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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, Moderna's chief executive officer. “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:
►Two-thirds of American states have now reported at least 5,000 COVID-19 deaths, Johns Hopkins University data show. New Mexico on Monday became the 34th state to report its 5,000th death. On the low end is Vermont, with 351 reported deaths, and on the high end are California and Texas, both of which have reported more than 70,000 deaths.
►Green Bay Packers wide receiver Davante Adams, who ranks second in the NFL in catches and third in receiving yards, has tested positive for COVID-19 and will likely miss Thursday's game against the unbeaten Arizona Cardinals. Adams has said he's vaccinated.
►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►The University of Maine system will mail letters this week informing more than 200 students they’re being withdrawn from classes for failure to get vaccinated or agree to tests, officials said.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.
►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 45.5 million confirmed COVID-19 cases and 737,300 deaths, according to Johns Hopkins University data. Global totals: More than 244 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 will face tougher rules for reentry into US
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 Gov. Ron DeSantis seeks to lure unvaccinated police officers with $5K bonuses
Florida Gov. Ron DeSantis is pushing for the state legislature to authorize $5,000 bonuses and other incentives to lure police officers from other states.
More specifically, DeSantis is aiming to recruit those from jurisdictions with vaccine requirements who don't want to comply, encouraging them to relocate to the mandate-less Sunshine State. In many parts of the nation, police officers and their unions have steadfastly resisted the requirement.
"In the next legislative session, I'm going to hopefully sign legislation that gives a $5,000 bonus to any out-of-state law enforcement that relocates in Florida," DeSantis said Sunday in a Fox interview. "So NYPD, Minneapolis, Seattle, if you're not being treated well, we'll treat you better here.''
DeSantis has raised his national profile, especially among the Republican base, by fiercely opposing mask and vaccine mandates during the pandemic.
'Brain fog' a long-term side effect of the coronavirus, study says
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
Rise in fentanyl overdose deaths linked to COVID
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
Index to measure economic recovery by tracking empty parking lots
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
Contributing: The Associated Press
This article originally appeared on USA TODAY: Moderna says its vaccine is safe for kids 6-11: COVID updates