Mod­er­na, Pfiz­er/BioN­Tech and John­son & John­son all re­ceived FDA clear­ance for their Covid-19 vac­cines a day af­ter the agency’s ad­vi­sors rec­om­mend­ed emer­gency au­tho­riza­tion. The same will not hap­pen for No­vavax.

The reg­u­la­tor’s out­side ex­perts rec­om­mend­ed 21 to 0 on Tues­day af­ter­noon to give an emer­gency green light to the Mary­land biotech’s vac­cine, but more than 36 hours lat­er, an of­fi­cial OK hasn’t been hand­ed down yet. The FDA re­ceived man­u­fac­tur­ing up­dates from the com­pa­ny just days be­fore the ad­vi­so­ry com­mit­tee’s hours-long hear­ing.

“On June 3, 2022, No­vavax sub­mit­ted an amend­ment with up­dat­ed man­u­fac­tur­ing and prod­uct in­for­ma­tion for the EUA to the FDA for re­view,” an FDA spokesper­son wrote in an emailed state­ment to End­points News. “FDA will care­ful­ly re­view this and any ad­di­tion­al in­for­ma­tion sub­mit­ted by the firm as part of its on­go­ing as­sess­ment and pri­or to au­tho­riz­ing the vac­cine for emer­gency use. The de­ci­sion to grant an EUA will al­so take in­to con­sid­er­a­tion the dis­cus­sion of clin­i­cal da­ta and vot­ing out­come of the June 7, 2022 VRB­PAC meet­ing.”

“The da­ta is a part of the stan­dard process im­prove­ments that have been made since sub­mis­sion and on June 3, No­vavax sub­mit­ted an amend­ment with this up­dat­ed man­u­fac­tur­ing in­for­ma­tion for the EUA to the FDA for re­view,” a com­pa­ny spokesper­son said in an emailed state­ment to End­points News.

Af­ter re­ceiv­ing more than a bil­lion dol­lars in gov­ern­ment fund­ing ear­ly in the pan­dem­ic, No­vavax failed to keep pace with its com­peti­tors, at least on the home front. The com­pa­ny’s vac­cine, made by the world’s largest vac­cine man­u­fac­tur­er, the Serum In­sti­tute of In­dia, has been giv­en var­i­ous lev­els of ap­proval in more than 40 coun­tries.

Fil­ip Dubovsky

No­vavax sub­mit­ted its CMC da­ta pack­age on Dec. 31, 2021, and then ap­plied for the EUA on Jan. 31.

The US has yet to sign off, and if the FDA does, the vac­cine will still have to wait for a nod from the CDC.

No­vavax, pub­lic com­menters, FDA of­fi­cials and some of the out­side ex­perts on Tues­day dis­cussed the vac­cine’s po­ten­tial to sway those who have yet to re­ceive an in­oc­u­la­tion for the pan­dem­ic virus. De­fin­i­tive proof of whether the tra­di­tion­al plat­form be­hind the vac­cine, as com­pared to the more nascent mR­NA tech­nol­o­gy in Mod­er­na and Pfiz­er’s, could not be pro­vid­ed by the com­pa­ny.

When asked by an ad­vi­sor whether the com­pa­ny had reached out to the vac­cine-hes­i­tant to see if they would take No­vavax’s vac­cine, CMO Fil­ip Dubovsky replied: “One in 10 Amer­i­cans hasn’t been vac­ci­nat­ed and we haven’t giv­en up on them.”

This sto­ry has been up­dat­ed with a com­ment from an FDA spokesper­son. 

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.