Escalate Life Sciences
Pfizer to test COVID pill in children as vaccinations in US plateau
Pfizer has started testing its COVID-19 pill in children as the U.S. shifts to a "test-to-treat" response to the now two-year-old pandemic.
The New York-based drugmaker on Wednesday said it's studying two different dosing regimens in kids between the ages of 6 and 17, with smaller doses for children weighing less than 40 kilograms, or about 88 pounds. The plan is to include kids younger than 6 after a developing a new formulation and assessing the initial data in the older age groups.
U.S. regulators have already given an emergency clearance to the pill, Paxlovid, for high-risk COVID-19 patients as young as 12 who meet certain criteria. A previous trial showed the medicine could reduce the risk of hospitalization or death by at least 88%.
As the U.S. and the world move toward a less restrictive future living with COVID-19, treatment is likely to play a large role. A new Biden administration initiative aims to create locations where people could get tested for the virus, then be assessed by a healthcare provider and given a prescription for an antiviral medicine such as Pfizer's Paxlovid.
Wider availability of treatments will also be critical as vaccinations plateau. After an initial spike when Pfizer's COVID-19 vaccine became available for children as young as 5 last fall, vaccination rates began to slow. Only about 26% of children between the ages of 5 and 11 are now fully vaccinated, according to data from the Centers for Disease Control and Prevention.
Children younger than 5 so far have no options for vaccination. Pfizer and partner BioNTech found that their initial two-dose vaccine for that age group wasn't effective enough and began testing a third dose. The companies briefly intended to try to win approval for the first two doses while continuing research but gave up on that plan last month.
At the same time, opponents of vaccination are gaining ground in some places. Florida's health officials recently recommended that healthy children not get vaccinated against COVID-19, contradicting CDC guidance and research that shows the shots are safe and effective.
Pfizer has been working to expand production of Paxlovid to meet anticipated demand. The company expects the pill to bring in sales of $22 billion this year, a figure that would put it among the world's top-selling medicines, perhaps second only to Pfizer's COVID-19 vaccine. Pfizer last month estimated that the vaccine's revenue would reach $32 billion this year.
The Food and Drug Administration has also cleared a pill made by Merck, but regulators limited its use to patients over the age of 18 who don't have other options after outside advisers expressed concerns about its use. Antibody treatments, meanwhile, are less convenient and don't appear to be as effective against the omicron variant.
Although the FDA cleared Paxlovid for certain patients as young as 12, the new study will be the first time Pfizer has tested the pill in patients under the age of 18. In deciding to give emergency approval for some patients under 18, the FDA relied on modeling that suggested the adult dose would have similar effects in the body for those patients as adults of a comparable weight in the original trial.
Published March 9, 2022
By Kristin Jensen
Original Source: https://www.biopharmadive.com/news/pfizer-paxlovid-trial-children-covid/620111/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-03-09%20BioPharma%20Dive%20%5Bissue:40259%5D&utm_term=BioPharma%20Dive