Regulatory approval of Moderna’s emergency use authorization application for its vaccine for children ages 12 to 17 has been delayed until at least January, the company said on Sunday.
The Massachusetts-based pharmaceutical company said in a statement that the Food and Drug Administration blamed the delay on an ongoing assessment of recent international analyzes of the risk of myocarditis – inflammation of the heart – after vaccination. Moderna works closely with the FDA and “is grateful to the FDA for its diligence,” the statement said.
An increased risk of myocarditis due to vaccines has been found, especially in young men after the second dose. The United States Centers for Disease Control and Prevention and the World Health Organization have said myocarditis after vaccination is rare and usually mild.
More than 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of reports of myocarditis in under-18s in Moderna’s Global Safety Database does not suggest an increased risk of myocarditis in this population, the statement said.
“Moderna is committed to conducting its own careful review of new external analyzes as they become available,” the statement said.
Also in the news:
►Singer Jon Bon Jovi, who recorded a song about life during the COVID era last year, has canceled a performance in Miami Beach after testing positive for the coronavirus. His publicist said Bon Jovi is vaccinated and is feeling well.
► Approximately 26,000 New York City police, firefighters, sanitation workers and other unvaccinated municipal workers will go on unpaid leave starting Monday. Mayor Bill de Blasio tweeted on Saturday night that 91% of the city’s employees had received the vaccine, which was a jump of about 83% on Friday night.
►An accidental duplication of vaccine records at Kentucky Kroger pharmacies was discovered this week, Governor Andy Beshear said. The adjustments dropped the state’s vaccination rate by 6%.
►New York State prisons are offering pizza and McDonald’s food to encourage inmates to be vaccinated against COVID-19 until December 8. Prisons cannot spend more than $ 10 per inmate, according to a rating obtained by the Auburn Citizen.
►Over 90% of Delta Air Lines employees are fully vaccinated thanks in part to a monthly surcharge of $ 200 on unvaccinated workers, said CEO Ed Bastian. The rate dropped from 75% when the surcharge policy was announced.
The numbers of the day: The United States has recorded more than 45.9 million confirmed cases of COVID-19 and more than 745,700 deaths, according to data from Johns Hopkins University. Global totals: Over 246.5 million cases and 4.9 million deaths. More than 192.2 million Americans – 57.9% of the population – are fully vaccinated, according to the CDC.
What we read: Peak flu season approaches as the coronavirus pandemic continues, and families across the country are on the lookout for fevers, congestion and other symptoms. Can you get a COVID-19 booster and a flu shot at the same time?
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White House press secretary Jen Psaki tested positive
White House press secretary Jen Psaki said she tested positive for the coronavirus on Sunday, five days after her last in-person meeting with President Joe Biden.
Psaki said she did not travel with the president’s party to the G-20 summit in Rome because family members contracted the virus, and said she was quarantined and tested negative every day from Wednesday to Saturday. Psaki said on Sunday that her test came back positive and that she made the disclosure for the sake of transparency.
“I last saw the president on Tuesday when we sat outside more than six feet apart and wore masks,” Psaki said in a statement. “Thanks to the vaccine, I only experienced mild symptoms which allowed me to continue working from home.”
She added: “I plan to return to work in person at the end of the ten-day quarantine following a negative rapid test.”
Ski resorts hope the coming season reflects the days before the pandemic
After a winter with mask warrants and restrictions on the number of people on the ski lifts, ski resorts expect the coming season to look more like the days before the pandemic on the slopes. All virus related protocols at resorts will vary depending on where they are located and the local health rules in place. Some resorts require masks indoors and in restaurants, others may continue to limit the number of skiers on the slopes for a better experience, and some will require people to show proof of vaccination at some sites. But the National Ski Areas Association says it doesn’t expect to see limited capacity on chairlifts, restrictions on who people can ride with and much less, if any, masks required outside.
“What’s new is a lot more optimism,” said JJ Toland, spokesperson for Jay Peak Resort in Vermont.
Iowiens sacked for refusing vaccines would get unemployment benefits
Iowans could have more leeway to claim medical and religious exemptions from employers’ COVID-19 vaccination mandates – and would be entitled to unemployment benefits if a company fires them for non-compliance – under a new draft law from state legislators. The bill, which immediately drew criticism from both business representatives and opponents of vaccination mandates, would mark a significant change in how Iowa approaches employer vaccination requirements if the Governor Kim Reynolds promulgates it, which she said she intends to do.
“I think we have found a meaningful solution to protect Iowa and Iowa businesses from the government overbreadth of the Biden administration,” House Speaker Pat Grassley said in a statement.
– Ian Richardson and Amber Mohmand, The Des Moines Register
Tennessee restricts authority of schools and health services
Tennessee lawmakers have passed a series of measures significantly limiting COVID-19 restrictions by businesses, schools, local health departments and even the governor, following overnight deliberations between two legislative chambers that ended early Saturday morning. Alarmed business groups and corporations, including Ford Motor Co., have sent letters and texts urging lawmakers not to infringe on their workplace policies.
The bill prohibits government entities and public schools from requiring masks unless cases of COVID-19 increase sharply. It also prohibits these entities, as well as many private companies, from requiring COVID-19 vaccines or proof of vaccination.
The bill has exceptions. Private companies, including private schools and correctional facilities, can still issue mask warrants as they wish. Venues can no longer require proof of vaccination, but may require proof of a negative COVID-19 test result or proof of COVID-19 antibodies from attendees.
– Yue Stella Yu and Mariah Timms, The Nashville Tennessean
Contribution: The Associated Press