Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine


SK Bio­science, a South Ko­re­an com­pa­ny, and Glax­o­SmithK­line will test their Covid-19 vac­cine can­di­date against As­traZeneca’s shot in about 4,000 peo­ple, the com­pa­nies said Tues­day.

Shots from Pfiz­er/BioN­Tech, Mod­er­na and As­traZeneca are ap­proved in South Ko­rea, and the SK shot is the coun­try’s first do­mes­tic can­di­date, po­ten­tial­ly help­ing not on­ly South Ko­rea, but the rest of Asia’s re­liance on shots from the West.

The GSK-SK jab would be­come avail­able through­out the world, through the WHO’s Co­v­ax vac­cine shar­ing pro­gram. Known as GBP510, it’s a self-as­sem­bled nanopar­ti­cle vac­cine can­di­date tar­get­ing the re­cep­tor bind­ing do­main of the spike pro­tein, com­bined with GSK’s pan­dem­ic ad­ju­vant. The anti­gen is be­ing de­vel­oped by SK in col­lab­o­ra­tion with the In­sti­tute for Pro­tein De­sign at the Uni­ver­si­ty of Wash­ing­ton.

Thomas Breuer, chief glob­al health of­fi­cer at GSK, said in a state­ment, “We are pleased to con­tribute with GSK’s pan­dem­ic ad­ju­vant and to be work­ing with SK to de­liv­er the vac­cine at scale via CO­V­AX if it is ap­proved.”

The vac­cine can­di­date ad­vanced to the Phase III tri­al fol­low­ing pos­i­tive in­ter­im Phase I/II da­ta which showed that all par­tic­i­pants who re­ceived the ad­ju­vant­ed vac­cine can­di­date de­vel­oped strong neu­tral­iz­ing an­ti­body re­spons­es. Neu­tral­iz­ing an­ti­body titers were be­tween five and a max­i­mum of eight times high­er com­pared to sera from peo­ple re­cov­ered from Covid-19, and no safe­ty con­cerns have been iden­ti­fied to date.

Re­sults from the Phase III study are ex­pect­ed in the first half of 2022.

CDC backs full ap­proval of Pfiz­er-BioN­Tech jab

A week af­ter the FDA cleared the Pfiz­er-BioN­Tech vac­cine for ap­proval, the Cen­ter for Dis­ease Con­trol and Pre­ven­tion’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices has unan­i­mous­ly vot­ed in fa­vor of the two-dose reg­i­men for those ages 16 and old­er.

The sign-off will hope­ful­ly al­low for the vac­cine to be more wide­ly ac­cept­ed, Bloomberg re­port­ed. CDC di­rec­tor Rochelle Walen­sky still needs to give the fi­nal ap­proval.

The vote comes as vac­ci­na­tion num­bers in the US have some­what ta­pered off in the last month, as the num­ber of ful­ly vac­ci­nat­ed Amer­i­cans has hov­ered around 50% since Ju­ly.

Com­pa­nies, schools and gov­ern­ments have put a vac­cine re­quire­ment in­to place al­ready as the vac­cine was ap­proved. Since gain­ing its emer­gency use au­tho­riza­tion in De­cem­ber, the Pfiz­er-BioN­Tech jab has been used the most, da­ta from the CDC said.

The pan­el did say that it could take a dif­fer­ent ap­proach to boost­er shots than what Pres­i­dent Joe Biden’s ad­min­is­tra­tion pro­posed. The pro­posed plan pri­or­i­tizes those who are high-risk, long-term care fa­cil­i­ty and health work­ers, rather than all el­i­gi­ble Amer­i­cans.

Biden’s ad­min­is­tra­tion has pre­vi­ous­ly said that boost­ers will be­come avail­able on Sep­tem­ber 20.

Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.

Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine
Feng Zhang (Susan Walsh/AP Images)

As one of the pioneers behind CRISPR, the Broad Institute’s Feng Zhang has fashioned himself into a gene editing Renaissance man in recent years with a finger in every pie. For RNA editing, one of his passion projects, Zhang has worked to crack a chronic delivery logjam — and his team has just made a big breakthrough there.

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine
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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine
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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine
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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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J&J’s HIV vaccine failed its first major trial Tuesday, handing another setback to the nearly 40-year effort to build a vaccine against one of the deadliest epidemics in history.

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine
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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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Covid-19 roundup: South Korean vaccine to go up against AstraZeneca shot in small Phase III; CDC's ACIP affirms full approval for Pfizer/BioNTech vaccine

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