In an ef­fort to boost the sup­ply of its AAV Covid-19 vac­cine abroad, As­traZeneca has amend­ed its li­cense agree­ment with Biokang­tai to com­mer­cial­ize the drug in main­land Chi­na, Pak­istan and In­done­sia, Biokang­tai an­nounced Wednes­day.

Biokang­tai will mar­ket, man­u­fac­ture and dis­trib­ute the drug to ease the short­ened sup­ply and make the vac­cine more ac­ces­si­ble. The vac­cine has been ap­proved in 185 coun­tries so far, the com­pa­ny said in a press re­lease, but short­ened sup­ply, cou­pled with is­sues sur­round­ing rare, but fa­tal, blood clots, have led vac­ci­na­tion num­bers to stall out.

In main­land Chi­na, around 63% of the pop­u­la­tion is ful­ly vac­ci­nat­ed.

Both As­traZeneca and Biokang­tai re­vealed the li­cense agree­ment at the Chi­na In­ter­na­tion­al Im­port Ex­po in No­vem­ber 2020.

As­traZeneca al­so has a li­cense agree­ment with The Serum In­sti­tute in In­dia, mak­ing it eas­i­er to gets dos­es in the arms of res­i­dents of a coun­try that is still see­ing 43,000 cas­es a day. That’s a stark im­prove­ment from May, when the num­ber of dai­ly cas­es hov­ered around the 400,000 mark, but still vul­ner­a­ble, with just 12% of the pop­u­la­tion ful­ly vac­ci­nat­ed. Near­ly 40% have re­ceived at least one dose.

Chi­nese pro­tein-based Covid-19 vac­cine gets man­u­fac­tur­ing OK

Mean­while, Chi­nese biotech Clover Bio­phar­ma­ceu­ti­cals an­nounced that its sub­sidiary Zhe­jiang Clover Bio­phar­ma­ceu­ti­cal re­ceived a man­u­fac­tur­ing per­mit to make their own pro­tein-based Covid-19 vac­cine can­di­date at a Changx­ing fa­cil­i­ty.

Clover’s end-to-end plat­form us­es sin­gle-use tech­nol­o­gy. The fa­cil­i­ty has the ca­pa­bil­i­ty to pro­duce a bil­lion dos­es of anti­gens for the Clover can­di­date SCB-2019, which is cur­rent­ly in Phase II/III tri­als. The com­pa­ny an­tic­i­pates launch­ing the can­di­date by the end of 2021, if grant­ed emer­gency ap­proval. If it is, it will be one of the first pro­tein-based Covid-19 vac­cines.

Us­ing its Trimer-Tag plat­form, Clover has de­vel­oped the vac­cine us­ing an orig­i­nal strain of the SARS-CoV-2 virus. The can­di­date com­bines SCB-2019 with Dy­navax’s CpG 1018 and alu­minum hy­drox­ide.

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.