The FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 16-1 that the ben­e­fits of Pfiz­er’s Covid-19 pill Paxlovid out­weigh the risks in adults with mild-to-mod­er­ate ill­ness.

The vote fol­lowed hours of dis­cus­sion on top­ics rang­ing from ef­fi­ca­cy in peo­ple who have al­ready been vac­ci­nat­ed or in­fect­ed to drug-drug in­ter­ac­tions (DDIs). Pfiz­er sub­mit­ted a re­quest to con­vert its EUA to a full ap­proval back in June, but the FDA ex­tend­ed its re­view pe­ri­od by three months to con­sid­er ad­di­tion­al da­ta sub­mit­ted, the com­pa­ny an­nounced in De­cem­ber. The cur­rent PDU­FA ac­tion date for a de­ci­sion by the FDA is May 2023.

Just one com­mit­tee mem­ber vot­ed against the ques­tion: “Is the over­all ben­e­fit-risk as­sess­ment fa­vor­able for Paxlovid (nir­ma­trelvir and ri­ton­avir tablets) when used for the treat­ment of mild-to-mod­er­ate COVID-19 in adults who are at high risk for pro­gres­sion to se­vere COVID-19, in­clud­ing hos­pi­tal­iza­tion or death?”

While mem­bers who vot­ed yes agreed that ef­fi­ca­cy and safe­ty have been demon­strat­ed, they added that it’s im­por­tant to un­der­stand who is at high-risk and who will ben­e­fit from the drug. They al­so echoed the need to keep an eye on DDIs, as well as on­go­ing and fu­ture stud­ies by Pfiz­er on symp­to­matic re­bound and the drug’s im­pact on im­muno­sup­pressed, pe­di­atric and preg­nant pa­tients.

Pa­tient rep­re­sen­ta­tive Ter­ry Gille­spie, who vot­ed no, said she has one lung and has had Covid four or five times. Gille­spie said she was nev­er of­fered Paxlovid by med­ical pro­fes­sion­als and is “con­cerned about the doc­tors know­ing ac­tu­al­ly when to pre­scribe it to some­body, say, like me.”

In com­ments on the strength of ev­i­dence for use of Paxlovid in pa­tients who have al­ready been vac­ci­nat­ed or pre­vi­ous­ly in­fect­ed, com­mit­tee mem­bers said more da­ta are need­ed.

“I would just agree with those that said the ev­i­dence isn’t as com­pelling as in those that are un­vac­ci­nat­ed,” com­mit­tee mem­ber Paige Wa­ter­man said. “I don’t think we’re ever go­ing to have a ful­ly vac­ci­nat­ed pop­u­la­tion, what­ev­er ful­ly vac­ci­nat­ed means, al­though tak­en to­geth­er with pri­or in­fec­tion I guess would give us de­cent num­bers. I agree with the points made about in­di­vid­u­al­ize de­ci­sions. As we’re say­ing, physi­cians need to rec­og­nize in­di­ca­tions. Who meets this cri­te­ria?”

If grant­ed full ap­proval, Paxlovid’s EUA will re­main in place so that ado­les­cents 12 years and old­er can con­tin­ue to be treat­ed with the drug. In the US, more than 10 mil­lion treat­ment cours­es of Paxlovid have been pre­scribed to date, ac­cord­ing to Pfiz­er.

While the FDA does not need to fol­low an ad­comm’s rec­om­men­da­tions, it typ­i­cal­ly does. Pfiz­er has an on­go­ing tri­al for Paxlovid in chil­dren and plans to file a sup­ple­men­tal NDA for ap­proval in chil­dren.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.