EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing bivalent COVID-19 vaccines from Pfizer/BioNTech and Moderna. The boosters target the omicron BA.1 sublineage. Assuming the European Commission follows CHMP’s recommendations, the European vaccine campaign will use bivalent vaccines targeting the original version of the omicron variant. U.S. regulators, by contrast, have backed…

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old. As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.…

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months and 5 years old can now be vaccinated in the U.S. FDA authorized the shots for young children on June 17, while CDC did so a day later. “The United States is now the first country in the world to offer safe…

Pfizer (NYSE: PFE) announced today that it will invest $120 million into its Kalamazoo, Michigan facility to support U.S.-based production of its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir). The investment is expected to create more than 250 additional, high-skilled jobs at the Kalamazoo site. The money will expand the production of active pharmaceutical ingredient (API) and registered…

The infectious disease physician-scientist Dr. David R Boulware filed for the emergency use authorization (EUA) of fluvoxamine, an established selective serotonin reuptake inhibitor (SSRI) whose brand name is Luvox. The FDA has rejected the application, explaining the COVID-19 treatment benefit of the drug was “not persuasive” in the TOGETHER study that was the basis of the…

Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…

White House officials have a plan to ramp up the availability of Pfizer’s COVID-19 antiviral Paxlovid, according to a report from Bloomberg. White House Covid-19 Response Coordinator Dr. Ashish Jha said that the administration would announce more details about the plans to make Paxlovid more widely available in the coming week. The administration plans to launch…

Johnson & Johnson (NYSE:JNJ) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast. The New Brunswick, New Jersey-based company posted profits of $5.1 billion, or $1.93 per share, on sales of $23.4 billion in the first quarter for a 16.9% bottom-line slide on sales growth of nearly 5%. Get the…

The NIH recently announced that it has started enrolling adults for a Phase 2 clinical trial evaluating various additional COVID-19 booster shots. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the COVID-19 Variant Immunologic Landscape (COVAIL) trial. “We are looking beyond the Omicron variant to determine the best strategy to protect against…

FDA has authorized a second booster dose of COVID-19 vaccine for individuals who are immunocompromised or 50 and over. The expanded emergency use authorization applies to the vaccines from Pfizer (NYSE: Pfizer) and Moderna (Nasdaq: MRNA). Individuals interested in obtaining a second booster dose must wait at least four months after receiving the first booster dose.…