The Thai Food and Drug Ad­min­is­tra­tion will soon re­view tri­al re­sults from its coun­try’s first lo­cal­ly-de­vel­oped Covid-19 vac­cine, which us­es the same mR­NA tech­nol­o­gy that suc­cess­ful vac­cines from Pfiz­er/BioN­Tech and Mod­er­na have al­so em­ployed. If all goes well, Thai­land will roll out its first home­grown vac­cine by the end of this year, its gov­ern­ment has said.

The first lot of the vac­cine was pro­duced by BioNet-Asia, and de­vel­oped by Chu­la­longko­rn Uni­ver­si­ty re­searchers, the Bangkok Post re­port­ed. The jab, dubbed Chu­la­Cov19, has yet to be­gin clin­i­cal tri­als in hu­mans but ex­pects to lat­er this year, the Chu­la Vac­cine Re­search Cen­ter said. The cen­ter worked in col­lab­o­ra­tion with UPenn Pro­fes­sor Drew Weiss­man, who al­so worked on the mR­NA vac­cine tech that Pfiz­er/BioN­Tech de­ployed.

The vac­cine’s pro­duc­tion was spurred by a 2.31 bil­lion baht ($67 mil­lion) in­vest­ment from the gov­ern­ment last year.

BioNet-Asia can make 20 mil­lion dos­es a year. More than a dozen vac­cines are be­ing de­vel­oped, ac­cord­ing to Bloomberg, in an ef­fort to cut back re­liance on for­eign sup­ply. Chu­la­longko­rn’s is the most ad­vanced. Thai­land is al­so home to As­traZeneca’s on­ly man­u­fac­tur­ing site in south­east Asia.

Racha­da Dhnadi­rek

Deputy gov­ern­ment spokes­woman Racha­da Dhnadi­rek told the Bangkok Post that Thai­land’s goal of pro­duc­ing its own vac­cine aligns with its 10-year strate­gic plan to be­come a med­ical hub by 2026.

“The goal was set be­fore the Covid-19 pan­dem­ic be­gan, and by be­com­ing a vac­cine pro­duc­tion cen­ter, more Thai peo­ple will have ac­cess to the vac­cine,” she told the out­let.

Last Ju­ly, As­traZeneca ran in­to vac­cine dis­tri­b­u­tion is­sues in Thai­land and was forced to ask the gov­ern­ment for a five-month ex­ten­sion of the time­line to de­liv­er 61 mil­lion dos­es, bring­ing its dead­line all the way to this May. The hic­cup led Thai­land to re­port­ed­ly con­sid­er im­pos­ing ex­port bans on lo­cal­ly pro­duced dos­es of the jab, as waves of the virus hit its pop­u­la­tion hard.

Two weeks ago, the Quad Vac­cine Part­ner­ship hand­ed over a con­sign­ment of Cov­di-19 vac­cines from In­dia to the gov­ern­ment of Thai­land. More than 200,000 made-in-In­dia dos­es of Cov­o­vax were giv­en to the Min­is­ter of Pub­lic Health Anutin Charn­vi­rakul on April 21 in Bangkok.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.