With Joe Biden ascending to the presidency with a Democrat-controlled Congress, COVID-19 is expected to take center stage in this administration. Biden unveiled a $1.9 trillion stimulus package aimed at supporting vaccine distribution efforts, as well as additional direct deposits to eligible Americans. Although the new administration is unlikely to have a direct impact on the regulatory processes for additional COVID-19 vaccines and therapeutics, they have taken several measures to ensure a smooth transition on the logistical front, says GlobalData, a leading data and analytics company.
Tiffany Chan, Immunology Analyst at GlobalData, explains: “Emergency Use Authorizations (EUAs) have been issued for hydroxychloroquine, remdesivir, and convalescent plasma, among others. In December 2020, both the Pfizer and Moderna COVID-19 vaccines also received approval via EUA. Initially, the speed of these approvals, the retraction of the hydroxychloroquine EUA, and the immediate walking back of the utility of convalescent plasma has undermined public trust in the process.”
Despite the approval of two vaccines, there is still pressure on the industry to approve additional therapeutics and vaccines in light of both distribution hurdles, as well as emerging new variants of the virus. The pipeline for novel therapies and vaccines against COVID-19 is very crowded, and there is also an increasing number of clinical trials for repurposed drugs.
Chan adds: “Although Biden plans to establish an Emerging Infectious Disease Clinical Trial Network, the Biden administration has not explicitly mentioned trying to influence EUAs. Following the November election, an additional oversight committee was put in place to validate the safety and efficacy of potential vaccines and treatments to aid the transition process.
“Additionally, Dr. Anthony Fauci has continued to act as Chief Medical Advisor in the new administration. These measures were ostensibly taken to reassure the American public that COVID-19 therapies and vaccines have been sufficiently vetted, despite an accelerated timeline. ”
