FDA urges adherence to specified intervals of mRNA COVID-19 vaccines
The Food and Drug Administration reminded the public of the importance of receiving COVID-19 vaccines in accordance to their agency authorizations, a process that FDA said will safely provide the “remarkable” levels of protection observed during large, randomized clinical trials.
Both approved vaccines, of the mRNA type, are approved for administration via two separate doses, given at either three- or four-week intervals.
“The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals,” FDA said.
2020 has been hard for many, but it has been especially challenging for doctors, nurses and health care workers.
AHA released a public service announcement thanking healthcare professionals working in America’s hospitals and and health systems for their dedication and compassion caring for communities throughout a relentless 2020.
We invite you to thank the women and men at your local hospital or health system for all they do to keep us healthy and safe.
The Centers for Medicare & Medicaid Services released new webinars and tools to support state Medicaid and Children’s Health Insurance Program agencies and their partners in efforts to improve maternal and infant health outcomes.
The resources focus on postpartum care visits, well-child visits and decreasing rates of cesarean section births in low-risk pregnancies. This work is part of a new five-year phase of CMS’ Maternal and Infant Health Initiative to help states improve the use, access and quality of care for women and infants.
Why Aren’t Highest-Risk People Better Represented in COVID Vaccine Trials?
Vaccination across the nation is now underway, with healthcare workers and those living and working in long-term care facilities among the first to receive the vaccines.
Long-term and nursing home residents make up about 1% of the U.S. population, but have accounted for roughly 40% of all COVID-19 deaths, while those older than 50 are more likely to die from COVID-19 than younger age groups. However, they’ve accounted for less than a quarter of total COVID-19 vaccine clinical trial participants. Why are they so scarcely represented in trials?
To learn more, we chatted with Sharon Inouye, MD, MPH, a professor of medicine at Harvard Medical School and geriatrician at Hebrew Senior Life.
U.S. health officials: More data needed on UK COVID-19 variant warning
Officials are somewhat more worried about a separate variant from South Africa, although it has not yet been identified among U.S. cases of the novel coronavirus, National Institutes of Health (NIH) Director Francis Collins and Dr. Anthony Fauci, President Joe Biden’s top COVID-19 medical adviser, also said.
Collins noted the UK’s data was preliminary, and said it was unclear why those with the UK variant faced a higher risk of death, whether by changes in the virus itself or other external causes such as pressures on the healthcare system.
OCR proposed rule on HIPAA privacy standards officially published
The Department of Health and Human Services’ Office for Civil Rights formally published in the Federal Register a proposed rule released Dec. 10 that would modify HIPAA privacy standards for individually identifiable health information. The 60-day comment period on the rule ends on March 22. AHA staff are reviewing the rule and plan to submit comments.
COVID Vaccine for Patient With Rare Disease? Best Guess Is Yes
— Clinicians favor vaccination in most groups, including people with pulmonary hypertension
Extrapolating from the limited data from the Pfizer/BioNTech and Moderna COVID-19 vaccine trials, clinicians say the products’ benefits likely outweigh the risks for people with pulmonary hypertension and other rare diseases.
“The reality is folks with rare diseases will never have enough to do the trials out of the gate,” said Tom Maddox, MD, MSc, of BJC HealthCare and Washington University School of Medicine in St. Louis.