The FDA’s vaccine advisory committee voted 17-4 with one abstention Dec. 10 to recommend an emergency use authorization (EUA) for the Pfizer Inc./Biontech SE mRNA vaccine BNT-162b2 to prevent COVID-19 in individuals 16 and older.
Roche Holding AG has revealed a partnership with Moderna Inc. involving the use of the Elecsys Anti-SARS-CoV-2 S antibody test in the latter’s mRNA-1273 vaccine research trials. The news comes shortly after Roche received emergency use authorization from the U.S. FDA for the antibody test.
Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
With the FDA perhaps days away from granting emergency use authorization (EUA) for the first U.S. COVID-19 vaccine, the Trump administration took a bow Dec. 8 at a summit called to celebrate what’s been accomplished and to explain what lies ahead in getting vaccines distributed throughout the country.
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
LONDON – The first of 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine arrived in the U.K., after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration beginning Dec. 8.
Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.
LONDON – The Oxford University team behind the development of Astrazeneca plc’s COVID-19 vaccine have become the first to publish full and complete interim phase III data in a peer-reviewed journal.
Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
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