Regulatory approval of Moderna’s Emergency Use Authorization request for use of its vaccine for kids 12 to 17 years of age has been delayed until at least January, Moderna announced Sunday.
The Massachusetts-based pharmaceutical giant 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 and 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:
► About 26,000 New York City police officers, firefighters, sanitation workers and other unvaccinated municipal workers will go on unpaid leave starting Monday.
► Accidental duplication of vaccine records at Kentucky Kroger pharmacies were 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 745,600 deaths, according to Johns Hopkins University data. Global totals: More than 246.3 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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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 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