Covid-19 roundup: Pfizer/BioNTech submit vaccine data to FDA for younger children; Doctors kept prescribing hydroxychloroquine
Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.
A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.
The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.
“These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age,” Pfizer said.
HCQ users tripled early on in the pandemic, a new study finds
Among commercially insured and Medicare Advantage patients, weekly new users of hydroxychloroquine tripled during the early surge in the Covid-19 pandemic, with the greatest increases in uses of the drug coming from doctors with no prior experience prescribing the drug, according to a new study in the Journal of General Internal Medicine.
And many of those prescriptions continued even after the drug proved ineffective. Although prescription rates fell below the early pandemic peak — when the number of new hydroxychloroquine prescriptions tripled — when the first rigorous data emerged, they remained well above pre-pandemic level through from mid-June through December 2020.
The authors from Harvard’s Program On Regulation, Therapeutics, And Law found that those doctors with no prior documented hydroxychloroquine prescribing saw a rise in prescribing hydroxychloroquine from 2.3% of new users in a pre-pandemic period to 51.4% during the first pandemic period, a 65-fold change. Those were concentrated among non-rheumatology specialists (10.6-fold) and primary care physicians (4.8-fold). Although trial data proved the drug to be ineffective, and the FDA retracted its EUA, former President Trump and other celebrities continued to endorse the drug publicly.
Ben Rome, the paper’s lead author, said in an interview that the data underscored the dangers of Trump’s rhetoric, while offering a warning for today, when a new anti-parasite drug, ivermectin, has become a popular Covid-19 drug, despite no evidence that it’s effective.
“What surprised us was that even through the end of the year, hydroxychloroquine prescriptions remained above baseline, and that’s even after studies came out showing it’s not effective,” he said. “The widespread misinformation on hydroxychloroquine at the beginning of the pandemic had long-lasting impacts.”