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Friday, February 28, 2025

Why Pfizer needs time to make COVID-19 treatment

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1093 days ago
20220303

An AP EX­PLAIN­ER By TOM MUR­PHY | AS­SO­CI­AT­ED PRESS

 

(AP) — Pfiz­er’s new COVID-19 treat­ment came with a catch when it de­buted late last year: Sup­plies were lim­it­ed, and it can take months to make the tablets.

Com­pa­ny lead­ers say they are ex­pand­ing pro­duc­tion and ex­pect big gains in the next sev­er­al months. That could help if an­oth­er wave of cas­es de­vel­ops.

 

WHAT’S THE LAT­EST ON SUP­PLIES?

 

The U.S. gov­ern­ment dis­trib­utes Paxlovid, the first pill au­tho­rized to treat the coro­n­avirus. White House coro­n­avirus re­sponse co­or­di­na­tor Jeff Zients said Wednes­day that the gov­ern­ment will have 1 mil­lion treat­ment cours­es avail­able this month. He ex­pects that to more than dou­ble in April.

Pfiz­er Chief Glob­al Sup­ply Of­fi­cer Mike Mc­Der­mott says there is “an am­ple amount” of Paxlovid avail­able for high-risk pa­tients who need it.

Physi­cians al­so have sev­er­al oth­er treat­ment op­tions, in­clud­ing a less ef­fec­tive cap­sule treat­ment from Mer­ck that U.S. reg­u­la­tors say should be con­sid­ered on­ly if oth­er op­tions aren’t avail­able or ap­pro­pri­ate.

Dr. Ray­mund Ra­zon­able of the Mayo Clin­ic said Paxlovid sup­plies would have to in­crease if an­oth­er surge ma­te­ri­al­izes that’s as big as the one caused re­cent­ly by the omi­cron vari­ant.

 

WHY DOES IT TAKE SO LONG TO MAKE PAXLOVID?

 

The short an­swer: It’s a com­plex drug that in­volves chem­i­cal re­ac­tions that need time to de­vel­op.

Pfiz­er’s man­u­fac­tur­ing ex­perts com­pare Paxlovid to a com­pli­cat­ed Lego mod­el where key parts are made at dif­fer­ent lo­ca­tions and then brought to­geth­er and com­bined.

The ini­tial build­ing blocks can take up to three months to make. Some chem­i­cal re­ac­tions need days to de­vel­op at a con­trolled tem­per­a­ture and pres­sure.

“If you put it all in to­geth­er very quick­ly, it can all go wrong,” said Char­lotte Aller­ton, Pfiz­er’s head of med­i­cine de­sign.

Those ini­tial build­ing blocks are shipped to an­oth­er lo­ca­tion that makes the main part of the drug, the ac­tive in­gre­di­ent. Tack on an­oth­er three months for that process.

Then the in­gre­di­ent heads to an ad­di­tion­al lo­ca­tion that turns it in­to tablets and pack­ages the med­i­cine. That can take six weeks. Add an­oth­er week for qual­i­ty checks and test­ing.

Paxlovid pro­duc­tion in­volves more than 20 dif­fer­ent sites in over 10 coun­tries.

 

IS THIS TIME FRAME UN­USU­AL?

 

No. Pfiz­er ex­ec­u­tives say some drugs for oth­er con­di­tions take even longer.

The com­pa­ny said it has al­ready shaved av­er­age Paxlovid pro­duc­tion time down to about sev­en months from close to nine.

The drug­mak­er is adding more man­u­fac­tur­ing and pack­ag­ing sites. It will try to cut pro­duc­tion time fur­ther, as long as it can do so with­out af­fect­ing qual­i­ty.

Mer­ck says it takes about six months to make its treat­ment, mol­nupi­ravir. The com­pa­ny ex­pects to re­duce that to around five over time.

 

WHY USE SO MANY LO­CA­TIONS?

 

Pfiz­er doesn’t have time to build a plant just to make Paxlovid.

Mer­ck al­so us­es 17 plants across eight coun­tries to make mol­nupi­ravir.

“If you knew you were go­ing to mak­ing this prod­uct for 10 years at a giv­en scale, you’d prob­a­bly build a plant just for it, but oth­er­wise this is the way we typ­i­cal­ly do busi­ness,” said John Mc­Grath, a Mer­ck se­nior vice pres­i­dent.

 

WHEN DID PFIZ­ER START MAK­ING PAXLOVID?

 

The com­pa­ny be­gan prepa­ra­tions in June, about six months be­fore the U.S. Food and Drug Ad­min­is­tra­tion au­tho­rized the med­ica­tion. That al­so was be­fore re­searchers fin­ished late-stage stud­ies on its ef­fec­tive­ness.

Pfiz­er made its first com­mer­cial batch of the ac­tive in­gre­di­ent at scale in Sep­tem­ber. The com­pa­ny then had to wait for FDA au­tho­riza­tion be­fore it could pack­age and la­bel.

The drug­mak­er spent about $1 bil­lion to get that head start, said Paul Duffy, a vice pres­i­dent with Pfiz­er Glob­al Sup­ply.

 

WILL SUP­PLIES IM­PROVE?

 

Yes. Mc­Der­mott said Pfiz­er ex­pects to make 30 mil­lion pa­tient packs by the mid­dle of the year and 120 mil­lion by the end of 2022.

Out­side those to­tals, Pfiz­er is let­ting some gener­ic drug­mak­ers pro­duce Paxlovid in a deal with the pub­lic health or­ga­ni­za­tion Med­i­cines Patent Pool. That’s ex­pect­ed to boost sup­ply, es­pe­cial­ly for low-in­come coun­tries.

Pres­i­dent Joe Biden an­nounced Tues­day night that his ad­min­is­tra­tion will launch a “test to treat” plan that in­volves pro­vid­ing free an­tivi­ral pills at phar­ma­cies to cus­tomers who test pos­i­tive for the virus.

When asked if Pfiz­er could han­dle ad­di­tion­al de­mands from that pro­gram, a spokesman said the com­pa­ny was “con­fi­dent in our sup­ply ca­pac­i­ty.” He added that the drug­mak­er re­mains on track to de­liv­er 10 mil­lion treat­ment cours­es to the U.S. gov­ern­ment by June.

___

AP video jour­nal­ist Em­ma H. To­bin con­tributed to this re­port.

COVID-19HealthPfizer


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