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CDC Advisors Like Pfizer’s COVID Vaccine For Adolescents But Are Less Sure Of Coadministration

 
• By Sarah Karlin-Smith

Without giving ACIP a chance to vote on the change or providing additional data, CDC announces new guidance allowing coadministration of COVID-19 vaccines with other immunizations. Needless to say, the decision raised a few eyebrows.

multiple types of vaccines
New CDC guidance allows for coadministration of COVID vaccines and other immunizations. • Source: Beata Predko / Alamy Stock Photo

Pfizer Inc. and BioNTech SE’s COVID-19 vaccine easily got the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimous endorsement for persons 12-15 years of age at a 12 May emergency meeting following the US Food and Drug Administration’s emergency use authorization for the population two days earlier. (Also see "Pfizer/BioNTech’s COVID-19 Vaccine Moves Into Adolescents; Adcomm To Weigh Broader Pediatric Issues" - Pink Sheet, 11 May, 2021.)

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• By Bridget Silverman

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease

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Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 
• By Bridget Silverman

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

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Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

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• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.