As of the end of January, SARS-CoV-2 has demonstrably infected more than 100 million individuals globally. It has killed more than 2 million. And the long-term sequelae of COVID infections – to say nothing of the health consequences of grief, social isolation and widespread economic distress – are still unfolding and will be for years to come.
The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
It has been a year since Wuhan health authorities first issued a bulletin about a cluster of pneumonia cases of unknown cause, first bringing what would become the COVID-19 pandemic to the attention of the World Health Organization. Now, a mutation that significantly increases SARS-CoV-2’s transmissibility has been detected in the U.S.
It has been a year since Wuhan health authorities first issued a bulletin about a cluster of pneumonia cases of unknown cause, first bringing what would become the COVID-19 pandemic to the attention of the World Health Organization. Now, a mutation that significantly increases SARS-CoV-2’s transmissibility has been detected in the U.S. On Dec. 29, Colorado public health authorities reported the first known case of infection with the SARS-CoV-2 VUI 202012/01 (Variant Under Investigation, year 2020, month 12, variant 01), also called B.1.1.7, variant in the U.S. The patient in question, a male in his 20s, has not traveled internationally, indicating that the variant is already circulating more widely in the U.S.
LONDON – The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use. The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27.