The U.S. Food and Drug Administration is aiming to give full approval for the Pfizer vaccine by early September, the New York Times reported on Aug. 3, citing people involved in the effort.
Moderna Inc. is in talks with U.S. regulators to expand the size of an ongoing trial testing the company’s Covid-19 vaccines in children aged between 5 and 11 years, the drugmaker said on July 26.
Following a manufacturing mistake that left Emergent BioSolutions with a botched batch of Johnson & Johnson’s Covid-19 vaccine, the company is facing a shareholder lawsuit accusing it of insider trading.
The U.S. Food and Drug Administration said Johnson & Johnson must throw away millions of doses of the company’s Covid-19 vaccine that were manufactured at a problem-plagued Baltimore factory, but also cleared millions for use.
The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc. and German partner BioNTech SE’s Covid-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on May 3, citing federal officials familiar with the regulatory agency’s plans.
The U.S. government will allot nearly 85 percent less Johnson & Johnson Covid-19 vaccines to states next week, data from Centers for Disease Control and Prevention (CDC) showed.
Emergent BioSolutions’ Phase III trial of SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) to treat hospitalized patients with COVID-19 showed that the addition of the treatment to Gilead Sciences’ remdesivir did not provide clinical benefit compared to standard of care plus placebo in hospitalized adult COVID-19 patients with symptoms for less than 12 days.
Johnson & Johnson said on March 31 the company had found a problem with a batch of the drug substance for its Covid-19 vaccine being produced by Emergent BioSolutions, and said the batch did not advance to the final fill-and-finish stage.
Dr. Anthony Fauci, the top U.S. infectious disease expert, said on March 14 he hopes former President Donald Trump will push his supporters to get the Covid-19 vaccine and emphasized that pandemic-related restrictions should not be lifted prematurely.
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temps: NYT (Reuters) – The U.S. Food & Drug Administration plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 vaccine at standard freezer temperatures instead of in ultra-cold conditions, the New York Times reported on Tuesday. The FDA is expected to […]