Pro­duc­tion prob­lems at a No­vavax fa­cil­i­ty in Mary­land have led to de­lays in the Co­v­ax vac­cine shar­ing pro­gram. Now, a short­age of 1 bil­lion dos­es is ex­pect­ed, as the sup­pli­er tries to nav­i­gate pro­duc­ing a shot up to reg­u­la­tors’ stan­dards, Politi­co re­port­ed Tues­day.

The com­pa­ny has run in­to trou­ble with the pu­ri­ty of the vac­cine. No­vavax has had trou­ble prov­ing it can pro­duce a shot con­sis­tent­ly up to stan­dards, and it has caused sig­nif­i­cant de­lays in the roll­out to low- and mid­dle-in­come coun­tries. This fol­lows sev­er­al de­lays at No­vavax that has put the ex­ec­u­tive crew on the de­fen­sive.

Three peo­ple be­tween No­vavax and the Biden ad­min­is­tra­tion con­firmed the de­lays to Politi­co, though they spoke on the con­di­tion of anonymi­ty. Pu­ri­ty lev­els have hov­ered around 70%, the source said, and low­er pu­ri­ty lev­els raise the chance of hav­ing con­t­a­m­i­nants or un­nec­es­sary sub­stances in the vac­cine. That’s dis­rupt­ing plans to get vac­cine sup­plies more broad­ly dis­trib­uted, and af­ter the US gov­ern­ment had in­vest­ed $1.6 bil­lion in 2020 alone.

No­vavax’s stock price plunged 21% ahead of the bell.

“In re­sponse to a re­cent news ar­ti­cle cit­ing anony­mous sources, No­vavax con­firms our con­fi­dence in our abil­i­ty to de­liv­er our high-qual­i­ty vac­cine,” the com­pa­ny said in a state­ment re­leased Wednes­day. “Fur­ther, we un­der­score our on­go­ing com­mit­ment to the strin­gent stan­dards of pro­duc­tion and man­u­fac­tur­ing for our re­com­bi­nant nanopar­ti­cle pro­tein-based COVID-19 vac­cine can­di­date with Ma­trix-M ad­ju­vant.”

In the state­ment, the com­pa­ny high­light­ed its part­ner­ship with the Serum In­sti­tute of In­dia, a man­u­fac­tur­ing site in the Czech Re­pub­lic and sev­er­al oth­er man­u­fac­tur­ing agree­ments in South Ko­rea, Japan and “around the world.”

Co­v­ax al­ready low­ered its 2021 vac­cine pro­duc­tion goal from 2 bil­lion dos­es to 1.425 bil­lion, and es­ti­mat­ed that a short­fall of up to 1 bil­lion dos­es is com­ing. If that is ac­cu­rate, hun­dreds of mil­lions of peo­ple could be left with­out pro­tec­tion from the virus and its vari­ants, fur­ther ex­tend­ing the pan­dem­ic.

“We are con­fi­dent that our vac­cine will soon play a sig­nif­i­cant role in the glob­al COVID-19 vac­cine ar­se­nal, dif­fer­en­ti­at­ed by its po­ten­tial to help ad­dress two ma­jor is­sues slow­ing the world’s abil­i­ty to end the pan­dem­ic: glob­al dis­tri­b­u­tion chal­lenges and vac­cine hes­i­tan­cy,” CEO Stan­ley Er­ck said in the state­ment.

Sil­via Tay­lor

No­vavax’s SVP of in­vestor re­la­tions and cor­po­rate af­fairs Sil­via Tay­lor told Politi­co that the com­pa­ny’s an­a­lyt­i­cal test­ing meth­ods have been val­i­dat­ed, but did not say whether or not the FDA signed off on them. No­vavax said it will still file for emer­gency use au­tho­riza­tion by the end of the year. No­vavax has nev­er man­u­fac­tured a vac­cine be­fore. The No­vavax jab us­es spike pro­teins, which can be more dif­fi­cult to man­u­fac­ture to scale.

The news comes at a tough time. Pres­i­dent Joe Biden and his ad­min­is­tra­tion are at odds with Cam­bridge, MA-based drug­mak­er Mod­er­na af­ter the com­pa­ny has been slow to pro­vide the 176.5 mil­lion dos­es to the vac­cine shar­ing pro­gram that have been pur­chased. The New York Times re­port­ed that on­ly about 1 mil­lion dos­es have gone to low-in­come coun­tries, com­pared to 8.4 mil­lion Pfiz­er dos­es and 25 mil­lion J&J dos­es. But much of that short­fall has been blamed on the op­er­at­ing pow­er of Mod­er­na, which dou­bled its work­force to around 1,600 em­ploy­ees in 2020, and still has far few­er staff than ei­ther of the oth­ers.

Mean­while, a mix­up at an Emer­gent plant in Bal­ti­more led to mil­lions of J&J dos­es be­ing quar­an­tined while the FDA in­ves­ti­gat­ed, and many of those were trashed.

In Sep­tem­ber, af­ter many de­lays, No­vavax sub­mit­ted its vac­cine to the World Health Or­ga­ni­za­tion for re­view. The com­pa­ny’s gone through some ups and downs dur­ing the pan­dem­ic, in­clud­ing man­u­fac­tur­ing strug­gles that led to oth­er com­pa­nies beat­ing them to the fin­ish line in the hunt for a vac­cine.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Daiichi Sankyo is looking to build a new manufacturing site close to home to begin producing the first made-in-Japan mRNA Covid vaccines.

According to a report from Nikkei Asia, Daiichi Sankyo is constructing a site with a capacity of 20 million doses a year by the fiscal year 2024. The report says that equipment has been installed at a location in the city of Kitamoto, Japan, northeast of Tokyo, and is operated by the subsidiary Daiichi Sankyo Biotech.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”