The FDA approved Pfizer-BioNTech COVID-19 Vaccine, on 8/23/2021, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee). Comirnaty will continue to be available through an EUA for individuals 12 to 15 years. The EUA also covers a booster dose for immunocompromised patients.
The FDA and AAP are warning physicians and parents not to vaccinate children under 11 years with the adult vaccine. Much smaller dosages are being used in clinical trials and not enough clinical evidence is currently available to predict the correct dose. Pfizer expects to have pediatric data available beginning in September. Trial results will be released for ages 5 to 11, then 2 to 5 and finally 6 months to 2 years in October or November. Once pediatric data is available Pfizer and BioNTech will request an EUA.
Moderna is also working on pediatric and adolescent studies. The Moderna vaccine has approval for adolescents in Europe.
AstraZeneca announced that in the 183-day, 5,172 patient, Phase III, PROVENT trial (NCT04625725), treatment with AZD7442, a long-acting monoclonal antibody combination of tixagevimab and cilgavimab, reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo in patients at high risk of developing COVID-19.
In a retrospective analysis of outcomes from 10,445 COVID-19 patients in Hong Kong, adding dexamethasone after starting remdesivir or giving the drugs simultaneously reduced hospital stay and hospital mortality compared to adding remdesivir two days after dexamethasone or not using remdesivir at all.
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