Health Highlights: Aug. 31, 2020
FDA Could Green Light COVID-19 Vaccines Before Clinical Trials Completed: Commissioner Children Can Carry Coronavirus for Weeks Without Symptoms: Study
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Could Green Light COVID-19 Vaccines Before Clinical Trials Completed: Commissioner
Emergency use authorization or approval for a COVID-19 vaccine before Phase 3 clinical trials are complete could be considered by the U.S. Food and Drug Administration, according to the agency's commissioner, Dr. Stephen Hahn.
"It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," he told the Financial Times, CNN reported.
"If they do that before the end of Phase Three, we may find that appropriate," Hahn added. "We may find that inappropriate, we will make a determination."
An EUA isn't the same as full-fledged approval, Hahn noted.
"Our emergency use authorization is not the same as a full approval," he said. "The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency."
Two vaccines are currently in Phase 3 trials in the United States and two more are expected to begin Phase 3 trials by mid-September, CNN reported.
Data, not politics, would guide any FDA decision on vaccines, according to Hahn.
"We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," he said, CNN reported. "This is going to be a science, medicine, data decision. This is not going to be a political decision."
Children Can Carry Coronavirus for Weeks Without Symptoms: Study
The new coronavirus can be present in children's noses and throats for weeks without causing any symptoms, according to a new study that suggests how the virus can spread silently.
Researchers found that among 91 pre-symptomatic and symptomatic South Korean children diagnosed with COVID-19 between Feb. 18 and March 31, 22% never had any obvious symptoms and another 20% didn't have symptoms initially but developed them later, CNN reported.
The study was published Monday in the journal JAMA Pediatrics.
"In this case series study, inapparent infections in children may have been associated with silent COVID-19 transmission in the community," the researchers wrote.
"Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection," Dr. Roberta DeBiasi and Dr. Meghan Delaney, both of Children's National Hospital in Washington, D.C., wrote in an accompanying editorial.
"In this study, the authors estimate that 85 infected children (93%) would have been missed using a testing strategy focused on testing of symptomatic patients alone," DeBiasi and Delaney wrote, CNN reported.
The study was released shortly after the U.S. Centers for Disease Control and Prevention issued new guidelines saying that some people without COVID-19 symptoms may not need to be tested for the new coronavirus, a policy change that's been criticized by many medical experts and groups, including the American Academy of Pediatrics.
"We know that children often show few or no symptoms of COVID-19. We also know they are not immune to this virus, and they can become very sick. Testing exposed individuals who may not yet show symptoms of COVID-19 is crucial to contact tracing, which helps identify and support other people who are at risk of infection," AAP President Dr. Sally Goza said in a statement, CNN reported.