 | Fri, May 27, 2022 | | | |
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Think a friend or colleague should be getting this newsletter? Share this link with them to sign up. Food and Drug Administration leaders and an Abbott executive faced a grilling in Congress this week over the baby formula shortage caused by the closure of the company's Michigan plant. FDA Commissioner Dr. Robert Califf detailed 'shocking' conditions at the Abbott plant, including bacteria growing from multiple sites. Grilled by lawmakers, Califf acknowledged that the FDA took too long to respond to infants falling ill after consuming Abbott's powdered formula. Califf said the U.S. baby formula supply should return to normal in the next two months. Abbott said it hopes to resume production at the Michigan plant on June 4. Monkeypox continues to spread globally, with nine cases now confirmed in the U.S. CDC officials alerted the LGBTQ community that the virus is spreading mostly among gay and bisexual men right now, but emphasized that anyone can catch it regardless of sexual orientation. In Covid news, Pfizer said its three-dose vaccine for kids under age 5 was 80% effective against omicron. The FDA advisory committee is now scheduled to meet on June 15 to discuss Pfizer and Moderna's shots for infants through preschoolers. Feel free to send any tips, suggestions, story ideas and data in the meantime to me at spencer.kimball@nbcuni.com. |
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Food and Drug Administration Commissioner Dr. Robert Califf gave a scathing review of "egregiously unsanitary" conditions at Abbott's baby formula plant in Michigan during sworn testimony before a House subcommittee about the baby formula shortage on Wednesday. Califf described bacteria growing from multiple sites in the facility, cracks in key equipment, leaks from the roof, standing water and a previous citation for inadequate handwashing. "Frankly, the inspection results were shocking," Califf told House lawmakers on the Oversight and Investigations subcommittee. "This is so far removed from my previous experience with the company that I am very concerned." |
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Pfizer and BioNTech's three-dose Covid vaccine for children 6 months to 5 years old was 80% effective at preventing illness during the omicron wave, according to preliminary clinical trial results released Monday. A third dose of the vaccine elicited a strong immune response and was well tolerated by the kids with a majority of the side effects mild to moderate, according to the companies. BioNTech CEO Ugur Sahin said the companies plan this week to complete their application asking the Food and Drug Administration to authorize the vaccine for emergency use. Pfizer CEO Albert Bourla said he hopes the vaccine will be available to younger kids as soon as possible. |
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The Food and Drug Administration's expert committee will meet June 15 to review new data on Pfizer's and Moderna's Covid vaccines for infants and toddlers, setting the stage for the shots to receive emergency use authorization early this summer.
"We know parents are anxious for us to determine if these vaccines are safe & effective," the FDA said in a post Monday on Twitter. "We are working as quickly as possible to carefully review all the data."
The FDA's committee of independent experts will review the safety and efficacy data of the vaccines in an open public meeting and make a recommendation on whether the agency should authorize the shots. The FDA is not obligated to follow the committee's recommendation, though it usually does. |
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The Centers for Disease Control and Prevention wants to calm public anxiety over how the monkeypox virus is transmitted, emphasizing that it doesn't spread that easily through the air because it requires close contact with an infected person. Monkeypox is primarily spread through sustained physical contact such as skin-to-skin touch with someone who has an active rash, CDC officials said this week. The virus can also spread through contact with materials that have the virus on it like shared bedding and clothing. A monkeypox patient with lesions in their throat or mouth can spread the virus through respiratory droplets if they are around someone else for an extended period of time. However, the virus does not spread easily that way, according to Dr. Jennifer McQuiston, a CDC official. |
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The Centers for Disease Control and Prevention on Monday alerted gay and bisexual men that monkeypox appears to be spreading in the community globally, warning people to take precautions if they have been in close contact with someone who may have the virus and to be on the lookout for symptoms. Dr. John Brooks, a CDC official, emphasized that anyone can contract monkeypox through close personal contact regardless of sexual orientation. However, Brooks said many of the people affected globally so far are men who identify as gay or bisexual. Though some groups have greater chance of exposure to monkeypox right now, the risk isn't limited only to the gay and bisexual community, he cautioned. "We want to help people make the best informed decisions to protect their health and the health of their community from monkeypox," Brooks said. |
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The CEO of Bavarian Nordic, maker of the only vaccine cleared by the FDA for both monkeypox and smallpox, told us they've been inundated with calls from governments seeking to secure doses. The U.S. is in a better position than other countries, he said, as it supported development and manufacturing of the vaccine, and has access to more than a million doses. |
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A growing number of national employers, large and small, are pledging to offer travel assistance to maintain access to abortion for their workers in states where it will be banned, if the Supreme Court overturns Roe v. Wade next month, as expected. Most are refraining from taking a stand, but behind the scenes they are working with benefit navigation firms and insurers to figure out how to navigate what could become a social and regulatory minefield, with potential backlash from all sides -- their own workers, politicians, and the public. |
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