A cell containing smallpox viruses, as captured by transmission electron microscopy

UP­DATE: Re­ports of small­pox-la­beled vials at Mer­ck plant con­tained 'no trace' of virus

Small­pox was de­clared erad­i­cat­ed  in 1980 by the World Health Or­ga­ni­za­tion, af­ter an ef­fort to vac­ci­nate the globe. But sev­er­al vials la­beled as the dis­ease were found at a Penn­syl­va­nia vac­cine re­search fa­cil­i­ty be­long­ing to Mer­ck, when a lab­o­ra­to­ry work­er was clean­ing out a freez­er.

The CDC re­leased a state­ment Thurs­day stat­ing that the vials con­tained no trace of the virus, but rather, the virus used in the small­pox vac­cine, and not var­i­o­la, the virus that caus­es small­pox.

“There is no ev­i­dence that the vials con­tain var­i­o­la virus, the cause of small­pox,” the state­ment said. “CDC is in close con­tact with state and lo­cal health of­fi­cials, law en­force­ment, and the World Health Or­ga­ni­za­tion about these find­ings.”

There’s no in­di­ca­tion that any­one was ex­posed to the vials, the CDC told CNN in an email. The lab work­er was wear­ing gloves and a face mask, and the FBI is now in­ves­ti­gat­ing.

The in­ci­dent is sim­i­lar to one in 2014, when em­ploy­ees of the Na­tion­al In­sti­tutes of Health found six vials of small­pox in an un­used stor­age room while pack­ing up a lab in Bethes­da, MD. Two of those vials had vi­able dos­es of the virus, but there was no ev­i­dence, at the time, that any­one had been ex­posed to it.

There’s been an on­go­ing de­bate among sci­en­tists whether or not to keep around sam­ples of the virus. Rou­tine vac­ci­na­tions against the virus stopped in 1972, CNN said, but some mil­i­tary per­son­nel still get the jab. Mean­while, boost­ers are rec­om­mend­ed every 3 to 5 years by the CDC.

“Be­cause of con­cern that var­i­o­la virus might be used as an agent of bioter­ror­ism, the US gov­ern­ment has stock­piled enough small­pox vac­cine to vac­ci­nate every­one who would need it if a small­pox out­break were to oc­cur,” the CDC says on its web­site. “When there is NO small­pox out­break, you should get the small­pox vac­cine if you are … a lab work­er who works with virus that caus­es small­pox or oth­er virus­es that are sim­i­lar to it.

“When there is a small­pox out­break, you should get the small­pox vac­cine if you are di­rect­ly ex­posed to small­pox virus.”

The small­pox vac­cine is not ad­min­is­tered in a shot, like oth­er vac­cines, but rather, giv­en with a two-pronged nee­dle that is dipped in­to the vac­cine so­lu­tion, then pricks the skin sev­er­al times. That is not deep but will cause a sore spot, and lead to a red le­sion de­vel­op­ing in three or four days.

Right now, there are on­ly two labs in the world that are au­tho­rized to store the virus, a CDC site in At­lanta and an­oth­er in Rus­sia.

Nei­ther Mer­ck, nor the CDC re­spond­ed to re­quests for com­ment by End­points News as of pub­li­ca­tion.

Small­pox’s his­to­ry dates as far back as the 6th cen­tu­ry, when an in­crease in trade be­tween Chi­na and Ko­rea brought the virus to Japan. On av­er­age, three of every 10 peo­ple who con­tract­ed the virus died, and those who sur­vived of­ten were left with se­vere scar­ring.

In 1959, the WHO start­ed a plan to rid the world of the virus, and cas­es were elim­i­nat­ed in North Amer­i­ca and Eu­rope by 1953. The last per­son to have ac­tive small­pox was a 3-year-old from Bangladesh in 1975, and the last per­son to die of small­pox was a med­ical pho­tog­ra­ph­er at Birm­ing­ham Uni­ver­si­ty Med­ical School. She died in 1978.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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