Scot Roberts, Altimmune CSO

Why mu­cos­al im­mu­ni­ty may be re­quired to end the pan­dem­ic

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to Amber Tong.

Fol­low­ing the re­cent emer­gency use au­tho­riza­tions of mul­ti­ple vac­cines for COVID-19, the first wave of peo­ple have al­ready be­gun the vac­ci­na­tion process — a tru­ly re­mark­able mile­stone. As some­one who has ded­i­cat­ed his ca­reer to drug de­vel­op­ment and dis­cov­ery fo­cused on vi­ral vec­tors and an­tivi­ral ther­a­pies, I can tell you that the sci­ence has moved fast, and we have every rea­son to cel­e­brate. The da­ta on these vac­cines are good. They are well stud­ied and their po­ten­tial for pub­lic health is promis­ing.

How­ev­er, I can al­so tell you that this is like­ly on­ly the be­gin­ning. I wor­ry that the roll­out of the cur­rent vac­cines will cre­ate a false sense of se­cu­ri­ty among a large pop­u­la­tion of peo­ple. There is a sce­nario that we need to be pre­pared for and one that could pos­si­bly de­rail our fight against this virus: These first-gen­er­a­tion vac­cines will be able to ef­fec­tive­ly block dis­ease, but not the trans­mis­sion of the SARS-CoV-2 virus.

Pfiz­er, Mod­er­na and near­ly every oth­er phar­ma­ceu­ti­cal com­pa­ny are pro­duc­ing in­jectable vac­cines. Their pro­tec­tive pow­er re­sults from sys­temic im­mu­ni­ty, mean­ing that they gen­er­ate an­ti­bod­ies that cir­cu­late in the blood to oth­er parts of the body. They were au­tho­rized based on their abil­i­ty to block the de­vel­op­ment of dis­ease, which is not the same as the abil­i­ty to in­hib­it vi­ral in­fec­tion or trans­mis­sion.

The best way to block both vi­ral in­fec­tion and trans­mis­sion is by in­duc­ing a spe­cial type of im­mune re­sponse called mu­cos­al im­mu­ni­ty. Mu­cos­al im­mu­ni­ty pro­tects the parts of the body that are in con­tact with the en­vi­ron­ment, and in the case of a res­pi­ra­to­ry pathogen, that means the nasal cav­i­ty and the lungs. Be­cause it is a lo­cal­ized type of re­sponse, a vac­cine needs to be de­liv­ered to the ap­pro­pri­ate com­part­ment if mu­cos­al im­mu­ni­ty is to be stim­u­lat­ed. In the case of a res­pi­ra­to­ry pathogen like SARS-CoV-2 that means in­tranasal vac­cine ad­min­is­tra­tion.

With­out mu­cos­al im­mu­ni­ty, the virus may con­tin­ue to thrive in a per­son’s nasal cav­i­ty al­low­ing for easy trans­mis­sion. This is why wear­ing a mask, even af­ter vac­ci­na­tion with an in­tra­mus­cu­lar vac­cine, will re­main crit­i­cal.

Thank­ful­ly, sci­en­tists, in­clud­ing our team, are work­ing on next gen­er­a­tion vac­cines that can elic­it mu­cos­al im­mu­ni­ty, in­clud­ing in­tranasal vac­cines that have the po­ten­tial to elic­it an im­mune re­sponse in the nose as well as sys­tem­i­cal­ly. This type of broad­er im­mune re­sponse could de­fend against in­fec­tion, dis­ease and trans­mis­sion. In fact, an in­tranasal vac­cine could al­so be used in com­bi­na­tion with an in­tra­mus­cu­lar vac­cine to elic­it mu­cos­al im­mu­ni­ty and serve as a boost­er for sys­temic im­mu­ni­ty.

We have a prece­dent. Flu­Mist is a live but weak­ened in­fluen­za vac­cine de­liv­ered by in­tranasal spray and this type of mu­cos­al vac­cine has been shown to de­crease the trans­mis­sion of in­fluen­za to close con­tacts.

Be­cause of their po­ten­tial to block trans­mis­sion, vac­cines that stim­u­late nasal mu­cos­al im­mu­ni­ty may be es­sen­tial to bring the pan­dem­ic to an end. How­ev­er, it will take a lit­tle more time to de­vel­op and test these new­er vac­cines as we can’t sac­ri­fice ef­fi­ca­cy and safe­ty for speed.

Un­til then, the pub­lic must take pre­cau­tions to keep this virus un­der con­trol. Even af­ter vac­ci­na­tion, our best weapon is so­cial dis­tanc­ing, test­ing and masks. They must re­main a core part of our pub­lic health strat­e­gy even as the first-gen­er­a­tion vac­cines roll out.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Henrietta Lacks

UP­DAT­ED: Fed­er­al judge weighs mo­tion to dis­miss HeLa law­suit against Ther­mo Fish­er

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.