More vac­cine dos­es are on the way as pe­di­atric vac­cines could be­gin to roll out as ear­ly as next week.

The US on Thurs­day pur­chased 50 mil­lion more dos­es of the Pfiz­er/BioN­Tech Covid-19 vac­cine, as part of ef­forts to sup­port pre­pared­ness for all pe­di­atric vac­ci­na­tions, in­clud­ing for chil­dren un­der 5 years of age, pend­ing au­tho­riza­tion. The com­pa­nies said they ex­pect to de­liv­er the dos­es by April 30, 2022. Ini­tial da­ta on the vac­cine for the youngest kids, down to 6 months, are ex­pect­ed as soon as the fourth quar­ter of this year or ear­ly first quar­ter 2022.

The cost of these 50 mil­lion dos­es was not ini­tial­ly made avail­able, al­though the cost of the Pfiz­er vac­cines has steadi­ly risen for the US. The gov­ern­ment ini­tial­ly paid $1.95 bil­lion for the first 100 mil­lion dos­es (about $19.50 per dose) in Ju­ly 2020, but in Ju­ly 2021 paid $24 a dose for 200 mil­lion more dos­es.

This most re­cent pur­chase of 50 mil­lion dos­es is the fi­nal pur­chase op­tion un­der the ex­ist­ing U.S. sup­ply agree­ment with the com­pa­nies, they said, bring­ing the to­tal num­ber of Pfiz­er vac­cine dos­es se­cured un­der the agree­ment since the start of the pan­dem­ic to 600 mil­lion. Sep­a­rate­ly, the com­pa­nies al­so pro­vid­ed 1 bil­lion dos­es to the US gov­ern­ment at a not-for-prof­it price for do­na­tion to low- and low­er-mid­dle-in­come coun­tries.

In to­tal, Pfiz­er and BioN­Tech ex­pect to man­u­fac­ture 3 bil­lion dos­es world­wide in 2021, and 4 bil­lion dos­es next year.

Vir and GSK un­veil PhI­II mAb find­ings in NE­JM

Vir Biotech­nol­o­gy and Glax­o­SmithK­line on Wednes­day evening pub­lished in the New Eng­land Jour­nal of Med­i­cine their Phase III tri­al re­sults for their re­cent­ly au­tho­rized mon­o­clon­al an­ti­body treat­ment for Covid-19, which has been shown to re­duce the risk of dis­ease pro­gres­sion in high-risk pa­tients with mild-to-mod­er­ate dis­ease.

The place­bo-con­trolled tri­al of 583 pa­tients showed that 3 pa­tients (1%) in the sotro­vimab group, ver­sus 21 pa­tients (7%) in the place­bo group, had dis­ease pro­gres­sion lead­ing to hos­pi­tal­iza­tion or death (rel­a­tive risk re­duc­tion, 85%; 97.24% con­fi­dence in­ter­val, 44 to 96; P=0.002).

Au­tho­rized by the FDA in May, the com­pa­nies re­cent­ly tran­si­tioned from dis­trib­ut­ing the treat­ment them­selves, to let the US gov­ern­ment take over. About 100,000 dos­es of sotro­vimab have been dis­trib­uted in the US so far, and Vir said in an SEC fil­ing that bind­ing agree­ments have been re­ceived for the sale of more than 420,000 dos­es of sotro­vimab world­wide.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.