Pfizer CEO Albert Bourla (L) and BioNTech CEO Ugur Sahin (AP Images)

Covid-19 roundup: FDA au­tho­rizes Pfiz­er/BioN­Tech vac­cine for 12- to 15-year-olds; No­vavax shares sink as com­pa­ny de­lays vac­cine time­line

Back-to-school sea­son could look much dif­fer­ent this year, as Pfiz­er and BioN­Tech’s Covid-19 vac­cine has be­come the first in the US to be au­tho­rized for chil­dren as young as 12 years old.

On Mon­day, the FDA ex­pand­ed its emer­gency use au­tho­riza­tion for the jab — which was orig­i­nal­ly OK’d for those 16 years and old­er — based on ef­fi­ca­cy da­ta from 190 ado­les­cents which showed their im­mune re­sponse to the vac­cine was at least as good as the re­sponse seen in old­er par­tic­i­pants.

Pfiz­er and BioN­Tech al­so con­duct­ed an analy­sis sev­en days af­ter the ado­les­cents were giv­en their sec­ond dos­es. No Covid-19 cas­es were found among 1,005 12- to 15-year-olds who re­ceived the vac­cine, ver­sus 16 cas­es in the place­bo group, sug­gest­ing the vac­cine was 100% ef­fec­tive.

Side ef­fects ex­pe­ri­enced by a group of 2,260 ado­les­cents who were test­ed for safe­ty — pain at the in­jec­tion site, tired­ness, headache, chills, mus­cle pain, fever and joint pain — were con­sis­tent with old­er groups, ac­cord­ing to the agency. More than half of the par­tic­i­pants were fol­lowed for at least two months af­ter their sec­ond dose, ac­cord­ing to the com­pa­nies.

Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER), told re­porters in a me­dia brief­ing that the dos­es won’t be ad­min­is­tered to 12- to 15-year-olds un­til Thurs­day (af­ter the CDC holds an Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing).

“We rec­og­nize that the next crit­i­cal step is hav­ing vac­cines avail­able for use through­out the pe­di­atric pop­u­la­tion,” Marks said in a state­ment on Mon­day.

Both the Mod­er­na and John­son & John­son vac­cines are cur­rent­ly au­tho­rized for adults 18 years and old­er, though Mod­er­na said last month that its Phase II/III Teen­COVE study was ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US.

CBER is plan­ning to con­vene a vir­tu­al meet­ing of the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) on June 10 to pro­vide a sta­tus up­date on the au­tho­riza­tion of Covid-19 vac­cines for kids 12 and up, and the da­ta need­ed to sup­port a BLA or EUA in those younger than 12.

“As with the ini­tial COVID-19 vac­cine au­tho­riza­tions, we want to en­sure that the pub­lic has a clear un­der­stand­ing of our ex­pec­ta­tions for the da­ta and in­for­ma­tion need­ed to sup­port re­quests for emer­gency use au­tho­riza­tion and bi­o­log­ics li­cense ap­pli­ca­tions for vac­cines in­tend­ed to pre­vent COVID-19 in this pe­di­atric age range,” Marks said.

Pfiz­er will con­tin­ue to mon­i­tor the safe­ty of the vac­cine.

No­vavax shares sink as com­pa­ny de­lays vac­cine time­line

No­vavax $NVAX shares slipped near­ly 8.8% on Tues­day morn­ing, as the com­pa­ny once again de­layed its time­line for vac­cine pro­duc­tion and reg­u­la­to­ry fil­ings.

In its Q1 earn­ings call, No­vavax said it’s now aim­ing to sub­mit reg­u­la­to­ry fil­ings in the US, UK and EU in Q3, ver­sus its pre­vi­ous plans to file in Q2. The com­pa­ny cit­ed the de­vel­op­ment of qual­i­fy­ing and po­ten­cy as­says to sat­is­fy the CMC por­tion of reg­u­la­to­ry sub­mis­sions as the pri­ma­ry rea­son for de­lay, ac­cord­ing to Jef­feries an­a­lyst Kelechi Chikere.

The com­pa­ny now ex­pects to hit its pro­duc­tion tar­get of 100 mil­lion dos­es a month by the end of Q3 and full pro­duc­tion ca­pac­i­ty in Q4 (rather than Q3). Here, No­vavax said sourc­ing raw ma­te­ri­als was its key is­sue.

“Mgmt re­mains very con­fi­dent that they will hit 150M dos­es per month be­fore the end of the year and ex­pects to main­tain that through­out 2022 and be­yond,” Chikere wrote.

This isn’t the first time No­vavax has pushed back its time­line for full-speed vac­cine pro­duc­tion. Last month, Reuters re­port­ed that sup­ply short­ages that in­clude bags used to grow cells have led to a de­lay in pro­duc­tion. Pre­vi­ous­ly, No­vavax had said that it ex­pect­ed full-scale pro­duc­tion by May or June, and clear­ance from the US as ear­ly as May.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

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Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

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Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

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