Robert Califf (AP Photo/Manuel Balce Ceneta)

FDA au­tho­rizes boost­er dose of Pfiz­er and BioN­Tech's Covid-19 vac­cine in 5- to 11-year-olds

The lat­est wave of the pan­dem­ic — marked by Omi­cron and its sub-vari­ants — has seen high­er hos­pi­tal­iza­tion rates for young chil­dren, health agen­cies have ob­served. That’s part of the rea­son why the FDA is au­tho­riz­ing a boost­er shot for kids be­tween 5 and 11 years old.

Reg­u­la­tors on Tues­day OK’d a sin­gle boost­er dose of Pfiz­er and BioN­Tech’s mR­NA vac­cine for chil­dren who re­ceived their pri­ma­ry se­ries with the same vac­cine at least five months ago. By Pfiz­er’s count, that makes more than 8 mil­lion 5- to 11-year-olds el­i­gi­ble for an­oth­er dose.

“While it has large­ly been the case that Covid-19 tends to be less se­vere in chil­dren than adults, the Omi­cron wave has seen more kids get­ting sick with the dis­ease and be­ing hos­pi­tal­ized, and chil­dren may al­so ex­pe­ri­ence longer term ef­fects, even fol­low­ing ini­tial­ly mild dis­ease,” FDA com­mis­sion­er Robert Califf said in a press re­lease. “Vac­ci­na­tion con­tin­ues to be the most ef­fec­tive way to pre­vent Covid-19 and its se­vere con­se­quences, and it is safe.”

The news comes months af­ter the FDA low­ered the age re­quire­ment for a Pfiz­er/BioN­Tech boost­er dose to in­clude 12- to 15-year-olds.

Reg­u­la­tors based their de­ci­sion on Phase II/III da­ta, which showed that a sin­gle boost­er dose of the vac­cine trig­gered a “strong im­mune re­sponse” in the younger age group, with no new safe­ty sig­nals ob­served, ac­cord­ing to Pfiz­er.

Pfiz­er and BioN­Tech have al­so filed for au­tho­riza­tion of a boost­er dose in the same age group in Eu­rope, and are plan­ning oth­er sub­mis­sions around the world, the com­pa­nies an­nounced.

Their Covid-19 vac­cine re­mains the on­ly op­tion for chil­dren as young as five years old, as Mod­er­na push­es for au­tho­riza­tion in the youngest kids un­der 6 years old. Pfiz­er is cur­rent­ly con­duct­ing a study for a 3-µg for­mu­la­tion of its orig­i­nal vac­cine on a three-dose sched­ule in kids be­tween 6 months and 4 years old, with ini­tial da­ta com­ing in the com­ing weeks, ac­cord­ing to the com­pa­ny.

“Since au­tho­riz­ing the vac­cine for chil­dren down to 5 years of age in Oc­to­ber 2021, emerg­ing da­ta sug­gest that vac­cine ef­fec­tive­ness against Covid-19 wanes af­ter the sec­ond dose of the vac­cine in all au­tho­rized pop­u­la­tions,” CBER di­rec­tor Pe­ter Marks said in a news re­lease.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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