Health Highlights: Sept. 23 2020
J&J; Coronavirus Vaccine Begins Final Stage of Clinical Trials Stricter Vaccine Approval Rules Coming From FDA Plastic Face Shields Don't Block Tiny Droplets: Study Perrigo Asthma Inhalers Recalled Due to Clog Risk
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
J&J Coronavirus Vaccine Begins Final Stage of Clinical Trials
The final stage of clinical trials for Johnson & Johnson's coronavirus vaccine have started, the company announced Tuesday.
The Phase 3 trials will include 60,000 people and be the largest for a coronavirus vaccine in the United States, The New York Times reported.
Johnson & Johnson's final-stage trials began months after similar trials of other coronavirus vaccines in the United States, but it may have some advantages over the other vaccines because it doesn't need to be stored in subzero temperatures and may require just one dose instead of two, according to experts.
"It would be fabulous if we had something at a single dose," because it could speed efforts to curb the pandemic, Dr. Judith Feinberg, vice chairwoman for research in medicine at West Virginia University, told the Times. She's not involved in the vaccine research.
Johnson & Johnson might know by the end of the year if the vaccine is safe and effective, Dr. Paul Stoffels, the company's chief scientific officer, said at a news conference on Tuesday, The Times reported.
Stricter Vaccine Approval Rules Coming From FDA
Stricter guidelines for emergency authorization use of a vaccine against the new coronavirus could soon be issued by the U.S. Food and Drug Administration.
The guidelines would outline more specific criteria for clinical trial data and recommend the data be reviewed by a committee of independent experts before the FDA authorizes any vaccine, people familiar with the draft told The New York Times.
If approved by the White House, the revised guidelines could be released as early as next week.
The move to tighten the rules on emergency vaccine approval come as President Donald Trump keeps promising that a vaccine will be available as early as next month, the Times reported.
Plastic Face Shields Don't Block Tiny Droplets: Study
Plastic face shields do little to reduce the spread of tiny airborne droplets that can carry the new coronavirus, Japanese researchers report.
Their computer modeling showed that while such face shields can block the spread of some large droplets, they're unable to contain microscopic droplets that are produced by actions such as talking, singing or sneezing and believed to play a major role in the spread of the new coronavirus, The New York Times reported.
The shields, marketed as an alternative to face masks, may protect the wearer from droplets produced by other people, but are essentially ineffective at protecting others from the wearer's droplets, according to study author Makoto Tsubokura, a professor at Kobe University in Japan.
The team at the Riken Center for Computational Science also found that both handmade and manufactured face masks are far more effective at blocking tiny droplets than face shields, the Times reported.
Perrigo Asthma Inhalers Recalled Due to Clog Risk
Perrigo inhalers have been recalled because they could clog and not provide patients with any or enough medication, the U.S. Food and Drug Administration says.
The retail recall is for all unexpired albuterol sulfate inhalation aerosol made by Catalent Pharma Solutions for Perrigo Pharmaceutical Company. The inhalers are used to treat asthma and other airway/lung conditions, such as chronic obstructive pulmonary disease.
Patients should continue to use the Perrigo inhaler they have, as needed and as directed by a doctor, the FDA said.
Some of the recalled inhalers stop working after several uses. If their rescue albuterol inhaler malfunctions and doesn't relieve symptoms in an emergency situation, patients should immediately seek emergency care if needed, the FDA advised.
It recommended that patients have extra inhalers or an alternative treatment available in case of inhaler malfunction.
For more information, patients should talk with their health care provider or pharmacist, the FDA said.