Covid Vaccines Might Soon Come With Cautionary FDA ‘Black Box’ Label
Dr. Vinay Prasad, the FDA's director of the Center for Biologics Evaluation and Research, is said to be making plans to unveil by the end of this year a plan to include the most serious warnings on the inoculations. Moderna and Pfizer have maintained that their shots are safe and effective.
CNN:
FDA Intends To Put Its Most Serious Warning On Covid Vaccines, Sources Say
The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans. (Tinker, Goodman and Tirrell, 12/12)
The New York Times:
Covid Vaccines Reduced Children’s Likelihood Of E.R. And Urgent Care Visits, The C.D.C. Reported
Covid vaccines administered last fall sharply decreased the risk of emergency department and urgent care visits in children, according to new data released on Thursday by the Centers for Disease Control and Prevention. The data, published in the Morbidity and Mortality Weekly Report, the agency’s premier publication provided a striking counterpoint to the Trump administration’s recent rhetoric about the vaccines. (Mandavilli, 12/11)
On hepatitis B vaccines —
The Hill:
New Chair Of CDC Vaccine Panel Fired From Pediatric Practice, Wife Says
The wife of the newly appointed chair of the vaccine advisory panel that recently voted to roll back infant hepatitis B vaccination guidelines said Thursday that he had been fired from his pediatric cardiology practice because of his position on the committee. Kimberly Milhoan, the wife of the recently appointed chair of the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC), Kirk Milhoan, wrote on her Substack post titled “Irony” that she and her husband were in Hong Kong this week for the World Congress of Pediatric Cardiology and Cardiac Surgery. (Choi, 12/11)
KFF Health News:
Vaccine Panel’s Hepatitis B Vote Signals Further Turbulence For Immunization Policy, Public Trust
When Su Wang was in medical school, she donated blood. That’s when she learned she was infected with hepatitis B, a virus that attacks the liver and can lead to cancer and death decades later. “I was 18, healthy, in college,” she said. “And suddenly I had a chronic illness I didn’t even know about.” (Gounder, 12/12)
More vaccine news —
CIDRAP:
In Call With Clinicians, CDC Recommends Flu Vaccines Widely
Today the Centers for Disease Control and Prevention (CDC) hosted its first Clinician Outreach and Communication Activity (COCA) call since September, focusing on seasonal influenza activity and vaccination, especially the importance of vaccinating children. “The time to get vaccinated is right now for those 6 months and older. [Flu] rates are increasing,” said Tim Uyeki, MD, MPH, MPP, the chief medical officer of the Influenza Division at CDC. (Soucheray, 12/11)
CIDRAP:
WHO Expert Panel Reaffirms No Link Between Vaccines And Autism
A new analysis released today by the World Health Organization’s (WHO’s) Global Advisory Committee on Vaccine Safety (GACVS) suggests that, based on the available evidence, there is no causal association between vaccines and autism spectrum disorders (ASD), reaffirming decades of evidence supporting the safety of childhood immunizations. ... The committee examined two claims: that thiomersal-containing vaccines are associated with an increased risk of ASD and that vaccines in general contribute to autism diagnoses. (Bergeson, 12/11)
ProPublica:
Sen. Ron Johnson Endorses Book Touting Chlorine Dioxide's Unproven Health Benefits
For years, Sen. Ron Johnson has been spreading conspiracy theories and misinformation about COVID-19 and the safety of vaccines. He’s promoted disproven treatments for COVID-19 and claimed, without evidence, that athletes are “dropping dead on the field” after getting the COVID-19 vaccination. Now the Wisconsin politician is endorsing a book by a discredited doctor promoting an unproven and dangerous treatment for autism and a host of ailments: chlorine dioxide, a chemical used for disinfecting and bleaching. (O'Matz, 12/11)
The Guardian:
Liam Neeson Denies Anti-Vax Views After Narrating Covid Documentary
Liam Neeson has lent his voice to a new documentary that questions the legitimacy of vaccines and praises Donald Trump’s health and human services secretary, Robert F Kennedy Jr. The film, called Plague of Corruption, is narrated by the Taken actor and based on a bestselling book co-authored by Judy Mikovits, a disgraced former scientist who gained notoriety during the Covid pandemic. She claimed Covid was caused by a bad strain of the flu vaccine and urged people not to get vaccinated. (Lee, 12/11)
