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Pandemic Perspectives: Safety Monitoring Boost For COVID Vaccines Creating ‘A New Normal’ For Pharmacovigilance

 
• By Sarah Karlin-Smith

Pink Sheet infographic puts together the many new and existing safety systems being used to track and evaluate COVID-19 vaccine adverse events. There are early signs the vaccination effort has led to heightened public attention on medication safety that may be here to stay.

puzzle pieces with Pandemic Perspectives logo
• Source: Shutterstock

COVID-19 vaccines are being subject to heightened safety scrutiny because of the speed of their development and regulatory clearance under the emergency use authorization pathway and because of the unusual amount of public attention on the rollout, given the vaccines potential to dampen a global pandemic. A third unique element is the evolving nature of the virus the vaccines are targeting.

Pandemic Perspectives

One year on from the World Health Organization declaring COVID-19 a global pandemic on 11 March 2020, editors across Informa Pharma Intelligence publications are taking a closer look at its impact and possible lasting implications for the biopharma and medtech industry.

To address the unusual challenge, the US has upped its safety efforts, creating two new pharmacovigilance systems for COVID-19 vaccines...

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Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

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Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
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The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

Novaxovid And mNexspike Reviewers

 
• By Bridget Silverman

Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

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Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
• By Sarah Karlin-Smith

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.