The vagaries of the COVID-19 market and the uncertainties of pandemic fatigue are hitting some biopharma companies in the pocketbook, at least for now. Due to lower-than-expected revenues from its COVID-19 Comirnaty vaccine and antiviral Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. reduced its 2023 revenue guidance by $9 billion after hours Oct. 13, saying it now anticipates full-year 2023 revenues to range from $58 billion to $61 billion – down from its previous guidance range of $67 billion to $70 billion.
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
Biontech SE and Pfizer Inc. filed a petition with the U.S. Patent Trial and Appeal Board for an inter partes review against Moderna Inc., the latest move in an ongoing patent battle over the mRNA technology used to develop COVID-19 vaccines.
Jiangsu Recbio Technology Co. Ltd. released phase II data showing its recombinant two-component COVID-19 vaccine Recov appeared more effective than Comirnaty (tozinameran), the mRNA vaccine developed by Biontech SE and Pfizer Inc., as a booster for users of inactivated vaccines.
Jiangsu Recbio Technology Co. Ltd. released phase II data showing its recombinant two-component COVID-19 vaccine Recov appeared more effective than Comirnaty (tozinameran), the mRNA vaccine developed by Biontech SE and Pfizer Inc., as a booster for users of inactivated vaccines.
Three of the biggest COVID-19 vaccine developers are heading into a legal battle. Moderna Inc. said it has filed lawsuits alleging the Pfizer Inc.-Biontech SE Comirnaty vaccine infringes patents Moderna filed between 2010 and 2016 that cover its mRNA technology. Pfizer and Biontech “unlawfully” copied the technology without permission, according to Moderna.
European regulators and health experts have recommended a second booster dose of mRNA COVID-19 vaccines for people between 60 and 79 years of age and for vulnerable people with medical conditions, as Moderna Inc. filed fresh data from its omicron subvariant-adapted shot.
Curevac NV has filed a patent lawsuit against fellow German mRNA pioneer Biontech SE claiming that the latter firm’s COVID-19 vaccine, Comirnaty, infringes its intellectual property.
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
When the U.S. FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) April 6 to advise on a path forward to the next generation of COVID-19 vaccines and boosters, there was a lot of talk about all the unknowns.