The FDA issued updated guidance indicating that it may decline to review emergency-use authorisation (EUA) requests for COVID-19 vaccines for the remainder of the coronavirus pandemic unless companies have already started discussions with the agency. The move means developers may instead have to go through the longer process of seeking full approval of their vaccines.
A new section in the revised guidance sheds light on how the FDA intends to prioritise EUA requests moving forward, highlighting the fact that "early interaction with the agency is critical" in order for it to be able to assess factors such as clinical trials and data integrity, product quality and whether manufacturing facilities meet standards. Moreover, it said that if companies have not interacted with the FDA "in an ongoing manner" during the development of their manufacturing process and clinical trials programme, they likely will not have had "the benefit of FDA feedback early and throughout the development process." Those that have, on the other hand, are more likely to submit EUA requests that contain the complete clinical and manufacturing information that the FDA can then properly assess, the agency added.
The US has so far granted EUAs to Pfizer/BioNTech's BNT162b2, Moderna's mRNA-1273 and Johnson & Johnson's single-dose vaccine Ad26.COV2.S. Earlier this month, Pfizer/BioNTech began the process of seeking full approval for their vaccine, with Moderna recently saying it planned to do the same starting in May.
AstraZeneca's vaccine Vaxzevria has not yet been submitted for an EUA, although during its last earnings call on April 30, the drugmaker suggested a filing could be submitted "in the coming weeks," as it gathered both trial and real-world data to support its application. However, sources recently indicated that AstraZeneca was considering going down the route of full approval instead, given the fact that the US has already granted EUAs to other vaccines and there would be little urgency in also authorising Vaxzevria at this point.
Meanwhile Novavax previously disclosed discussions with the FDA and has indicated that it does not intend to seek regulatory authorisation of its COVID-19 vaccine candidate in the US, along with the UK and Europe, until the third quarter of this year (see ViewPoints: Novavax, Inovio become the victims of Pfizer's success). Medicago, which recently reported positive Phase II results for its plant-based COVID-19 vaccine that uses GlaxoSmithKline's pandemic adjuvant, has also said it was in talks with US regulators over a potential EUA.
In related news, the US Centers for Disease Control and Prevention (CDC) confirmed that its Advisory Committee on Immunization Processes (ACIP) will meet and make a recommendation on booster vaccines. However, discussions surrounding boosters are not yet under way, according to one current ACIP member. Some health experts say that any recommendation about booster doses of COVID-19 vaccines should be made by public health officials at the CDC and FDA, and not by pharmaceutical executives, a few of which have weighed in on the matter publicly.
Pfizer CEO Albert Bourla, for example, recently predicted that another dose of COVID-19 vaccine would likely be needed within a year of being fully vaccinated in order to stave off infection, while Moderna's chief executive Stéphane Bancel has said his company will make a third booster dose for its two-dose vaccine available in the US by the fall.
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