The antibodies developed by people who have received Pfizer and BioNTech’s COVID vaccine can neutralize the virus carrying the N501Y mutation, according to the companies.
N501Y enables the virus’ spike protein to adhere tightly to its receptor. The mutation is found in some highly contagious variants, including the new strain called B.1.1.7 strain, which was first identified in the UK and is now reported in the US and other nations.
A study, published on bioRxiv, has found that serum from 20 people who had received two doses of Pfizer/BioNTech vaccine neutralized the virus with and without N501Y equally well.
The companies said in a news release, “This indicates that the key N501Y mutation … does not create resistance to the Pfizer-BioNTech vaccine-induced immune responses.”
Meanwhile, the Food and Drug Administration (FDA) has been cautioning medical providers that the PCR tests may “yield false-negative results if the part of the virus’ genome assessed by the tests mutates.”
The US drug regulatory body has identified three molecular tests that may be affected by genetic mutations, which include “the Accula SARS-Cov-2 Test, the TaqPath COVID-19 Combo Kit, and the Linea COVID-19 Assay Kit”
The agency said the effect on the Accula test’s performance “does not appear to be significant.”
The other two tests have significantly reduced sensitivity with some mutations, including the B.1.1.7 variant.
Nevertheless, the FDA said because the tests are “designed to detect multiple genetic targets, the overall test sensitivity should not be impacted.” It advised providers to “consider negative results in combination with clinical observations, patient history, and epidemiological information.”
