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Pfizer’s COVID Vaccine Raises No Safety Red Flags, But Managing Reactogenicity May Be Practical Challenge

 
• By Sue Sutter

Phase III data show no specific safety concerns that would preclude issuance of an EUA, US FDA says in advisory committee briefing document; however, high rate of local injection site and systemic adverse events could complicate compliance with 21-day, two-dose regimen.

Senior citizen couple taking a walk in a park during autumn morning.
Injection site and systemic reactions with Pfizer's COVID-19 vaccine will be no walk in the park. • Source: Shutterstock

Adverse events reported in the Phase III study for Pfizer Inc./BioNTech SE’s COVID-19 vaccine do not appear to preclude an emergency use authorization at this point in time, based upon US Food and Drug Administration review documents.

However, the reactogenicity side effects of the mRNA vaccine are likely to create some practical concerns among the FDA’s external experts with regard to how to prepare vaccinated individuals...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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