US FDA May Grant More Emergency Use Authorizations For COVID-19 Treatments This Fall
Executive Summary
Convalescent plasma, anti-inflammatory agents among those that could be considered for EUAs, Commissioner Hahn says during congressional hearing on the coronavirus response.
More potential coronavirus therapies are expected to become candidates for US Food and Drug Administration emergency use authorizations (EUAs) in the coming months.
Commissioner Stephen Hahn told members of the House Energy and Commerce Committee on 23 June that there are 131 clinical trials ongoing for potential treatments and suggested that a surge of EUA requests may be on the horizon. When asked whether more EUAs are expected to be issued in the fall, Hahn indicated that data for some of the more popular treatments being investigated may be ready for review at that time.
“I anticipate that we will receive data regarding several therapies in the future. Plasma being one of them,” he said during the committee hearing on the coronavirus response. “Potentially also with some anti-inflammatory agents, as well as for monoclonal antibodies. Those are being accelerated through the pipeline and are potential therapeutics as well as prophylaxis moving forward.”
Several candidates in the preclinical stages seek to use antibodies from patients who have recovered from coronavirus to reduce illness severity or help recovery, and some are moving into clinical development, according to the Pink Sheet coronavirus pipeline tracker. The steroid dexamethasone also showed promise in reducing coronavirus mortality rates. (Also see "Dexamethasone COVID-19 Findings Leave Authorities Bracing for Yet Another Demand Surge" - Pink Sheet, 16 Jun, 2020.)
Unclear When Treatment EUAs Could Be Granted
Hahn would not say whether he expected the FDA to grant any more EUAs for the treatments being tested.
The agency “can’t prejudge the EUA process because we have to see the data, but I do anticipate that we will be receiving data,” he told the House committee.
The EUA pathway is not a full approval, but allows temporary use based on a review of data available at the time. The authorization could be revoked later if the data does not confirm what the initial data showed.
FDA officials have issued multiple EUAs for coronavirus diagnostic tests, but far fewer have been issued for drugs. The two most visible so far were for the anti-malarial hydroxychloroquine and Gilead Sciences Inc.’s remdesivir.
The hydroxychloroquine EUA was approved in late March after President Trump touted the potential of the product but the agency decided to revoke the authorization in mid-June after several studies showed a lack of benefit. (Also see "Hydroxychloroquine EUA Is First Rx Victim Of Hahn’s ‘Move Fast, Course Correct’ Philosophy" - Pink Sheet, 15 Jun, 2020.)
Remdesivir received an EUA as a coronavirus treatment in May after positive clinical trial data emerged. (Also see "After Remdesivir's Emergency Use Authorization, US Gov't Must Now Decide How To Distribute Limited Supply" - Pink Sheet, 1 May, 2020.)
Hahn, National Institute for Allergy and Infectious Diseases Director Anthony Fauci, Centers for Disease Control and Prevention Director Robert Redfield and Health and Human Services Department Assistant Secretary for Health Brett Giroir appeared at the hearing in person. Most of the committee members asked their questions virtually.
When the four men were called to a May Senate hearing, Hahn, Fauci and Redfield did not appear in person because they were self-quarantining after potential exposure to the virus. (Also see "Multiple Coronavirus Vaccines Is Policy Aim, But Will Complicate Supply Chain" - Pink Sheet, 12 May, 2020.)
Fauci ‘Flinched A Little’ Over ‘Warp Speed’ Name
Hahn and Fauci also were pressed on the timeline for a coronavirus vaccine EUA.
Hahn again said he cannot prejudge when an EUA could be issued, reiterating that the FDA would rely on science and available data to make a decision.
Fauci said that based on early data on candidate vaccine response, he was cautiously optimistic that one will be available by the start of 2021.
The White House commissioned Operation Warp Speed to help streamline and quicken development and distribution of the most promising vaccine candidates.
Fauci said during the hearing that he “flinched a little” upon hearing the name because it may imply the process is reckless, and reminded the committee that safety and efficacy standards are not being compromised by the program. The risk being taken is financial because the government is preparing clinical trial sites and manufacturing before a vaccine is confirmed successful, he said.
Indeed, polling suggests Americans may be hesitant to take a coronavirus vaccine if it is viewed to have been rushed and there are concerns that anti-vaccine efforts were emboldened by the Warp Speed name. (Also see "Speed Of Coronavirus Vaccine Development May Hurt Public Confidence" - Pink Sheet, 14 Jun, 2020.)
Warp Speed officials now are narrowing 14 vaccine candidates to seven. Among the requirements to join the program is the ability to scale up manufacturing quickly. (Also see "Manufacturing Pace Is Key For COVID-19 Vaccine Candidates Hoping To Jump To ‘Warp Speed’" - Pink Sheet, 16 Jun, 2020.)