Two lots of the Covid-19 treat­ment Vek­lury have been re­called by Gilead, the com­pa­ny said last week, af­ter the ap­pear­ance of glass par­tic­u­lates. A cus­tomer com­plaint was con­firmed by Gilead’s in­ves­ti­ga­tion.

Vek­lury, al­so known as remde­sivir 100 mg for in­jec­tion, is used in more than half of hos­pi­tal­ized pa­tients with Covid-19, ac­cord­ing to Gilead. It raked in around $2.8 bil­lion last year, and was the on­ly drug ap­proved by the FDA for this set­ting. But a study out of Eu­rope dubbed Dis­CoV­eRy found that no clin­i­cal ben­e­fit was ob­served in pa­tients who re­ceived the drug over those who got stan­dard of care alone. And while pre­vi­ous stud­ies have linked remde­sivir to a faster time to re­cov­ery, that re­sult was not seen in the Dis­CoV­eRy tri­al.

Those re­sults have peo­ple ques­tion­ing the drug’s ap­proval, and its cost of $3,000. The FDA gave it full ap­proval in Oc­to­ber based on three dif­fer­ent stud­ies.

The drug gained emer­gency use au­tho­riza­tion in May 2020, and was fa­mous­ly giv­en to US Pres­i­dent Don­ald Trump when he was bat­tling the coro­n­avirus. Gilead has said that the drug re­duced the risk of death by 62% when com­pared with oth­er stan­dards of care.

The treat­ment is in­tend­ed for adults and chil­dren above the age of 12 who re­quire hos­pi­tal­iza­tion for Covid-19. The two lots af­fect­ed by the re­call, 2141001-1A and 2141002-1A, were dis­trib­uted through­out the US in Oc­to­ber 2021. They both have ex­pi­ra­tion dates of Jan­u­ary 2024.

If a drug with glass par­tic­u­late is in­ject­ed in­to a pa­tient, side ef­fects could be as sim­ple as red­ness and swelling at the in­jec­tion point, to trav­el­ing to or­gans and block­ing blood ves­sels in the heart, lungs or brain. That can lead to stroke and death.

So far, there have been no re­ports of any events re­lat­ed to the re­call, Gilead said. Any­one who has ex­pe­ri­enced side ef­fects from the shot should reach out to the FDA’s ad­verse event re­port­ing pro­gram on­line at www.fda.gov/med­watch/re­port.htm or by call­ing them at 1-800-332-1088.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Despite initial flops, Jean-Pierre Sommadossi believes his antiviral biotech still has a role to play in what he sees as a long fight against Covid-19.

“COVID-19 continues to be a global emergency with waning efficacy from vaccines, therapeutics and prior infections driving an unmet medical need. New antivirals with improved profiles are urgently needed,” Sommadossi, the CEO of Atea Pharmaceuticals, said in a quarterly update.