FDA Delays Moderna Vaccine for Teens Until Heart Condition Studied + More
U.S. FDA Delays Decision on Moderna’s COVID Vaccine for Adolescents
The U.S. health regulator is delaying its decision on authorizing Moderna Inc’s (MRNA.O) COVID-19 vaccine for adolescents to check if the shot could increase the risk of a rare inflammatory heart condition, the Wall Street Journal reported on Friday.
The U.S. Food and Drug Administration (FDA) has been inspecting the risk of the condition, myocarditis, among younger men vaccinated with Moderna’s shot, especially versus Pfizer‘s vaccine, after certain Nordic countries limited use of the shot, the report said, citing people familiar with the matter.
The agency has not yet determined whether there is heightened risk, and the delay could be several weeks, though the timing was unclear, the report said.
Colin Powell, First Black U.S. Secretary of State, Dies of COVID Complications Amid Cancer Battle
Colin Powell, the first Black U.S. secretary of state whose leadership in several Republican administrations helped shape American foreign policy in the last years of the 20th century and the early years of the 21st, has died from complications from COVID-19, his family said on Facebook. He was 84.
“General Colin L. Powell, former U.S. Secretary of State and Chairman of the Joint Chiefs of Staff, passed away this morning due to complications from COVID 19,” the Powell family wrote on Facebook, noting he was fully vaccinated.
Dozens of Lawsuits Seek to Force Hospitals to Treat COVID With Ivermectin
The lawsuits follow much of the same format; families have gotten a prescription for the drug, but hospitals refuse to use it on the patients, many of whom are on a ventilator, close to death, the news outlet noted.
Many of the lawsuits are filed by Ralph Lorigo, an attorney in Buffalo, N.Y. who says doctors “are not gods because they wear white jackets,” adding that he takes issue with the choice not to use ivermectin on patients, according to the AP.
Fauci Allegedly Misled Trump Administration on Gain-of-Function Research in Wuhan: Book
“Fauci’s public persona as a cautious, careful medical professional is contradicted by his central role in kickstarting exceptionally fraught gain-of-function research in the United States after the ban introduced in the Obama era, along with his role in funding coronavirus research in China in unsafe laboratories. Laboratories that intelligence agencies suspect may have sparked the pandemic,” Sharri Markson details in her new book, “What Really Happened In Wuhan.”
WHO Says It ‘Cannot Cut Corners’ in Approving India’s Covaxin Shot
The World Health Organization on Monday asked for further data from India’s Bharat Biotech to consider the company’s request for an emergency-use listing for its COVID-19 shot, saying the WHO could not “cut corners” in making a decision.
Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78% efficacious.
Valneva Says Its COVID Vaccine Shows Similar Protection to AstraZeneca’s, Fewer Side Effects
Valneva SE (VLS.PA) on Monday said its experimental COVID-19 vaccine demonstrated efficacy “at least as good, if not better” than AstraZeneca‘s (AZN.L) shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.
Valneva, among a handful of drugmakers testing their vaccines against one already in use, is hoping its candidate, which uses more traditional technology than the mRNA vaccines, could be a more reassuring option for Europeans still reluctant to be immunised. read more
Israel to Give AstraZeneca Vaccine to Those Affected by Pfizer
Israel will start offering the option of receiving a coronavirus AstraZeneca vaccine starting from Thursday, the Health Ministry announced Monday.
The vaccine will be available with a specific medical referral, which will be given to those who cannot receive an mRNA vaccine for medical reasons or who have experienced significant side effects after Pfizer, or in other special circumstances.
The vaccine by AstraZeneca is based on a different technology than Pfizer’s and Moderna’s, which are both messenger RNA vaccines. AstraZeneca uses a weakened animal virus as a viral vector, and it contains the coronavirus spike protein so that the body’s cells will be able to recognize it and produce antibodies.
Vaccines, Masks? Japan Puzzling Over Sudden Virus Success
Almost overnight, Japan has become a stunning, and somewhat mysterious, coronavirus success story. Daily new COVID-19 cases have plummeted from a mid-August peak of nearly 6,000 in Tokyo, with caseloads in the densely populated capital now routinely below 100, an 11-month low.
The bars are packed, the trains are crowded, and the mood is celebratory, despite a general bafflement over what, exactly, is behind the sharp drop.
Japan, unlike other places in Europe and Asia, has never had anything close to a lockdown, just a series of relatively toothless states of emergency.
Mexico City Lowers Pandemic Alert to Lowest Level
Mexico’s capital returned to the lowest level on its COVID-19 pandemic warning system Monday for the first time since June. In practice, the shift from the yellow to green category changes meant only small changes to daily life.
Mask wearing is still common in streets of the city of 9 million, but the rhythm of life in the capital has long since regained a high degree of normalcy.
Massive outdoor events, which had been operating at 75% capacity, now face no capacity restrictions, though attendees will still be required to wear masks. The move comes just weeks ahead of Mexico City hosting a Formula 1 race.
Why COVID Boosters Weren’t Tweaked to Better Match Variants
And that has some experts wondering if the booster campaign is a bit of a missed opportunity to target Delta and its likely descendants.
“Don’t we want to match the new strains that are most likely to circulate as closely as possible?” Dr. Cody Meissner of Tufts Medical Center, an adviser to the Food and Drug Administration, challenged Pfizer scientists recently.
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