Anti-Vaccine Group Founded By RFK Jr. Calls For Covid Shots To Be Pulled
Children's Health Defense filed a citizen's petition asking the FDA to deem Moderna's and Pfizer's covid vaccines "misbranded" and to revoke their licenses "due to a lack of compliance with FDA regulations." Meanwhile, the FDA investigates adult deaths possibly linked to the covid vaccine.
Axios:
COVID Vaccines Should Be Taken Off The Market, RFK Jr.'s Anti-Vaccine Group Argues
Health Secretary Robert F. Kennedy Jr. may have said he won't take vaccines away from anyone, but that's exactly what the anti-vaccine organization he founded asked the Food and Drug Administration to do in a petition this week. (Owens, 12/11)
More on the covid vaccine —
Stat:
Cause Of Very Rare Covid Vaccine Side Effect, Myocarditis, Identified
While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked. (Wosen, 12/10)
The New York Times:
FDA Expands Covid Vaccine Inquiry To Adult Deaths
The Food and Drug Administration has expanded its investigation of deaths possibly linked to the Covid vaccine to include adults as well as children, according to a Trump administration official. (Jewett, 12/9)
CIDRAP:
MRNA COVID Vaccines Tied To Drop In Death Rate For 4 Years
A large national cohort study from France didn’t observe any increase in all-cause mortality in adults up to four years after receipt of a COVID mRNA vaccine, and vaccination was linked to a 74% lower risk of death from severe COVID-19 and a 25% lower risk of death from any cause. (Bergeson, 12/10)
In other vaccine news —
CNN:
CDC Vaccine Advisers’ New Focus On Hepatitis B Tests In Pregnancy Is Not Enough, Some Doctors Warn
Many medical organizations and frontline health care providers are grappling with a challenge they haven’t had to face in many years: how to protect newborns against hepatitis B. (Howard, 12/10)
MedPage Today:
How Do We Know Aluminum Adjuvants In Vaccines Are Safe?
HHS Secretary Robert F. Kennedy Jr.'s vaccine advisors have set their sights on aluminum adjuvants in vaccines as part of their review of the U.S. pediatric vaccine schedule. While the concept of injecting a metal into children can, on the surface, sound frightening to parents, the aluminum salt adjuvants on the market have a long track record of safety, experts told MedPage Today. Vaccine adjuvants have been used for about a century now, and aluminum adjuvants in particular have been included in marketed vaccines for more than 90 years. (Fiore, 12/10)
Becker's Hospital Review:
The FDA’s New Vaccine Approval Road Map, Explained
The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency has not formally issued draft guidance, recent public comments, advisory committee discussions and internal policy memos outline a framework that is intended to streamline clinical trials, tighten manufacturing oversight and modernize postmarket safety monitoring. (Jeffries, 12/10)
CIDRAP:
Large Study Suggests Midlife Flu Vaccination Does Not Cut Parkinson’s Risk
A new population-based study of more than 1.1 million adults in the United Kingdom found that receiving an influenza vaccine between ages 40 and 50 was not tied to a lower long-term risk of developing Parkinson’s disease (PD), but the data suggest a possible benefit in certain instances. The findings were published late last week in JAMA Network Open. (Bergeson, 12/10)