Infectious disease

FDA
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.
Clinical Catch-Up for February 14
The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.
New research published this week gives a greater understanding of why the CDC warned of an increased risk of stillbirth for women infected by SARS-CoV-2 during pregnancy in November.
On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.
The promising results from the pediatric expansion are what fuels Novavax’s next move to apply for regulatory approval for the 12-to-17-year age group by the first quarter of 2022.
The speakers extolled the benefits of telehealth while noting the challenges posed by a lack of high-speed Internet in some parts of the country.
kENUP had called the mRNA vaccine efforts in Africa “doomed to fail” since the project likely infringes on BioNTech and Moderna patents on the vaccine.
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