FDA removes clinical hold on Covid-19/flu combo trial

FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine
Novavax has received the green light from the US Food and Drug Administration (FDA) to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long clinical hold.
Novavax to Move Forward With Covid-19-Flu Vaccine After FDA Lifts Clinical Hold -- Update
Novavax is already poised to benefit from a separate combined Covid-flu vaccine via a deal with Sanofi announed earlier this year. Under the $1.4 billion co-licensing agreement, announced in May, Sanofi will have the sole right to use Novavax's existing Covid-19 vaccine in combination with its own flu vaccine.
FDA Lifts Hold on COVID-Flu Combo Vaccine Trial
The FDA has lifted its clinical hold on Novavax's combined COVID-19 and influenza vaccine trial, finding no link between the vaccine and a reported adverse neurological event. This decision enables Novavax to resume late-stage testing.
Trial shows safety of getting COVID, flu vaccines at same time
The authors said the main outcomes of the study were reactogenicity, including fever, chills, muscle aches, and/or joint pain of moderate or greater severity within 7 days after vaccination. Serious adverse events and adverse events of special interest were assessed for 121 days.
Novavax: FDA removes clinical hold on Covid-19/flu combo trial
Novavax (NVAX) announced that the U.S. FDA has removed the clinical hold on Novavax’s Investigational New Drug application for its
Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Key Takeaways Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.Regulators stopped testing last month as one patient had a serious adverse event after taking the shot.
FDA lifts clinical hold on Novavax's combo COVID-flu shot
The Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after identifying a safety concern.
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