Moderna’s vaccine for kids ages 6 through 11 shows a “robust” immune response in a study of more than 4,500 youths, the Massachusetts-based pharmaceutical company said Monday.
Moderna said it plans to submit the data to the U.S. Food and Drug Administration “in the near term.” The randomized, observer-blind, placebo-controlled expansion study involved a two-dose vaccine. The dosage is half that of the adult vaccine.
The majority of adverse events were mild or moderate in severity, the company said, with the most common ones being fatigue, headache, fever and pain in the injection site.
“We are encouraged by the immunogenicity and safety profile,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
The FDA has not yet announced a decision on Moderna’s vaccine for youths ages 12 through 17. Moderna submitted results from that study in June.
A panel of FDA advisers will vote this week on whether to authorize the Pfizer-BioNTech COVID-19 vaccine for use in children 5 to 11.
Also in the news:
►Protesters marched Monday across the Brooklyn Bridge toward City Hall in Manhattan in support of nearly 50,000 New York City municipal workers who have yet to get vaccinated against COVID-19 and face the threat of being placed on leave without pay if they don’t get their first shot by Friday.
►Proof of vaccination or a negative COVID-19 test is required beginning Monday to enter restaurants, bars, gyms, theaters or entertainment venues in Washington state’s King County, which includes Seattle.
►The University of Maine system will mail out letters this week informing more than 200 students they’re being withdrawn from classes for failure to get vaccinated or agree to tests, officials said. Friday was the deadline.
►Nueta Hidatsa Sahnish College, on the Fort Berthold Indian Reservation in North Dakota, is offering $500 to students who can verify they are fully vaccinated. The shots must be completed by Nov. 4.
►A Georgia man accused of using a pandemic relief loan to buy a $57,000 Pokemon card is charged with lying on an application for a pandemic economic relief loan. Vinath Oudomsine faces one count of wire fraud; his lawyers declined comment.
📈 Today’s numbers: The U.S. has recorded more than 45.4 million confirmed COVID-19 cases and more than 736,000 deaths, according to Johns Hopkins University data. Global totals: More than 243.8 million cases and 4.95 million deaths. More than 190.6 million Americans – 57.7% of the population – are fully vaccinated, according to the CDC.
📘 What we’re reading: Research during the pandemic has shown those with mental health disorders are more vulnerable to COVID-19, but it wasn’t until last week that the CDC added them to the list of underlying medical conditions associated with a higher risk of severe disease.
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Unvaccinated Americans reentering the country will face stricter rules beginning Nov. 8, when the U.S. will again open its doors to foreign travelers — provided they’re fully vaccinated against COVID-19.
American citizens without proof of vaccination “will have to produce documentation of a negative test within one day of departure” to be allowed back in the U.S., the White House said Monday. The current rule allows the test to be conducted within three days of travel.
Fully vaccinated Americans will still have a three-day window for COVID-19 testing with negative results as long as they can show proof of vaccination.
— Bailey Schulz and Eve Chen
Florida’s top health official was asked to leave a meeting after refusing to wear a mask at the office of a state senator who has cancer. Tina Polsky, a Florida senator, recently received a breast cancer diagnosis and asked state Surgeon General Dr. Joseph Ladapo to wear a mask when he arrived for a Wednesday meeting. He refused.
Ladapo had asked to meet with Polsky as he seeks confirmation in the Senate after being named to the post by Gov. Ron DeSantis last month. DeSantis has been steadfast in his opposition to COVID-19 vaccination mandates, calling them unfair and discriminatory.
“It was so shocking to me that he treated me in this manner,” Polsky said. “If he is a surgeon general for the next several years, I am really concerned about a future public health emergency and not being able to rely on him for necessary guidance and proper scientific leadership.”
Democrats have opposed the appointment of Ladapo, criticizing him for comments and actions related to the pandemic. He has said masks have “little or no effect on respiratory virus transmission,” contradicting CDC guidance. At a Thursday news conference with DeSantis, Ladapo said, “The reality of how safe these vaccines are is absolutely not public.”
Information about the vaccines’ safety has been made public by the FDA, CDC and numerous independent studies.
Long-term COVID-19 side effects could include memory loss and other cognitive dysfunctions commonly labeled as “brain fog,” according to a study that examined 740 patients in the Mount Sinai Health System. The study was published in the peer-reviewed medical journal JAMA Network Open.
Another study that documented “brain fog” was published by Oxford University and the National Institute for Health Research earlier this month. Cognitive symptoms were seen in about 8% of patients and were more common among the elderly. The study also found common lingering symptoms, such as trouble breathing, abdominal ailments, fatigue, pain, anxiety and depression.
– Michelle Shen
Synthetic opioids such as Fentanyl have become the leading cause of overdose deaths in America, according to the National Institute on Drug Abuse. Overdose deaths hit a new record in the U.S. at 96,779 from March 2020 to March 2021, driven in part by the pandemic, according to the CDC.
Matthew Dyman, a Customs and Border Patrol public affairs officer, told USA TODAY in an email that COVID travel restrictions hindered some aspects of land border drug trafficking, but demand was high.
“There was less traffic and more time could be spent examining travelers, which increased drug seizures,” he said. “But with people staying home instead of going to work, there was an increased demand for drugs.”
– Asha C. Gilbert
An overwhelming majority of registered nurses surveyed by the New York Professional Nurses Union say they are experiencing increased levels of stress, anxiety and burnout since the start of COVID-19 pandemic in March 2020. Among findings: 83% of nurses feel more stressed since March 2020; over 75% feel burned out since March 2020; almost 100% of nurses feel more anxious since March 2020.
Nearly 50% of nurses have experienced more hostility and aggression from patients or visitors in the hospital in the last 18 months, according to the survey of 589 nurses.
“Nurses are not superheroes; nurses are human heroes,” said Eileen Toback, the union’s executive director of the New York Professional Nurses Union. “Nurses care for our communities at our weakest and most vulnerable moments – it’s sickening to see people scapegoat them in response to the implications of this pandemic.”
How’s the economy doing? Just check the parking lot at your local mall or big-box store to find out. That old maxim is being turned into a science of sorts with a new “road to recovery index.” A tech company hopes a tool that takes the pulse of the parking industry will also serve as a larger economic indicator for a nation still digging itself out of the COVID-19 recession.
FlashParking, a technology supplier to top parking garage operators, has started surveying its clients in eight metro areas — New York, Los Angeles, Chicago, Philadelphia, San Francisco, Houston, Miami and Atlanta — about their financial performance.
Parking revenue plunged to 44% of its pre-pandemic level last year and returned to just 50% of its pre-crisis mark by mid-2021. That’s a dimmer snapshot of the economy’s health than other measures.
– Paul Davidson, USA TODAY
Fox News anchor Neil Cavuto is urging others to get vaccinated after testing positive for COVID-19. In his first interview since his diagnosis Wednesday, the “Your World with Neil Cavuto” host shared a health update during his appearance on “MediaBuzz” on Sunday.
“I’m feeling better,” he said. “(My wife) tested positive for COVID as well soon after I did. I feel bad about that. The dog’s OK, so hopefully that remains the case.”
While discussing the “hyper-politicized” nature of vaccines, Cavuto, who was previously diagnosed with multiple sclerosis and is fully vaccinated, acknowledged that taking the jab is a “private decision.” However, he still implored viewers to get vaccinated to protect others at risk.
“Half the cases on the breakthrough front are among the immunocompromised, people like me who have had and have MS or prior heart situations or cancer,” he said. Cavuto faced cancer in the 1980s and underwent open-heart surgery in 2016.
– Jenna Ryu, USA TODAY
Contributing: The Associated Press