Max Bayer

Novavax expects post-marketing Covid study to cost up to $90M Novavax says conducting a post-marketing study for its Covid-19 vaccine will cost between $70 million and $90 million, following the FDA's more stringent approval framework that strongly advised the c...

The first bit of detail I've seen on the cost of these Phase 4 studies strongly recommended by the FDA to Covid-19 vaccine makers. endpoints.news/novavax-expe...

Prasad again overrode FDA vaccine reviewers, this time on Moderna’s Covid shot for young kids CBER chief Prasad overrides reviewers, approves Moderna's Covid shot only for at-risk kids 6mo-11yrs, marking his third override of review team recommendations.

FDA staff were overruled again by Vinay Prasad, who limited Moderna’s Covid vaccine to high-risk children under 12, arguing that healthy kids wouldn’t see sufficient clinical benefit.

Prasad again overrode FDA vaccine reviewers, this time on Moderna’s Covid shot for young kids CBER chief Prasad overrides reviewers, approves Moderna's Covid shot only for at-risk kids 6mo-11yrs, marking his third override of review team recommendations.

Vinay Prasad overrode Covid vaccine reviewers for a third time when he approved Moderna's Covid vaccine for at-risk young kids. The company had applied for approval for all kids 6 months to 11 years old, though its unclear what exactly reviewers decided. endpoints.news/prasad-overr...

Nearly 1 in 3 teens have prediabetes, CDC finds, in ‘wake-up call’ Nearly 1 in 3 American adolescents have prediabetes, a CDC report finds. An official notes "it’s not too late to change course."

About 1 in 3 young people who are 12 to 17 years old have prediabetes, new national data show.
www.statnews.com/2025/07/09/p...

CDC expands RSV vaccine recommendations, siding with previous panel of agency advisors The CDC will recommend RSV vaccines for all at-risk adults in their 50s, expanding its current guidance on the shots and siding with the agency's former panel of vaccine experts.

Our @endpts.com coverage, with my colleague Alexis Kramer: endpoints.news/cdc-expands-...

ACIP Recommendations ACIP approved the following recommendations by majority vote and were adopted by the CDC Director.

Breaking: HHS Sec. Kennedy has adopted ACIP recommendations made in April, including for RSV vaccines. The recommendation for RSV expanded their use to at-risk 50-59 year olds. Updated meningococcal rec also adopted. www.cdc.gov/acip/vaccine...

Without even addressing the merits of that goal, why does disconnecting from left-wing groups mean tying yourself to right-wing messaging? Regardless of whether it's meant to be ironic, the people behind this are implicitly conceding that Project 2025 as a package was good communication strategy.

One of the citations used to reach that conclusion is an extended essay authored in part by him, FDA commish
Marty Makary and senior advisor for clinical sciences Tracy Beth Høeg. Høeg's work is cited throughout the memo.

CBER chief Prasad suggests Covid vaccine harms may outweigh benefits in 'low-risk populations' CBER director Vinay Prasad says the benefits of Covid-19 vaccination have depreciated and may no longer outweigh the risks in adults who aren’t prone to more severe illness.

The FDA uploaded a number of new documents earlier this month involving Novavax's Covid-19 approval. New CBER chief Vinay Prasad wrote in a decisional memo that the harms of Covid vaccination may outweigh the benefits in "low-risk populations." endpoints.news/cber-chief-p...

Debate on a long-scrutinized vaccine ingredient consumes CDC panel in its second day Clinicians and infectious disease specialists clashed with the majority of the CDC’s remade vaccine advisory committee on Thursday, arguing that the panel’s debate over an ingredient in a small number...

ACIP voted to remove thimerosal from all flu vaccines, following a contentious debate between the rebuilt panel and clinicians.

The sole former ACIP member on the new panel, Dr. Cody Meissner, was the only "no" vote. Our @endpts.com story: endpoints.news/cdc-vaccine-...

The politics of vaccination take center stage as RFK Jr.’s rebuilt CDC panel is set to meet A newly rebuilt CDC vaccine advisory panel will meet for the first time this week, informing whether America's public health agency will continue to back data and evidence that have long guided its im...

Our @endpts.com preview story ahead of this week's ACIP meeting. Politics and science are on a collision course, with the nation's vaccine guidance hanging in the balance. endpoints.news/politics-col...

punches

Here's that CDC email

Updated: HHS chief Kennedy removes all ACIP members, dismantling vaccine board HHS Secretary Robert F. Kennedy Jr. announced the move in a Wall Street Journal op-ed, citing conflict of interest concerns.

A remarkable few hours. Every ACIP member has been terminated. Many weren't notified before RFK's op-ed. Some are now receiving a succinct notice from CDC. Our @endpts.com story: endpoints.news/trump-admini...

We are a crossroads. CDC immunization schedule lists a shared clinical decision-making recommendation for healthy kids. But HHS reiterates in a statement to me that recommendations have been removed for that group and pregnant women.

Q&A: Why former Sen. Kyrsten Sinema is backing a psychedelic medicine with potentially more upside, but more risk Sinema has backed a bill advancing in the Arizona legislature that would include a $5 million grant to a neurological institute to conduct a clinical study into ibogaine.

Had the opportunity to chat with former senator Kyrsten Sinema about psychedelics and ibogaine. Really interesting to hear what's galvanized her and why she's specifically backing this drug. endpts.com/former-sen-k...

Summit says bispecific misses overall survival in closely-watched lung cancer study Summit Therapeutics' ivonescimab shows 48% PFS benefit but misses OS endpoint in Phase 3 lung cancer trial; drug's regulatory future unclear after mixed EGFR+ NSCLC results.

⚡ BREAKING: Summit says PD-1xVEGF bispecific ivonsecimab misses overall survival in closely-watched lung cancer study $SMMT
endpts.com/summit-says-...

As I noted on X, the foundational science behind the vaccine technology was awarded a Nobel Prize in 2023.

The NOTUS reporters said they spent five days (!) going through the 522 citations in the report.

Updated: Trump administration halts more than $750M in funds for Moderna’s bird flu vaccine The Trump administration has killed two awards worth $766 million to help Moderna develop a bird flu vaccine, according to the company.

Our coverage: endpts.com/trump-axes-m...

Moderna's response to HHS saying that mRNA technology "remains under-tested" after axing funding for a bird flu vaccine:

"Results during the pandemic speak for themselves, including demonstrated efficacy and a safety profile established in over a billion people worldwide."

The fate of Moderna’s next-gen Covid shot looms large after a flurry of policy changes The US’ stance on Covid-19 vaccines under HHS chief Robert F. Kennedy Jr. is coming into focus with a new approval framework, new immunization guidance and, more broadly, a new attitude about the vacc...

Will Moderna's next-gen Covid vaccine be approved? I don't know! It very well might fit within the framework the FDA just put out. It's also technically the first "new" Covid vaccine in front of the FDA. I previewed the decision for @endpts.com. endpts.com/will-the-fda...

A new dawn for psychedelics? Compass could be the first to find out Compass awaits Phase 3 COMP360 trial results for treatment-resistant depression amid renewed optimism for psychedelics.

At the risk of sounding too horse race-y, Lykos' pain last year was Compass' gain in the race for the first FDA approved #psychedelic. My colleague Ayisha Sharma has a deeply reported story on the new frontrunner, and how commercial preparations are already underway.

endpts.com/a-new-dawn-f...

So it's here as well

The ‘MAHA report’: Four key takeaways on vaccines, medicine and the pharma industry The White House released its first MAHA Commission report, detailing some of the Trump administration’s top priorities for revamping the US healthcare system and issuing a “call to action.”

The White House MAHA Commission is out with its first report. Here are my four takeaways for the drug industry: endpts.com/the-maha-rep...

Makary, Prasad spell out FDA ground rules for future Covid vaccine approvals FDA chief Marty Makary and new CBER Director Vinay Prasad said that future Covid-19 vaccine approvals will focus on adults over 65 and high-risk people 6 months to 64 years ...

Breaking: Marty Makary and Vinay Prasad spell out new FDA framework for future Covid vaccine approval in @nejm.org editorial. The two will elaborate at town hall later this afternoon. For @endpts.com: endpts.com/future-covid...

RFK Jr. adopts new chikungunya vaccine guidance; other recommendations remain under review HHS Secretary Kennedy adopts CDC advisors' chikungunya vaccine guidance for Bavarian Nordic's shot, while RSV vaccine recommendations remain pending. Valneva's vaccine still approved for 18+.

RFK has adopted updated ACIP guidance for the chikungunya vaccines but recommendations for RSV and meningococcal shots remain under review.

For @endpts.com: endpts.com/kennedy-adop...

admittedly, i never really made Bluesky my default social media site, but i did find it difficult to commit to because decision makers in US government aren't on here. X as a product is complete crap but i do still learn things there...bots and spam aside.

From deal to disaster: Drugmakers face a changed Washington as Trump embraces ‘most favored nation’ prices President Trump met with pharma CEOs at the White House. After praising investments, a 'most favored nation' drug pricing plan has sparked industry alarm.

From deal to disaster: Drugmakers face a changed Washington as Trump embraces ‘most favored nation’ prices

Good reporting from @maxbayer.bsky.social and @drewsnews.bsky.social:

endpts.com/drugmakers-t...

From deal to disaster: Drugmakers face a changed Washington as Trump embraces ‘most favored nation’ prices President Trump met with pharma CEOs at the White House. After praising investments, a 'most favored nation' drug pricing plan has sparked industry alarm.

An @endpts.com exclusive: President Trump met privately with Dave Ricks last Wednesday following a White House event with CEOs celebrating new US investments. But for the pharma industry, the party quickly ended.

With @drewsnews.bsky.social

endpts.com/drugmakers-t...