Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)
Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.
With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).
They did not breakdown rates of any specific adverse events, but said ‘the adverse event profile was generally consistent with other clinical safety data for the vaccine’ and that no serious safety concerns were observed.
The analysis looked at 2,228 trial participants in the teen trial, finding that in the placebo group there were 30 confirmed symptomatic cases of Covid and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100% (95% confidence interval [CI, 87.5, 100.0]).
‘These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age,’ Ugur Sahin, CEO of BioNTech, said in a statement.
The new Pfizer data analysis comes after Moderna recently said the FDA needs more time to review the company’s vaccine in teens aged 12 to 17 years old because the agency wants to ‘evaluate recent international analyses of the risk of myocarditis after vaccination,’ Moderna said. The company originally filed its EUA in this population last June, but now says FDA’s review could take until January 2022.
Moderna’s plans to file an EUA request for the pediatric population (which it defines as 6-11 years of age) will now be pushed back too while the agency completes its adolescent review. Moderna’s new CMO Paul Burton spoke to reporters earlier this month, attempting to defend his company’s vaccine against questions around heart-related risks that appear to be cropping up in very rare instances among younger men.
The media push comes as the Moderna vaccine has proven to be overwhelmingly safe in more than 155 million individuals internationally. But countries like Finland, Sweden, Norway and Denmark have limited use of the Moderna vaccine to men over the age of 30, as it found the younger men who received the vaccine, known in Europe as Spikevax, had a slightly higher risk of developing myocarditis when compared to other vaccines.
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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.
And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’
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Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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We are wrapping up this year’s special report on 20 trailblazing women in biopharma R&D, and can’t be more excited to share their stories on December 7, both through the written profiles and a live event, followed by a panel on gender issues moderated by Nicole DeFeudis and myself. Learn more and sign up here.
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GlaxoSmithKline’s newest TV ads for Trelegy (screenshot above) embrace the realities of living with COPD.
When GlaxoSmithKline launched its first campaign for three-drug combo Trelegy inhaler, it used a catchy ‘1-2-3’ pop song. A customized version of a 1970s Jackson Five hit, GSK’s custom lyrics repeated the power of ‘Trelegy 1-2-3’ throughout a series of four TV ads that first debuted in 2018.
The strategy made sense. As the first three-in-one COPD drug, the upbeat song reinforced the product message. And it worked. Trelegy awareness soared, and the campaign climbed the ranks to GSK’s best performing respiratory ad. GSK employees were humming the ad in the hallways and Trelegy sales began climbing.
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Emily Leproust, Twist CEO
Twist Bioscience has come a long way since dipping its toes into the antibody discovery space a couple years ago, spinning out its first company just last week to take a Covid-19 antibody into the clinic. There’s plenty more where that came from, CEO Emily Leproust says — and she thinks a small biotech’s mice are the key to getting there.
Leproust is putting down up to $10 million in cash and another $140 million in stock to buy out Massachusetts-based Abveris (formally known as AbX Biologics) and its family of hyperimmune mouse models, she announced on Monday morning. If Abveris hits an internal revenue target next year, it’s eligible for up to another $40 million in Twist shares.
Lonnie Moulder (L) and Hua Mu
More than three years after its lead program failed a Phase II study, Xencor is passing off the drug to an up-and-coming Hong Kong biotech.
Xencor sold exclusive worldwide rights for obexelimab, a bispecific targeting FcγRIIb and CD19 to treat autoimmune diseases, to Lonnie Moulder’s Zenas BioPharma, the companies announced Sunday evening. In exchange, Xencor gets a slice of equity equaling 15% of Zenas’ shares following its next financing round, up to $480 million in milestones and royalties.
Now that the PD-(L)1 craze has (largely) swept through China, resulting in the approval of more than a dozen drugs with more to come, two of the top domestic oncology players are teaming up to go after the other checkpoint target.
Hengrui is licensing exclusive China rights to CStone’s CTLA-4 inhibitor, CS1002, in a deal worth up to $200 million, which covers research, development, registration, manufacturing and commercialization.
Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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https://endpts.com/new-pfizer-biontech-covid-vaccine-data-in-teens-show-strong-protection-lining-up-sbla-filing/
