Drug development during a pandemic requires a coordinated effort from scientists, manufacturers, and regulatory bodies to ensure not only the safety and efficacy of new products but also that sufficient quantities of quality product can be manufactured and distributed. As industry springs into action and the number of COVID-19 cases continues to rise worldwide, close communication and collaboration with regulators to ensure safe and effective products are rapidly available has become critical.

Efforts from industry, academia, and other institutions are contributing toward ongoing work in the US and abroad aimed at developing and optimizing diagnostics, prophylactics, treatments, and serological tests for COVID-19. Each product type is regulated federally by the FDA. In response to the pandemic, the agency has released multiple new guidance documents that offer increased flexibility for product developers while assuring safety for patients and observing the constraints of current US law.

Throughout February and March, FDA policy around diagnostics has evolved. The FDA now allows states to authorize protocols for SAR-CoV-2 (the virus that causes COVID-19) testing kits and commercial manufacturers to distribute validated diagnostic kits prior to Emergency Use Authorization (EUA) submission. A recent Avalere timeline and analysis details how the policies evolved in response to the public need. Because of these coordinated efforts, more test kits are available, including novel assays that provide results more quickly.

In addition to advancements in methods for diagnosis, advances in prophylactic vaccine development has accelerated. A recent Avalere analysis found that at least 80 vaccine developers and academic institutions have publicly stated their intent to develop novel vaccine candidates for COVID-19. Although vaccine development may take many months or years and faces a high risk of failure, innovative clinical trial design including real-world evidence and expedited and streamlined regulatory processes, alongside supplemental support from the Biomedical Advanced Research and Development Authority and other governmental organizations, may accelerate this process. The FDA oversight to ensure safety is essential to mitigate potential adverse events a vaccine may cause, a problem that was seen with the 1976 Swine Flu Vaccination Program.

Beyond diagnosing the disease and developing a vaccine to prevent infection, treatments are urgently needed for those currently infected with the virus. Previously FDA-approved products are being tested and novel products are in development to investigate their effectiveness for a COVID-19 indication. A benefit to using FDA-approved products is that safety profiles are established and large capacity manufacturing protocols are well known. For all products, clinical trials are necessary to demonstrate safety and efficacy, specifically in the population experiencing symptoms caused by the virus.

Progressing Toward COVID-19 Treatments

Several countries have launched clinical trials, with the World Health Organization (WHO) sponsoring and coordinating multinational trials. These trials largely focus on products that have been FDA approved (with one product that is not yet approved). While the US is not participating in the WHO coordinated trials, clinical trials are running in parallel.

Thus far, multiple sponsors have already announced the mass manufacture of potential therapies to allow for quick availability if a trial succeeds.

Several companies are also launching trials to discover entirely new products. Expectations are that if a product that is not FDA-approved is found to be effective, the FDA will respond quickly and flexibly. The focus of these efforts is on other antivirals as well as anti-inflammatory products. The FDA announced on March 31 that the agency has a new program called the Coronavirus Treatment Acceleration Program (CTAP), which will allow reviewers in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to expedite and streamline their efforts. Part of CTAP also redeploys medical and regulatory staff to focus specifically on COVID-19 therapies.

Locally Sourcing COVID-19 Treatments: Convalescent Plasma

Research is occurring with convalescent plasma, a therapy that is also called passive immunity, where plasma is transferred from a patient who has already recovered from COVID-19 to a patient with active disease. The convalescent plasma includes antibodies to the virus, leading to quicker clearance of the virus within the recipient. Clinical trials are currently underway throughout the US. On March 24, the FDA released guidance on the use of convalescent plasma to ease regulatory barriers once efficacy data is determined as well as use of EUAs.

Right Drug, Right Patient, Right Dose, Right Time

Despite the urgency of the pandemic, treatments given to patients with COVID-19 must provide greater benefit than harm and comply with current law. This process will take time but fortunately has a shorter timeline than vaccine development, likely on the order of weeks to months rather than months to years.

The risk/benefit considerations for a prophylactic product verses that of a treatment are different, and vaccines face a particularly high hurdle as they are administered to healthy people. So too is the risk/benefit analysis for a patient with minor symptoms different compared with someone struggling to survive. Controlled clinical trials are valuable to determine dose and frequency of administration for these products to effectively treat the disease while minimizing side effects.

Products currently in consideration for treating or preventing COVID-19 are required to register as Investigational New Drugs if they are aiming to collect data through a clinical trial. The FDA has demonstrated flexibility in regulations for diagnostics, devices such as ventilators, and convalescent plasma, along with strong engagement and communication with industry thus far. Each suggests that once data is released supporting the efficacy of a particular treatment for COVID-19, regulators will act quickly to minimize any barriers to patient access.

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