FDA spells out guidelines for approving Covid-19 vaccines

FDA spells out guidelines for approving Covid-19 vaccines

The agency said development can be sped up through creative clinical trial designs that allow for scientists to adapt dosing and options based on rolling data. Those designs, known as adaptive or seamless trials, are fleshed out in the guidance.

FDA said it will also be important to study vaccine candidates in patients with confirmed infections, since many people seeking out a vaccine may had already unknowingly contracted the virus without experiencing symptoms.

The agency said Covid-19 vaccines must meet all the standard laws and regulatory requirements for any other vaccines to be approved, including manufacturing and control requirements.

What’s next: One of the leading vaccine candidates, developed by NIH and Moderna, is slated to begin phase III trials in July. Moderna’s CEO has said that if early data is positive, it could begin dosing health care workers in the fall. Other drugmakers, including Johnson & Johnson and Pfizer, have said they could have millions of doses ready by early 2021 if their data is positive.