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.

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.