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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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