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COVID-19

FDA Announces Recall Of Over 2 Million Home COVID Tests Over False Positives

The FDA’s recall is a Class I, meaning it is “the most serious” of the types of recalls.

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Ellume COVID-19 Home Test
Ellume COVID-19 Home Test

The U.S. Food and Drug Administration has announced a recall of over 2 million at-home COVID-19 tests from the Australian medical technology company Ellume due to potential false positives.

The FDA’s recall is a Class I, meaning it is “the most serious” of the types of recalls. The FDA warned that “Use of these tests may cause serious adverse health consequences or death.”

“The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older. The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms,” the FDA explained, adding, “The FDA issued an Emergency Use Authorization (EUA) on December 15, 2020 and authorized a revision to the EUA on February 11, 2021 to allow emergency use of the Ellume COVID-19 Home Test.”

“The company first informed the FDA about the defect in some lots in October,” NPR reported. “On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA.”

As reported by CNN, “In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.”
A spokesperson for Ellume told
The New York Times that the cause of the defects has now been identified.

“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” the spokesperson said. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”

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COVID-19

Former Harvard medical professor says he was fired for opposing Covid lockdowns and vaccine mandates

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Covid

“My hope is that someday, Harvard will find its way back to academic freedom and independence.” That is the heartfelt message from Dr. Martin Kulldorff, a former Harvard University professor of medicine since 2003, who recently announced publicly he was fired for “clinging to the truth” in his opposition to Covid lockdowns and vaccine mandates.

Kulldorff posted the news on social media alongside an essay published in the City Journal last week. The epidemiologist and biostatistician also spoke with National Review about the incident. Kulldorff says he was fired by the Harvard-affiliated Mass General Brigham hospital system and put on a leave of absence by Harvard Medical School in November 2021 over his stance on Covid.

Nearly two years later, in October 2023, his leave of absence was terminated as a matter of policy, marking the end of his time at the university. Harvard severed ties with Kulldorff “all on their initiative,” he said.

The history of the medical professional’s public stance on Covid-19 vaccines and mandates is detailed by National Review:

Censorship and rejection led Kulldorff to co-author the Great Barrington Declaration in October 2020 alongside Dr. Sunetra Gupta of Oxford University and Dr. Jay Bhattacharya of Stanford University. Together, the three public-health scientists argued for limited and targeted Covid-19 restrictions that “protect the elderly, while letting children and young adults live close to normal lives,” as Kulldorff put it in his essay.

“The declaration made clear that no scientific consensus existed for school closures and many other lockdown measures. In response, though, the attacks intensified—and even grew slanderous,” he wrote, naming former National Institutes of Health director Francis Collins as the one who ordered a “devastating published takedown” of the declaration.

Testifying before Congress in January, Collins reaffirmed his previous statements attacking the Great Barrington Declaration.

Despite the coordinated effort against it, the document has over 939,000 signatures in favor of age-based focused protection.

The Great Barrington Declaration’s authors, who advocated the quick reopening of schools, have been vindicated by recent studies that confirm pandemic-era school closures were, in fact, detrimental to student learning. The data show that students from third through eighth grade who spent most of the 2020–21 school year in remote learning fell more than half a grade behind in math scores on average, while those who attended school in person dropped a little over a third of a grade, according to a New York Times review of existing studies. In addition to learning losses, school closures did very little to stop the spread of Covid, studies show.

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