By ZEKE MILLER-As­so­ci­at­ed Press

WASH­ING­TON (AP) — U.S. reg­u­la­tors are urg­ing drug­mak­er Pfiz­er to ap­ply for emer­gency au­tho­riza­tion for a two-dose reg­i­men of its COVID-19 vac­cine for chil­dren 6 months to 5 years old while await­ing da­ta on a three-dose course, aim­ing to clear the way for the shots as soon as late Feb­ru­ary, a per­son fa­mil­iar with the mat­ter told The As­so­ci­at­ed Press Mon­day.

The com­pa­ny’s ap­pli­ca­tion was ex­pect­ed to be sub­mit­ted as soon as Tues­day.

Ear­ly Pfiz­er da­ta has shown the vac­cine — which is ad­min­is­tered to younger kids at one-tenth the strength of the adult shot — is safe and pro­duces an im­mune re­sponse. But last year Pfiz­er an­nounced the two-dose shot proved to be less ef­fec­tive at pre­vent­ing COVID-19 in kids ages 2-5, and reg­u­la­tors en­cour­aged the com­pa­ny to add a third dose to the study on the be­lief that an­oth­er dose would boost the vac­cine’s ef­fec­tive­ness much like boost­er dos­es do in adults.

Now, the Food and Drug Ad­min­is­tra­tion is push­ing the com­pa­ny to sub­mit its ap­pli­ca­tion based on the two-dose da­ta for po­ten­tial ap­proval in Feb­ru­ary, and then to re­turn for ad­di­tion­al au­tho­riza­tion once it has the da­ta from the third dose study, which is ex­pect­ed in March, the per­son fa­mil­iar with the mat­ter said. The two-step au­tho­riza­tion process could mean that young chil­dren could be vac­ci­nat­ed more than a month ear­li­er than pre­vi­ous es­ti­mates, as­sum­ing the FDA and the Cen­ters for Dis­ease Con­trol and Pre­ven­tion green­light the shots.

The per­son spoke on the con­di­tion of anonymi­ty to dis­cuss sen­si­tive reg­u­la­to­ry is­sues. The per­son said the de­creased ef­fec­tive­ness of the two-dose vac­cine was not un­ex­pect­ed giv­en the emer­gence of the high­ly trans­mis­si­ble omi­cron vari­ant of COVID-19. Al­low­ing young kids to be vac­ci­nat­ed with a two-dose shot ear­li­er would ul­ti­mate­ly ac­cel­er­ate when they could get the ex­pect­ed stronger pro­tec­tion from a third dose.

That would be wel­come news for par­ents of young chil­dren, the last re­main­ing age group with­out ap­proval of COVID-19 shots.

Young chil­dren are far less like­ly than adults to de­vel­op se­ri­ous com­pli­ca­tions or to die from COVID-19, but in­ci­dences of ill­ness among the age group have risen amid the na­tion­wide spike in cas­es from the omi­cron vari­ant. Most cas­es and deaths oc­cur among old­er peo­ple, es­pe­cial­ly those who are un­vac­ci­nat­ed.

Speed­ing the au­tho­riza­tion of pe­di­atric vac­cines against COVID-19 has been a pri­or­i­ty for more than a year of the Biden ad­min­is­tra­tion, which be­lieves them crit­i­cal to re­open­ing and keep­ing open schools and day care cen­ters — and for free­ing up par­ents oc­cu­pied by child­care re­spon­si­bil­i­ties to re­turn to the work­force.

Vac­cines for kids ages 5-12 were ap­proved by U.S. reg­u­la­tors in No­vem­ber, though up­take of shots has been slow­er than U.S. of­fi­cials hoped.

Pfiz­er’s pri­ma­ry se­ries is ad­min­is­tered three weeks apart. The third dose for young kids is be­ing stud­ied for ad­min­is­tra­tion at least two months af­ter the sec­ond dose.

News of the ear­li­er reg­u­la­to­ry re­view was first re­port­ed by The Wash­ing­ton Post.