The U.S. Food and Drug Administration (FDA) granted emergency use authorization on Oct. 29 for children aged 5–11 years to receive the Pfizer-BioNTech coronavirus vaccine. Nearly 2 million children in this age group have been infected, federal health officials report, with at least 146 related deaths. Regulators cleared them for vaccination based on clinical trial data showing that a reduced dose was 91 percent effective in preventing COVID-19 disease in this population. The agency was particularly focused on safety, because the vaccine has been tied to rare cases of heart inflammation problems in teen boys and young men. No serious adverse events were observed, however, among the estimated 3,100 children in the study who received the vaccine. "Vaccinating younger children against [...]

Detroit — When Nikki Neuzil opened her vintage clothing shop in 2018, the exterior of the century-old building on Vernor Highway needed lots of repairs. The storefront for Flamingo Vintage has a deep glass display windows where Neuzil shows off the clothing, accessories and housewares she sells. However, it lacked proper signage, had running tar, and mortar was crumbling from the façade. “The outside was rough,” Neuzil said. Neuzil received funding this year from Southwest Detroit Business Association’s Façade Matching Grant and Design Assistance Program to restore the brick, install wrought iron flower boxes and add a bright turquoise awning with the business logo. Flamingo Vintage is among seven recently completed improvement projects in the West Vernor and Springwells and West Michigan Avenue commercial districts. “My business [...]

Following FDA's lead a day earlier, CDC on Thursday sanctioned COVID-19 boosters from Moderna and Johnson & Johnson. CDC Director Rochelle Walensky endorsed unanimous recommendations from the Advisory Committee on Immunization Practices on boosters for the two vaccines and on allowing mixing and matching of vaccines. "The evidence shows that all three COVID-19 vaccines authorized in the United States are safe — as demonstrated by the over 400 million vaccine doses already given," Walensky said. "And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating delta variant." Regardless of which brand they received for their initial immunization, tens of millions of Americans at risk of severe [...]

As the FDA moves to authorize boosters of the Moderna and Johnson & Johnson COVID-19 vaccines, expected no later than Wednesday night, the regulator appears receptive to brand flexibility in the choice of additional doses. An advisory committee to FDA heard evidence last week showing that people who initially received J&J's single-dose vaccination saw antibody levels increase fourfold about 2 weeks after receiving a booster from the same company but registered a 76-fold gain after receiving a booster from Moderna. In presenting the data, University of Maryland School of Medicine professor Kirsten E. Lyke warned that the study "was not powered or designed to compare between groups" and, thus, there is no proof than any particular combination of vaccines was [...]

An FDA advisory panel on Oct. 15 reached a consensus on COVID-19 boosters for the 15 million Americans who initially received the single-dose Johnson & Johnson vaccine. The recommendation covers recipients 18 years or older who were immunized at least two months earlier. Committee members appeared at least partially motivated by the fact the J&J product is the least durable of the three coronavirus vaccines authorized in the United States. "There is a public health imperative here, because what we're seeing is that this is a group with overall lower efficacy than we have seen with the mRNA vaccines," explained Arnold Monto, MD, acting committee chair. "So there is some urgency there to do something." Many of the panel participants [...]