Editorial: Restore faith in COVID-19 vaccines
Pfizer officials announced on Oct. 16 that the pharmaceutical giant won’t be ready to apply for FDA approval of its COVID-19 vaccine until the third week of November.That means there will be no miracle Election Day vaccine — which should assuage fears that this potentially lifesaving development might be prematurely rushed past scientific protocols for political ends.A credible vaccine is needed, especially with coronavirus cases once again trending upward across the country.However, to prevent the spread of the potentially deadly virus, any vaccine must not only be safe and effective, it must...
The Seattle Times
Abbott gets emergency FDA approval for antibody test that detects recent COVID-19 infections
CHICAGO — Abbott’s latest antibody test — meant to show whether a person has recently had COVID-19 — has gained emergency use authorization from the U.S. Food and Drug Administration.The blood test detects a type of antibody, called IgM, that’s present after a person has been recently infected with COVID-19, Abbott said in a news release.It’s the second antibody test made by Illinois-based Abbott to gain emergency use authorization, in which the FDA allows the use of unapproved medical products to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met.Ab...
Johnson & Johnson vaccine trial halted by participant's illness
Johnson & Johnson has paused its COVID-19 vaccine study because one of its participants was taken ill.The 60,000-patient clinical trial met the criteria for a “pausing rule,” reported Stat News, meaning the online system that enrolls patients has been closed and the independent committee that monitors patient safety in the clinical trial will be convened.Johnson & Johnson confirmed that a document obtained by Stat News halting the trial did indicate the study was on hold, saying only that it was due to “an unexplained illness in a study participant,” without providing more detail, the news out...
New York Daily News
UC Davis conducting clinical trials of experimental drug that Trump took for coronavirus
SACRAMENTO, Calif. — Dr. Timothy Albertson said Friday evening that he hopes COVID-19 patients at Sacramento’s University of California, Davis Medical Center will be willing to join a clinical trial of the experimental antibody cocktail that President Donald Trump said he’s taking to combat the disease.“There are trials where they focus on outpatients, and Dr. Stu Cohen (also with UCD) is involved in one of those trials where patients who have been exposed to family members or workers who have known disease can enroll in that trial,” Albertson said. “My trial with this drug is with patients wh...
The Sacramento Bee
COVID vaccine trials lack important study participants
ATLANTA — Gwinnett County Transit driver Mikesha Walker talked to co-workers recently about whether they would participate in a COVID-19 vaccine research trial.They’re ideal participants, many researchers say. They spend more time with the public, which puts them at greater exposure to the disease. Many workers are Black, a demographic that is not adequately represented in trials.However, Walker said the drivers are very reluctant to participate. Many feel underappreciated and underpaid for continuing to work during the pandemic. They’re also aware of health studies done decades ago, such as t...
The Atlanta Journal-Constitution
Will there be a coronavirus vaccine by Nov. 1?
The federal government has told states to be ready to distribute doses of a coronavirus vaccine by Nov. 1 — two days before the election.The move raises major questions we can’t answer yet. Is President Donald Trump exerting political pressure to make good on his promise of a vaccine “before the end of the year, or maybe even sooner”? Is it possible to bring vaccines to market that quickly without leaving doubts about safety and effectiveness that will discourage their use?Here are some facts to help make sense of the situation.Is there time for any vaccine to complete the standard three phase...
The Philadelphia Inquirer
Researchers working on COVID-19 antibody trial
MINNEAPOLIS — The federal government has tapped researchers at the University of Minnesota to oversee international clinical trials of synthetic antibody therapies, and whether they can treat COVID-19.The goal is to harness the natural power of antibodies, produced by the immune system in response to infections, and to mass produce it against an infectious disease in COVID-19 for which there are few proven treatments.“This has been considered the highest priority study by the NIH,” said James Neaton, the U biostatistics professor who is leading the research.Neaton’s INSIGHT network was selecte...
Star Tribune (Minneapolis)
COVID-19 vaccine trial kicks off in Florida, with volunteers getting up to $1,000
FORT LAUDERDALE, Fla. — Another major clinical trial is underway in the global race for a COVID-19 vaccine — with researchers this time planning to pay participants hundreds of dollars in Palm Beach County.The experimental vaccine, called AZD1222, was developed by AstraZeneca in conjunction with the University of Oxford. The drug arrived Monday morning to the campus of the JFK Medical Center in Atlantis, and the first 10 patients for the study will start the process Tuesday morning. The vaccine is one of just five that are in the crucial stage of Phase 3 testing, according to Dr. Larry Bush, l...
COVID-19 clinical trials lack diversity, study says
Although people of color have disproportionately been diagnosed with COVID-19, they are underrepresented in clinical trials, according to a study released by a team of researchers from the universities of Georgia, Colorado and Phoebe Putney Memorial Hospital in Albany.In a federally-funded trial that is testing the efficacy of the antiviral remdesivir, Black Americans accounted for 20% of the total patient population, the researchers found. In the Gilead-funded clinical trial of the drug, about one out of every 10 patients given remdesivir were Black. Latinx and Native Americans comprised 23% ...
The Atlanta Journal-Constitution
Nation and world news briefs
1 in 3 Americans would refuse COVID-19 vaccine, new Gallup poll findsOne in 3 Americans would refuse an FDA-approved coronavirus vaccine even if it were offered at no cost, a new Gallup poll released Friday found.The results, based on survey conducted between July 20 and Aug. 2, found that 65% of respondents said they would accept the offer and get themselves vaccinated while 35% said they would not.The new poll falls in line with previous Gallup findings suggesting political party preference plays a strong role in Americans’ views on COVID-19.Eighty-one% of Democrats would be willing to get v...
Tribune News Service