Stanley Erck, Novavax CEO (Lee Jin-wook/Yonhap via AP Images)

No­vavax says its vac­cine is 80% ef­fec­tive in teens, but man­u­fac­tur­ing ques­tions con­tin­ue to cloud fu­ture

No­vavax fi­nal­ly sub­mit­ted an ap­pli­ca­tion for emer­gency use au­tho­riza­tion for its Covid-19 vac­cine late last month. Now a sec­ond ap­pli­ca­tion may al­ready be in the off­ing.

The oft-de­layed but nev­er-bor­ing Mary­land-based vac­cine com­pa­ny an­nounced pos­i­tive re­sults from its ado­les­cent tri­al on Thurs­day. The biotech’s vac­cine, known as Nu­vax­ovid, was 80% ef­fec­tive at pre­vent­ing symp­to­matic dis­ease in pa­tients 12 to 17 years old.

The 2,247-per­son tri­al was con­duct­ed while the Delta vari­ant — sig­nif­i­cant­ly more in­fec­tious and slight­ly eva­sive to im­mune re­spons­es against the orig­i­nal virus — was dom­i­nant in the US. The com­pa­ny said it se­quenced 11 out of 20 con­firmed Covid-19 cas­es in the tri­al; all were Delta.

The vol­un­teers al­so showed about 50% more neu­tral­iz­ing an­ti­bod­ies as adults had in pre­vi­ous tri­als, meet­ing an FDA re­quire­ment for non-in­fe­ri­or­i­ty.

The new da­ta raise the prospect that a third vac­cine could be­come avail­able for teenagers in the US and oth­er parts of the world, join­ing the mR­NA shots from Pfiz­er and Mod­er­na. Al­though those dos­es have been avail­able for months in the US, vac­ci­na­tion rates for teenagers re­main low rel­a­tive to adults: Just 57% of Amer­i­cans be­tween 12 and 17 have re­ceived at least 2 dos­es, ac­cord­ing to the New York Times track­er, com­pared with 71% of 18 to 65 year-olds and 89% of those over 65.

No­vavax has long ar­gued its pro­tein-based shot could be more at­trac­tive for some peo­ple, par­tic­u­lar­ly the vac­cine-hes­i­tant, than mR­NA shots: Its tech­nol­o­gy is old­er and used in oth­er shots, they note, and it has a low­er side ef­fect pro­file.

Sil­via Tay­lor

Those same fac­tors, they ar­gued, could make Nu­vax­ovid an at­trac­tive op­tion in help­ing vac­ci­nate teens, al­though it’s not clear whether the shot is suf­fi­cient­ly less re­ac­to­genic than mR­NA to boost up­take.

Around half of the vac­ci­nat­ed vol­un­teers each re­port­ed mus­cle pain, fa­tigue and headache. In Mod­er­na’s ado­les­cent tri­al, by con­trast, those symp­toms each ap­peared in about 70% of vac­ci­nat­ed par­tic­i­pants. (No­vavax did not re­lease pre­cise break­downs, opt­ing for a graph in­stead.)

”We be­lieve that our ef­fi­ca­cy and safe­ty pro­file will make us a de­sir­able op­tion in the pe­di­atric pop­u­la­tion,” Sil­via Tay­lor, No­vavax’s VP of cor­po­rate af­fairs, told re­porters Thurs­day.

No­vavax safe­ty da­ta

Click on the im­age to see the full-sized ver­sion

No­vavax has al­so made large com­mit­ments to dis­trib­ut­ing its vac­cine around the world at a time when vac­cine ac­cess is still in­equitable.

But the com­pa­ny’s plans for kids will face the same hur­dles as the com­pa­ny’s plans have faced in adults.

For one, the Omi­cron vari­ant has made its shot sig­nif­i­cant­ly less ef­fec­tive, al­though like its mR­NA ri­vals, the com­pa­ny has shown that a boost­er shot at least tem­porar­i­ly re­coups much of the lost ac­tiv­i­ty. And the com­pa­ny showed da­ta Thurs­day that an­ti­bod­ies teenagers de­vel­oped from the shot were able to neu­tral­ize Omi­cron, al­beit at re­duced po­ten­cies.

And then there’s man­u­fac­tur­ing: The com­pa­ny strug­gled for near­ly a year and a half to re­li­ably pro­duce its shot at scale, al­though there are signs those is­sues are fi­nal­ly abat­ing. The vac­cine is now au­tho­rized by the WHO and Eu­ro­pean reg­u­la­tors and is al­so en­ter­ing use in the UK, In­done­sia, In­dia and oth­er parts of the globe.

Al­though the FDA has yet to is­sue a de­ci­sion on No­vavax’s shot, the com­pa­ny’s choice to sub­mit an EUA sug­gests it be­lieves that the man­u­fac­tur­ing is­sues that re­peat­ed­ly de­layed au­tho­riza­tion have been re­solved.

Nev­er­the­less, Reuters re­port­ed this week that No­vavax has de­layed ship­ments to Eu­rope and oth­er parts of the globe. The Philip­pines, for ex­am­ple, said it has not re­ceived a sin­gle one of the 30 mil­lion shots it or­dered and was now con­sid­er­ing rene­go­ti­at­ing its con­tract.

Asked about the de­lays, Tay­lor on­ly ad­dressed the sit­u­a­tion in Eu­rope — where she said EU ship­ments have to un­der­go lo­cal test­ing in the Nether­lands be­fore be­ing dis­trib­uted to lo­cal coun­tries — but didn’t ad­dress de­lays else­where. She al­so re­it­er­at­ed the com­pa­ny will have the ca­pac­i­ty to pro­duce 2 bil­lion dos­es an­nu­al­ly, a goal No­vavax has been promis­ing since 2020. As re­cent­ly as last April, they said they would reach the ca­pac­i­ty by Q3 2021.

Tay­lor, though, de­clined to say how many dos­es the com­pa­ny is pro­duc­ing at the mo­ment — on­ly that they would meet their promis­es.

“We have com­mit­ments in place for 2 bil­lion dos­es,” she said. “That is a good match, we can make as much as we need to sup­ply our dose com­mit­ments.”

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

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Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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