Additional info reported by the NY Times on what has happened with the patient in the AstraZeneca vaccine trial: AstraZeneca Pauses Vaccine Trial for Safety Review
So these trials get shut down based on one possible anomaly? It seems like all kinds of oddities will happen on an individual basis.
The whole point of clinical trials is to look for anomalies like this and make sure they are just anomalies and not something caused by the treatment.
Understood. I guess my thought was that in trials this big there will be a plethora of anomalies and that you would need to see some sort of pattern to determine it as being more than that. I guess I am asking is this the norm, or is this "anomaly" actually a bigger deal than some others?
No, this is not shut down. The halt dosing new patients until a full investigation into the patient who became ill is completed. This goes on all of the time (I am guessing) but it has never been done in front of the live internet before, so we are hearing every single gory detail. The poor impacted person could just have easily been infected with another virus and the timing was coincidence. However, they cannot continue, in good conscience, to dose additional people until they understand more. Dr. Scott Gottlieb (former director of the FDA) said this morning a 2-4 week pause would not be unreasonable based on past experience. However, it also does not mean the end of this trial by any means.
Actually, I am pretty sure that I heard them say that this happens as a response to a virus invading the body. And, since this particular vaccine candidate is made from a modified chimp virus, the body may be reacting to it. The Flu virus is also known to cause this condition in a very small number of people each year. AZD1222 SARS-CoV-2 Vaccine
From what I know it is standard for admitted patients either IV or oral depending upon the severity of patient. I don't believe the "viral phase" is over that fast (depends on patient), I have one friend who got it bad and tested COVID positive for over 50 days. He is a terrible diabetic and was on a vent for about 42-45 days.
Actually from what I have seen it was transverse myelitis, which is very rare, I've seen like 5 cases in 20+ years. It will be important to note prior medical history this subject may well have had it prior to dosing. Its not uncommon do have a indolent case causing mild low back pain for weeks that could easily be dismissed as chronic low back pain. A few of the patients I treated got it form IVDA, the others it was never really determined with any certainty.
It would depend on the severity of the reaction, the likely hood or unlikely-hood the reaction was related to the study drug. Phase 1 trials have a much lower threshold to pause as one would expect.
AstraZeneca reportedly have only re-started the Phase 3 trial in the UK (which is much smaller). They are negotiating with regulators in the US, Brazil and South Africa to try to continue with the trials. AstraZeneca resumes Covid-19 vaccine trials in the U.K.
I know a number of people who had it, ranging from asymptomatic and shocked to be diagnosed, to the person who died. Luck of the draw.
Atrazenica started testing monoclonal antibody treatments in Britain https://www.usnews.com/news/health-...us-antibody-drug-enters-phase-one-trial-in-uk The first participants in a phase one trial of AstraZeneca's potential COVID-19 drug have been dosed, according to the British drugmaker. The trial will include up to 48 healthy participants in the United Kingdom aged 18 to 55 and focus on the safety and tolerability of the drug, which is called AZD7442. It is a combination of two monoclonal antibodies derived from patients who had recovered from the coronavirus. The company said the antibodies "should afford at least six months of protection from COVID-19." "This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19," Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a statement. "This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance."
Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus. It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. The first patients will be given the new drugs in the coming weeks. Prof Martin Landray from the University of Oxford, who is co-leading the Recovery Trial, said: “This is the first type of treatment that's targeted for this specific virus.
Pfizer CEO has said that they will know if their vaccine candidate is successful before the end of October. In the meantime, they are expanding production agreements to ramp and now they are asking permission increase the size of their Phase 3 trial from 30,000 to 44,000 participants. AstraZeneca, Oxford restart stalled COVID-19 test as Pfizer ramps up trial numbers for its vaccine
