Pfizer Inc. and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration’s authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years.
Virios Therapeutics announced Monday its lead asset IMC-1 fell short of its primary endpoint in the Phase IIb FORTRESS study in patients with fibromyalgia.
There is no authoritative data on the frequency of suicides among sufferers. Several scientists from organizations including the U.S. National Institutes of Health and Britain’s data-collection agency are beginning to study a potential link following evidence of increased cases of depression and suicidal thoughts among people with long COVID, as well as a growing number of known deaths.
Updated data released on Tuesday showed 13 children had COVID-19, at least seven days after receiving a third dose of the Pfizer-BioNTech COVID-19 vaccine, compared with 21 cases among those who received a placebo.
Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.
Moderna Inc will supply 12 million doses of its COVID-19 shot adapted to target the Omicron variant of the coronavirus to Canada, the company said on Monday.
UK’s Joint Committee on Vaccination and Immunisation agency will now decide how shot should be deployed. In addition Moderna anticipates Australia, Canada, and EU approvals soon.
Booster campaigns using upgraded shots specifically targeting the Omicron variant are expected to increase demand in autumn. Pending regulatory approval, BioNTech said, both of its adapted vaccines would be available in time for the campaigns.
The Omicron variant may be more efficient at infecting children through the nose than previous versions of the coronavirus, a small study suggests.
‘Living with COVID’: Where the pandemic could go next By Jennifer Rigby and Julie Steenhuysen LONDON/CHICAGO, Aug 1 (Reuters) – As the third winter of the coronavirus pandemic looms in […]