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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis snaps up the rights to a Covid-19 an­tivi­ral af­ter see­ing mid-stage re­sults. So where are the da­ta?

Nearly two months after getting the boot from the NIH’s ACTIV-3 study over a failed futility analysis, Novartis and Molecular Partners are back with mid-stage results they say prove their Covid-19 antiviral works better in patients who aren’t hospitalized — and CEO Vas Narasimhan likes what he sees.

The pharma giant is putting down more than $162 million to in-license ensovibep from Molecular Partners after the candidate met its primary endpoint of viral load reduction over eight days in the first part of a Phase II/III study, the partners announced on Monday.

Stéphane Bancel (AP Images, Boston Herald)

Covid-19 roundup: FDA short­ens in­ter­val for Mod­er­na boost­er dose to 5 months; Mod­er­na CEO says an­oth­er boost­er could be nec­es­sary this fall — re­port

The FDA has shortened the recommended interval between the primary series of Moderna’s Covid-19 vaccine and a booster shot to at least five months for adults.

The news comes days after the agency shortened the time interval between Pfizer and BioNTech’s primary series and booster to five months for children and adults 12 years and older. The FDA has also cleared a third dose of the Pfizer/BioNTech shot for certain kids ages five through 11 who are immunocompromised.

FDA los­es FOIA suit over Pfiz­er vac­cine doc­u­ments, must re­lease 55,000 pages per month

A district court in Texas will likely tie up the FDA’s FOIA office for months, as the court ruled late Thursday that the agency must release all documents related to its review of Pfizer-BioNTech’s Covid-19 vaccine.

The order from district judge Mark Pittman, handed down late Thursday, notes that while the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA, there also “may not be” a more important issue at the FDA right now than the pandemic, the Pfizer vaccine, getting every American vaccinated, and making sure to the American public that the process was not rushed.

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Covid-19 roundup: In­vestors call to link CEO salaries to vac­cine ac­cess; Why there aren't more ini­tial sup­plies of the Pfiz­er pill

A group of institutional investors from Nomura, BMO, GAM and more than 60 others representing trillions in assets are now calling on Covid-19 vaccine developers to link their executives’ pay to ensure the vaccines are available globally.

“It is clear that currently a large part of the world population still does not have sufficient and equitable access to vaccines,” the investors said in explaining their reasoning behind Thursday’s letter to the execs at Pfizer, Moderna, AstraZeneca and J&J.

UP­DAT­ED: US restarts ship­ments of two mAbs that don't work against Omi­cron as Mer­ck pills see wider dis­tri­b­u­tion

For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.

More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.

Photo by Anthony Behar/Sipa USA)(Sipa via AP Images

Covid-19 roundup: FDA au­tho­rizes Pfiz­er-BioN­Tech boost­er for 12-to-15-year-olds; Ear­ly re­sults sug­gest an­tivi­rals may hold up against Omi­cron

Children between the ages of 12 and 15 years old are now eligible for a third dose of the Pfizer-BioNTech vaccine after the FDA authorized it Monday, as well as a third shot for those between 5 and 11 who are immunocompromised.

The FDA also shortened the time between the completion of a primary vaccine and a booster shot to five months for Pfizer’s jab, although Moderna’s booster interval remains at 6 months. The moves come as Omicron has ripped through the US, causing the number of positive cases to skyrocket.

Covid-19 man­u­fac­tur­ing roundup: In­di­an man­u­fac­tur­er waives vac­cine pro­tec­tions for mi­grants; EMA gives go-ahead for French J&J pro­duc­tion site

Amid fears that millions of migrants may not have access to Covid-19 vaccines from Covax following liability fears, the Serum Institute of India has announced that it will waive its protection from legal liabilities for any AstraZeneca-Oxford doses it provides to the program, Reuters reported Wednesday.

Covishield can now be allocated to the Covax Humanitarian Buffer, a program designed to ensure that the most vulnerable portions of populations, such as conflict zones or humanitarian settings that are not able to be reached by government vaccination campaigns, are not left behind. Gavi sees it most effective in areas that have been impacted by state failure or areas controlled by groups that are not the government. Asylum seekers, refugees, detainees, and people who are stateless are all eligible.

Robert Davis, Merck CEO

FDA au­tho­rizes new Mer­ck Covid-19 pill de­spite sci­en­tist­s' con­cerns on its mech­a­nism of ac­tion

The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.

While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.

Covid-19 roundup: No­vavax says vac­cine shows 'broad cross-re­ac­tiv­i­ty' against Omi­cron; France can­cels or­der on Mer­ck’s an­tivi­ral pill — re­port

Novavax said Wednesday that initial data suggest its Covid-19 vaccine demonstrated “broad cross-reactivity against Omicron and other circulating variants” after two doses — though neutralization was around 4-fold lower against Omicron compared to the original strain.

As a result, the company says it’s working on an Omicron-specific vaccine and plans to launch clinical studies in the first quarter of 2022.

(Photo courtesy Pfizer)

FDA au­tho­rizes the first at-home pills from Pfiz­er to treat Covid-19

The FDA on Wednesday signed off on Pfizer’s Covid-19 pills, which are meant to help keep people out of the hospital.

The news comes at a crucial moment, as the Omicron variant has taken over Delta as the prominent strain in the US, and as monoclonal antibody infusions will likely be in very short supply as two of the three currently marketed are ineffective against Omicron.

Pfizer will see early supply constraints of their pills, which are made up of nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use, meaning doctors will have to be very careful on how they’re doled out. And if Merck’s pill is authorized soon too, there may be more options, although there’s also a drastic difference in efficacy between the two.