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.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.