In what seems to be the most obvious signs of an expedited COVID-19 vaccine launch, the Trump administration has urged US states to get ready to distribute a potential Covid-19 vaccine by November 1.
Robert Redfield, Director of the Centers for Disease Control and Prevention, in a letter to regional stakeholders said “CDC urgently requests your assistance in expediting applications for these distribution facilities.”
Dallas-based American pharmaceutical wholesaler McKesson Corp. already has a deal in place with the federal government to set up centers to distribute a coronavirus vaccine when it becomes available.
The CDC, “if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by Nov. 1, 2020,” two days before the US presidential election, the CDC Director said the letter.
The US Food and Drug Administration (US FDA) has also raised the possibility that a vaccine might be given emergency approval before the end of trials designed to ensure its safety and effectiveness.
As noted by FDA chief Stephen Hahn during his interview with the Financial Times, a similar request for such extraordinary approval would have to come from the vaccine developer.
The CDC has already provided states with documents giving details of a vaccine rollout plan, adding that vaccines would either be approved as licensed vaccines or under emergency use authorization.
Recipients would probably require a second “booster” dose depending on which vaccine they are administered. The letter said that “Vaccine and ancillary supplies will be procured and distributed by the federal government at no cost to enrolled COVID-19 vaccination providers.
Last month, executives from mRNA based vaccine developers Moderna and Pfizer had separately intimated CDC and Prevention’s Advisory Committee on Immunization Practice in the USA about extreme conditions (low temperatures hard to maintain at primary health centers and clinics) required to store their potential COVID-19 vaccines.
