Coronavirus New Variant Strain Patients Figures 82, Flight 250 Flight From UK

Pablo Tucker
January 9, 2021

"At this time, we believe the data suggests that the now authorized COVID-19 vaccines may still be effective against this strain", FDA Commissioner Stephen Hahn, M.D., said in a statement. The B.1.1.7 variant is associated with an increased risk of transmission of COVID-19, so early identification of the variant may help reduce further spread of infection.

The new SARS-CoV-2 genetic variant originally detected in the United Kingdom may cause some false negatives on certain molecular tests, the FDA said in an alert to healthcare providers and laboratories on Friday. "While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants. Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat".

The agency has alerted clinical laboratory staff and health care providers to the possible false negative results from any molecular test, and has asked them to consider such results in combination with clinical observations, and repeat testing with a different test if COVID-19 is still suspected.


"At this time, we believe the data suggests that the now authorized COVID-19 vaccines may still be effective against this strain", said FDA Commissioner Stephen Hahn, MD, in a separate statement.

Tests that use multiple areas of the coronavirus's genome to establish a positive match may offer more chances to pick up an accurate result, the agency said.

However, since both the tests are created to detect multiple genetic targets, the overall test sensitivity should not be impacted, the FDA said.


The FDA will continue to communicate with the public as it has additional information to share.

Britain said in December rapid lateral flow tests being deployed in the country's mass-testing program can identify the variant, while Roche said its molecular test for COVID-19 was unlikely to be affected by the mutant strain of the virus.


Other reports by iNewsToday

FOLLOW OUR NEWSPAPER