Last week the FDA issued guidance to vaccine manufacturers providing new criteria for requesting Emergency Use Authorization for their SARS CoV2 vaccines. The new guidance makes it clear that the FDA wants to see 2 full months of Phase III clinical trial data before they will consider an EUA application. This is good in my opinion.

The White House had earlier blocked the FDA from releasing this decision. The New York Times reported that chief of staff Mark Meadows questioned the need for 2 months of safety data and suggested that FDA Commissioner was overly influenced by the agency’s career scientists.

Fortunately, the FDA prevailed. We need to make sure that the public has full confidence that the vaccines are following a tried and true process to ensure that they are both safe and effective if we’re going to get enough folks to voluntarily get the vaccines when they become available. Making sure that adequate Phase III data are collected and adequately analyzed will be critical.