Amer­i­can chil­dren un­der the age of five may not be vac­ci­nat­ed un­til mid-2022, as Pfiz­er said Fri­day that it’s go­ing to now test a third dose of its Covid-19 vac­cine in the tri­al.

The de­ci­sion comes as Pfiz­er an­nounced non-in­fe­ri­or­i­ty was not met for chil­dren be­tween the ages of two and five when com­pared to old­er teenagers in the cur­rent tri­al.

Pfiz­er pre­vi­ous­ly said it might ap­ply for an EUA in this youngest pop­u­la­tion by the end of De­cem­ber or ear­ly next year, but now says that if the three-dose study proves suc­cess­ful, Pfiz­er and BioN­Tech ex­pect to sub­mit da­ta to reg­u­la­tors to sup­port an EUA “in the first half of 2022.”

The shift to three dos­es was made af­ter a rou­tine re­view by the ex­ter­nal in­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee, and the tri­al will now eval­u­ate a third dose of 3 µg at least two months af­ter the sec­ond dose in this young age group. Here’s how Pfiz­er ex­plained the non-in­fe­ri­or­i­ty is­sue with the 2- to 5-year-old group in the tri­al:

While the study is on­go­ing and re­mains blind­ed, a pre-spec­i­fied im­muno­genic­i­ty analy­sis was con­duct­ed on a sub­set of the study pop­u­la­tion one month fol­low­ing the sec­ond dose. Com­pared to the 16- to 25-year-old pop­u­la­tion in which high ef­fi­ca­cy was demon­strat­ed, non-in­fe­ri­or­i­ty was met for the 6- to 24-month-old pop­u­la­tion but not for the 2- to un­der 5-year-old pop­u­la­tion in this analy­sis. No safe­ty con­cerns were iden­ti­fied and the 3 µg dose demon­strat­ed a fa­vor­able safe­ty pro­file in chil­dren 6 months to un­der 5 years of age.

Pfiz­er and BioN­Tech are al­so shift­ing to a three-dose reg­i­men for all ages, as the com­pa­nies plan to eval­u­ate a third dose of the 10 µg for­mu­la­tion in chil­dren five to un­der 12 years of age. Ad­di­tion­al­ly, the com­pa­nies have ini­ti­at­ed a low dose sub-study of a third dose of 10 µg or 30 µg in ap­prox­i­mate­ly 600 ado­les­cents aged 12- to 17 to as­sess safe­ty and im­muno­genic­i­ty.

Ini­tial­ly, the Phase I/II/III tri­al, which en­rolled about 4,500 chil­dren aged six months to un­der 12 years in the US, Fin­land, Poland and Spain, was de­signed to eval­u­ate the safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty of the Pfiz­er-BioN­Tech vac­cine on a two-dose sched­ule (ap­prox­i­mate­ly 21 days apart) in three age groups: ages five to un­der 12 years; ages two to un­der five years; and ages six months to un­der two years.

In ad­di­tion to Pfiz­er, Mod­er­na is work­ing on its own Covid-19 vac­cine tri­al for those be­tween the ages of six months and 12.

Stephen Hoge, pres­i­dent of Mod­er­na, said in the com­pa­ny’s Q3 earn­ings call that the com­pa­ny sub­mit­ted da­ta from its Kid­Cove study to the FDA as well as to oth­er coun­tries.

But Hoge not­ed that the com­pa­ny was re­cent­ly no­ti­fied by the FDA that the agency “will re­quire ad­di­tion­al time to eval­u­ate our pro­posed amend­ment due to re­cent analy­sis of the risk of my­ocardi­tis af­ter vac­ci­na­tion in some pop­u­la­tions. The agency ex­pects this eval­u­a­tion may ex­tend un­til Jan­u­ary 2022.”

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.