Zachary Brennan

RFK Jr.’s Plan to Eliminate Vaccines Think VICP

This is ominous.

open.substack.com/pub/pauloffi...

FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked with rooting out dangerous manufacturing practices.

NEW: With deep job cuts at the FDA, inspectors say the ongoing strain could compromise policing an industry spread across more than 90 countries.

“Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.

6 (from today). RFK says he made no promises to Cassidy

Revised Recommendations for Covid-19 Vaccines — U.S. Vaccination Policy under Threat | NEJM A series of recent actions by the Trump administration upend the country’s approach to Covid-19 vaccination and may portend a broader shift in the government’s role in protecting the public health.

Things are very bad for U.S. vaccination policy these days and are only going to get worse. In @nejm.org, I examine the recent news about COVID-19 vaccines and ACIP, what likely lies ahead, and what the medical and public health communities should do to lessen the damage www.nejm.org/doi/full/10....

New CDC advisers will skip some expected topics and explore a target of antivaccine activists U.S. Health Secretary Robert F. Kennedy Jr.’s new vaccine advisers meet next week. Their agenda suggests they’ll skip some expected topics, including a vote on COVID-19 shots.

New CDC advisers will skip some expected topics and explore a target of antivaccine activists apnews.com/article/acip...

Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection

BREAKING: The FDA has approved a twice-yearly injection that provided a near-perfect shield against H.I.V. infection in clinical trials. But the Trump administration has gutted the programs that might have paid for it in low-income countries
(Gift article)

www.nytimes.com/2025/06/18/h...

👀

Feeling a lot like I did in early days of the pandemic these days. It is so clear what’s coming: The people that will die because of cuts in global health, because of cuts to research, because of the concerted anti-vaccine push.
It’s clear what’s coming, but we will have to wait to count the dead.🧪

Image shows PDF of article.

Viewpoint: The FDA's non-standard review of Novavax's #COVID19 vaccine raises concerns about regulatory integrity and the influence of political considerations on public health decisions.

https://ja.ma/3TepavL

How a discovery in Yellowstone National Park led to the development of PCR - Richmond Scientific A discovery in Yellowstone National Park led to the development of PCR, the gold-standard COVID-19 tests used to fight the global pandemic.

Reminder: Nobel-prize winning PCR (1983), used in basically all genetic tech today, was only possible because of extremophile bacterium discovered in 1964 in Yellowstone funded by a small ~$80k NSF grant with no obvious application at the time. #science 🧪
www.richmondscientific.com/how-a-discov...

the 10 out, 1 in policy is agency-wide, not at all specific to cell/gene therapies and there was no mention at that meeting of deregulating or changing any regs (RFK was talking about adding some, and asking for requests/lists on which to cut)

So it looks like #ACIP will be meeting later this month.
It will be interesting.
🍿
public-inspection.federalregister.gov/2025-10432.pdf

An increase of 10.9 million uninsured people, plus millions of others who will lose coverage if enhanced ACA premium tax credits expire this year, would reverse much of the gains in insurance coverage from the ACA.

FDA’s AI tool for medical devices struggles with simple tasks On Monday, the agency announced that a separate AI tool, called Elsa, had been rolled out to all FDA employees. Sources say that it also has issues.

NEW - A new FDA AI tool that could speed up reviews of medical devices is struggling with simple tasks, like uploading documents, according to two people familiar.

A separate tool, called Elsa, which was rolled out to FDA employees Monday is also having issues.

www.nbcnews.com/health/healt...

DOGE set today as their last day at FDA. Instead, they're continuing to get full pay and don't work FDA lawyer and other federal health agency workers remain on paid leave amid Trump administration cuts, awaiting court decisions while searching for new jobs.

Meet the FDAers who were cut by DOGE but still get paid in full w/benefits as they look for new work (going on month 3 now..) endpoints.news/laid-off-fda...

A screenshot of a table that reads: "Ages 19 Years or Older Legend Recommended vaccination for adults who meet age requirement, lack documentation of vaccination, or lack evidence of immunity Recommended vaccination for adults with an additional risk factor or another indication Recommended vaccination based on shared clinical decision-making No Guidance/Not Applicable Vaccine Pregnancy Immuno-compromised (excluding HIV infection) HIV infection CD4 percentage and count Men who have sex with men Asplenia, complement deficiency Heart or lung disease Kidney failure, End-stage renal disease or on dialysis Chronic liver disease; alcoholisma Diabetes Health care Personnelb <15% or <200/mm3 ≥15% and ≥200/mm3 COVID-19 more info icon. See Notes"

For pregnant women, CDC now lists COVID-19 vaccines during pregnancy as "No Guidance/Not Applicable"

www.cdc.gov/vaccines/hcp...

The MAHA Report Cites Studies That Don’t Exist The Trump administration’s “Make America Healthy Again” report misinterprets some studies and cites others that don’t exist, according to the listed authors.

This is what happens when you put internet conspiracy theorists in charge of major government departments.

If someone has to read halfway through your story before finding out Kennedy's step on COVID vaccination today is not in alignment with the scientific evidence you are doing it wrong.

ACOG Statement on HHS Recommendations Regarding the COVID Vaccine During Pregnancy ACOG strongly opposes the U.S. Department of Health and Human Services' decision to stop recommending the COVID vaccination during pregnancy, citing clear evidence of its safety and effectiveness in p...

These ACOG views were based on a significant studies. it will be interesting to see if the recommendation against vaccination is based on new evidence or some kind of interpretation of the old evidence.

www.acog.org/news/news-re...

The House reconciliation bill would penalize states to the tune of $92 billion if they use their own funds to provide health care to undocumented immigrants.
www.kff.org/medicaid/iss...

Goddamn. The dek really says it all.

Federal Officials May Limit Recommendations for Covid Vaccine

Come this fall, only older Americans and those with chronic health problems may be urged to get the Covid shot — assuming the vaccine is available at all.

www.nytimes.com/2025/05/15/h...

ENDPOINTSNEWS New CBER chief Prasad is readying 'massive frame-work' around vaccines, Makary says

The guy who demanded his predecessors do RCTs and bashes Big Pharma trials is suddenly going to pivot and claim the government has no role in generating evidence, and only Big Pharma trials are reliable.

I think it depends on which office approves it although the 2025 novel approvals page looks up to date for CDER

None of the approvals are there and the lack of one for Zevaskyn is prob more bc so many cell/gene therapy folks left rather than a comms issue — they’ve been posting PRs for updated labels too

Wait that’s not true - every new drug approval since the Trump admin started has received a PR

This is the equivalent of someone asking where Albany is located and you wrongly guess Vermont, and they say, “No, actually, it’s the United States.”

RFK Jr. said multiple times during his house and senate hearings today that no scientists have been fired from federal agencies. Our reporting has shown that hundreds, if not thousands, of scientists have been let go from NIH/CDC/FDA

ACF falls under HHS…there were quite a few gaffes in this exchange from Alsobrooks too

Why I’m Resigning from the NSF and Library of Congress I cannot participate in systems that require dishonesty as the price of belonging.

"For me, the answer now lies in refusal, the withdrawal of participation from systems that require dishonesty as the price of belonging."

Today I am resigning from the National Science Board and the Library of Congress Scholars Council.

I wrote about my decision in TIME.

time.com/7285045/resi...