Peter Marks (Greg Nash/Pool via AP Images)

FDA's top vac­cine leader ex­plains why Covid-19 'boost­er­s' may re­al­ly just be the 3rd shot in the pri­ma­ry se­ries

Don’t call it a boost­er. Well, call it a boost­er for a lit­tle while longer but then we’ll just say it’s the third dose of a three-dose vac­cine, ac­cord­ing to FDA’s top vac­cine leader Pe­ter Marks.

Speak­ing on a stake­hold­er call with physi­cian groups ear­li­er this week, Marks ex­plained how flu­id the sit­u­a­tion is with ter­mi­nol­o­gy, af­ter a rep­re­sen­ta­tive from the Amer­i­can Acad­e­my of Fam­i­ly Physi­cians said there’s con­fu­sion around whether what the FDA au­tho­rized last week is ac­tu­al­ly a boost­er or the third dose in this ini­tial se­ries of Covid-19 vac­cine shots.

“This is again some­thing in a time of tran­si­tion,” Marks said in re­sponse. “Hon­est­ly, the rea­son why we’ve some­times called them third dos­es is be­cause the third dose is be­ing giv­en at six months and may in­deed be the third dose of a pri­ma­ry se­ries. It may be that af­ter this pan­dem­ic is over, much like the he­pati­tis B vac­cine or the he­pati­tis A vac­cine or oth­er adult vac­ci­na­tions, there will be three dos­es at 0, 1, and 6 months.”

He al­so said that the FDA is cur­rent­ly call­ing this third shot a boost­er so as not to alarm the gen­er­al pub­lic about not be­ing ful­ly vac­ci­nat­ed.

“Just to be to­tal­ly trans­par­ent, the rea­son for call­ing it a boost­er and not the third dose of a pri­ma­ry se­ries, is that we ac­tu­al­ly don’t want to alarm the en­tire pop­u­la­tion by sud­den­ly telling them that they’re no longer com­plete­ly vac­ci­nat­ed with a three dose se­ries. So it’s a boost­er for now and ul­ti­mate­ly we may tran­si­tion in­to call­ing it a three dose se­ries,” Marks said.

But he told physi­cian groups that in or­der to stay on the same page, they should stick with call­ing these third shots boost­ers be­cause that’s what they’re called on the la­bel, and that’s what peo­ple un­der­stand. For those who are im­muno­com­pro­mised, “we can call them third dos­es,” he added, while not­ing that it may turn out that im­muno­com­pro­mised peo­ple may need ad­di­tion­al boost­ing.

Janet Wood­cock, act­ing com­mis­sion­er of the FDA, al­so not­ed that in some im­muno­com­pro­mised peo­ple, that ad­di­tion­al boost may not work.

“You may be able to give them nu­mer­ous vac­ci­na­tions and they don’t re­spond, and that’s where we will be look­ing at pre-ex­po­sure pro­phy­lax­is and treat­ment with mon­o­clon­als and maybe some an­tivi­rals on the hori­zon,” Wood­cock added.

The com­ments fol­low a tu­mul­tuous few weeks of fig­ur­ing out who ex­act­ly should be the first to re­ceive the boost­ers (or third dos­es). The FDA gave the ex­pand­ed EUA for the Pfiz­er/BioN­Tech boost­er shot last week for a more nar­row pop­u­la­tion than the com­pa­nies ini­tial­ly want­ed.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News. 

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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