Clinical Trials and Research News Weekly Roundup | Trump issues EUA for Convalescent Plasma

Aug 31, 2020 | Digital Media, Video, Weekly Roundup

TrialSite News Weekly Roundup
Trump Defies Fauci? Emergency Use Authorization Issued for Convalescent Plasma for COVID-19 : On August 19, we first reported on the FDA’s decision to halt use of convalescent plasma for COVID-19. On August 21, we dug a bit deeper into the story; Mayo Clinic investigators were “puzzled” by the decision, and there is evidence that NIH Director Francis Collins and NIAID Director Fauci intervened with the FDA to at least temporarily halt the plasma EUA. Dr. Michael Joyner of the Mayo Clinic led their National Convalescent Plasma project, along with 34 other institutions from 17 states. This project has included 8,000 doctors, 3,000 hospitals, and 100,000 enrollees. And while “there have been rumblings that the Mayo Clinic nation program has monopolized clinical trial subjects,” Dr. Joyner says, “That’s a false dichotomy.” Apparently, the FDA was about to issue an EUA for plasma, but Collins and Fauci intervened positing that the data on efficacy was inadequate. Results so far from the Mayo project are considered unreliable as there was no control group or RCT. According to CNN, President Trump announced the FDA will maintain an EUA for convalescent plasma. https://www.trialsitenews.com/trump-d…
 
Municipality of Lucknow in the State of Utter Pradesh India Now Distributes Free Ivermectin via Kiosks to Treat COVID-19: Is there a RWE Study Backing This Effort? With approximately 3 million inhabitants, Lucknow is the largest city in the Indian state of Uttar Pradesh. Taking advantage of that state’s embrace of the anti-parasite drug Ivermectin as a supporting treatment for COVID-19, Lucknow’s municipal administration and health department formed a collaborative endeavor and set up 40 mobile kiosks throughout the city to freely distribute Ivermectin tablets to the city’s asymptomatic COVID-19 patients. With the greenlight from the state, local authorities seek economical and safe ways to treat the pandemic. This coincides with a well-known Australian physician-researcher calling for physicians in that country to consider using Ivermectin off-label with doxycycline and zinc or the Australian triple therapy.” In Bangladesh, the regimen is known as “the People’s Medicine.” Health department officials in Lucknow start handing out the medicine on Monday, August 24. https://www.trialsitenews.com/municip…
 
Beijing Grants Ad5-nCOV Patent: the First Such COVID-19 Vaccine in China: CanSino Biologics was granted the first patent approval from the Chinese government in Beijing for its COVID-19 vaccine called Ad5-nCOV, reported state media sources. The very first COVID-19 vaccine patent granted, the China National Intellectual Property Administration, reported the patient was issued August 11, 2020. Initially conceived of by smart, dedicated, and ambitious Chinese nationals while working overseas in Canada, a combination of science, politics and business execution challenges may dilute the strength of this latest milestone. https://www.trialsitenews.com/beijing…
 
Pfizer and BioNTech Announce COVID-19 Vaccine Data in Phase 1/2 Trial On August 12, Pfizer and the German firm BioNTech announced interim results from a combined Phase 1/2 trial of their COVID-19 candidate, the mRNA vaccine BNT162b1. As reporte d in The Indian Express, the vaccine induces a “robust” immune response in healthy subjects aged 18-55. BNT162b1, “elicits an immune response by mimicking the mRNA molecule used by the novel coronavirus SARS-CoV-2 to build its infectious proteins.” Such vaccines are generally considered safe. Some participants had mild to moderate side effects such as fatigue, headache, or fever. They found that the “robust” response was substantially increased with higher doses and with a second dose. SARS-CoV-2 antibodies were present in patients 21 days a single vaccination, with a substantial increase in antibodies seven days after a second dosage. Neutralizing antibodies “were 1.9 to 4.6 times higher,” then in recovering COVID-19 patients who did not get the vaccine. While the data is promising, the researchers think Phase 3 trials are needed to determine efficacy. The study was peer-reviewed and published in Nature; it included 45 healthy adults and a placebo-controlled, double-blind protocol. https://www.trialsitenews.com/pfizer-…
 

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