U.S. FDA suspends Bill Gates-backed at-home COVID-19 testing program

The Gates Foundation in March said it was providing technical assistance for SCAN, which had been approved by regulators in Washington state, one of the first U.S. states to be hit hard by the outbreak.

Reuters

May 17, 2020 / 08:59 IST

An at-home coronavirus testing project in Seattle backed in part by the Bill and Melinda Gates Foundation said on Saturday it was working with U.S. regulators to resume the program after being suspended by the Food and Drug Administration.

The Seattle Coronavirus Assessment Network (SCAN), which aims to monitor the spread of the novel coronavirus in the region, had said it was suspending its testing of patient samples collected at home after the Food and Drug Administration tightened guidelines to require emergency approval first.

"The FDA has not raised any concerns regarding the safety and accuracy of SCAN's test, but we have been asked to pause testing until we receive that additional authorization," SCAN said.

The Gates Foundation in March said it was providing technical assistance for SCAN, which had been approved by regulators in Washington state, one of the first U.S. states to be hit hard by the outbreak. Bill Gates has also privately funded SCAN, according to the foundation.

On Thursday, SCAN in a statement said it has been in talks with the FDA since March 1 and initiated its request for emergency use authorization (EUA) on March 23, submitting data on April 13.

COVID-19 Vaccine

Frequently Asked Questions

How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

Show