(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee on Tues­day vot­ed 17-0, with one pan­elist ab­stain­ing, that the ben­e­fits of the Pfiz­er-BioN­Tech Covid-19 vac­cine out­weigh the risks for chil­dren be­tween the ages of five and 12.

The vote will like­ly trig­ger a process that could al­low the shots to be­gin rolling out as ear­ly as next week.

The vac­cine, which is one-third of the adult Pfiz­er dose, proved to be about 90% ef­fec­tive in a place­bo-con­trolled tri­al in which about 1,500 kids in this age range re­ceived the vac­cine, and on­ly about 12% of those re­ceiv­ing the vac­cine had any ad­verse event. All se­ri­ous ad­verse events in the tri­al were un­re­lat­ed to the vac­cine.

William Gru­ber

Pfiz­er’s William Gru­ber pre­sent­ed the find­ings of his com­pa­ny’s tri­al, not­ing that vac­ci­nat­ing chil­dren can help re­duce hos­pi­tal­iza­tions, as well as of­fer oth­er so­ci­etal ben­e­fits in terms of help­ing the US reach herd im­mu­ni­ty and lim­it­ing com­mu­ni­ty spread and school out­breaks and clo­sures.

“The ob­served AE pro­file in this study did not sug­gest any safe­ty con­cerns” for vac­ci­nat­ing this age group with Pfiz­er’s vac­cine, Gru­ber said.

The FDA, mean­while, mod­eled six dif­fer­ent sce­nar­ios look­ing at po­ten­tial Covid-19 case­loads and the ben­e­fits and risks of each — from peak Delta surge to the low­est record­ed in­ci­dence of Covid-19 from last June. The agency found that the ben­e­fits of the vac­cine out­weighed the risks in every sce­nario, and “the over­all ben­e­fits of the vac­cine may still out­weigh the risks un­der this low­est in­ci­dence sce­nario.”

Near­ly every ad­comm mem­ber seemed to agree, de­spite ex­press­ing some reser­va­tions about mak­ing such a de­ci­sion based on the lim­it­ed da­ta in this pop­u­la­tion.

Paul Of­fit

Pan­elist Paul Of­fit, pro­fes­sor of pe­di­atrics at Chil­dren’s Hos­pi­tal of Philadel­phia, made clear the de­ci­sion was “nerve-wrack­ing” be­cause the tri­al in­volved on­ly a few thou­sand chil­dren. But over­all, he vot­ed yes, and said he found sev­er­al dif­fer­ent as­pects of the da­ta around a rare heart side ef­fect, known as my­ocardi­tis, re­as­sur­ing.

Ad­comm mem­ber Er­ic Ru­bin, ed­i­tor-in-chief of the New Eng­land Jour­nal of Med­i­cine and an ad­junct Har­vard pro­fes­sor, al­so not­ed the dif­fi­cul­ty of the de­ci­sion, but vot­ed “yes,” ex­plain­ing ear­li­er that if he had a child who’s a trans­plant re­cip­i­ent, he would want them to be vac­ci­nat­ed, even if there are some kids who should not be vac­ci­nat­ed. “It’s a rel­a­tive­ly close call,” he said.

Michael Kuril­la

CBER di­rec­tor Pe­ter Marks al­so weighed in sev­er­al times dur­ing the meet­ing on Tues­day, try­ing to steer the con­ver­sa­tion away from talk of vac­cine man­dates, while ex­plain­ing at one point that the US has au­tho­rized vac­cines for kids, such as with the flu, where there are on­ly about 100 deaths per year.

But pan­elist Michael Kuril­la of NIH — the on­ly ad­comm mem­ber to ab­stain from vot­ing — said ear­li­er in the day that the ben­e­fit of this vac­cine for kids of this age is as­sumed to be pre­ven­tion of se­vere dis­ease, but par­tic­u­lar­ly as the CDC es­ti­mates about 40% of this pop­u­la­tion has al­ready had Covid, the ques­tion then be­comes: Does this of­fer any ben­e­fit to them at all?

He al­so raised con­cerns about chil­dren in­fect­ed with the Delta strain and what a vac­ci­na­tion might do for the fu­ture, with dif­fer­ent type of vari­ants. “We have no idea,” adding that he thought one dose might be suf­fi­cient, but al­so ac­knowl­edg­ing that “for high-risk chil­dren, it’s very dif­fer­ent.”

Kathrin Jansen, head of R&D at Pfiz­er, said in a state­ment:

COVID-19 is an on­go­ing threat for the more than 28 mil­lion young chil­dren in this age group in the U.S., as they re­main at risk for this in­fec­tion. About 10% of all week­ly U.S. cas­es oc­cur in chil­dren 5 to un­der 12 years of age with a po­ten­tial risk of com­pli­ca­tions. In ad­di­tion, im­mu­niz­ing chil­dren will help to get us clos­er to herd im­mu­ni­ty, with the po­ten­tial to stem the pan­dem­ic soon­er. We thank the FDA ad­vi­so­ry com­mit­tee for their re­view and pos­i­tive rec­om­men­da­tion in sup­port of Emer­gency Use Au­tho­riza­tion to help pro­tect this young pop­u­la­tion.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

WHO rec­om­mends against the use of con­va­les­cent plas­ma for Covid-19

The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.

The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:

Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.

Gilead re­calls 2 lots of Vek­lury af­ter in­ves­ti­ga­tion con­firms com­plaint of glass par­tic­u­lates

Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.

Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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