Novavax starts allowing participants on placebo to get covid vaccine in trials
Allowing volunteers to crossover to the active vaccine offers them an incentive to continue in the trials even when other authorized vaccines are available.
Novavax Inc said on Monday participants in its ongoing COVID-19 vaccine trials in South Africa and the UK can now receive additional shots, ensuring those who received a placebo can also get the active vaccine.
Allowing volunteers to crossover to the active vaccine offers them an incentive to continue in the trials even when other authorized vaccines are available.
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The company said it planned to cross over participants in its ongoing large, late-stage study in the United States and Mexico, for which the company plans to read out initial clinical data during the second quarter.
"The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term," said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. "We are grateful to the volunteers who stepped forward to take part in our clinical trials, without whom we would be unable to develop, study and ultimately deliver what we hope will be a significant tool in the fight against COVID-19."
As part of the updated trial design, all participants of the trials in the UK and the U.S. will be offered the chance to receive an additional round of shots, the company said.
Participants who opt to do so will receive two additional doses of either vaccine for those who initially received placebo, or placebo for those who first got vaccine.
All participants will continue to be "blinded" or not know if they got the experimental vaccine or a placebo.
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