Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Needs More Safety Data on COVID-19 Vaccines, Experts Say
At a meeting of the U.S. Food and Drug Administration’s vaccine advisory board, some experts warned that the guidelines requiring two months of safety data after a volunteer has been vaccinated were not enough, the New York Times reported Thursday.
The stakes are very high, experts said. A vaccine is essential to ending the pandemic, but polls show that Americans are getting more skeptical about a vaccine and worry that the approval process is being rushed.
“In this particular case, public trust equals success,” Sheldon Toubman, the consumer representative on the advisory group, told the Times. “Lack of trust means no success.”
The meeting also included a presentation by a nonprofit group that talked to people about their fears of coronavirus vaccine. Some people of color were worried about whether the vaccine had been studied in Blacks, Latinos or Native Americans.
Their skepticism had roots dating to the Tuskegee Syphilis Study, in which government scientists lied to Black men allowing them to go untreated for syphilis. “I firmly believe that this is another Tuskegee experiment,” one participant said.
The agency said it would ask the panel for its opinion before approving any vaccine for emergency use. The agency usually, but not always, follows the advice of its outside experts, the Times said.
Several experts said the agency should ask the companies to wait for more safety data. Collecting longer-term data would allow them to evaluate potential risks, such as if immunity wanes after a few months, or if rare side effects occur, the Times reported.
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McConnell Dismisses Health Concerns Despite Bruises, Bandages
Senate Majority Leader Mitch McConnell wouldn’t answer questions about his health saying there were “no concerns” when reporters asked about bruises and bandages visible on his hands, CNN reported Thursday.
“Of course not,” McConnell said when asked if he had any health problems people should know about.
McConnell told CNN there were “no concerns” when asked about the apparent bruises or if he had any other problems.
McConnell 78, who is up for election didn’t respond when asked if he was being treated by a doctor. An aide to McConnell also wouldn’t give any details when asked several times about his health.
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CDC Plans Cellphone COVID Vaccine Tracking System
When a COVID-19 vaccine becomes available, the U.S. Centers for Disease Control and Prevention will monitor those taking the vaccine for any health problems via text messages and online surveys, CNN reported Thursday.
“V-SAFE is a new smartphone-based active surveillance program for COVID-19,” Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said during a meeting of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Thursday.
Health checks will be done by text messages and email every day during the first week after someone is vaccinated and weekly thereafter for six weeks, according to the CDC’s website, CNN reported.
If a problem occurs, V-SAFE will help report it to the U.S. Department of Health and Human Services’ Vaccine Adverse Event Reporting System, CNN reported.
The program will be a way to monitor the vaccine in real time, Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security in Baltimore, told CNN.
“I don’t think there’s anything quite like this, but I think there’s been clearly a trend towards this type of program,” Adalja said. “This isn’t the exclusive way that they are going to get information. It’s an additive way.”
The CDC also has two other safety monitoring systems: The CDC’s National Health Care Safety Network tracks information among acute care and long-term care facilities, and a larger insurer and payer claims-based database is available through the FDA, CNN reported.
“It’d be important to have alternative methods for reporting adverse reactions as well and not just rely on the mobile cell reporting,” Claire Standley, an assistant research professor within the Center for Global Health Science and Security at Georgetown University in Washington, D.C., told CNN.
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