Keeping tabs on Covid-19: MIT engineer paper-based coronavirus diagnostic, Pfizer and BioNTech granted fast track of m-RNA vaccine candidate and FDA issues EUA for nerve device

Since the beginning of the Covid-19 pandemic, the US Food and Drug Administration (FDA) and other regulatory bodies have been working to facilitate the development and availability of new medical products and equipment to help patients and physicians stay safe.

In this week’s round, Pharma IQ dives into how the FDA is using emergency authorities, such as Emergency Use Authorizations (EUAs), to ensure newly engineered tests and medical products are made available as quickly as possible to treat patients.

MIT and 3M collaborate to develop paper-based coronavirus diagnostic

The Massachusetts Institute of Technology (MIT) has partnered with 3M to jointly develop a rapid paper-based test for Covid-19 and establish processes for scaling it. The chemical engineering team at MIT found that RNA tests in widespread use can take days to provide results and have been difficult to scale in the US.

Hadley Sikes, an associate professor of chemical engineering at MIT, said: “Our test looks for the proteins of the virus rather than its genetic material and you don’t need to send a sample to the lab for processing. Our goal is that someone with minimal training could perform the test within minutes.”

The National Institutes of Health (NIH) selected the rapid Covid-19 test for accelerated development and commercialization support after a rigorous review by an expert panel. The test is in the Rapid Acceleration of Diagnostics Tech (RADx Tech) program, an aggressively-paced Covid-19 diagnostics initiative from the NIH’s National Institute of Biomedical Imaging and Bioengineering.

Pending validation of the test, Sikes, 3M and RADx Tech claim the end goal is to produce millions of affordable and accurate tests for coronavirus in the US. In a statement, 3M, which operates across the globe, said: “The company could eventually build up manufacturing capacity to support tests all around the world.”

Pfizer and BioNTech granted FDA fast track for investigation m-RNA-based vaccine candidates against Covid-19

The FDA has granted Pfizer and BioNTech permission to fast track two investigational vaccine candidates from their BNT162 mRNA-based programs.

BNT162b1 and BNT162b2 are the two most advanced candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the US and Germany.

Peter Honig, senior vice president, global regulatory affairs at Pfizer, said: “The FDA’s decision to grant these two Covid-19 vaccine candidates fast track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2. We look forward to continuing to work closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

Özlem Türeci, chief medical officer at BioNTech, commented: “We are pleased to have received fast track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward.”

The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. Subject to regulatory approval, the companies claim they are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

FDA issues EUA for nerve stimulation device for asthma patients facing Covid-19

electroCore, Inc., a bioelectronics medicine company, has announced the FDA has issued an EUA for use of gammaCore Sapphire CV, a non-invasive vagus nerve stimulation (nVNS) at home or in a healthcare setting, to treat adult patients with known or suspected Covid-19 infection and who are experiencing asthma-related dyspnea and reduced airflow.

The EUA for the gammaCore Sapphire CV device is in effect for the duration of the Covid-19 pandemic. Dan Goldberger, chief executive officer at electroCore, said: “We are very pleased to have received this EUA. We intend to work vigorously to make this novel therapy available to physicians treating known or suspected Covid-19 patients who are experiencing an exacerbation of asthma-related breathing difficulty.”

Peter Staats, MD, chief medical officer, added: “Results from prior pilot studies that evaluated gammaCore for the acute treatment of asthma support our belief that nVNS may provide much-needed relief to patients who are experiencing asthma-related breathing difficulty, which can be particularly debilitating in patients with Covid-19.”

JP Errico, electroCore board member, co-founder and co-inventor of gammaCore, commented: “This FDA decision is an encouraging first step toward developing evidence that may provide a basis for electroCore to pursue expansion of nVNS into reactive airway disease, which was the first area of research for electroCore.”  

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If you missed last week’s Covid-19 update, head to our keeping tabs on pharma content hub to read more.