Albert Bourla, Pfizer CEO (Patrick Semansky/AP Images)

FDA takes a rare step and asks Pfiz­er to sub­mit a Covid-19 vac­cine EUA for the youngest chil­dren

What does the FDA know that we don’t? Hope­ful­ly a lot.

With­out of­fer­ing much de­tail, the FDA yes­ter­day af­ter­noon asked Pfiz­er to send over a rolling sub­mis­sion to amend its Covid-19 vac­cine EUA to in­clude chil­dren 6 months to un­der 5 years of age.

The tricky part in mak­ing such a re­quest is that last month, Pfiz­er an­nounced that its vac­cine (a 3 µg dose for the youngest pop­u­la­tion) demon­strat­ed non-in­fe­ri­or­i­ty for the 6- to 24-month-old pop­u­la­tion, when com­pared to the 16- to 25-year-old pop­u­la­tion in which high ef­fi­ca­cy was demon­strat­ed, but not for the 2- to un­der 5-year-old pop­u­la­tion.

The com­pa­ny said it would con­tin­ue to study the vac­cine in these youngest chil­dren with a third dose, and doesn’t seem to be chang­ing its tune even with this lat­est FDA re­quest.

“Ul­ti­mate­ly, we be­lieve that three dos­es of the vac­cine will be need­ed for chil­dren 6 months through 4 years of age to achieve high lev­els of pro­tec­tion against cur­rent and po­ten­tial fu­ture vari­ants. If two dos­es are au­tho­rized, par­ents will have the op­por­tu­ni­ty to be­gin a COVID-19 vac­ci­na­tion se­ries for their chil­dren while await­ing po­ten­tial au­tho­riza­tion of a third dose,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

No safe­ty con­cerns were iden­ti­fied in that pri­or analy­sis of the 3 µg dose da­ta among chil­dren 6 months to un­der 5 years of age, Pfiz­er said.

While the FDA of­ten re­quests that com­pa­nies pro­vide ad­di­tion­al safe­ty or ef­fi­ca­cy da­ta (usu­al­ly be­fore a new drug or vac­cine is ap­proved or au­tho­rized), the agency rarely re­quests a spe­cif­ic sub­mis­sion, but act­ing FDA com­mis­sion­er Janet Wood­cock said this is a pri­or­i­ty right now for the agency.

“I don’t think au­tho­riz­ing two dos­es in chil­dren ages 2 to 4 years of age where ef­fec­tive­ness in this age group hasn’t been con­firmed is go­ing to con­vince the ma­jor­i­ty of par­ents to vac­ci­nate their chil­dren,” Nor­man Bay­lor, pres­i­dent and CEO of Bi­o­log­ics Con­sult­ing and a for­mer head of the FDA’s vac­cine of­fice, told STAT News. “If the vac­cine in this age co­hort is a three-dose vac­cine, FDA should re­view the da­ta from the three-dose se­ries be­fore au­tho­riz­ing the vac­cine.”

On Feb. 15, the FDA will con­vene its VRB­PAC, an ad­comm of out­side ad­vi­sors to dis­cuss this ap­pli­ca­tion. The com­mit­tee kicked off the Covid-19 vac­cine boost­er sea­son last fall by pledg­ing to not re­quire boost­ers for all, and then boost­ers were rec­om­mend­ed for all, and have proven to be help­ful in re­duc­ing cas­es and hos­pi­tal­iza­tions in this lat­est Omi­cron surge.

An­oth­er big ques­tion, as has been the case for the en­tire pan­dem­ic, is up­take in this youngest pop­u­la­tion. The FDA notes that as of Dec. 19, the Cen­ters for Dis­ease Con­trol and Pre­ven­tion said just 8.7 mil­lion Covid-19 vac­ci­na­tions have been giv­en to kids 5 through 11 years of age, which is on­ly about one-third of the 24 mil­lion US kids this age range. There are about 23 mil­lion chil­dren less than 5 years of age in the US, the FDA es­ti­mat­ed.

Hes­i­tan­cy has been a big is­sue na­tion­wide, with the US trail­ing be­hind the vac­ci­na­tion rates of oth­er wealthy na­tions around the globe. But Wood­cock pre­vi­ous­ly told End­points News that this fight might be about more than just vac­cines.

“Well the loss of trust seems to be a gen­er­al an­ti-au­thor­i­ty, an­ti-sci­ence thing,” she wrote. “Very strong streak of this in the US over the cen­turies. Sure, it would be fine to have an­oth­er tra­di­tion­al type voice mak­ing pub­lic health state­ments, but this may need to be fought out in the so­cial me­dia and oth­er cur­rent in­fo sources, oth­er­wise you are just preach­ing to the con­vert­ed. FDA would need more comms staff — our peo­ple are pret­ty ex­haust­ed and most­ly have the tra­di­tion­al skillset.”

FDA’s top vac­cine of­fi­cial Pe­ter Marks said in a re­cent keynote, re­flect­ing on some of the things that keep him up at night, “The lack of trust in a ba­sic pub­lic health mea­sure that saves lives is cat­a­stroph­ic in this coun­try.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.