Reposted by Hexagon
Great post @ruxandrabio.bsky.social on FDA’s refusal to review Moderna’s flu vaccine, changing its position on what trial design was acceptable.
Regulatory uncertainty doesn’t just mean missing out on this vaccine, but also reduces future R&D investment:
clinicaltrialsabundance.blog/p/the-modern...
Regulatory uncertainty doesn’t just mean missing out on this vaccine, but also reduces future R&D investment:
clinicaltrialsabundance.blog/p/the-modern...
February 11, 2026 at 4:17 PM
Great post @ruxandrabio.bsky.social on FDA’s refusal to review Moderna’s flu vaccine, changing its position on what trial design was acceptable.
Regulatory uncertainty doesn’t just mean missing out on this vaccine, but also reduces future R&D investment:
clinicaltrialsabundance.blog/p/the-modern...
Regulatory uncertainty doesn’t just mean missing out on this vaccine, but also reduces future R&D investment:
clinicaltrialsabundance.blog/p/the-modern...
Reposted by Hexagon
BREAKING: @lizzylawrence.bsky.social reports that CBER director Vinay Prasad overruled career #FDA staff and unilaterally decided to refusal to accept #Moderna 's #flu vaccine submission. www.statnews.com/2026/02/11/m...
February 11, 2026 at 3:38 PM
BREAKING: @lizzylawrence.bsky.social reports that CBER director Vinay Prasad overruled career #FDA staff and unilaterally decided to refusal to accept #Moderna 's #flu vaccine submission. www.statnews.com/2026/02/11/m...
Reposted by Hexagon
RFK Jr says, falsely, that Covid vaccines are “the most deadly vaccines in history,” & he says, falsely, that "Gardasil HPV vaccine appears to be increasing the risk of cervical cancer in vaccinated age groups," so it's no surprise the next targets of his anti-vaxx activism are Covid & HPV vaccines😔
Federal vaccine advisers are setting their sights on the next targets: the mRNA Covid shots, and vaccines offered to pregnant women. One panelist, Robert Malone, says he is “trying to force FDA to come clean” on data showing harms of COVID shots
Gift link: www.nytimes.com/2026/02/06/h...
Gift link: www.nytimes.com/2026/02/06/h...
Federal Vaccine Advisers Take Aim at Covid Shots
www.nytimes.com
February 6, 2026 at 4:38 PM
RFK Jr says, falsely, that Covid vaccines are “the most deadly vaccines in history,” & he says, falsely, that "Gardasil HPV vaccine appears to be increasing the risk of cervical cancer in vaccinated age groups," so it's no surprise the next targets of his anti-vaxx activism are Covid & HPV vaccines😔
Reposted by Hexagon
Federal vaccine advisers are setting their sights on the next targets: the mRNA Covid shots, and vaccines offered to pregnant women. One panelist, Robert Malone, says he is “trying to force FDA to come clean” on data showing harms of COVID shots
Gift link: www.nytimes.com/2026/02/06/h...
Gift link: www.nytimes.com/2026/02/06/h...
Federal Vaccine Advisers Take Aim at Covid Shots
www.nytimes.com
February 6, 2026 at 3:14 PM
Federal vaccine advisers are setting their sights on the next targets: the mRNA Covid shots, and vaccines offered to pregnant women. One panelist, Robert Malone, says he is “trying to force FDA to come clean” on data showing harms of COVID shots
Gift link: www.nytimes.com/2026/02/06/h...
Gift link: www.nytimes.com/2026/02/06/h...
Reposted by Hexagon
NEW: The F.D.A. refused to accept an application from Moderna for its mRNA flu vaccine.
Its reason: The agency did not think Moderna compared the new vaccine to one of the best flu shots available. The company spent $750M+ on a 41,000 person study.
www.nytimes.com/2026/02/10/h...
Its reason: The agency did not think Moderna compared the new vaccine to one of the best flu shots available. The company spent $750M+ on a 41,000 person study.
www.nytimes.com/2026/02/10/h...
F.D.A. Refuses to Review Moderna Flu Vaccine
www.nytimes.com
February 10, 2026 at 11:12 PM
NEW: The F.D.A. refused to accept an application from Moderna for its mRNA flu vaccine.
Its reason: The agency did not think Moderna compared the new vaccine to one of the best flu shots available. The company spent $750M+ on a 41,000 person study.
www.nytimes.com/2026/02/10/h...
Its reason: The agency did not think Moderna compared the new vaccine to one of the best flu shots available. The company spent $750M+ on a 41,000 person study.
www.nytimes.com/2026/02/10/h...
Reposted by Hexagon
Reposted by Hexagon
Huh.
It's almost as if betting the world on a game of "let's pretend" between a bunch of pseudoscientific cosplayers wasn't a great public health strategy for dealing with COVID after all. 🤔
It must be nothing though. I'm sure we could trust management-class MDs to tell us if they got it wrong...
It's almost as if betting the world on a game of "let's pretend" between a bunch of pseudoscientific cosplayers wasn't a great public health strategy for dealing with COVID after all. 🤔
It must be nothing though. I'm sure we could trust management-class MDs to tell us if they got it wrong...
February 11, 2026 at 12:32 AM
Huh.
It's almost as if betting the world on a game of "let's pretend" between a bunch of pseudoscientific cosplayers wasn't a great public health strategy for dealing with COVID after all. 🤔
It must be nothing though. I'm sure we could trust management-class MDs to tell us if they got it wrong...
It's almost as if betting the world on a game of "let's pretend" between a bunch of pseudoscientific cosplayers wasn't a great public health strategy for dealing with COVID after all. 🤔
It must be nothing though. I'm sure we could trust management-class MDs to tell us if they got it wrong...
Reposted by Hexagon
This is troubling for multiple reasons, but one big one is companies won’t want to invest in R&D and clinical trials if they don’t think they can get a fair regulatory review—which is at the end of a long and extremely expensive process.
www.nytimes.com/2026/02/10/h...
www.nytimes.com/2026/02/10/h...
F.D.A. Refuses to Review Moderna Flu Vaccine
www.nytimes.com
February 11, 2026 at 12:37 AM
This is troubling for multiple reasons, but one big one is companies won’t want to invest in R&D and clinical trials if they don’t think they can get a fair regulatory review—which is at the end of a long and extremely expensive process.
www.nytimes.com/2026/02/10/h...
www.nytimes.com/2026/02/10/h...
Reposted by Hexagon
It is absolutely outrageous that Moderna’s flu vaccine was met with a “refusal-to-file” even after their approved their protocol with FDA and carried out the trial as agreed. This vaccine works better in older adults than the current flu vaccines.
apnews.com/article/mode...
apnews.com/article/mode...
Moderna says FDA refuses its application for new mRNA flu vaccine
The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA technology.
apnews.com
February 11, 2026 at 12:13 AM
It is absolutely outrageous that Moderna’s flu vaccine was met with a “refusal-to-file” even after their approved their protocol with FDA and carried out the trial as agreed. This vaccine works better in older adults than the current flu vaccines.
apnews.com/article/mode...
apnews.com/article/mode...
Reposted by Hexagon
“They are refusing to review a new vaccine with a more flexible technology, while creating a real risk we will not have traditional vaccines for next year," @doritreiss.bsky.social said.
www.theguardian.com/us-news/2026...
www.theguardian.com/us-news/2026...
FDA declines to review Moderna application for new flu vaccine
Moderna requests meeting to discuss refusal as decision could have implications for all new and updated vaccines
www.theguardian.com
February 11, 2026 at 12:08 AM
“They are refusing to review a new vaccine with a more flexible technology, while creating a real risk we will not have traditional vaccines for next year," @doritreiss.bsky.social said.
www.theguardian.com/us-news/2026...
www.theguardian.com/us-news/2026...
Reposted by Hexagon
NEW: The AMA and a leading public health research group focused on vaccines are teaming up to create a parallel system to review vaccine safety and effectiveness.
The CDC’s vaccine review process has “effectively collapsed” under RFKJr. My story.
www.washingtonpost.com/health/2026/...
www.washingtonpost.com/health/2026/...
AMA joins effort to launch vaccine science review amid CDC turmoil
The American Medical Association and a partner group are taking on a new role in reviewing vaccine safety and effectiveness as the CDC’s review process faces criticism.
www.washingtonpost.com
February 10, 2026 at 12:15 PM
NEW: The AMA and a leading public health research group focused on vaccines are teaming up to create a parallel system to review vaccine safety and effectiveness.
The CDC’s vaccine review process has “effectively collapsed” under RFKJr. My story.
www.washingtonpost.com/health/2026/...
www.washingtonpost.com/health/2026/...
Reposted by Hexagon
For most people, the pandemic days of masking are behind us. In certain corners of the Winter Olympics, though, things still look a lot like they did in Covid times. Some athletes are taking extreme measures to stay healthy. n.pr/4akK70l
Olympic Covid restrictions are gone, but some athletes still self-quarantining
For most people, the pandemic days of masking are behind us. In certain corners of the Winter Olympics, though, things still look a lot like they did in Covid times. Some athletes are taking extreme measures to stay healthy.
n.pr
February 9, 2026 at 1:16 PM
For most people, the pandemic days of masking are behind us. In certain corners of the Winter Olympics, though, things still look a lot like they did in Covid times. Some athletes are taking extreme measures to stay healthy. n.pr/4akK70l
Reposted by Hexagon
An airborne virus is a virus that can infect other people through unseen particles in the air, sometimes for hours after the sick person has left the area! Masks and clean, ventilated air can reduce the risk of getting sick from airborne viruses or infecting others.
February 5, 2026 at 4:48 PM
An airborne virus is a virus that can infect other people through unseen particles in the air, sometimes for hours after the sick person has left the area! Masks and clean, ventilated air can reduce the risk of getting sick from airborne viruses or infecting others.
Reposted by Hexagon
Our new paper:
Synthesis challenges in complex evidence: A critical analysis of systematic reviews of face mask efficacy
#episky #healthpolicy #medsky
www.cambridge.org/core/journal...
Synthesis challenges in complex evidence: A critical analysis of systematic reviews of face mask efficacy
#episky #healthpolicy #medsky
www.cambridge.org/core/journal...
Synthesis challenges in complex evidence: A critical analysis of systematic reviews of face mask efficacy | Research Synthesis Methods | Cambridge Core
Synthesis challenges in complex evidence: A critical analysis of systematic reviews of face mask efficacy
www.cambridge.org
February 6, 2026 at 10:25 AM
Our new paper:
Synthesis challenges in complex evidence: A critical analysis of systematic reviews of face mask efficacy
#episky #healthpolicy #medsky
www.cambridge.org/core/journal...
Synthesis challenges in complex evidence: A critical analysis of systematic reviews of face mask efficacy
#episky #healthpolicy #medsky
www.cambridge.org/core/journal...
Reposted by Hexagon
74,000 patients enrolled in clinical trials were affected.
You don’t terminate funding for clinical trials midway & “order” patient care to continue.
That’s not how it works.
I can’t tell whether Jay Bhattacharya is lying or just showing off his sparkling incompetence.
🧪 archive.today/ooHj6
You don’t terminate funding for clinical trials midway & “order” patient care to continue.
That’s not how it works.
I can’t tell whether Jay Bhattacharya is lying or just showing off his sparkling incompetence.
🧪 archive.today/ooHj6
February 3, 2026 at 7:02 PM
74,000 patients enrolled in clinical trials were affected.
You don’t terminate funding for clinical trials midway & “order” patient care to continue.
That’s not how it works.
I can’t tell whether Jay Bhattacharya is lying or just showing off his sparkling incompetence.
🧪 archive.today/ooHj6
You don’t terminate funding for clinical trials midway & “order” patient care to continue.
That’s not how it works.
I can’t tell whether Jay Bhattacharya is lying or just showing off his sparkling incompetence.
🧪 archive.today/ooHj6
Reposted by Hexagon
This is good news. I was wondering aloud to my students recently as to whether other states would follow California's lead in joining this. Hopefully we'll see others too from these new cross-state health alliances (e.g., the Governors' Health Alliance IL & CA are part of). 🛟 health policy idsky 😷
Illinois joins WHO global outbreak network after U.S. withdraws
Article Summary JB Pritzker announced Illinois will join the World Health Organization’s Global Outbreak Alert and Response Network, allowing the
capitolnewsillinois.com
February 3, 2026 at 11:54 PM
This is good news. I was wondering aloud to my students recently as to whether other states would follow California's lead in joining this. Hopefully we'll see others too from these new cross-state health alliances (e.g., the Governors' Health Alliance IL & CA are part of). 🛟 health policy idsky 😷
Reposted by Hexagon
Reposted by Hexagon
Under RFK, Jr., the CDC's authority has crumbled: it is no longer updating dozens of health databases, and has abandoned vaccine guidelines. But states and governors are trying to fill the void, @laurenjyoung.bsky.social writes @scifri.bsky.social: www.scientificamerican.com/article/stat...
A ‘shadow CDC’ is scrambling to fill gaps in public health data
Dozens of routinely updated CDC databases have gone quiet. Here’s what states and medical societies are doing to preserve U.S. public health
www.scientificamerican.com
February 3, 2026 at 5:18 PM
Under RFK, Jr., the CDC's authority has crumbled: it is no longer updating dozens of health databases, and has abandoned vaccine guidelines. But states and governors are trying to fill the void, @laurenjyoung.bsky.social writes @scifri.bsky.social: www.scientificamerican.com/article/stat...
Reposted by Hexagon
Only 10 cases of Guinea worm disease were recorded *globally* last year.
It may become the second human disease we eradicate, after smallpox.
It may become the second human disease we eradicate, after smallpox.
February 4, 2026 at 11:38 AM
Only 10 cases of Guinea worm disease were recorded *globally* last year.
It may become the second human disease we eradicate, after smallpox.
It may become the second human disease we eradicate, after smallpox.
Reposted by Hexagon
An infant in New Mexico has just died from listeria.
Public health officials think it is because the mother drank raw milk during pregnancy.
I can imagine this family’s pain.
Please, please don’t drink raw milk. It is of no benefit whatsoever.
Public health officials think it is because the mother drank raw milk during pregnancy.
I can imagine this family’s pain.
Please, please don’t drink raw milk. It is of no benefit whatsoever.
New Mexico warns against consuming raw milk after newborn dies from listeria
While the New Mexico Department of Health said it can't pinpoint the baby's exact cause of death, officials believe it could have been linked to the mother's drinking raw milk during pregnancy.
www.nbcnews.com
February 4, 2026 at 1:08 PM
An infant in New Mexico has just died from listeria.
Public health officials think it is because the mother drank raw milk during pregnancy.
I can imagine this family’s pain.
Please, please don’t drink raw milk. It is of no benefit whatsoever.
Public health officials think it is because the mother drank raw milk during pregnancy.
I can imagine this family’s pain.
Please, please don’t drink raw milk. It is of no benefit whatsoever.
Reposted by Hexagon
Singapore’s Ministry of Health studied 19,689 patients and found that early COVID-19 monoclonal antibody treatment did not reduce long COVID overall but was linked to at least double the risk of autoimmune diseases like lupus and rheumatoid arthritis.
www.sciencedirect.com/science/arti...
www.sciencedirect.com/science/arti...
Early administration of neutralising monoclonal antibodies and post-acute sequelae of COVID-19
Post-acute sequelae of COVID-19 (PASC) are more common in unvaccinated or immunocompromised individuals. In Singapore, neutralising monoclonal antibod…
www.sciencedirect.com
February 4, 2026 at 12:26 AM
Singapore’s Ministry of Health studied 19,689 patients and found that early COVID-19 monoclonal antibody treatment did not reduce long COVID overall but was linked to at least double the risk of autoimmune diseases like lupus and rheumatoid arthritis.
www.sciencedirect.com/science/arti...
www.sciencedirect.com/science/arti...
Reposted by Hexagon
Lots to think about in my annual roundup of peer review research:
- AI, mostly bad; some suggestions of ways it may help
- Evidence on financial rewards for peer review
- Influence of editors' biases
More on equity & diversity; librarians & systematic reviews
absolutelymaybe.plos.org/2026/02/02/5...
- AI, mostly bad; some suggestions of ways it may help
- Evidence on financial rewards for peer review
- Influence of editors' biases
More on equity & diversity; librarians & systematic reviews
absolutelymaybe.plos.org/2026/02/02/5...
5 Things We Learned About Journal Peer Review in 2025 - Absolutely Maybe
Back in 2019 I wrote a couple of posts summarizing what we had learned from research about peer review at journals. Since…
absolutelymaybe.plos.org
February 3, 2026 at 6:56 AM
Lots to think about in my annual roundup of peer review research:
- AI, mostly bad; some suggestions of ways it may help
- Evidence on financial rewards for peer review
- Influence of editors' biases
More on equity & diversity; librarians & systematic reviews
absolutelymaybe.plos.org/2026/02/02/5...
- AI, mostly bad; some suggestions of ways it may help
- Evidence on financial rewards for peer review
- Influence of editors' biases
More on equity & diversity; librarians & systematic reviews
absolutelymaybe.plos.org/2026/02/02/5...
Reposted by Hexagon
There are approximately 1000 research groups on the #NIH campuses, including Steve Rosenberg's research group, which develops groundbreaking T-cell therapies for cancer.
Effectively all of those groups were suddenly prohibited from buying any (!) supplies last year.
That is on the leadership.
Effectively all of those groups were suddenly prohibited from buying any (!) supplies last year.
That is on the leadership.
BHATTACHARYA: I do not believe patients' care was disrupted. If there were disruptions, it's the responsibility of the researchers, not the NHS
HASSAN: That is an unacceptable and outrageous response. You can make an edict - 'Don't disrupt care!' - but that can be a very complicated thing
HASSAN: That is an unacceptable and outrageous response. You can make an edict - 'Don't disrupt care!' - but that can be a very complicated thing
February 3, 2026 at 10:45 PM
There are approximately 1000 research groups on the #NIH campuses, including Steve Rosenberg's research group, which develops groundbreaking T-cell therapies for cancer.
Effectively all of those groups were suddenly prohibited from buying any (!) supplies last year.
That is on the leadership.
Effectively all of those groups were suddenly prohibited from buying any (!) supplies last year.
That is on the leadership.
Reposted by Hexagon
"Doctors nationally are describing harrowing consequences for patients who delayed seeking care or skipped it altogether..." @danielpayne.bsky.social reports on the ICE crackdown's chilling effect on immigrants seeking necessary health care. www.statnews.com/2026/02/03/i...
Fearing ICE crackdown, immigrants nationally are avoiding treatment, sometimes with dire consequences
Doctors nationally are describing harrowing consequences for patients who put off medical care because of fears of ICE.
www.statnews.com
February 3, 2026 at 3:18 PM
"Doctors nationally are describing harrowing consequences for patients who delayed seeking care or skipped it altogether..." @danielpayne.bsky.social reports on the ICE crackdown's chilling effect on immigrants seeking necessary health care. www.statnews.com/2026/02/03/i...
