As chil­dren re­turn to school and youth Covid-19 hos­pi­tal­iza­tions hit a new high, BioN­Tech is re­port­ed­ly prep­ping a launch for its mR­NA vac­cine de­vel­oped with Pfiz­er in those be­tween 5 and 11 years old.

BioN­Tech CMO Özlem Türe­ci told the week­ly Ger­man mag­a­zine Der Spiegel that the com­pa­ny will file the re­sults of its tri­al in 5- to 11-year-olds with reg­u­la­tors across the world “over the next few weeks,” and that fi­nal pro­duc­tion steps are be­ing ad­just­ed to bot­tle a low­er-dose pe­di­atric ver­sion of the vac­cine.

“Things are look­ing good, every­thing is go­ing ac­cord­ing to plan,” CEO Ugur Sahin told Der Spiegel.

The Pfiz­er/BioN­Tech vac­cine is cur­rent­ly au­tho­rized for chil­dren as young as 12 years old, and back in Au­gust be­came the first Covid-19 vac­cine ful­ly ap­proved in the US for peo­ple 16 years and old­er.

Mod­er­na’s vac­cine is au­tho­rized for those 18 years and old­er. The com­pa­ny be­gan re­cruit­ing in March for a tri­al test­ing the mR­NA jab in kids younger than 12, and said it would en­roll in three age brack­ets: 6 to 11 years old; 2 to 5 years old; and 6 months to 1 year old.

Sino­vac weighs vac­cine pro­duc­tion site in South Africa — re­port

Chi­na’s Sino­vac is re­port­ed­ly con­sid­er­ing a new vac­cine pro­duc­tion site in South Africa, where its Covid-19 vac­cine Coro­n­aVac is cur­rent­ly in a Phase III tri­al in chil­dren and ado­les­cents.

“This clin­i­cal tri­al is a pre­cur­sor to the es­tab­lish­ment of a South African vac­cine man­u­fac­tur­ing fa­cil­i­ty part­nered by Sino­vac and Nu­molux Group that will cov­er the en­tire spec­trum of vac­ci­na­tions be­yond just the COVID-19 re­sponse,” Hilton Klein, CEO of Sino­vac’s South Africa-based part­ner Nu­molux, said per Reuters. 

South Africa’s reg­u­la­to­ry au­thor­i­ty, SAH­PRA, gave con­di­tion­al au­tho­riza­tion to Sino­vac’s vac­cine back in Ju­ly for those be­tween 18 and 59 years old.

Sino­vac’s vac­cine — which was just ef­fec­tive enough to meet reg­u­la­to­ry stan­dards — was au­tho­rized in Chi­na last sum­mer and be­came the first Chi­nese Covid-19 vac­cine to be con­sid­ered by the Eu­ro­pean Med­i­cines Agency back in May. How­ev­er, the EMA said yes­ter­day that it needs more da­ta on both the Sino­vac and Rus­sia’s Sput­nik V vac­cines be­fore it can progress rolling re­views, ac­cord­ing to Reuters.

Sino­vac and Nu­molux are cur­rent­ly en­rolling 2,000 par­tic­i­pants be­tween the ages of 6 months and 17 years in the South Africa co­hort of their glob­al tri­al.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.