A whirlwind of new vaccine directives from the Food and Drug Administration has pharmaceutical companies hesitating on new vaccine research — and anxiously waiting to see what the agency does next.
Under increasingly urgent scrutiny are seasonal flu vaccines, which are designed for the following flu season in February and March each year. The FDA is set to release new guidelines describing what will be required for flu vaccine clinical trials, according to an agency planning document.
The Trump administration has been mum on what those requirements will be, but recent decisions and rhetoric from officials have drugmakers worried the government will drop new guidance without warning — and include requirements that could make it difficult or impossible to craft a flu shot each year.