President Biden in the East Room of the White House (Evan Vucci/AP Images)

Opin­ion: How the con­fus­ing boost­er shot de­ba­cle aligns Biden with Trump's pan­dem­ic re­sponse

When Pres­i­dent Joe Biden took of­fice, many pub­lic health ad­vo­cates heaved a sigh of re­lief, as­sum­ing the US was back to fol­low­ing the sci­ence dur­ing this once-in-a-life­time pan­dem­ic, and gone were the days of an Amer­i­can pres­i­dent tout­ing in­ef­fec­tive treat­ments to the world.

But this lat­est de­ba­cle around the Pfiz­er/BioN­Tech boost­er shot has now not on­ly led to the re­tire­ments of two top FDA vac­cine of­fi­cials, both of whom would’ve been key re­sources as the US soon re­views Covid vac­cines for chil­dren, but al­so to ques­tion marks around con­flict­ing FDA and CDC opin­ions and lin­ger­ing de­bates on who ex­act­ly should re­ceive a boost first and who should be the one that makes that de­ci­sion.

This ul­ti­mate de­ci­sion to give a third Pfiz­er dose to vir­tu­al­ly any­one who asks for one casts a spot­light on those ear­ly Biden as­sump­tions from last win­ter.

“What Pres­i­dent Biden did es­sen­tial­ly was side­line the FDA and CDC and say, ‘I’m go­ing to de­clare this truth'” on boost­ers, Paul Of­fit, a mem­ber of the FDA’s vac­cine ad­comm and a vac­cine ex­pert at Chil­dren’s Hos­pi­tal of Philadel­phia, told me this morn­ing. “It’s rem­i­nis­cent to the last ad­min­is­tra­tion, which de­clared a se­ries of truths on hy­drox­y­chloro­quine and con­va­les­cent plas­ma.”

But Saad Omer, di­rec­tor of the Yale In­sti­tute for Glob­al Health, told End­points that this con­fus­ing boost­er process was “of a dif­fer­ent na­ture” when com­pared to what tran­spired with the Trump ad­min­is­tra­tion’s re­sponse to the pan­dem­ic be­cause Trump’s tech­ni­cal ex­perts tried to in­ter­vene and un­der­mine the process, as well as pres­sure the FDA com­mis­sion­er to align the vac­cine au­tho­riza­tion sched­ule with the elec­tion.

“That is qual­i­ta­tive­ly dif­fer­ent” from the boost­ers, Omer said.

Get­ting ahead of the sci­ence

Even still, just as Trump’s ad­min­is­tra­tion pushed for EUAs for con­va­les­cent plas­ma and hy­drox­y­chloro­quine pre­ma­ture­ly, and on na­tion­al tele­vi­sion no less in the case of plas­ma, Pres­i­dent Biden in Au­gust got way ahead of fed­er­al sci­en­tists and ad­vi­sors by set­ting a time­line for when the boost­ers would be ready, be­fore the da­ta had even been sub­mit­ted.

That ex­pe­dit­ed time­line meant that out­side ad­vi­sors to the FDA didn’t even have ad­e­quate time to re­view the da­ta ahead of their meet­ing.

“It was rushed. We were rushed. Usu­al­ly we get the doc­u­ments from the FDA and com­pa­ny two weeks be­fore [the ad­comm meet­ing], or no less than one week. Here we got it the day be­fore. And one of the pa­pers on which the con­tention was based that im­mu­ni­ty was fad­ing” came out the day be­fore too, Of­fit said.

Af­ter the ad­comm unan­i­mous­ly vot­ed that the boost­ers should not be pro­vid­ed to just any­one, the FDA had to scram­ble to ask the ad­comm an­oth­er ques­tion on whether to give boost­ers to se­niors and oth­ers who might be at risk of a se­ri­ous case of Covid-19.

“No­body had any prob­lem giv­ing this to peo­ple who are old­er. You get old­er, your im­mune sys­tem isn’t as ro­bust, so that was easy,” Of­fit said. “Then it be­came hard­er. It was not a leap to give it to peo­ple over 50 with high-risk med­ical con­di­tions, be­cause they might ben­e­fit. But then ACIP strug­gled” with younger pop­u­la­tions.

The strug­gling and scram­bling with­in the CDC and FDA oc­curred as the FDA’s own ca­reer of­fi­cials were dis­put­ing the need for boost­ers in the Lancet.

Make no mis­take, if Mar­i­on Gru­ber and Phil Krause had re­tired dur­ing the Trump ad­min­is­tra­tion, much more hys­te­ria would’ve en­sued on what ex­act­ly was play­ing out be­hind the scenes.

Of­fit said he thought the two FDA vac­cine of­fi­cials, Gru­ber and Krause, are re­tir­ing now be­cause they “didn’t like the way this played out. They see their job as pro­tect­ing the pub­lic from phar­ma­ceu­ti­cal com­pa­nies’ prod­ucts that may not have not been ad­e­quate­ly test­ed and I think that’s what wor­ries them about this.”

“The morale is low in both of these agen­cies,” Omer added. “I think, un­for­tu­nate­ly, a lot of peo­ple with a lot of ex­pe­ri­ence have been benched with­in these or­ga­ni­za­tions. And that in­cludes ex­ter­nal ad­vis­ers and in­ter­nal staff. A lot of spe­cial­ized ex­per­tise has been un­der­uti­lized and that’s a prob­lem.”

It’s re­al­ly the un­vac­ci­nat­ed 

Just as HCQ and con­va­les­cent plas­ma did not end the pan­dem­ic or speed its demise, Of­fit won­dered whether a third dose would have any ma­jor im­pact on the pan­dem­ic.

“Phar­ma­cists aren’t go­ing to ask where you work. If you want a third dose, you’ll get a third dose. But the prob­lem with this pan­dem­ic is not boost­ing, it’s get­ting peo­ple who are not vac­ci­nat­ed to get vac­ci­nat­ed,” Of­fit said. “Chil­dren and adults aren’t ad­mit­ted to the ICU be­cause they haven’t got a third dose, but be­cause they haven’t got any dose.”

Ja­son Schwartz

Oth­er vac­cine ex­perts like Yale’s Ja­son Schwartz agreed.

“This has to be far from what the White House want­ed, as the events of the past month have cre­at­ed so much con­fu­sion sur­round­ing the ne­ces­si­ty and ur­gency of boost­ers for the ful­ly vac­ci­nat­ed, while tak­ing at­ten­tion away from the much more press­ing need to reach the tens of mil­lions of Amer­i­cans who are el­i­gi­ble for vac­ci­na­tion but have yet to re­ceive their ini­tial dos­es,” Schwartz told the Wash­ing­ton Post.

So if the first and sec­ond dos­es are the key to wran­gling this pan­dem­ic, should the US just ship its stock­pile of boost­ers abroad?

Yes, Of­fit says, as first and sec­ond dos­es pro­vide far more of an im­pact than giv­ing a third dose.

Omer al­so stressed the need for glob­al vac­cine eq­ui­ty, but he said he thought the US could ad­min­is­ter boost­er shots while in­creas­ing vac­cine do­na­tions to needy coun­tries.

“We can walk and chew gum at the same time,” he said.

‘What’s the prob­lem’

Where­as the da­ta or lack there­of have been of such para­mount im­por­tance through­out this pan­dem­ic in de­ter­min­ing which treat­ments to use and which to stop us­ing, the da­ta be­hind the boost­er shots were much more lim­it­ed than what the FDA and CDC re­lied on for the ini­tial ap­proval. It still re­mains un­clear if an ad­di­tion­al boost­er will be nec­es­sary in an­oth­er six months or year.

“The frus­tra­tion for me in all this is: What’s the prob­lem? Dr. [Rochelle] Walen­sky and oth­ers have said they’re try­ing to pre­vent se­ri­ous ill­ness. All of the da­ta pre­sent­ed by the CDC or pub­lished by the CDC have shown these vac­cines do ex­act­ly that,” Of­fit said. “The ad­min­is­tra­tion ul­ti­mate­ly got what it want­ed, which is the doors were opened.”

An­oth­er pos­si­ble rea­son the Biden ad­min­is­tra­tion want­ed to set a boost­er time­line is be­cause of the mas­sive num­ber of dos­es that may end up wast­ed with­out this third shot cam­paign.

“Why give Sept. 20 as a date? One pos­si­bil­i­ty is they have enough vac­cines to vac­ci­nate every­one in this coun­try. They paid for dos­es that are sit­ting around, and we’d be bet­ter off with this vac­cine in arms than in trash cans,” Of­fit added.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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