Yesterday, the U.S. Department of Health and Human Services withdrew leadership mandating that COVID-19 tests be approved by the Food and Drug Administration (FDA) for use, under an executive order from President Donald Trump.
As part of the ongoing department-wide review of the Department of Regulatory Flexibilities introduced since the launch of COVID-19, the Department has determined that the Food and Drug Administration (“FDA”) does not require a premarket evaluation of laboratory-developed tests (“LDT”)) absent notice-and-comment rule, “HHS said in a document posted yesterday on its website.
The decision will allow private and commercial laboratories to produce and manage tests, including labs monitored by Quest Diagnostics and LabCorp. According to Politico, most COVID-19 tests currently used in the United States are made by device manufacturers and thus subject to FDA review.
LDTs are typically not used in a pandemic setting, but due to the failure of the Centers for Disease Control and Prevention (CDCs) test in February, the FDA is releasing restrictions on testing to increase testing in the country.
Testing has dropped in recent weeks, despite a 2-month rise in cases across the Sunbelt. Yesterday, the U.S. registered 47,408 new COVID-19 cases and 1,356 deaths, according to the Johns Hopkins COVID-19 tracker.
The total of the United States now stands at 5,562,440 cases and 173,882 deaths. Also today, Florida became the fifth state to reach the grim milestone of more than 10,000 deaths, a marker in Texas earlier this week.
HHS: Pharmacists can perform routine vaccinations
In an effort to increase the inclusion of vaccines for children, the HHS announced yesterday that licensed pharmacists can administer FDA-approved vaccines to children ages 3 to 18 years.
“Today’s action means easier access to rescue faxes for our children as we try to ensure that immunization rates remain high during the COVID-19 pandemic,” HHS Secretary Alex Azar said in a press release. “The Trump administration has worked to allow pharmacists – in addition to all heroic workers in America – to practice at the top of their licenses, and to provide the public with more options to protect their health and well-being.”
In May, the CDC warned that rates of child immunizations were falling across the country because parents feared a trip to the doctor’s home in the early months of the pandemic and orders to stay home.
In related news, Massachusetts yesterday became the first state to mandate that all children enrolled in public childcare, daycare, K-12, and postsecondary schools receive a flu vaccine on December 31st.
Experts across the country, including CDC Director Robert Redfield, MD, have warned that it is critical to get a seasonal flu vaccine this year, as COVID-19 and seasonal influences co-circulate.
More school debate in New York, Detroit
Teachers across the country are planning to go on strike if school districts do not meet their personal learning safety requirements in the coming weeks.
In New York City, the nation’s largest school district, personal hybrid learning, with most students in school buildings just 2 days a week, is set to begin on Sept. 10. Yesterday, the president of the city’s teachers’ union said Mayor Bill DeBlasio must make major changes to meet the union’s criteria for a safe school opening, and if he does not, teachers are ready to stekken.
According to National Public Radio, the union asks all students and staff members not to test more than 10 days before school starts. The union also calls for all schools to meet the criteria on a three-page security document.
In Detroit, teachers voted yesterday to authorize a potential strike over safety concerns regarding Detroit School District’s plans to reopen. More than 90% of teachers in the Detroit Union agreed to this security strike.
“In recent months, our members have been concerned about the District’s redevelopment plan,” said Detroit Federation of Teachers President Terrence Martin. “The choice of distance or personal work has yet to be codified with signatures and guaranteed for all our members. It is imperative that the District establish protocols to protect both staff and students.”
And the New York Times reported today that before the pandemic, only 40% of public schools in the country had a full-time school nurse, and 25% had no nurse at all. Although some districts have hired more nurses in light of COVID-19, there is no national plan to increase staffing.
In related news yesterday, Trump continued to urge college and university campuses to stay open, even as recent outbreaks have stopped the learning of individuals just days into the semester. “For college students, the chance of serious illness is less than or equal to the risk of a seasonal flu,” Trump said Wednesday in a press release.
