COVID-19

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.…

FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to some patients with a high risk of COVID-19. While the move allows pharmacists to prescribe Paxlovid, it has limits. It instructs the professionals to refer patients to a physician if there is insufficient…

FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter. But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works. Pfizer and Moderna have both said…

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…

All U.S. states but Florida have pre-ordered COVID-19 vaccine doses for children under the age of 5, according to the Miami Herald. The federal government had a deadline of June 14 for states to pre-order vaccine doses. In a statement, the Florida Department of Health said it decided not to order vaccine doses for young children…

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…

Entegris (Nasdaq:ENTG) announced today that it opened a new Life Sciences Technology Center in Billerica, Massachusetts. The new facility was built to offer life sciences customers the opportunity to leverage Entegris’ cold-chain supply expertise to optimize processes, reduce costs and increase speed to market, according to a news release. Entegris’ tools and technologies will be…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children. Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial in young children evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong…

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…

A new congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated. Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in…