Starting in late August there have been media reports indicating that the Trump Administration was considering granting Emergency Use Authorization (“EUA”) for the Oxford-AstraZeneca Covid-19 vaccine currently undertaking Phase 3 trials in the UK. These reports follow an earlier announcement made by the U.S. Department of Health & Human Service’s Biomedical Advance Research and Development Authority that the Oxford-AstraZeneca partnership had been granted more than $1 billion to aid in the development of a Covid-19 vaccine. If the Oxford-AstraZeneca vaccine were to be grant an EUA upon completion of its Phase 3 trials, it would be the first vaccine in U.S. history to ever be fast tracked in this fashion.
What is an EUA?
Under section 564 of the Federal Food, Drug and Cosmetic Act (“FD&C Act”), the Food and Drug Administration (“FDA”) Commission has the authority to allow unapproved medical products to be used in specific circumstances. EUAs require an eme
rgency where there are no available alternatives, and where the potential benefit of using the unapproved product outweighs the known and potential risks to the public. Medical products approved pursuant to EUAs are subject to far less stringent standards prior to approval than ordinary approvals.
In the past EUAs have been granted during declared Public Health Emergencies, including National Postal Model Anthrax EUAs (2011), Ebola Preparedness and Response EUAs (2014-2019), Zika Virus Response EUAs (2016-2019).
What EUAs have been granted during the Covid-19 Public Health Emergency?
As of August 28, 2020, there have been EUAs granted for the manufacture and distribution of six categories of medical products: 1) in vitro diagnostic products; 2) high complexity molecular-based laboratory developed tests; 3) sars-CoV-2 antibody Tests; 4) personal protective equipment and related devices; 5) ventilators and other medical devices; 6) drug products. No EUA has been granted in the history of the FDA for a vaccine.
What is the regular vaccine product approval process for the FDA?
Current authority for the regulation of vaccines resides in Section 351 of the Public Health Service Act and specific sections of the FD&C. Any entity who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA. Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic: Phase 1 – safety and immunogenicity studies performed on a small number of patients; Phase 2 – dose-ranging studies which may enroll hundreds of subjects; Phase 3 – effectiveness and additional safety studies enrolling tens of thousands of subjects.
The current Phase 3 trial for the Oxford-AstraZeneca vaccine is designed to conform to EU regulatory standards, rather than FDA, and represents a “relatively small…trial” which “was not designed to produce sufficient data of the kind that would be required for [FDA] authorization.” Notably, the FDA has withstood public pressure to grant EUAs for other Covid-19 vaccines in development in the United States following successful completion of Phase 2 trials.
What implications would an EUA have for importers of the Oxford-AstraZeneca vaccine, other vaccines, or other medical products granted an EUA?
In the ordinary course of business, the manufacturer, the medical product, and the initial importer of any medical product into the United States must first be registered with the FDA. The establishment registration fee was listed as $5,236 for FY 2020. Under Customs and FDA’s joint Cargo Systems Messaging Service updates, medical products brought pursuant to an EUA do not require either the manufacturer, the medical product, or the initial importer be registered with the FDA.
When importing any medical product pursuant to an EUA, importers must input a unique Intended Use Code (940.00: Compassionate Use/Emergency Use Device) and the regular corresponding FDA product code. In some instances, a newly generated FDA product code may apply when entering previously unapproved medical products now approved pursuant to an EUA may apply (e.g. for Non-NIOSH-Approved Respirators: 80QKU).
Please contact any Barnes, Richardson & Colburn attorney if you have any questions regarding the import of medical products into the United States.