The ID Pipeline: FDA Activity From the Week of March 29, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of March 29, 2020.

FDA Launches Coronavirus Treatment Acceleration Program

The US Food and Drug Administration (FDA) has launched the Coronavirus Treatment Acceleration Program to accelerate the development of treatments for COVID-19.

The goal of the program will be to quickly bring effective medical countermeasures to patients while also supporting research to assess the safety and efficacy of these therapies.

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FDA Provides Update on COVID-19 Diagnostic Review

According to the agency, the US Centers for Disease Control and Prevention (CDC) typically takes point on developing the first diagnostic when a novel health threat emerges since samples of the virus must be used to verify accuracy.

In the COVID-19 situation, the CDC and FDA worked collaboratively to combat problems with diagnostic manufacturing and used a commercial manufacturer to make the tests.

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COVID-19 Vaccine Candidate Shows Immune Response in Early Testing

A coronavirus disease 2019 (COVID-19) vaccine candidate has shown promise in early testing, according to a paper published by investigators from the University of Pittsburgh School of Medicine in EBioMedicine. In mouse models, the vaccine produced antibodies which may offer sufficient protection against SARS-CoV-2.

The investigational vaccine, PittCoVacc, led to a surge of antibody production within 2 weeks of administration.

The vaccine is delivered through a novel approach, known as a microneedle array. The microneedle array is a fingertip-sized patch of 400 small needles. The patch is placed like a bandage and the needles, made of protein pieces and sugar, dissolve into the skin.

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