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.

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.

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.

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.”