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Thursday, May 8, 2025

COVID-19 pill rollout stymied by shortages as omicron rages

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1210 days ago
20220114
FILE - This image provided by Pfizer shows the company's COVID-19 Paxlovid pills. Pfizer's and Merck's COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. are in short supply and have played little role in the fight against the omicron wave of infections. (Pfizer via AP, File)

FILE - This image provided by Pfizer shows the company's COVID-19 Paxlovid pills. Pfizer's and Merck's COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. are in short supply and have played little role in the fight against the omicron wave of infections. (Pfizer via AP, File)

By MATTHEW PER­RONE-As­so­ci­at­ed Press

 

WASH­ING­TON (AP) — Two brand-new COVID-19 pills that were sup­posed to be an im­por­tant weapon against the pan­dem­ic in the U.S. are in short sup­ply and have played lit­tle role in the fight against the omi­cron wave of in­fec­tions.

The prob­lem, in part, is that pro­duc­tion is still be­ing ramped up and the med­i­cines can take any­where from five to eight months to man­u­fac­ture.

While the sup­ply is ex­pect­ed to im­prove dra­mat­i­cal­ly in the com­ing months, doc­tors are clam­or­ing for the pills now, not just be­cause omi­cron is caus­ing an ex­plo­sion of cas­es but be­cause two an­ti­body drugs that were once the go-to treat­ments don’t work as well against the vari­ant.

“This should be a re­al­ly joy­ous time be­cause we now have high­ly ef­fec­tive an­tivi­ral pills,” said Erin Mc­Creary, a phar­ma­cist and ad­min­is­tra­tor at the Uni­ver­si­ty of Pitts­burgh Med­ical Cen­ter. “In­stead, this feels like the hard­est and most chaot­ic stretch of the pan­dem­ic.”

The pills — and oth­er COVID-19 drugs, for that mat­ter — are be­ing care­ful­ly ra­tioned, re­served for the high­est-risk pa­tients.

“Jan­u­ary is go­ing to be a ter­ri­ble month with a mil­lion cas­es a day,” said Uni­ver­si­ty of North Car­oli­na vi­rol­o­gist Dr. My­ron Co­hen. “Most peo­ple will do per­fect­ly well, but we have to se­lect out the peo­ple who won’t and give them the drugs we have avail­able.”

The Food and Drug Ad­min­is­tra­tion au­tho­rized the two pills from Pfiz­er and Mer­ck late last month based on stud­ies show­ing they cut the risk of se­vere dis­ease and death when giv­en short­ly af­ter symp­toms ap­pear. They are the first COVID-19 treat­ments pa­tients can take at home, and thus could re­duce the bur­den on hos­pi­tals.

The U.S. didn’t make the kind of mass pur­chas­es in ad­vance that it did with vac­cines.

Pfiz­er’s pill, Paxlovid, is con­sid­ered far su­pe­ri­or to Mer­ck’s, but be­cause of the six to eight months it takes to man­u­fac­ture, the com­pa­ny says it can sup­ply on­ly about 250,000 cours­es of the treat­ment by the end of this month.

The U.S. has or­dered enough Paxlovid to treat 20 mil­lion peo­ple, but the first 10 mil­lion or­ders won’t be de­liv­ered un­til June.

White House COVID-19 co­or­di­na­tor Jeff Zients said this week that the gov­ern­ment col­lab­o­rat­ed with Pfiz­er to help speed up de­vel­op­ment of the pill by sev­er­al months, and that of­fi­cials con­tin­ue to work with the com­pa­ny to look for ways to boost pro­duc­tion.

Pfiz­er said it is adding ca­pac­i­ty: “We ex­pect to use our strong man­u­fac­tur­ing ca­pa­bil­i­ties and our ex­ten­sive sup­pli­er net­work to con­tin­ue to im­prove out­put rapid­ly.”

Mer­ck’s pill, mol­nupi­ravir, was pro­duced in greater ad­vance quan­ti­ties. It takes six months to man­u­fac­ture, though the com­pa­ny says that can be com­pressed to five months if nec­es­sary.

But fi­nal test­ing showed the drug was far less ef­fec­tive than Pfiz­er’s pill and car­ried sig­nif­i­cant risks, in­clud­ing the po­ten­tial for birth de­fects when tak­en by preg­nant women. As a re­sult, it is con­sid­ered the last-choice op­tion un­der fed­er­al guide­lines.

Mer­ck said it has de­liv­ered 900,000 cours­es of the drug and is on track to ship all 3 mil­lion or­dered by the U.S. by the end of the month.

Since last month, the gov­ern­ment has sent states enough Pfiz­er pills to treat 164,000 peo­ple, al­lo­cat­ing them by pop­u­la­tion. That ap­proach is com­ing un­der fire from some states with heav­ier case­loads.

The amount al­lo­cat­ed to New York — enough to treat about 20,000 peo­ple — is in­suf­fi­cient, said Health Com­mis­sion­er Dr. Mary Bas­sett.

“We need more of these drugs in or­der to make them al­ter the course of the pan­dem­ic and re­duce hos­pi­tal­iza­tion,” she said.

State guide­lines gen­er­al­ly rec­om­mend doc­tors give pri­or­i­ty for the drugs to those at the high­est risk, in­clud­ing can­cer pa­tients, trans­plant re­cip­i­ents and peo­ple who have lung dis­ease or are preg­nant. New York’s guide­lines al­so rec­om­mend pri­or­i­tiz­ing cer­tain racial and eth­nic mi­nori­ties, giv­en their high­er rates of se­vere ill­ness and death.

States are dis­trib­ut­ing the pills dif­fer­ent­ly.

In Michi­gan, all ini­tial ship­ments went to 10 phar­ma­cies in the hard­est-hit ar­eas. Penn­syl­va­nia, Mary­land, Texas and many oth­er states have dis­trib­uted the pills more wide­ly, so that at least one phar­ma­cy in each coun­ty car­ries the drug.

De­spite the strict pre­scrib­ing guide­lines, some pa­tients have been able to get the pills through luck and per­sis­tence.

Craige Camp­bell, a web­site man­ag­er from Desert Hot Springs, Cal­i­for­nia, be­gan leav­ing mes­sages with his doc­tor im­me­di­ate­ly af­ter test­ing pos­i­tive for COVID-19 and de­vel­op­ing a 101-de­gree fever. De­spite hav­ing no un­der­ly­ing health con­di­tions, he was soon able to get a pre­scrip­tion.

The on­ly phar­ma­cy dis­pens­ing the drug was more than an hour’s dri­ve away, so Camp­bell had a friend pick it up for him.

“I felt a bit priv­i­leged in a way,” he said. “The odds that it would land in my plate in the right amount of time were pret­ty ex­tra­or­di­nary.”

At the same time, there is a short­age of an­ti­body med­ica­tions, the in­fused or in­ject­ed drugs that can head off death and hos­pi­tal­iza­tion. On­ly one of them, from Glax­o­SmithK­line, ap­pears ef­fec­tive against omi­cron, and it, too, is be­ing ra­tioned.

Fed­er­al of­fi­cials are lim­it­ing ship­ments of it to about 50,000 dos­es per week. This week, the gov­ern­ment an­nounced it is buy­ing 600,000 more dos­es, on top of 400,000 pur­chased in No­vem­ber.

At the UPMC hos­pi­tal sys­tem in Penn­syl­va­nia, the staff can treat few­er than 1,000 pa­tients per week with an­ti­bod­ies, down from as many as 4,000 ear­li­er in the pan­dem­ic.

Doc­tors and nurs­es around the U.S. have de­vel­oped com­plex means of de­cid­ing who should get the scarce med­ica­tions, based on pa­tients’ symp­toms, their un­der­ly­ing med­ical risks, where they live and whether they are healthy enough to trav­el for an in­fu­sion.

“What do we have on hand?” is the first ques­tion, said Uni­ver­si­ty of Mary­land Med­ical Cen­ter’s Dr. Greg Schrank. “Among those ther­a­pies, what’s the most ef­fec­tive and how can we di­rect it to the peo­ple that we know are of great­est risk?”

The in­creas­ing­ly com­pli­cat­ed treat­ment pic­ture comes as ex­haust­ed, frus­trat­ed hos­pi­tal work­ers try to man­age ris­ing ad­mis­sions.

As of Sun­day, near­ly 128,000 Amer­i­cans were in the hos­pi­tal with COVID-19, sur­pass­ing the all-time high of around 125,000 last Jan­u­ary. While few­er COVID-19 pa­tients now re­quire in­ten­sive care, the surge is push­ing hos­pi­tals to the break­ing point.

Con­sid­er­ing that threat, Pfiz­er’s pill ar­rived just in time, Schrank said.

“It’s not go­ing to turn the tide on the to­tal num­ber of cas­es, but it could re­al­ly help damp­en the im­pact on hos­pi­tals,” he said.

AP Writ­ers Bob­by Cal­van in New York and David Eg­gert in Lans­ing, Mich. con­tributed to this sto­ry.

 

COVID-19


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