(Wall Street Journal) – Federal regulators are asking Novavax to complete an additional randomized clinical trial on its Covid-19 vaccine after previously delaying approval, people familiar with the matter said, a request that could be so prohibitively expensive the company might not be able to fulfill it. 

The Maryland-based company was asked by the Food and Drug Administration to show its vaccine is effective with another randomized study after appointees under Health Secretary Robert F. Kennedy Jr. intervened in the approval process, the people said. The additional step goes beyond what other Covid-19 vaccine makers had to do to win approval, and could be an early sign of new challenges for drugmakers hoping to get approvals. (Read More)