Moderna says its vaccine is safe for kids 6-11: COVID updates

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Moderna’s vaccine for children ages 6 to 11 shows a “robust” immune response in a study of more than 4,500 young people, the Massachusetts-based pharmaceutical company said Monday.

Moderna said it plans to file the data “soon” with the U.S. Food and Drug Administration. The randomized, observer-blind, placebo-controlled extension study involved a two-dose vaccine. The dose is half that of the adult vaccine.

Most side effects were mild or moderate in severity, the company said, with the most common being fatigue, headache, fever and injection site pain.

“We are encouraged by its immunogenicity and safety profile,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to submitting the application to regulatory authorities worldwide 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 youth ages 12 to 17. Moderna submitted the results of that study in June.

A panel of FDA advisors will vote this week on whether or not to authorize the Pfizer-BioNTech COVID-19 vaccine for use in children ages 5 to 11.

Also in the news:

►Protesters marched across the Brooklyn Bridge on Monday toward City Hall in Manhattan in support of nearly 50,000 New York City workers who have yet to get vaccinated against COVID-19 and risk being placed on unpaid leave if they don’t get it their first shot on Friday.

►Evidence of vaccination or a negative COVID-19 test will be required as of Monday to enter restaurants, bars, gyms, theaters or entertainment venues in King County, Washington State, including Seattle.

►The University of Maine system will send letters this week informing more than 200 students they are being withdrawn from classes for failing to vaccinate or agree to tests, officials said. The deadline was Friday.

►Nueta Hidatsa Sahnish College, on the Fort Berthold Indian Reservation in North Dakota, is offering $500 to students who can verify that they are fully vaccinated. Shooting must be completed by November 4.

►A Georgia man accused of using a pandemic emergency loan to buy a $57,000 Pokemon card is accused of lying about applying for a pandemic economic emergency loan. Vinath Oudomsine faces a count of wire fraud; his lawyers declined to comment.

📈 Today’s figures: The US has recorded more than 45.4 million confirmed cases of COVID-19 and more than 736,000 deaths, according to data from Johns Hopkins University. Global totals: over 243.8 million cases and 4.95 million deaths. According to the CDC, more than 190.6 million Americans — 57.7% of the population — have been fully vaccinated.

📘 What we read: Research during the pandemic has shown that people 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 serious illness.

Keep updating this page for the latest news. Want more? Sign up for USA TODAY’s Coronavirus Watch newsletter to receive updates straight to your inbox and join our Facebook group.

Unvaccinated Americans re-entering the country will face stricter rules from November 8, when the US will reopen its doors to foreign travelers – provided they are fully vaccinated against COVID-19.

US citizens without proof of vaccination “will have to provide documentation of a negative test within a day of departure” in order to return to the US, the White House said Monday. The current rule allows the test to be performed within three days of travel.

Fully vaccinated Americans 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 senator who has cancer. Tina Polsky, a Florida senator, was recently diagnosed with breast cancer 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 appointed to the post by Governor 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 this way,” Polsky said. “If he is a surgeon general in the next few years, I am really concerned about a future public health emergency and cannot rely on him for the necessary guidance and good scientific leadership.”

Democrats have opposed Ladapo’s nomination, criticizing him for comments and actions related to the pandemic. He has said masks have “little or no effect on the transmission of respiratory viruses,” contrary to CDC guidelines. At a news conference Thursday with DeSantis, Ladapo said, “The reality of how safe these vaccines are is by no means public.”

Information on the safety of the vaccines has been made public by the FDA, CDC and numerous independent studies.

Long-term COVID-19 side effects can include memory loss and other cognitive impairment commonly referred to 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 documenting “brain fog” was published earlier this month by the University of Oxford and the National Institute for Health Research. Cognitive symptoms were seen in approximately 8% of patients and were more common in the elderly. The study also found common lingering symptoms, such as difficulty breathing, abdominal discomfort, 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 high in the US of 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 hampered some aspects of drug trafficking at the land borders, but demand was high.

“There was less traffic and more time could be spent researching travelers, leading to more drug attacks,” he said. “But because people stayed at home instead of going to work, there was a greater demand for drugs.”

-Asha C. Gilbert

An overwhelming majority of registered nurses surveyed by the New York Professional Nurses Union say they have experienced increased stress, anxiety and burnout since the start of the COVID-19 pandemic in March 2020. Among the findings: 83% of nurses feel more stressed since March 2020; more than 75% feel burned out since March 2020; almost 100% of nurses feel more anxious since March 2020.

According to the survey of 589 nurses, nearly 50% of nurses have experienced increased hostility and aggression from patients or visitors to the hospital in the past 18 months.

“Nurses are not superheroes; “Nurses are human heroes,” said Eileen Toback, executive director of the New York Professional Nurses Union. “Nurses care for our communities in our weakest and most vulnerable moments – it’s sickening to see people scapegoating them in response to the implications of this pandemic.”

How’s the economy doing? Just look in the parking lot at your local mall or major retail store to find out. That old maxim is being turned into a kind of science with a new ‘road to recovery index’. A tech company hopes that a tool that takes the pulse of the parking industry will also serve as a greater economic indicator for a country that is still pulling itself out of the COVID-19 recession.

FlashParking, a technology provider to the largest parking garage operators, has begun surveying its customers in eight metropolitan areas — New York, Los Angeles, Chicago, Philadelphia, San Francisco, Houston, Miami and Atlanta — about their financial performance.

Parking revenues fell to 44% of pre-pandemic levels last year and returned to just 50% of pre-crisis levels by mid-2021. That is a weaker snapshot of the health of the economy than other measures.

– Paul Davidson, USA TODAY

Fox News host Neil Cavuto is urging others to get vaccinated after testing positive for COVID-19. In his first interview since his diagnosis Wednesday, the host of “Your World with Neil Cavuto” shared a health update during his appearance on “MediaBuzz” on Sunday.

“I feel better,” he said. “(My wife) also tested shortly after I was positive for COVID. I feel bad about that. The dog is fine, so hopefully it stays that way.”

While discussing the “hyperpoliticized” nature of vaccines, Cavuto, who was previously diagnosed with multiple sclerosis and has been fully vaccinated, acknowledged that taking the shot is a “private decision.” However, he still begged viewers to get vaccinated to protect others at risk.

“Half of the cases on the breakthrough front are immunocompromised people, like me who have and have had MS or previous heart conditions or cancer,” he said. Cavuto was diagnosed with cancer in the 1980s and underwent open heart surgery in 2016.

– Jenna Ryu, USA TODAY

Contributions: The Associated Press

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