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Thursday, Apr 28 2022

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Moderna Requests FDA Authorization Of Covid Vaccine For Young Kids

Moderna applied Thursday for emergency use authorization from the Food and Drug Administration for its covid shot to be allowed for children ages 6 months to 5 years. It's a long-awaited move by parents with young kids, though the FDA and CDC decisions aren't expected until June.

Moderna asked the Food and Drug Administration on Thursday to expand the use of its Covid-19 vaccine to children ages聽6 months聽to聽5 years. The drugmaker's request will now be considered by the FDA, which is expected to make a final decision in June. The agency is expected to seek the advice of its advisory committee, the Vaccines and Related Biological Products Advisory Committee. Children under 5 are the only group in the U.S. ineligible to receive a Covid vaccine; the Pfizer-BioNTech vaccine is available to anyone as young as 5, while Moderna's and Johnson & Johnson's shots are only available to adults. (Lovelace Jr., 4/28)

Frustrated families are waiting impatiently for a chance to protect the nation鈥檚 littlest kids as all around them people shed masks and other public health precautions -- even though highly contagious coronavirus mutants continue to spread. Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers -- albeit not as effectively during the omicron surge as earlier in the pandemic. (Neergaard, 4/28)

Moderna still needs to complete its emergency use authorization filing by sending final datasets to the agency, which the company said will not happen until next week. The FDA has also committed to holding a meeting of its outside advisory committee before authorizing any vaccines for young children, meaning that while the agency can now begin to consider Moderna鈥檚 shot for distribution to the public, a decision could still be weeks away. Under questioning Tuesday from Sen. Patty Murray (D-Wash.), top FDA vaccine regulator Peter Marks told lawmakers that the agency planned to publish a tentative timeline next week showing when it planned to hold outside advisory committee meetings on the vaccines for young children 鈥 a move that could offer more precise insight into when the agency plans to authorize the shots. (Cancryn, Owermohle, Lim and Foley, 4/28)

In other news about the vaccine rollout 鈥

A new study published in Clinical Infectious Diseases shows a third dose of Pfizer or Moderna mRNA vaccines were 89.6% to 78.8% protective against deaths during the Omicron surge compared to no vaccination. The study adds to a growing body of literature which suggests booster does can raise antibody levels to fight circulating strains, despite being formulated to fight the original strain of SARS-CoV-2. (4/27)

Tribal health clinics emerged last year as聽top聽providers聽of聽the COVID-19 vaccine in Oklahoma, especially in rural parts of the state. Now as the latest surge of coronavirus wanes, tribal leaders and health experts are reflecting on the聽public health crisis response and learning from it. 鈥淲e have the knowledge and we have the understanding 鈥 when there is a virus in the air, that we need to take it seriously,鈥 said Cheyenne and Arapaho Gov. Reggie Wassana.聽(Young, 4/27)

And in updates on vaccine and mask mandates 鈥

The decision marks a partial victory for the city, but does not carry immediate practical impact: Mayor Michelle Wu鈥檚 vaccine mandate for city workers remains on hold pending separate legal proceedings. 鈥淭he ongoing COVID-19 pandemic, with new variants and rising cases, coupled with the City鈥檚 interest in protecting the wellbeing of its employees and the public with whom they interact, and ensuring that there is sufficient staff to provide vital public safety services, exempts the City from having to negotiate with the Union over the decision to require vaccinations,鈥 Gail Sorokoff, an investigator with the labor department, wrote Tuesday. 鈥淭he City has established that exigent circumstances permitted it to implement the revised policy in January, 2022, even though the parties had not completed impact negotiations.鈥 (Platoff, 4/27)

For weeks in 2019, the shouting of anti-vaccine activists echoed through the halls of the California Capitol. Protesters pounded on the chamber doors, disrupting floor debates, as lawmakers weighed the latest bill to tighten school vaccine rules. On the final night of the session, a protester tossed a menstrual cup from the Senate gallery onto the chamber floor below, splattering lawmakers with blood. 鈥淭hat鈥檚 for the dead babies!鈥 she shouted. (Colliver, 4/27)

Sharmy Aldama has spent the majority of her career enforcing mask rules on airplanes. The Miami-based flight attendant, who works for a budget carrier and spoke on the condition that her employer not be named so she could comment freely, started the job in late 2018. After the pandemic began, getting passengers to follow masking rules became an everyday struggle. But since a federal judge struck down the mask mandate for planes and other transportation settings last week, she has noticed a lighter mood among passengers and crew and has felt a personal sense of relief. 鈥淏eing able to just show up [to work] and give people what they need and not have to be on guard all the time has been so refreshing,鈥 she said. (Diller, 4/27)

A high school teacher in suburban New York was charged Wednesday with submitting a forged COVID-19 vaccination card in an effort to get around the school district鈥檚 rule mandating either vaccination or weekly testing for the coronavirus. Tricia Manno, a teacher at Sewanhaka High School on Long Island, was arraigned on charges including criminal possession of a forged instrument and offering a false instrument for filing, Nassau County District Attorney Anne Donnelly announced. (4/27)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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