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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.