Opin­ion: The FDA's mR­NA vac­cine full ap­proval re­views are mov­ing plen­ty fast. Start the man­dates now

As the US con­tin­ues to en­joy a sur­plus of pro­tec­tive Covid vac­cines, some ex­perts are hop­ing that a tran­si­tion from EUA to full ap­proval sta­tus for the two mR­NA vac­cines will boost the pub­lic’s trust in them and in turn, amp up the coun­try’s vac­ci­na­tion lev­els just in time to block the resur­gence of Covid that we’re see­ing else­where dri­ven by the Delta vari­ant.

While such a quick up-shift may have that im­me­di­ate ef­fect, let’s not lose sight of the fact that the FDA is like­ly to re­view the Pfiz­er/BioN­Tech and Mod­er­na vac­cines in record time. And their mas­sive trove of re­al-world safe­ty and man­u­fac­tur­ing da­ta don’t make that easy. Even still, the FDA is plan­ning its Covid vac­cine ap­proval re­views to last about half the time (3-4 months) that it cur­rent­ly takes the agency to sign off on a pri­or­i­ty drug/vac­cine ap­pli­ca­tion (6 months), and just a frac­tion of the time for a non-ex­pe­dit­ed new drug ap­pli­ca­tion (12 months).

There’s no ques­tion the agency should pick up the speed for both Pfiz­er and Mod­er­na’s ap­pli­ca­tions. Em­ploy­ers may be more will­ing to push for man­dates once the vac­cines are ful­ly ap­proved. Let’s not for­get the rea­son we’re in this en­vi­able po­si­tion, with al­most 160 mil­lion peo­ple ful­ly vac­ci­nat­ed in the US in just a lit­tle more than a year and a half since the pan­dem­ic be­gan: The FDA was able to move quick­ly on the stel­lar ef­fi­ca­cy da­ta at hand from both vac­cines, and en­sure the man­u­fac­tur­ing process was ro­bust enough and could be repli­cat­ed in a way to make all of those hun­dreds of mil­lions of dos­es safe­ly and ef­fi­cient­ly.

A rub­ber stamp push from EUA to full ap­proval doesn’t help the mil­lions of Amer­i­cans who still haven’t been vac­ci­nat­ed, may be hes­i­tant, or may be en­tire­ly op­posed to the idea just be­cause of the EUA sta­tus. And as the EUA to full ap­proval tran­si­tion is com­ing, em­ploy­ers across the coun­try need to stand strong and re­quire vac­ci­na­tions so we can re­main pro­tect­ed. As lawyers have in­di­cat­ed, there’s noth­ing il­le­gal about re­quir­ing the ad­min­is­tra­tion of vac­cines un­der EUAs.

Er­ic Topol, pro­fes­sor of mol­e­c­u­lar med­i­cine at Scripps Re­search, re­cent­ly au­thored an op-ed in the New York Times, call­ing on the FDA to ful­ly ap­prove the mR­NA vac­cines now, not­ing that they “have over­whelm­ing­ly been proved safe and ef­fec­tive by clin­i­cal tri­als, in­de­pen­dent re­search and the ex­pe­ri­ence of mil­lions of peo­ple around the world who re­ceived them.”

But FDA’s re­views of Pfiz­er’s and Mod­er­na’s vac­cines have so far last­ed less than 3 months. And there is noth­ing in the EUA or re­al-world da­ta for ei­ther the Mod­er­na or the Pfiz­er/BioN­Tech vac­cine that should bring pause or some­how sug­gest ei­ther vac­cine’s clin­i­cal da­ta pack­age isn’t equal to oth­er, man­dat­ed vac­cines that have al­ready won full ap­proval.

And while some seem to sug­gest the FDA is drag­ging its feet, the size (thou­sands of pages long) and com­plex­i­ty of a full ap­proval pack­age should not be tak­en light­ly. If the FDA needs to take longer to en­sure the vac­cines are man­u­fac­tured prop­er­ly enough to win a full ap­proval, so be it.

Pe­ter Marks

As FDA’s top vac­cine of­fi­cial Pe­ter Marks made clear from the very be­gin­ning, the vac­cines were cleared at a high­er bar than the oth­er treat­ments win­ning EUAs, and the Amer­i­can pub­lic should be just as con­fi­dent in the vac­cines un­der EUAs as un­der full ap­provals.

For those who re­main un­vac­ci­nat­ed, Marks and Janet Wood­cock re­it­er­at­ed the ur­gent need to move now, even with the very rare my­ocardi­tis risk in most­ly younger men, as part of a stake­hold­er call last week. The CDC al­so made clear on Tues­day evening that more than half of all cas­es in the US are now the re­sult of the Delta vari­ant, which orig­i­nat­ed in In­dia.

“The Delta vari­ant is ris­ing in this coun­try and its in­ci­dence may dou­ble every week or so, and ex­perts ex­pect it will be the dom­i­nant vari­ant with­in a month or so,” Wood­cock said. The time to get vac­ci­nat­ed is now, with or with­out a full ap­proval.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.