Peter Marks (Jim Lo Scalzo/Pool via AP Images)

UP­DAT­ED: FDA's Pe­ter Marks to Con­gress: Youngest kids vac­cine won't need to hit 50% ef­fi­ca­cy mark

The FDA’s top vac­cine leader told a con­gres­sion­al com­mit­tee on Fri­day af­ter­noon that al­though the adult vac­cines had to meet a 50% thresh­old for ef­fi­ca­cy against Covid-19 in­fec­tions, that same stan­dard will not need to be met for the vac­cines for the youngest group of chil­dren, for which a vac­cine is not yet avail­able.

The agency is cur­rent­ly re­view­ing da­ta from Mod­er­na’s two-shot vac­cine for this youngest group as it awaits fur­ther da­ta from Pfiz­er on its po­ten­tial three-dose shot. Mod­er­na has said its vac­cine is 51% ef­fec­tive in chil­dren 6 months to 2 years of age and 37% ef­fec­tive in 2- to 5-year-olds. The agency al­so pre­vi­ous­ly sched­uled and then can­celed an ad­comm to re­view da­ta on two dos­es of Pfiz­er’s vac­cine for chil­dren un­der the age of 5.

Ac­cord­ing to a read­out of the meet­ing from the House se­lect sub­com­mit­tee on the coro­n­avirus cri­sis, Marks ex­plained that the FDA would not with­hold au­tho­riza­tion — de­spite pre­vi­ous guid­ance — for a pe­di­atric vac­cine sole­ly be­cause it did not reach a 50% ef­fi­ca­cy thresh­old at block­ing symp­to­matic in­fec­tions. All of the oth­er adult and chil­dren’s vac­cines cur­rent­ly au­tho­rized in the US have lost sig­nif­i­cant amounts of ef­fi­ca­cy due to the Omi­cron vari­ant, but they still re­main ef­fec­tive at re­duc­ing the risk of se­vere dis­ease, hos­pi­tal­iza­tion and death.

“If these vac­cines seem to be mir­ror­ing ef­fi­ca­cy in adults and just seem to be less ef­fec­tive against Omi­cron like they are for adults, we will prob­a­bly still au­tho­rize,” Marks said.

Jim Clyburn

Mean­while, Marks di­rect­ly ad­dressed con­cerns that the agency might slow-play the Mod­er­na ap­pli­ca­tion and wait to re­view both ap­pli­ca­tions to­geth­er, say­ing that the VRB­PAC meet­ings set for next month will be moved up if nec­es­sary.

“Ob­vi­ous­ly if we get through re­views faster, then we will send them to com­mit­tees soon­er,” Marks said, ac­cord­ing to Rep. Jim Clyburn’s ac­count of the meet­ing. Marks al­so told Clyburn and his staff that VRB­PAC mem­bers have re­served ear­li­er dates, en­abling FDA to po­ten­tial­ly “move dates up even by a week for any of these re­views.”

But he al­so ex­plained that re­view­ing these vac­cines for the youngest chil­dren in­volves more “com­plex­i­ty” than the re­view of adult vac­cines, and the agency’s re­view process may re­quire more time.

He al­so said that the emer­gence of new vari­ants made the process of re­view­ing vac­cines more com­plex, ex­plain­ing it “was a lit­tle sim­pler for the orig­i­nal sub­mis­sions in late 2020 when we didn’t have the vari­ants and tons of im­muno­genic­i­ty da­ta to go through.

“At the end of the day, we want peo­ple to have con­fi­dence in get­ting vac­ci­nat­ed,” he said, ac­cord­ing to Clyburn. Marks al­so re­it­er­at­ed the im­por­tance of vac­ci­na­tions to pro­tect chil­dren against the coro­n­avirus, stat­ing: “We need to get more kids vac­ci­nat­ed, not just in the younger than 5 age range, but al­so old­er than 5.”

Since mak­ing these re­marks to Clyburn, Marks told a me­dia brief­ing ear­li­er this week that he will main­tain the stan­dard for 50% ef­fi­ca­cy for this shot for the youngest kids group, but that “it’s pos­si­ble in sub­pop­u­la­tions they might be a lit­tle less ef­fec­tive than 50%.”

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with Marks’ lat­est com­ment and to note Mod­er­na’s stat­ed ef­fi­ca­cy for its vac­cine for these two groups of the un­der 6 pop­u­la­tion.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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