. Merck said
a decision on V114 is expected from the FDA by July 18.
Eli Lilly and Co. reported mid-stage trial data showing that individuals with mild to moderate Alzheimer's disease who took its monoclonal antibody drug donanemab had 32% slower cognitive decline rate compared with those who were given placebo. Donanemab treatment also correlated with removal and persistent absence of amyloid plaques after six to 12 months, according to Eli Lilly Chief Scientific Officer Dr. Daniel Skovronsky.
Researchers say clinical trials in Brazil shows a COVID-19 vaccine under development by China's Sinovac Biotech was only 50.4% effective. The vaccine is one of two recommended by Brazilian officials, but efficacy rate may not be high enough for regulatory approval.
Recruiting volunteers for placebo-controlled clinical trials of next-generation COVID-19 vaccines has been rendered nearly impossible by the regulatory approval of several vaccines, and some volunteers in ongoing trials have already asked to drop out. Researchers are designing other ways to prove efficacy, such as by splitting cohorts so that twice as many participants receive the vaccine as the placebo, using an approved vaccine as the control or measuring immunity biomarkers to judge efficacy, but all have drawbacks.
Gilead Sciences CEO Daniel O'Day said the company is testing remdesivir to find out if it is effective in treating new variants of the novel coronavirus discovered in South Africa and the UK. "Remdesivir works at the source in the cell where the virus replicates, and what we know is in these new variants, that part of the cell is not changing at all in fact. So, we fully expect remdesivir to be effective against these new strains, " O'Day said.
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