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      Moderna CEO brazenly defends 400% COVID shot price hike, downplays NIH’s role

      news.movim.eu / ArsTechnica · Wednesday, 22 March, 2023 - 21:42 · 1 minute

    Moderna CEO Stephane Bancel testifies before the Senate Health, Education, Labor, and Pensions Committee in the Hart Senate Office Building on Capitol Hill on March 22 in Washington, DC.

    Enlarge / Moderna CEO Stephane Bancel testifies before the Senate Health, Education, Labor, and Pensions Committee in the Hart Senate Office Building on Capitol Hill on March 22 in Washington, DC. (credit: Getty | Chip Somodevilla)

    In Congressional testimony Wednesday, Moderna CEO Stéphane Bancel unabashedly defended the company's plans to raise the US list price of its COVID-19 vaccines by more than 400 percent—despite creating the vaccine in partnership with the National Institutes of Health, receiving $1.7 billion in federal grant money for clinical development, and making roughly $36 billion from worldwide sales.

    Bancel appeared this morning before the Senate's Health, Education, Labor, and Pensions committee, chaired by Sen. Bernie Sanders (I-Vt.), who has long railed at the pharmaceutical price gouging in the US and pushed from policy reforms. After thanking Bancel for agreeing to testify, Sanders didn't pull any punches. He accused Moderna of "profiteering" and sharing in the "unprecedented level of corporate greed" seen in the pharmaceutical industry generally.

    Sanders contrasted a recent survey finding that 37 percent of Americans can't afford their prescription drugs to the billions of dollars in profits reaped by drug companies. He noted several times that Bancel became a billionaire overnight amid the pandemic. Bancel is now estimated to be worth over $4 billion, Sanders added.

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      Moderna CEO says private investors funded COVID vaccine—not billions from gov’t

      news.movim.eu / ArsTechnica · Tuesday, 7 March, 2023 - 23:22

    Moderna pharmaceutical and biotechnology company's CEO Stephane Bancel speaks during a session of the World Economic Forum annual meeting in Davos on January 18, 2023.

    Enlarge / Moderna pharmaceutical and biotechnology company's CEO Stephane Bancel speaks during a session of the World Economic Forum annual meeting in Davos on January 18, 2023. (credit: Getty | Fabrice COFFRINI )

    Moderna CEO Stéphane Bancel on Monday pushed back on criticism of the company's plans to raise the price of its mRNA-based COVID-19 vaccines by 400 percent, arguing that the billions of dollars in federal funding the company received played little role in the vaccine's development.

    Speaking at the Wall Street Journal Health Forum , Bancel suggested that the vaccine's development is thanks to private investors and that the federal funding merely hastened development that would have occurred regardless. The comments came in response to a question of whether the company has a "moral obligation" to give back to the taxpayers who helped develop the life-saving immunization—presumably by not dramatically hiking the vaccine's price as it moves from federal distribution to the commercial market this year.

    While the government most recently paid $26 per dose for Moderna's updated booster dose, the company is planning to raise the price of its shots to $110 to $130 per dose .

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      Vaccine mandates work, especially when they’re done right

      WIRED · news.movim.eu / ArsTechnica · Saturday, 28 August, 2021 - 11:07 · 1 minute

    Vaccine mandates work, especially when they’re done right

    Enlarge (credit: Mario Tama | Getty Images)

    On Monday, the US Food and Drug Administration gave formal, full approval to the Covid-19 vaccine made by the drug companies Pfizer and BioNTech. You might’ve already gotten a dose of it, of course; millions of Americans have, thanks to an “ emergency use authorization awarded in December 2020. But the new designation was more than just a formality. “If you’re one of the millions of Americans who said they will not get the shot until it has full and final approval from the FDA, it has now happened,” President Joe Biden said when he announced the approval. And, in the same speech: “If you’re a business leader, a non-profit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that—require it.”

    Pretty much right away, a lot of places did. Vaccines are safe, effective, and free, but somewhere around 30 percent of Americans haven’t got their shots. Carrots didn’t work; here come the sticks. And they might be able to crush the fourth wave of the Covid pandemic in the US—if they’re done right.

    Like the other vaccines still available under EUA, the Pfizer drug is extraordinarily good at keeping people from getting really sick or dying from Covid. But with more than 100,000 people in the hospital with Covid in the US—the most since January—and with the vast majority of them unvaccinated, it’s clear that alone isn’t enough. States, localities, and businesses have tried inducements like prizes, cash, or lotteries , little tricks designed to corral people into doing what’s good for them. In the language of behavioral economics, that’s called a nudge. But in states with low vaccine uptake, those nudges didn’t change the momentum. So now, it’s time for mandates . If you’re one of the 30 percent or so of Americans who haven’t gotten vaccinated yet, get ready for a good hard shove.

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      Covid-19: Moderna veut augmenter de 50% la capacité de ses flacons de vaccin

      AFP · news.movim.eu / HuffingtonPost · Saturday, 13 February, 2021 - 02:01 · 1 minute

    Une infirmière américaine remplissant une seringue seringues avec le vaccin Moderna, dans le Connecticut aux États-Unis, le 12 février 2021.

    VACCIN - La société américaine de biotechnologie Moderna a indiqué ce vendredi 12 février avoir demandé l’autorisation à différentes autorités sanitaires du monde entier, d’augmenter de 50% la capacité de ses flacons de vaccin contre le Covid-19 , afin d’accélérer les campagnes de vaccination en cours.

    “Afin d’optimiser les ressources et les opportunités de livrer plus de doses plus rapidement sur chaque marché, Moderna a proposé de remplir ses flacons avec jusqu’à 15 doses de vaccin, en comparaison des 10 d’avant”, a indiqué la société dans un communiqué à l’AFP.

    L’Agence américaine du médicament (FDA) a déjà autorisé l’augmentation de 40% du contenu des flacons, selon le New York Times , citant des sources proches du dossier.

    Une porte-parole a précisé que des discussions étaient en cours avec la FDA et les autorités des différents pays où le vaccin est utilisé, et que cette augmentation ne nécessiterait pas de changement dans le conditionnement des fioles.

    “Ce serait un grand pas en avant”

    “Tout changement serait soumis à l’autorisation finale des différentes autorités de régulation. La mise en place de tout changement prendrait environ deux à trois mois”, a-t-elle ajouté.

    Pour augmenter les doses, les lignes de production devraient être transformées, ce qui prendrait moins de dix semaines, soit d’ici la fin avril, a pour sa part indiqué le New York Times .

    “Ce serait un grand pas en avant”, a salué dans le quotidien Moncef Slaoui, ancien conseiller en chef du programme de vaccination américain sous Donald Trump.

    “Je pense que cela aura un impact à court terme”, a-t-il ajouté.

    Plus de 10% de la population américaine a reçu au moins une dose de vaccin contre le coronavirus, presque la moitié avec celui de Moderna et un peu plus de la moitié avec celui de Pfizer.

    Le président Joe Biden a confirmé jeudi que les deux sociétés allaient fournir 600 millions de doses au total, soit assez pour vacciner 90% des habitants.

    À voir également sur Le HuffPost : ″Ça vous excite?” La photo d’Olivier Véran se faisant vacciner a inspiré Stephen Colbert

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      Les effets secondaires des vaccins anti-Covid que l'ANSM demande de surveiller

      Le HuffPost avec AFP · news.movim.eu / HuffingtonPost · Friday, 12 February, 2021 - 08:59 · 3 minutes

    Vaccins Pfizer/BioNTech, 11 février 2021. (JORGE GUERRERO / AFP)

    SANTÉ - Les 73 cas d’hypertension artérielle, de courte durée, déclarés depuis le début de la vaccination avec le vaccin Pfizer/BioNTech contre le Covid-19, ne remettent pas en cause sa sécurité, mais “constitue un signal qui doit être surveillé” a estimé, jeudi 11 février, l’Agence du médicament ANSM.

    Pour le vaccin AstraZeneca destiné au moins de 65 ans, l’ANSM relève “un signal potentiel”, avec 149 déclarations de syndrome grippal, souvent de forte intensité (fièvre élevée, courbature, maux de tête), touchant pour la plupart des professionnels de santé d’âge moyen de 34 ans, parmi les quelque 10.000 personnes vaccinées entre le 6 et le 10 février 2021. “Ces effets indésirables sont connus et décrits avec les vaccins”, indique l’ANSM.

    Un problème rencontré notamment au CHRU de Brest où des syndromes grippaux avec maux de tête et fortes fièvres, ont obligé 20 à 25 % des personnels vaccinés à se mettre en arrêt de travail, rapporte Le Télégramme . Au CHU de Rennes, deux personnes ont eu une température supérieure à 39°C. La manifestation de “ce type d’effets secondaires” évoque “un défaut de communication sur les effets indésirables transitoires”, confie l’infectiologue François Bénézit au quotidien régional. Selon lui, ces effets sont “désagréables mais pas très graves”.

    Le professeur Alain Fischer, monsieur vaccination du gouvernement, a confirmé sur franceinfo la possibilité de tels symptômes mais il recommande non pas de suspendre mais d’espacer la vaccination.

    “Les établissements de santé sont informés de ce signal potentiel” avance l’ANSM et pour “limiter le risque” de perturbation du fonctionnement des services de soin, il est recommandé de vacciner de façon échelonnée le personnel d’un même service, indique l’agence sanitaire en recommandant, si besoin, de privilégier l’utilisation du paracétamol à la dose la plus faible et le moins longtemps possible.

    Ne pas hésiter à faire des contrôles

    L’ANSM précise que le lot de ce vaccin, utilisé depuis le 6 février, qui a fait l’objet d’un contrôle strict avant sa commercialisation, “a été utilisé dans 21 autres pays de l’UE” et “qu’à ce jour, il n’y a pas de déclarations équivalentes dans d’autres pays”.

    Concernant le vaccin Comirnaty de Pfizer/BioNTech, les 73 cas d’augmentation de la tension artérielle, immédiatement après la vaccination ou de façon différée, ont été de courte durée et d’évolution favorable, détaille l’ANSM.

    Devant tout symptôme évocateur d’une hypertension artérielle tel qu’un malaise des maux de têtes, des vertiges, l’ANSM recommande aux personnes vaccinées d’effectuer un contrôle de la pression artérielle pour une prise en charge médicale la plus précoce possible, si cela s’avère nécessaire.

    Les informations concernant ces deux vaccins ont été transmises à l’Agence européenne du médicament (EMA), indique l’agence. “À ce jour, il n’y a pas de signal de sécurité avec le vaccin Moderna ”, ajoute l’ANSM.

    À voir également sur Le Huffpost: Cette députée veut un “passeport sanitaire” pour relancer le tourisme

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      Moderna shamed with “Shkreli Award” over high COVID vaccine prices

      Beth Mole · news.movim.eu / ArsTechnica · Wednesday, 6 January, 2021 - 16:36

    COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left).

    Enlarge / COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left). (credit: Drew Angerer / Florian Gaertner / Getty Images)

    One of the leading developers of COVID-19 vaccines has now been placed in the ranks of people like Martin Shkreli—the disgraced pharmaceutical executive infamous for jacking up the price of an old, life-saving drug by more than 5,000 percent. He is now serving an 84-month prison sentence from a 2017 conviction on fraud counts unrelated to the drug pricing.

    Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. The awards, announced annually for four years now, go to “perpetrators of the ten most egregious examples of profiteering and dysfunction in health care.”

    Award judges cited Moderna’s pricing of its COVID-19 vaccine, which was developed with $1 billion in federal funding. Still, despite the tax-payer backing, Moderna set the estimated prices for its vaccine significantly higher than other vaccine developers.

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      Second COVID vaccine approved for use in the US

      John Timmer · news.movim.eu / ArsTechnica · Saturday, 19 December, 2020 - 13:07 · 1 minute

    Image of a syringe in front of a Moderna company logo.

    Enlarge (credit: DeFodi Images )

    Late Friday, the Food and Drug Administration issued an emergency authorization to a COVID-19 vaccine from a company called Moderna. The move follows an enthusiastic endorsement of the vaccine following an evaluation of clinical trial data by the FDA's Vaccines and Related Biological Products Advisory Committee. Moderna already has millions of doses prepared, and the federal government has pre-issued a large order for more, which will enable more extensive vaccinations than would be possible previously, where the agency had only issued an authorization to the Pfizer/BioNTech vaccine .

    The authorization was considered to be a matter of time following the release of safety and efficacy data from a large clinical trial that had enrolled over 30,000 people. Emergency Use Authorizations require that a product or treatment meet a number of criteria, including the declaration of a medical emergency, which was done earlier this year, and the lack of an FDA approved alternative. (FDA approval is distinct from an Emergency Use Authorization, so the authorization of the Pfizer/BioNTech vaccine isn't a barrier to further authorizations.)

    Beyond that, the product must be considered likely to be effective, and its potential benefits need to outweigh its potential risks. The votes from the members of the Vaccine Advisory Committee were unanimous that the benefits outweighed the risks, a conclusion that was well supported by the clinical trial data. That cleared the way for Friday's Authorization, which took place on a similar schedule to the authorization of the Pfizer/BioNTech vaccine the week prior.

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      Vaccines ready, but no distribution? Operation Warp Speed meets speed bumps

      John Timmer · news.movim.eu / ArsTechnica · Friday, 18 December, 2020 - 15:59 · 1 minute

    Vaccines ready, but no distribution? Operation Warp Speed meets speed bumps

    Enlarge (credit: Aurich Lawson / Getty Images)

    As we're waiting for word on the authorization of a second vaccine for use in the US, glitches have been striking the distribution of the first through the federal government's "Operation Warp Speed." This week, the US saw the first use of the vaccine developed by a Pfizer/BioNTech collaboration. But immediately afterwards, many states started saying that orders for shipments in the ensuing weeks were being cut. After some in the federal government had indicated that the problem might be in production, Pfizer issued a statement indicating that it had doses in its warehouse ready to ship out, but no indication of where to ship them too.

    All in all, about what you'd expect in the first weeks of a massive undertaking like this.

    State of denial

    One of the first states to report problems was Illinois, where its governor, J.B. Pritzker, said that it had indications it would only be receiving half the expected doses of the Pfizer/BioNTech vaccine next week. Since then, over a dozen states have indicated that they'll be receiving fewer doses than planned in the second week ( this article seems to have a fairly comprehensive list).

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      Moderna vaccine gets the thumbs-up for emergency use

      John Timmer · news.movim.eu / ArsTechnica · Thursday, 17 December, 2020 - 22:44

    Image of a building with the Moderna logo behind a security fence.

    Enlarge / This unassuming building in Massachusetts has taken on remarkable significance in recent weeks. (credit: JOSEPH PREZIOSO / Getty Images )

    Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the agency as it decides whether to grant an emergency use authorization similar to the one it gave the Pfizer/BioNTech vaccine .

    After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.

    Emergency use authorizations have a number of requirements once a health emergency hsa been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It's that final question—the risk vs. benefit balance—that the advisory committee was called to address.

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