Posts tagged with "Emergency use authorization by FDA"

Moderna’s vaccine is highly effective, FDA says, clearing way for second vaccine

December 16, 2020

Moderna’s COVID-19 vaccine is 94% effective at preventing symptomatic illness—and appears to prevent the spread of the virus, as well—according to an FDA briefing document released on Tuesday, December 15, NBC News reports. .

The findings set the Moderna vaccine up for emergency use authorization by the FDA—which would double the number of COVID-19 vaccines available, after the first shots of Pfizer-BioNTech’s vaccine were given to healthcare workers nationwide in the USA on Monday.

The high efficacy of the Moderna vaccine was achieved after two doses given 28 days apart. This is about the same level of effectiveness as the Pfizer-BioNTech vaccine.E

But there is also evidence that just one dose of Moderna’s may stop the virus’s spread. A second document published on the FDA website shows asymptomatic infection was reduced by 63% after the first shot.

Still, it is expected that regulators will require two doses of the vaccine for maximum protection, NBC News notes.

A committee independent of the FDA, the Vaccines and Related Biological Products Advisory Committee, will meet Thursday to decide whether to recommend that the agency greenlight the Moderna vaccine. The meeting will largely mirror the one from last Thursday, when the panel of experts ultimately recommended that the FDA authorize Pfizer’s vaccine.

The vaccines from both drugmakers use similar technology.

It is widely anticipated that the Moderna vaccine’s path to approval will be similar to Pfizer’s. Indeed, NBC reports, an authorization could come as soon as Friday. And officials with Operation Warp Speed are already planning for widespread distribution of the Moderna vaccine.

Research contact: @NBCNews

Abbott launches a $5 rapid COVID-19 antigen test—with results in 15 minutes

August 28, 2020

Abbott Laboratories announced on Wednesday, August 26, that its new rapid COVID-19 antigen test—which will cost $5 and provide results in 15 minutes—has been  granted emergency use authorization by the U.S. Food and Drug Administration.

The Illinois-based company said it plans to ship tens of millions of the test kit, called the BinaxNOW COVID-19 Ag Card, next month, and expects to increase to 50 million tests a month in early October. Results can be read directly from the testing card—which is about the size of a credit card. This simple design is fast and efficient for healthcare providers and patients and does not require the use of an analyzer.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a public statement from the agency.

How it works: A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.

Where it can be used: This test could be used at point-of-care settings, like a doctor’s office, emergency room, or some schools.  It has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset.

Test details: In general, antigen tests are very specific, but are not as sensitive as molecular tests. Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions. Negative results from an antigen test should be considered in the context of clinical observations, patient history, and epidemiological information.

Research contact: @FDA