It is still unknown if the participant was receiving a placebo or vaccine, a point that would be determined by an independent advisory group, known as the Data Protection Monitoring Board (DSMB). Another vaccine using a similar technique from AstraZeneca (AZN) is still on hold following a serious adverse event from a trial participant in September. Testing continues in Britain, but is on hold in the US
“Incidents – illnesses, accidents, etc. – even those that are serious are an expected part of any clinical study, especially larger studies,” J&J said in a late-night statement Monday, “Unexpected The study can be stopped if a serious adverse event occurs. ” (SAE) “is something that may or may not be related to testing. The company promised to “carefully review all medical information” before beginning the study.
Mathai Mammen, head of research and development of the pharmaceutical arm of J&J, J&J, said that information from the company is kept confidential until the DSMB is reviewed.
“There will be at least a few days for the right set of information to be collected and evaluated,” Mammen said during an investor call on Tuesday.
The two leading candidates in the US, Modern (MRNA) and Pfizer (PFE), along with BioNTech (BNTX), are using technology that has never been approved, but no significant adverse events have occurred so far.
Meinwheel, Pfizer’s non-peer-reviewed data showed some side effects, but nothing that would have triggered a halt. Pain at the point of injection and fatigue is considered a common vaccine side effect – often seen after flu shots.
The experimental treatment used by President Donald Trump has been gaining momentum since he was at Walter Reed Military Medical Center as the country awaits a vaccine by the end of the year.
Monoclonal antibody treatments, which are laboratory-made antibodies from a sample of recovered patients, have been seen as a bridge between standard treatment and a vaccine, as well as an option for those who cannot be vaccinated . This is because it can both cure and defend against the virus.
Trump received a high dose of Regeneron (REGN) antibody cocktail, which spurred the company and Eli Lilly (LLY), which is also developing an antibody treatment, to apply to the Emergency Use Authority (EUA). The US Food and Drug Administration (FDA) is yet to provide an update on these experiences from last week, but analysts speculate authorizations after Trump’s treatment.
Meanwhile, Operation War Speed announced a collaboration with AstraZeneca to test and produce a monoclonal antibody cocktail, which will be provided free once authorized by the FDA.
Adding to the portfolio of candidates, the National Institutes of Health (NIH) announced on Tuesday that it would begin a randomized placebo-controlled trial – the gold standard – to compare investigative antibody treatments.
Anthony Fayesi, director of the National Institute of Allergy and Infectious Diseases, said, “The goal here is to identify experimental therapies that demonstrate the most clinical promises as COVID-19 therapies and take them to a larger scale. ”
He said that the study in 100 participants is “an efficient way to both find promising treatments and eliminate those that are not.”
The trial will test a monoclonal antibody developed by Bohringer Ingelheim and ABVV (ABBV) in association with Gillhead Sciences’ (GILD) antiviral drug Remedisvir. The latter is the sole-authorized branded to-date, and has been used as the standard protocol for COVID-19 patients, including the President. Recent data has shown that it works best on patients who require supplemental oxygen.
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