President Donald Trump and former Vice President Joe Biden have touted their responses to infectious disease outbreaks as part of their bids to win the presidential election in November. An analysis by HRI shows that both candidates’ experiences delivered therapies in similar timeframes but that the Trump administration’s pandemic response is notable for the sheer number of Emergency Use Authorizations (EUAs).
At the Republican National Convention last month, Trump highlighted his administration’s work to address the COVID-19 pandemic, including the use of the Defense Production Act, the production of ventilators and the procurement of personal protective equipment (PPE). Trump also cited his administration’s authorization of therapies and the rapid development of vaccines.
During his acceptance speech last month, Democratic presidential nominee Biden also highlighted his plan for the pandemic, including a more robust national response and national production of medical supplies and PPE. Other speakers said that Biden could use his experience during the 2009 H1N1 pandemic and the Ebola crisis in 2014 to manage the ongoing COVID-19 pandemic.
The characteristics of the H1N1 influenza, Ebola and SARS-CoV-2 viruses are different, with varying degrees of infectivity, transmissibility and morbidity (and associated economic and social disruptions). However, the outbreaks associated with all three were declared national public health crises. These events prompted many of the same governmental regulatory actions, including EUAs for therapeutics and tests, special guidance documents and the rapid approval of vaccines.
HRI’s analysis of EUAs during those three crises found that the largest number of EUAs have been issued for COVID-19. As of Sept. 4, the FDA had issued 242 EUAs for tests. The agency’s three EUAs for therapeutics have come within seven months of the pandemic being declared a public health emergency effective Jan. 27. The agency also authorized seven devices, 11 decontamination systems and more than 160 emergency uses for PPE in that time.
During H1N1 in 2009-10, the FDA granted a similar number of EUAs for therapeutics (a total of three), with the authorizations coming within four months of the pandemic being declared a public health emergency in April. From May 2009 until May 2010, 18 EUAs for diagnostic tests were issued. The FDA granted one EUA for N95 respirators.
Vaccines were also prioritized. Four H1N1 vaccines were approved in September 2009; a fifth was approved in November. While the trials were started in July, many of the vaccines relied on existing technology used for seasonal influenza, resulting in smaller trial sizes per a recommendation from the FDA’s advisory committee on vaccines and related biologics at the time. An analysis by HRI of the labels for H1N1 vaccines approved found some with studies in fewer than 200 people while others had over 2,000 in a randomized controlled trial.
HRI found that the FDA’s EUA volume during COVID-19 had already surpassed that seen during the Ebola crisis in 2014. For Ebola, the agency authorized 16 products, mostly diagnostics. The first Ebola vaccine was approved last year.