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.

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.