AstraZeneca ON HOLD
“The Lord shall smite thee in the knees and in the legs with a sore boil that cannot be healed, from the sole of thy foot unto the top of thy head” Deuteronomy 28:35
WASHINGTON, Sept 9 — Pharmaceutical company AstraZeneca said yesterday it had “voluntarily paused” a randomised clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.
The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a Covid-19 vaccine.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” a spokesperson said.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
AstraZeneca’s vaccine is the first Covid-19 trial put on hold upon reaching Phase 3, according to Stat. The study on phases one and two, published in July by the medical journal Lancet, noted that about 60 percent of the participants had developed side effects – fever, headaches, muscle pain, and injection site reactions, mainly – that were described as “mild or moderate” and subsided during the course of the trials.
It is unclear what effect the UK pause will have on the plans for Phase 3 testing in the US, which is supposed to enroll some 30,000 participants at 80 locations, according to the National Institutes of Health.
But Anthony Fauci warns against premature release of vaccine
“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorisation) before you have a signal of efficacy,” Fauci said.
“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enrol people in their trial.”
But Trump told reporters: “We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about.”
Joel Huan
The Mystery of Ephraim 