Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the regulatory agency authorize Novavax Inc.’s COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.
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Johnson & Johnson and Emergent BioSolutions are accusing each other of breaching their COVID-19 vaccine supply agreement.
Contract manufacturer Emergent BioSolutions Inc. said on Monday U.S. drugmaker Johnson & Johnson (JNJ.N) had breached an agreement by failing to buy the minimum quantity of COVID-19 vaccines made by the company.
U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc.’s vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.
In the months before it acknowledged its first official COVID-19 outbreak, North Korea suddenly imported millions of face masks, 1,000 ventilators, and possibly vaccines from China, trade data released by Beijing showed.
Drugmakers Pfizer Inc and BioNTech SE said on May 23 that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.
The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.
Ocugen Inc. said on May 23 the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by the company’s Indian partner Bharat Biotech.
White House COVID-19 response coordinator Dr. Ashish Jha said on May 22 he expects a U.S. Food and Drug Administration decision on authorizing Moderna’s vaccine for children under age five within the next few weeks.
North Korea on May 21 reported more than 200,000 new patients suffering from fever for a fifth consecutive day, as the country fought its first confirmed coronavirus outbreak.
