Vaccines
The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.
Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.
The FDA in February slapped Moderna’s vaccine with a refusal-to-file letter—though the agency backtracked a few days later and accepted a revised submission for review. An advisory committee in June unanimously backed mFLUVISA’s approval.
Lower vaccine demand across every market and more acute pressures in Germany led BioNTech to lower the midpoint of its sales outlook by almost 20%.
Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.
The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.
Improved survival on display at the American Society of Clinical Oncology (ASCO) in Chicago; Pfizer’s unusual pact with China’s Innovent highlights a new type of collaboration; Eli Lilly continues its nonstop deal streak, including with Chinese biotechs; and looking ahead to this weekend’s American Diabetes Association meeting.
Riding a newfound surge of interest on infectious disease concerns, Moderna is linking up with a global vaccine foundation in hopes of developing a vaccine to slow the new surge in Ebola underway in the Congo and Uganda.
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