Look out, pharma. A 'tidal wave' of side effect reports is coming amid COVID-19 vaccine rollouts

12 January 2021

Eric Sagonowsky / FirecePharma

With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow.

With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said.

All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview.

“That’s not insignificantly on top of a trend that has already been going on for years—more and more reports," Cope added. “The already strained system is going to face an even bigger deluge of reports." 

In turn, companies and regulators need to step up efforts to gather as much “quality information” as they can to quickly identify serious safety concerns. To help explain the issue and to help companies navigate the “coming tidal wave” of reports, the firm has published a white paper. "Pharmacovigilance teams across all companies must be prepared,” the firm figures. 

Several factors will play into adverse event reporting and potential litigation for COVID-19 vaccine launches. Development timelines have been shortened, for one, and regulators are allowing the shots to be used under emergency authorizations, meaning a lower scientific bar than usual. Lastly, tens of millions of people are set to be immunized in a short time. 

Meanwhile, the speed of the vaccine rollouts and the media's focus will serve to drive high numbers of adverse event reports, the experts say. The profile of the launches is “unprecedented,” Cope said, noting that media attention typically drives more adverse event reporting. 

With the phased COVID-19 vaccine rollouts, vulnerable people are receiving some of the first vaccines, Michelle Ramirez, a partner in Sidley Austin’s Products Liability & Mass Torts Litigation, added. They’re likely on multiple medications, she said, and companies marketing those drugs can expect new adverse event reports.  

The U.S. implemented the PREP Act last March “to provide immunity for activities related to COVID-19 countermeasures,” the firm notes. But that immunity applies directly to COVID-19 products in the U.S.; Potential liability for other products and other markets will vary.  

“Therefore, given the variation and limitations on immunity from prosecution, it is essential that pharma companies implement risk management plans for their COVID-19 portfolios or those products likely to be impacted by COVID-19 vaccinations or medicines,” the firm notes. 

From a liability perspective, Ramirez said juries want to know “what the company knew, and when it knew it.” Juries don’t typically forgive backlogs of information or delayed action on adverse event reports, she added. 

In the end, trust from the public and transparency will enable the vaccine launches to succeed, the lawyers said. 

“Now more than ever, the public is looking to pharmaceutical companies and regulatory bodies for transparency,” Ramirez said.

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