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Monday, March 3, 2025

Novavax hopes its COVID shot wins over FDA, vaccine holdouts

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1005 days ago
20220602
Novovax COVID-19 vaccine's incubate in flasks at the company research laboratory in Gaithersburg, Md., on May 24, 2022. The company is hoping to find a niche among some of the unvaccinated millions who might agree to their more traditional protein vaccine as a shot. (AP Photo/Angie Wang)

Novovax COVID-19 vaccine's incubate in flasks at the company research laboratory in Gaithersburg, Md., on May 24, 2022. The company is hoping to find a niche among some of the unvaccinated millions who might agree to their more traditional protein vaccine as a shot. (AP Photo/Angie Wang)

By LAU­RAN NEER­GAARD-As­so­ci­at­ed Press

 

GAITHERS­BURG, Md. (AP) — Amer­i­cans may soon get a new COVID-19 vac­cine op­tion -- shots made with a more tried-and-true tech­nol­o­gy than to­day’s ver­sions. The big ques­tion: Why should they care?

Af­ter long de­lays, the Food and Drug Ad­min­is­tra­tion is ex­pect­ed to de­cide with­in weeks whether to au­tho­rize No­vavax’s vac­cine. It’s late in the pan­dem­ic for a new choice, with about three-quar­ters of U.S. adults al­ready vac­ci­nat­ed.

But the com­pa­ny is hop­ing to find a niche among some of the un­vac­ci­nat­ed mil­lions who might agree to a more tra­di­tion­al kind of shot -- a pro­tein vac­cine — and al­so to be­come a top choice for boost­ers, re­gard­less of which type peo­ple got first. On­ly about half of vac­ci­nat­ed adults have got­ten a boost­er.

The No­vavax vac­cine al­ready is used in parts of Eu­rope and mul­ti­ple oth­er coun­tries, but FDA clear­ance is a key hur­dle. And health ex­perts are close­ly watch­ing to see if a new tool of­fers ad­van­tages, ei­ther in en­tic­ing vac­cine hold­outs or maybe even of­fer­ing some­what broad­er im­mu­ni­ty.

“What I’ve seen of the No­vavax da­ta so far is it’s a re­al­ly im­pres­sive pro­tein vac­cine,” said Uni­ver­si­ty of Penn­syl­va­nia im­mu­nol­o­gist E. John Wher­ry.

WHAT’S DIF­FER­ENT?

The No­vavax vac­cine trains the body to fight the coro­n­avirus by de­liv­er­ing copies of its out­er coat­ing, the spike pro­tein. Those spike copies are grown in in­sect cells, pu­ri­fied and pack­aged in­to nanopar­ti­cles that to the im­mune sys­tem re­sem­ble a virus, said No­vavax re­search chief Dr. Gre­go­ry Glenn.

Then an im­mune-boost­ing in­gre­di­ent, or ad­ju­vant, that’s made from the bark of a South Amer­i­can tree is added that acts as a red flag to en­sure those par­ti­cles look sus­pi­cious enough to spark a strong re­sponse.

“It’s ba­si­cal­ly a soap bub­ble. It’s made of stuff that you find in root beer,” Glenn said. “When an im­mune cell sees that, it be­comes quite ac­ti­vat­ed. ... We su­per­charge the im­mune re­sponse.”

Pro­tein vac­cines have been used for years to pre­vent he­pati­tis B, shin­gles and oth­er dis­eases.

It’s a very dif­fer­ent ap­proach than the Pfiz­er and Mod­er­na shots. Those so-called mR­NA vac­cines have saved count­less lives and changed the course of the pan­dem­ic but still, some peo­ple are un­com­fort­able with the new tech­nol­o­gy that de­liv­ers ge­net­ic in­struc­tions for the body to make its own spike copies. A third U.S. op­tion, from John­son & John­son, isn’t as wide­ly used.

WHY SO LATE?

Man­u­fac­tur­ing prob­lems held up the vac­cine glob­al­ly, but No­vavax CEO Stan­ley Er­ck said those prob­lems have been re­solved and “are well be­hind us.” The com­pa­ny said more than 40 mil­lion dos­es had been dis­trib­uted by March to coun­tries in Asia, Eu­rope and else­where.

No­vavax, a small biotech com­pa­ny, cre­at­ed the vac­cine in its re­search lab, but the Serum In­sti­tute of In­dia, the world’s largest vac­cine mak­er and oth­er fac­to­ries pro­duce the shots.

Er­ck said the Serum In­sti­tute re­cent­ly passed an FDA in­spec­tion, clear­ing the way for the agency to fin­ish eval­u­at­ing the vac­cine.

HOW WELL DO THE SHOTS WORK?

Ear­li­er in the pan­dem­ic, large stud­ies in the U.S., Mex­i­co and Britain found two dos­es of the No­vavax vac­cine were safe and about 90% ef­fec­tive at pre­vent­ing symp­to­matic COVID-19. When the delta vari­ant emerged last sum­mer, No­vavax re­port­ed a boost­er dose revved up virus-fight­ing an­ti­bod­ies that could tack­le that mu­tant.

Now an even more con­ta­gious branch of the coro­n­avirus fam­i­ly tree is dom­i­nant, the omi­cron mu­tant and its rel­a­tives. While none of the world’s COVID-19 vac­cines have proved as strong against omi­cron, Glenn said lab tests show No­vavax shots do trig­ger cross-pro­tec­tive an­ti­bod­ies.

Like oth­er vac­cine mak­ers, No­vavax is brew­ing shots up­dat­ed to bet­ter tar­get omi­cron. It opened a study in Aus­tralia to test how well an omi­cron-tar­get­ed boost­er revs up im­mu­ni­ty in peo­ple who ini­tial­ly got Pfiz­er or Mod­er­na dos­es.

And in flasks full of in­sect cells in the com­pa­ny’s Mary­land-based re­search lab, sci­en­tists are de­sign­ing spike pro­teins to match even new­er omi­cron sib­lings, in case they’re need­ed.

WHAT’S NEXT?

On June 7, the FDA’s sci­en­tif­ic ad­vis­ers will pub­licly eval­u­ate ev­i­dence back­ing the No­vavax vac­cine for adults -- and al­most cer­tain­ly will de­bate when and how it might be used as a boost­er. If the FDA au­tho­rizes the vac­cine, the next step would be rec­om­men­da­tions from the Cen­ters for Dis­ease Con­trol and Pre­ven­tion on how to use it.

Eu­ro­pean reg­u­la­tors are con­sid­er­ing ex­pand­ing No­vavax shots to teenagers based on a U.S. study of those as young as 12 dur­ing last sum­mer’s delta wave. The com­pa­ny plans fur­ther tests in younger chil­dren soon.

 

 

 

COVID-19COVID-19 deathsCOVID-19 casesCovid vaccines


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