Regulatory approval of Moderna’s emergency use authorization request for its vaccine for kids 12 to 17 years of age has been delayed until at least January, the company announced Sunday.
The Massachusetts-based pharmaceutical firm said in a statement that the Food and Drug Administration blamed the delay on an ongoing evaluation of recent international analyses of the risk of myocarditis – inflammation of the heart – after vaccination. Moderna is working closely with the FDA and “is grateful to the FDA for their diligence,” the statement said.
An increased risk of myocarditis from the vaccines has been discovered, particularly in young men following the second dose. The U.S. Centers for Disease Control and Prevention and the World Health Organization have said myocarditis following vaccination has been rare and generally mild.
Over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of myocarditis reports in those less than 18 years of age 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 analyses as they become available,” the statement said.
Also in the news:
►Singer Jon Bon Jovi, who recorded a song about life in COVID times last year, canceled a performance in Miami Beach after testing positive for the coronavirus. His publicist said Bon Jovi is vaccinated and feels fine.
►About 26,000 New York City police officers, firefighters, sanitation workers and other unvaccinated municipal workers will go on unpaid leave starting Monday. Mayor Bill de Blasio tweeted Saturday night that 91% of city workers had received the vaccine, which represented a jump from about 83% as of Friday night.
►Accidental duplication of vaccine records at Kentucky Kroger pharmacies was discovered this week, Gov. Andy Beshear announced. Adjustments dropped the state’s vaccination rate 6%.
►New York’s state prisons are offering pizza and McDonald’s food as incentives for inmates to get COVID-19 vaccines through Dec. 8. Prisons can’t spent more than $10 per inmate, according to a memo obtained by the Auburn Citizen.
►More than 90% of Delta Air Lines employees are fully vaccinated thanks in part to a $200 monthly surcharge on unvaccinated workers, CEO Ed Bastian said. The rate is up from 75% when the surcharge policy was announced.
📈Today’s numbers: The U.S. has recorded more than 45.9 million confirmed COVID-19 cases and more than 745,700 deaths, according to Johns Hopkins University data. Global totals: More than 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’re reading: Peak flu season is approaching 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 tests positive
White House press secretary Jen Psaki said she tested positive for the coronavirus 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 members of her family had contracted the virus, and said she had been quarantining and tested negative every day from Wednesday to Saturday. On Sunday, Psaki said her test came out positive and she made the disclosure in the interest 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 have only experienced mild symptoms which has enabled me to continue working from home. “
She added: “I will plan to return to work in person at the conclusion of the ten-day quarantine following a negative rapid test.”
Ski resorts hoping coming season mirrors pre-pandemic days
After a winter with mask mandates and restrictions on the number of people on lifts, ski resorts are expecting the upcoming season to be more like the pre-pandemic days on the slopes. Any virus-related protocols at resorts will vary depending on where they are and the local health rules in place. Some resorts are requiring masks indoors and at 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 certain venues. But the National Ski Areas Association says it does not expect to see limited capacity on chairlifts, restrictions on who people can ride with and far fewer, if any, mask requirements outdoors.
“What’s new is a lot more optimism,” said J.J. Toland, a spokesperson for Jay Peak Resort in Vermont.
Iowans fired for refusing vaccines would get unemployment benefits
Iowans could have wider latitude to claim medical and religious exemptions from employer COVID-19 vaccination mandates – and would qualify for unemployment benefits if a business fires them for not complying – under a new bill by state lawmakers. The bill, which immediately drew criticism both from business representatives and from opponents of vaccine mandates, would mark a significant change in the way Iowa approaches vaccination requirements by employers if Gov. Kim Reynolds signs it into law, which she said she plans to do.
“I believe we have found a meaningful solution to protect Iowans and Iowa businesses from the Biden administration’s extreme government overreach,” state House Speaker Pat Grassley said in a statement.
– Ian Richardson and Amber Mohmand, The Des Moines Register
Tennessee restricts authority of schools, health departments
Tennessee lawmakers passed a series of measures significantly limiting COVID-19 restrictions by businesses, schools, local health departments and even the governor, following late-night deliberations between two legislative chambers that ended early Saturday morning. Alarmed business groups and companies, including Ford Motor Co., sent letters and texts urging lawmakers not to intrude on their workplace policies.
The bill bars government entities and public schools from requiring masks unless COVID-19 cases rise sharply. It also prohibits those entities, as well as many private businesses, from mandating COVID-19 vaccines or proof of vaccination.
The bill comes with exceptions. Private businesses, including private schools, and correctional facilities, can still issue mask mandates however they want. Entertainment venues can no longer require proof of vaccination but can require proof of a negative COVID-19 test result or proof of COVID-19 antibodies of attendees.
– Yue Stella Yu and Mariah Timms, The Nashville Tennessean
Contributing: The Associated Press