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Novavax COVID Vaccine Clears Key Step on Path to FDA Authorization After Committee Endorses the Shot
Novavax’s two-dose dose COVID-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration authorization on Tuesday.
The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention to recommend authorization of the shot for use in the U.S. after an all-day public meeting in which they weighed safety and effectiveness data. The FDA usually follows the committee’s recommendations, though it is not obligated to do so. The agency could clear Novavax’s vaccine for distribution in the U.S. as soon as this week.
The Centers for Disease Control Prevention would still need to sign off on the shots before pharmacies and other health-care providers can start administering them to people.
Pennsylvania Governor Tests Positive for COVID-19 for Second Time
Pennsylvania Gov. Tom Wolf (D) tested positive for COVID-19 on Monday for a second time but is experiencing “mild” symptoms.
He tweeted Monday night that he is “grateful” that he recently received a second COVID-19 booster shot and will be isolating at his home in accordance with guidance from the Centers for Disease Control and Prevention.
The Food and Drug Administration authorized a second booster shot in late March for anyone aged 50 or older after at least four months have passed since their first booster.
Moderna Announces First Participants Dosed in Phase 3 Study of Seasonal Influenza Vaccine Candidate (mRNA-1010)
A biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participants have been dosed in a Phase 3 study of the Company’s seasonal influenza vaccine candidate (mRNA-1010). The trial is expected to enroll approximately 6,000 adults in Southern Hemisphere countries.
“We are pleased to begin this Phase 3 study of our seasonal influenza vaccine candidate, mRNA-1010, our fourth mRNA vaccine candidate to begin a pivotal Phase 3 study. mRNA-1010 is the first of several influenza vaccine candidates we are developing with the aim of iteratively improving traditional vaccines by inducing broad and robust immune responses. We believe our mRNA platform, with the flexibility and speed of our manufacturing process, is well-positioned to address the significant unmet need in seasonal flu,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“Influenza vaccines are a key pillar in our respiratory vaccine strategy that includes the development of combination candidates targeting multiple viruses in a single vaccine, including influenza with SARS-CoV-2 and respiratory syncytial virus. With the start of dosing for its mRNA-1010 program, Moderna now has four programs in late stage Phase 3 studies, including its SARS-CoV-2 booster, RSV, seasonal flu and CMV vaccine candidates. Beginning in the fall of 2022, the Company’s Phase 3 pipeline could lead to three respiratory commercial launches over the next two to three years.”
Omicron Sub-Variants BA.4 and BA.5 Account for up to 13% of COVID Variants in U.S. – CDC
The BA.4 and BA.5 sub-variants of Omicron are estimated to make up nearly 5% and 8% of the coronavirus variants in the United States as of June 4, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.
The two sublineages, which were added to the World Health Organization’s monitoring list in March and designated as variants of concern by the European Centre for Disease Prevention and Control (ECDC), were present in all U.S. regions.
Last month, South African scientists found that the sublineages of the Omicron coronavirus variant can dodge antibodies from earlier infection well enough to trigger a new wave.
Court Bans Expert From Alleging Cover-Up of COVID-19 Chinese Lab Origins
A scientist who accused a COVID-19 expert of hiding that the virus originated in a Chinese lab has been banned from spreading “fake news” after a legal challenge.
Hamburg-based nanoscience specialist Professor Dr. Roland Wiesendanger alleged in an interview with German magazine Cicero, published in February of this year, that Professor Dr. Christian Drosten from Berlin’s Charite Clinic was consciously refusing to tell people the truth about the origin of the COVID-19 virus.
Wiesendanger further alleged there was evidence that a botched experiment at a Chinese lab was at the core of the pandemic.
Study: Ineffective Blood Oxygen Readers Have Endangered Black and Latino COVID-19 Patients
Black and Latino patients experienced significant delays in obtaining life-saving COVID-19 treatments due to a popular medical device that inaccurately reads darker skin tones, according to a study released last week in JAMA Internal Medicine.
The report shows that pulse oximeters, a device that clips onto a person’s fingertips and reads oxygen levels, is more likely to produce inaccurate results in Black, Latino and Asian Americans than in white patients. The device can make patients of color appear healthier than they actually are, researchers said.
“Not only less accurate, but in particular, more optimistic,” Tianshi David Wu, a co-lead author of the study and assistant professor of pulmonary medicine at Baylor College of Medicine in Texas, told NBC News. “In this study we found that minority patients appeared healthier than they really were based on this bias in pulse oximetry.”
Suicide-Related Ambulance Calls Rose By More Than 50% During COVID, Australian Study Finds
Suicide-related ambulance presentations in Australia increased by more than 50% in the first year of the COVID-19 pandemic, new research suggests.
Analysis of ambulance data between March 2020 and March 2021 found a significant and sustained increase in attendances for suicide attempts, suicidal ideation and self-harm compared to before the pandemic.
The study, published as a preprint that has not yet been peer-reviewed, drew on data from the National Ambulance Surveillance System. Its findings contrast with previous data showing that the rate of death by suicide decreased in Australia in 2020 compared to the previous year.
