Posts tagged with "US FDA"

J&J vaccine provides strong shield against acute COVID-19, prevents hospitalizations

February 1, 2021

Johnson & Johnson’s one-shot vaccine has generated strong protection against acute COVID-19 in a large, late-stage trial—raising hopes that it can rapidly reshape a stumbling immunization campaign, Bloomberg reports.

In a study of more than 43,000 people, the vaccine prevented 66% of moderate to severe cases of COVID-19, according to a company statement released on Friday, January 29.

And it was particularly effective at stopping severe disease—preventing 85% of severe infections and 100% of hospitalizations and deaths.

“If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress and human suffering” of the pandemic, said Anthony Faucidirector of the National Institute of Allelrgy and Infectious Diseases (NIAID) and the top U.S. infectious-disease official—at a briefing on the results with company and government officials.

Based on the result, J&J plans to file with the U.S. Food and Drug Administration for an emergency-use authorization next week. The drug giant’s top scientist said this month he expects a clearance in March, and that it would have product ready to ship then.

The company didn’t specify how much of the vaccine would be available immediately, although it reaffirmed that the United States will receive 100 million doses by the end of June, Bloomberg said.

J&J’s vaccine is different from the messenger RNA-based shots made by Moderna and partners Pfizer and BioNTech SE. It is based on an adenovirus, or cold germ that has been modified to make copies of the coronavirus spike protein—which the pathogen uses to force its way into cells. The altered virus can’t replicate in humans, but it triggers an immune response that prepares the body to defend itself against the coronavirus. J&J uses the same technology in a vaccine to fight Ebola.

J&J’s R&D head said the company’s trial, conducted at the height of the pandemic, had to deal with resistant variants that arose mainly after Moderna’s and Pfizer’s trials were finished. When counting cases, it also focused on somewhat sicker patients, Mammen said.

“If those vaccine programs accrued cases at the same time as us, when viral infections were so much higher, incidents were higher, and variants were all around us, they would have gotten different numbers,” he said. “The fact that we could do this level of efficacy with a single shot—people don’t have to come back for another, and it’s conveniently stored— well that makes this the vaccine of choice.”

At the outset of the pandemic, U.S. government officials said any vaccine showing greater than 50% efficacy would be considered a success.

Research contact: @Bloomberg

Breakthrough: FDA authorizes first COVID-19 diagnostic self-test for home

November 19, 2020

On November 17, the U.S. Food and Drug Administration announced that it had issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home. Better yet, it’s a test that provides rapid results.

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D, in a press release from the agency.

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.

It also is authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.

The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display, which shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2.

Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider—as negative results do not preclude an individual from SARS-CoV-2 infection.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, adding, “We look forward to proactively working with test developers to support the availability of more at-home test options.”

An important component to successful at-home testing is the ability to efficiently track and monitor results. Prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions, and health care provider instructions to assist with reporting.

Research contact: @US_FDA