Albert Bourla, Pfizer CEO (John Thys, Pool/AFP via Getty Images)

Covid-19 roundup: Pfiz­er, BioN­Tech seek au­tho­riza­tion of vac­cine for 5- to 11-year-olds; Fin­land halts roll­out of Mod­er­na vac­cine in younger men — re­port

Pfiz­er and BioN­Tech have of­fi­cial­ly asked the FDA to au­tho­rize their Covid-19 vac­cine for emer­gency use in chil­dren be­tween the ages of 5 and 11 years old, the phar­ma an­nounced Thurs­day on Twit­ter.

The FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee will meet on Oct. 26 to dis­cuss the sub­mis­sion. If ap­proved, the Covid-19 vac­cine would be the first avail­able to kids of this age group.

“We know from our vast ex­pe­ri­ence with oth­er pe­di­atric vac­cines that chil­dren are not small adults, and we will con­duct a com­pre­hen­sive eval­u­a­tion of clin­i­cal tri­al da­ta sub­mit­ted in sup­port of the safe­ty and ef­fec­tive­ness of the vac­cine used in a younger pe­di­atric pop­u­la­tion, which may need a dif­fer­ent dosage or for­mu­la­tion from that used in an old­er pe­di­atric pop­u­la­tion or adults,” act­ing FDA com­mis­sion­er Janet Wood­cock said in a state­ment.

The news comes just over a week af­ter Pfiz­er and BioN­Tech sub­mit­ted ini­tial da­ta from their pe­di­atric tri­al to the agency, show­ing a 10 μg dose giv­en to chil­dren be­tween 5 and 11 years old achieved a com­pa­ra­ble re­sponse to 30 μg dos­es giv­en to peo­ple be­tween 16 and 25. The 10 μg dose was “care­ful­ly se­lect­ed as the pre­ferred dose for safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty” in the younger age group, the com­pa­nies said.

Topline read­outs on the vac­cine’s per­for­mance in chil­dren be­tween 2 and 4 years old, and be­tween 6 months and 1 year old are ex­pect­ed by the fourth quar­ter of this year.

“With new cas­es in chil­dren in the U.S. con­tin­u­ing to be at a high lev­el, this sub­mis­sion is an im­por­tant step in our on­go­ing ef­fort against #COVID19,” Pfiz­er tweet­ed on Thurs­day.

Ac­cord­ing to the phar­ma, chil­dren un­der the age of 18 ac­count­ed for around 27% of all Covid cas­es in the US last week. Of­fi­cials told the Wash­ing­ton Post that an au­tho­riza­tion for 5- to 11-year-olds could come be­tween Hal­loween and Thanks­giv­ing.

Fin­land halts roll­out of Mod­er­na vac­cine in younger men over heart in­flam­ma­tion — re­port

Fin­land is slam­ming the brakes on the use of Mod­er­na’s Covid-19 vac­cine in younger men over re­ports of a rare car­dio­vas­cu­lar side ef­fect called my­ocardi­tis, Reuters re­port­ed on Thurs­day.

My­ocardi­tis refers to in­flam­ma­tion of the mid­dle lay­er of the heart wall, which can lead to chest pain, an ab­nor­mal heart­beat, and short­ness of breath. Mi­ka Salmi­nen, di­rec­tor of the Finnish health in­sti­tute, said an un­pub­lished study in Swe­den, Fin­land, Nor­way and Den­mark showed men un­der the age of 30 who re­ceived Mod­er­na’s shot were at a slight­ly high­er risk of de­vel­op­ing the con­di­tion.

As a re­sult, Sami­nen said Pfiz­er’s vac­cine would now be giv­en to men born af­ter 1991, ac­cord­ing to Reuters.

It was first re­port­ed that Swe­den and Den­mark had al­so paused dis­tri­b­u­tion of the vac­cine in younger men, but Den­mark said on Fri­day that it was still of­fer­ing Mod­er­na’s vac­cine to men un­der 18, and that any sug­ges­tion oth­er­wise had been a mis­com­mu­ni­ca­tion.

“The Dan­ish Health Agency con­tin­ues to as­sess that both COVID-19 vac­cines, both the one from Pfiz­er/BioN­Tech and the one from Mod­er­na, are high­ly ef­fec­tive vac­cines that have an im­por­tant place in the gen­er­al vac­ci­na­tion pro­gramme in Den­mark,” the Dan­ish Health Agency said, per Reuters.

A Mod­er­na spokesper­son told the news agency that the my­ocardi­tis cas­es were typ­i­cal­ly mild, and in­di­vid­u­als tend to re­cov­er in a “short time fol­low­ing stan­dard treat­ment and rest.”

My­ocardi­tis, the spokesper­son point­ed out, is al­so a risk af­ter Covid-19 in­fec­tion.

The CDC has not­ed that cas­es of my­ocardi­tis have been re­port­ed af­ter vac­ci­na­tion with both the Pfiz­er-BioN­Tech and Mod­er­na vac­cines, es­pe­cial­ly in male ado­les­cents and young adults. But the agency has stressed that the ben­e­fits of the vac­cine far out­weigh the risks.

“The known risks of COVID-19 ill­ness and its re­lat­ed, pos­si­bly se­vere com­pli­ca­tions, such as long-term health prob­lems, hos­pi­tal­iza­tion, and even death, far out­weigh the po­ten­tial risks of hav­ing a rare ad­verse re­ac­tion to vac­ci­na­tion, in­clud­ing the pos­si­ble risk of my­ocardi­tis or peri­cardi­tis,” the CDC said in a state­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Aaron Siri, Siri & Glimstad

FDA shuts down an­ti-vax lawyer's pe­ti­tion to end Mod­er­na and J&J EUAs

Despite the efforts of a law firm leading the charge on the anti-vaccination movement, the emergency use authorization for Moderna and J&J’s Covid-19 vaccines will not be revoked, the agency said in a response letter Monday.

The FDA said so in a letter to an anti-vax lawyer based in New York City. Aaron Siri, from Siri & Glimstad, requested in a formal petition that the EUAs granted to Moderna and J&J be revoked after weeks of back-and-forth email correspondence with Peter Marks, Lorrie McNeill and others at the FDA.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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