With the WHO de­clar­ing the mon­key­pox out­break a glob­al health emer­gency, the FDA has now signed off on a Bavar­i­an Nordic man­u­fac­tur­ing fa­cil­i­ty that will in­crease the pro­duc­tion of the on­ly vac­cine.

On Wednes­day, Bavar­i­an Nordic an­nounced the ap­provals from the FDA and EMA to man­u­fac­ture the Jyn­neos small­pox vac­cine at its fill-fin­ish fa­cil­i­ty in Den­mark. With the ap­provals in hand, the com­pa­ny is now al­lowed to de­liv­er the vac­cine man­u­fac­tured at its site to the US and the EU. The in­spec­tions were com­plet­ed with no ob­ser­va­tions made by the reg­u­la­tors.

A pre-ap­proval in­spec­tion in Den­mark was al­ready con­duct­ed by the FDA at the fa­cil­i­ty at the be­gin­ning of Ju­ly, and an or­der for 2.5 mil­lion more dos­es of the vac­cine was placed and is be­ing ful­filled at a CMO in the US.

Ac­cord­ing to an FDA state­ment, the ap­proval will pave the way for ad­di­tion­al man­u­fac­tur­ing ca­pa­bil­i­ties at the Dan­ish plant, as the agency com­plet­ed its in­spec­tion ear­li­er this month.

The FDA al­so fa­cil­i­tat­ed the ship­ment of pre­vi­ous­ly man­u­fac­tured dos­es to the US so that they could be dis­trib­uted once the man­u­fac­tur­ing changes were ap­proved. Man­u­fac­tured dos­es can al­so now be fur­ther dis­trib­uted. Ac­cord­ing to HHS, an ad­di­tion­al 786,000 dos­es of vac­cine can now be dis­trib­uted for use in the US.

“This ac­tion by the FDA is a crit­i­cal step for­ward in our plans to strength­en and ac­cel­er­ate our mon­key­pox re­sponse, which in­cludes dis­trib­ut­ing a safe and ef­fec­tive vac­cine to those at high­est risk of ex­po­sure to mon­key­pox,” HHS Sec­re­tary Xavier Be­cer­ra said in a state­ment.

Paul Chap­lin

The thumbs-up from the EMA came af­ter Bavar­i­an ap­plied for au­tho­riza­tion in June 2022 and re­ceived it late last week. An ear­li­er ap­proval was al­so grant­ed by the Dan­ish Med­i­cines Agency.

“We are thank­ful to both FDA and EMA for ac­cel­er­at­ing their re­view, dur­ing this mon­key­pox out­break, which now has been named a pub­lic health emer­gency of in­ter­na­tion­al con­cern by the WHO, and we look for­ward to con­tin­u­ing our work with health au­thor­i­ties around the globe to en­sure sup­ply of vac­cines against mon­key­pox,” said Bavar­i­an Nordic CEO Paul Chap­lin.

The FDA and EMA ap­provals come at a piv­otal time as the cas­es of mon­key­pox are over 19,000 and still ris­ing, ac­cord­ing to the CDC. The US now has over 3,500 cas­es, and the virus is in 76 coun­tries to­tal.

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen. Kyrsten Sinema (D-AZ) reportedly pledged her support on Thursday — but will they fit it in before recess?

Sinema said she has agreed to “move forward” with the reconciliation bill with some stipulations, including the removal of a carried tax provision, according to recent reports. The bill is still expected to reduce the deficit by $300 billion, and Sen. Chuck Schumer (D-NY) said that he now anticipates “support from the entire Senate Democratic conference,” the Washington Post reported. 

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.