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RFK Jr, HHs & Public Health News | Measles outbreak, etc.

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Five Takeaways From RFK Jr.’s Grilling on Capitol Hill​

Health secretary faces intense questioning over cuts to his agency, vaccines and more​


🎁 —> https://www.wsj.com/politics/policy...c3?st=aY6j59&reflink=mobilewebshare_permalink

“… Kennedy hesitated when asked whether he would vaccinate his child today with the measles mumps rubella (MMR) vaccine, saying he probably would. “My opinions on vaccines are irrelevant,” he said. “I don’t think people should be taking medical advice from me.”

He also declined to answer the same question regarding the chickenpox and polio vaccines.

“I am not going to just tell people everything is safe and effective if I know there are issues,” he said about vaccines generally.

Kennedy also denied that David Geier, an antivaccine activist, was hired by his department to examine the causes of autism. He instead said that Geier is examining whether data is missing from the Vaccine Safety Datalink, a Centers for Disease Control and Prevention database that helps monitor vaccine safety. …”
 
I genuinely believe that RFK, Jr sole purpose in the St. Donald of Mar-a-Lago's administration is to flood the zone with so much BS that the Democrats just can't stay focused on the real objectives (cut taxes on and regulation of the ultra-wealthy) of the Trump agenda long enough to be an effective opposition.
 

F.D.A. Poised to Restrict Access to Covid Vaccines​

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many others may not be able to get the shots

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www.nytimes.com

“
The Food and Drug Administration will permit use of Covid vaccines by adults over 65 and those with certain medical conditions in the fall, but may require additional studies before approving the shots for healthy Americans younger than 65, agency officials said on Tuesday.

At this point, the additional doses offer “uncertain” benefits to many young and middle-aged people who have already been vaccinated or have had Covid, Dr. Vinay Prasad, the F.D.A.’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner, wrote in The New England Journal of Medicine.

“The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the officials wrote.

Until now, annual Covid shots were recommended for everyone aged 6 months and older. Scientific advisers to the F.D.A. are set to meet Thursday to decide on the composition of the Covid vaccine to be made available in the fall.…”
 
nycfan said:

F.D.A. Poised to Restrict Access to Covid Vaccines​

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many others may not be able to get the shots

Loading…

www.nytimes.com

“
The Food and Drug Administration will permit use of Covid vaccines by adults over 65 and those with certain medical conditions in the fall, but may require additional studies before approving the shots for healthy Americans younger than 65, agency officials said on Tuesday.

At this point, the additional doses offer “uncertain” benefits to many young and middle-aged people who have already been vaccinated or have had Covid, Dr. Vinay Prasad, the F.D.A.’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner, wrote in The New England Journal of Medicine.

“The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the officials wrote.

Until now, annual Covid shots were recommended for everyone aged 6 months and older. Scientific advisers to the F.D.A. are set to meet Thursday to decide on the composition of the Covid vaccine to be made available in the fall.…”
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“… During a livestreamed “town hall” on Tuesday afternoon, Dr. Prasad said he thought the new approach to Covid vaccination was “a reasonable compromise,” leaving the shots available to many Americans “but also generating evidence.”

… Before approving Covid vaccines for wider use, the F.D.A. “anticipates the need” for new clinical trials in which participants under 65 are randomly assigned to receive the new shots or a placebo, Dr. Prasad and Dr. Makary wrote in the journal.

… A spokesman for the agency later said that clinical trials would be required, not just recommended or anticipated.

… Some experts said the new criteria go too far, erecting barriers for people who will want the shots.

… Some experts said that while they agreed with aspects of the agency’s rationale, the new restrictions would unnecessarily limit access for healthy Americans who may be at high risk from Covid because of their jobs or for other reasons.

… The proposed regulations align with the agency’s recent decision to narrow the eligibility for the Novavax Covid vaccine.

The F.D.A. on Friday approved that shot for use only in adults over 65 and for others over age 12 who have at least one medical condition that puts them at high risk should they contract Covid.

The decision was met with some criticism, given the absence of new evidence to suggest concerns about the effectiveness or side effects. …”
 
Had a meeting about the new COVID guidelines. My company is developing a new vaccine, and previously FDA was adamant that it should be compared to the standard of care- either Pfizer’s or Moderna’s vaccine. Now they seem to be suggesting that any trial will require a placebo comparator which should theoretically make it easier/cheaper to demonstrate effectiveness (since less patients are needed to demonstrate a true difference in the number of cases of COVID with a placebo). I have a feeling they will ask us to enroll huge amounts of patients and follow them for long enough periods of time as to make development cost-prohibitive, but that’s speculation.

New vaccines being compared to a placebo control has been an anti-vax position for a long time. They seem to think that’s the only way we can really characterize the true extent of adverse reactions and/or that the side effects will look so much worse in comparison that it will discourage the public from taking it (or that the FDA can declare that it is not safe). They certainly seem to be implying that the current vaccines aren’t fit to serve as a comparator.
 
nrsair said:
Had a meeting about the new COVID guidelines. My company is developing a new vaccine, and previously FDA was adamant that it should be compared to the standard of care- either Pfizer’s or Moderna’s vaccine. Now they seem to be suggesting that any trial will require a placebo comparator which should theoretically make it easier/cheaper to demonstrate effectiveness (since less patients are needed to demonstrate a true difference in the number of cases of COVID with a placebo). I have a feeling they will ask us to enroll huge amounts of patients and follow them for long enough periods of time as to make development cost-prohibitive, but that’s speculation.

New vaccines being compared to a placebo control has been an anti-vax position for a long time. They seem to think that’s the only way we can really characterize the true extent of adverse reactions and/or that the side effects will look so much worse in comparison that it will discourage the public from taking it (or that the FDA can declare that it is not safe). They certainly seem to be implying that the current vaccines aren’t fit to serve as a comparator.
Click to expand...
Will this negatively impact people's ability to get the annual COVID booster?
 
CFordUNC said:
Will this negatively impact people's ability to get the annual COVID booster?
Click to expand...
I'm no expert on this but I've been looking into it over the last couple of days and here's my guess --

1. It certainly doesn't help.
2. It could mean it's harder to find available shots.
3. The "high risk" categories are broad enough that anyone who wants a shot should still be able to get one. But you'll probably have to pay out of pocket for it.
 
The MAHA commission also released a draft report on children’s health. Healthier food, limited use of technology and increased physical activity are things I wholeheartedly hope the government can encourage. They also talk about limiting exposure to environmental chemicals, which is certainly good but also at odds with, say, the EPA lifting limits on PFAS in drinking water.

There is a section on vaccines which reads to me like they will have an attempt at revising the childhood immunization schedule.

www.nytimes.com

Read the Full ‘Make America Healthy Again’ Report

The White House released an expansive report that blames a crisis of chronic disease in children on ultraprocessed foods, chemical exposures, lack of physical activity, stress and excessive use of prescription drugs.
www.nytimes.com www.nytimes.com
 
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