27 Oct 2020
Posted in Pharma
With US election days away, speed of future COVID-19 therapies and vaccine hang in the balance, says GlobalData
The use of Emergency Use Authorizations (EUA) has been deeply polarizing in the US. With only days left until the presidential election, a growing number of pharmaceutical companies are expected to file for emergency use of their products—both therapeutic and prophylactic—to allow for expedited approval and distribution, according to GlobalData, a leading data and analytics company.
Tiffany Chan, Immunology Analyst at GlobalData, explains: “Although EUAs have historically been an apolitical process, there is increased pressure from the Republican Party to approve vaccines and therapies prior to the 3 November election to win political favor.”
Trump’s response to COVID-19 has been criticized for touting unproven treatments. He has also been accused of attempting to exert greater control than the presidential position allows – such as when he was reported to have said he could override FDA guidelines on more stringent safety and efficacy standards for a COVID-19 vaccine.
Chan adds: “These actions have given rise to concerns about political influence on nonpartisan agencies such as the Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention (CDC). During the COVID-19 pandemic, EUAs have already been used to facilitate the availability of treatments that have not completed all clinical trial research.”
By contrast, the Biden campaign is taking a more measured and cautious approach. Although Biden plans to establish an Emerging Infectious Disease Clinical Trial Network, the Biden campaign has not explicitly mentioned trying to influence EUAs.
Chan continues: “Since March, EUAs have been issued for remdesivir, hydroxychloroquine, and convalescent plasma. Although remdesevir received approval on Oct 22 via Priority review, questions still remain about hydroxychloroquine and convalescent plasma. 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.
“Although it is unlikely that new therapies or vaccines will be approved prior to the election, the outcome is expected to have ramifications for regulatory approvals moving forward. Down ballot Congressional races could also impact the ultimate trajectory of regulatory approvals, since Congress is responsible for allocating funds. If Democrats are able to gain control of the Senate, the FDA and entire EUA process will come under much closer scrutiny.”