#COMIRNATY

[pierre-hector]

Effets secondaires indésirables

Les complotistes agitent leur biais de confirmation – “Vous voyez, hein ! On vous l’avait bien dit !” à cœur joie et à qui mieux mieux –, mais Pfizer ne va pas manquer d’objecter que les effets secondaires graves n’ont lieu que dans d’infimes proportions des populations du monde. N’empêche, comme le faisait remarquer le docteur, feu regretté, Marc Vercoutère, le rapport bénéfice/risque, pour les parents dont l’enfant est gravement atteint des suites d’une vaccination, c’est du risqué à 100 %.

“Mise à jour” vaccinale tous les six mois

« L'action d'aujourd'hui de l'ACIP[Comité consultatif sur les pratiques d'immunisation] fait suite aux recommandations récentes et précédentes du CDC. » … dont : « Après l'autorisation et l'approbation par la FDA de notre formule de vaccin Pfizer-BioNTech COVID-19 2023-2024 plus tôt ce mois-ci, l'ACIPa recommandé à toute personne âgée de 6 mois et plus de recevoir un vaccin COVID-19 mis à jour pour se protéger contre la maladie COVID-19 cet automne et cet hiver. […]

Informations de sécurité importantes

[…]

Les vaccins à ARNm contre la COVID-19 autorisés ou approuvés présentent des risques accrus de myocardite (inflammation du muscle cardiaque) et de péricardite (inflammation de la muqueuse extérieure du cœur), en particulier au cours de la première semaine suivant la vaccination. Pour COMIRNATY, le risque observé est le plus élevé chez les hommes âgés de 12 à 17 ans. Consultez immédiatement un médecin si vous présentez l’un des symptômes suivants après avoir reçu le vaccin, en particulier au cours des 2 semaines suivant la réception d’une dose du vaccin :

• douleur thoracique �� essoufflement • sensation d'avoir un cœur qui bat vite, palpite ou bat la chamade.

D'autres symptômes, en particulier chez les enfants, peuvent inclure :

• Évanouissement • Fatigue inhabituelle et persistante ou manque d'énergie • Vomissements persistants • Douleur persistante au ventre • Peau fraîche et pâle inhabituelle et persistante

Des évanouissements peuvent survenir après avoir reçu des vaccins injectables, notamment COMIRNATY. Votre vaccinateur peut vous demander de vous asseoir ou de vous allonger pendant 15 minutes après avoir reçu le vaccin.

Les personnes dont le système immunitaire est affaibli peuvent avoir une réponse immunitaire réduite à COMIRNATY

COMIRNATY pourrait ne pas protéger tous les vaccinés

[…]

Les effets indésirables les plus fréquemment rapportés (≥ 10 %) après l'administration d'une dose de COMIRNATY étaient des douleurs au site d'injection (jusqu'à 90,5 %), de la fatigue (jusqu'à 77,5 %), des maux de tête (jusqu'à 75,5 %), des frissons (jusqu'à 49,2 %). %), douleurs musculaires (jusqu'à 45,5 %), douleurs articulaires (jusqu'à 27,5 %), fièvre (jusqu'à 24,3 %), gonflement au site d'injection (jusqu'à 11,8 %) et rougeur au site d'injection (jusqu'à 10,4 %).

Ce ne sont peut-être pas tous les effets secondaires possibles du vaccin. Appelez le prestataire de vaccination ou le prestataire de soins de santé au sujet des effets secondaires gênants ou des effets secondaires qui ne disparaissent pas.

Vous devez toujours demander un avis médical à vos prestataires de soins concernant les événements indésirables. Signalez les effets secondaires du vaccin à la Food and Drug Administration (FDA) des États-Unis et au Vaccine Adverse Event Reporting System (VAERS) des Centers for Disease Control and Prevention (CDC). Le numéro gratuit du VAERS est le 1-800-822-7967 ou signalez-le en ligne sur www.vaers.hhs.gov/reportevent.html . Vous pouvez également signaler les effets secondaires à Pfizer Inc. sur www.pfizersafetyreporting.com ou en appelant le 1-800-438-1985.

[…]

Une myocardite (inflammation du muscle cardiaque) et une péricardite (inflammation de la muqueuse extérieure du cœur) sont survenues chez certaines personnes ayant reçu des vaccins à ARNm contre la COVID-19. La myocardite et la péricardite consécutives aux vaccins Pfizer-BioNTech contre la COVID-19 sont survenues le plus souvent chez les adolescents de sexe masculin âgés de 12 à 17 ans. Chez la plupart de ces personnes, les symptômes sont apparus quelques jours après la vaccination. La probabilité que cela se produise est très faible. Consultez immédiatement un médecin si votre enfant présente l'un des symptômes suivants après avoir reçu le vaccin, en particulier au cours des 2 semaines suivant la réception d'une dose du vaccin :

• Douleur thoracique • Essoufflement ou difficulté à respirer • Sentiment d'avoir un cœur qui bat vite, qui palpite ou qui bat très fort

Des symptômes supplémentaires, en particulier chez les enfants, peuvent inclure :

• Évanouissement • Irritabilité inhabituelle et persistante • Mauvaise alimentation inhabituelle et persistante • Fatigue inhabituelle et persistante ou manque d'énergie • Vomissements persistants • Douleur persistante au ventre • Peau fraîche et pâle inhabituelle et persistante • Des évanouissements peuvent survenir après avoir reçu des vaccins injectables, notamment le vaccin Pfizer-BioNTech contre la COVID-19. Pour cette raison, votre prestataire de vaccination peut vous demander de rester à l'endroit où vous avez reçu le vaccin pour un suivi après la vaccination. • Les personnes dont le système immunitaire est affaibli peuvent avoir une réponse immunitaire réduite au vaccin Pfizer-BioNTech contre la COVID-19 • Le vaccin Pfizer-BioNTech contre la COVID-19 ne protège peut-être pas tout le monde • Informez votre vaccinateur de tous vos problèmes de santé, y compris si vous :

– avez des allergies – a eu une myocardite (inflammation du muscle cardiaque) ou une péricardite (inflammation de la paroi extérieure du cœur) – a de la fièvre – souffre d’un trouble de la coagulation ou prend un anticoagulant – est immunodéprimé ou prend un médicament qui affecte le système immunitaire – est enceinte ou allaite – a reçu un autre vaccin contre la COVID-19 – s'est déjà évanoui à la suite d'une injection

• Les effets secondaires signalés avec les vaccins Pfizer-BioNTech contre la COVID-19 comprennent :

– Réactions allergiques sévères – Réactions allergiques non graves telles qu'éruption cutanée, démangeaisons, urticaire ou gonflement du visage – Myocardite (inflammation du muscle cardiaque) – Péricardite (inflammation de la muqueuse extérieure du cœur) – Douleur/sensibilité au site d'injection – Fatigue – Mal de tête – Douleur musculaire – Des frissons – Douleur articulaire – Fièvre – Gonflement au site d’injection – Rougeur au site d'injection – Nausée – Se sentir pas bien – Ganglions lymphatiques enflés (lymphadénopathie) – Diminution de l'appétit – Diarrhée – Vomissement – Douleur au bras – Évanouissement associé à l’injection du vaccin – Vertiges – Irritabilité [...] »

‣ Pfizer, « Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV » (« Pfizer élargit le portefeuille de vaccins respiratoires recommandé par le comité consultatif du CDC avec ABRYSVO ™ pour RSV » – trad. via Google), pub. 22 sept. 2023, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-broadens-portfolio-respiratory-vaccines-recommended (cons. 21 oct. 2023).

[thomas-querqy]

ARTE Regards Vaccination anti-Covid : vivre avec les effets indésirables (Allemagne 2022, 32′)

Empathie pour ces jeunes qui étaient en pleine forme avant de recevoir leur 2e dose de vaccin anti Covid et qui ne parviennent pas à faire reconnaître la responsabilité du vaccin dans leur état.

Soutien à eux et à tous ceux qui se trouvent dans la même situation pour qu’ils parviennent enfin à mobiliser les pouvoirs publics en faveur d'une recherche sur leurs pathologies, de l’obtention d’un revenu de remplacement puisqu’ils ne peuvent plus travailler, ainsi que d’une indemnisation à la hauteur du préjudice immense qu’ils ont subi.

La diffusion en Allemagne le 12/3/23 sur ZTE d’un autre reportage sur d’autres jeunes victimes de syndromes post vaccination Covid a contraint le ministre de la santé allemand à annoncer un programme de recherche sur ces accidents vaccinaux et sur le Covid long. A quand la même chose en France ?

Certains courageux attaquent en justice Pfizer ou BioNtech, bien que les contrats de fourniture à l’UE signés par la Commission européenne comportent une clause d’irresponsabilité transférant le risque aux États (le vaccin se trouvait alors en phase III de développement, contrairement à ce qu’il a pu être affirmé par le gouvernement).

On notera que les labos concernés ne sont pas cités dans le documentaire pour ne pas avoir de problèmes avec leur armada d’avocats toujours prête à faire taire les plaignants, et qu’il n’est pas souligné, une bonne fois pour toute, que le bénéfice-risque pour les jeunes plaidait contre l’obligation vaccinale dans cette catégorie.

[momosammy]

connor meijou/mr.comirnaty RTU

[covid-safer-hotties]

FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants - Published Aug 22, 2024

Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.

What You Need to Know

=Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.

=Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or =Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).

=Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.

=Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine.

=Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.

=Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines.

For today’s approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks.

On an ongoing basis, the FDA will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action.

The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc.

The approval of Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was issued to ModernaTX Inc.

[allthecanadianpolitics]

Health Canada has given its stamp of approval to Pfizer-BioNTech Comirnaty’s new COVID-19 vaccine that targets the Omicron XBB.1.5 subvariant. The health department says it received Pfizer-BioNTech's submission on June 29, 2023 and decided to authorize the shot's use for individuals aged six months and older after “a thorough and independent review of the evidence.” Health Canada says the vaccine is authorized as a one-dose vaccine for individuals five years of age and older, regardless of their COVID-19 vaccination history.

Continue Reading.

Tagging: @politicsofcanada

[darkmaga-returns]

Per COMIRNATY's FDA-approved package insert, the majority of adults and children in a Pfizer FDA-study had active SARS-CoV-2 infection after being fully-vaxxed and boosted.

Karen Kingston

Nov 20, 2024

November 20, 2024: This article was original published on August 15, 2024.

Manufacturers are legally required to ensure that their FDA-approved prescription products available for interstate commerce meet their FDA-approved indication. (period) An indication is what an FDA-approved product promises to do.

Pfizer’s FDA-approved labeling alone proves that the COVID-19 mRNA injections are not vaccines because their��own package insert shows that the injections cause COVID-19 disease.

This extremely valuable Kingston Report is free. Feel FREE to share.

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Manufacturers are legally required to ensure that their products available for interstate commerce meet their FDA-approved indication. (period) An indication is what an FDA-approved product promises to do.

Pfizer’s FDA-approved labeling alone proves that the COVID-19 mRNA injections are not vaccines because their own package insert shows that the injections cause COVID-19 disease.

Pfizer’s FDA-approved indication for their COVID-19 mRNA injection is;

“COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.”

Content of this article is copyright of Karen Kingston, The Kingston Report.

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Pfizer’s FDA-approved promise to the American people is that their COVID-19 mRNA injections provide immunity against SARS-CoV-2. Meaning you don’t get infected with SARS-CoV-2 if you get injected.

However, in the same FDA-approved labeling promising SARS-CoV-2 immunity, the majority of adults and children in a Pfizer FDA-study subset had active SARS-CoV-2 infection after being fully-vaxxed and boosted.

[allthebrazilianpolitics]

Brazilian-developed vaccine against Covid-19 registered by Anvisa

The new vaccine against Covid-19 developed by the Brazilian company Zalika Farmacêutica has been entered into the National Health Surveillance Agency (Anvisa) this week, Agencia Brasil reported. The drug can be used in people aged 12 and over and is to be administered in two doses, 21 days apart, with boosters after 6 months for those over 18 years of age.

The technology used in the Zalika vaccine is called “recombinant” because its molecules are formed by combining two different sources. In this case, the protein S antigen (spike) -capable of promoting a response from the immune system- and the saponin-based adjuvant allow the mixture to enhance the production of antibodies. This form of production brings greater safety to the pharmaceutical industry, Anvisa explained in a statement.

The new immunizer is the sixth to receive definitive individual registration from Anvisa, in addition to Comirnaty Ipfizer/Wyeth, Comirnaty bivalent (Pfizer), Janssen Vaccine (Janssen-Cila), Oxford/Covishield (Fiocruz and Astra-Zeneca) and Spikevax bivalent vaccines have received this type of authorization. Pfizer/Biontech, Astra-Zeneca, Janssen, Moderna, Sinopharm, and Sinovac also have definitive registration in the form of the Covax Facility consortium.

Continue reading.

[scogito]

Sperma decimato, ovaie danneggiate: La "vaccinazione" Covid può compromettere la fertilità. Ciò che è stato a lungo negato come una teoria della cospirazione è ora scritto nero su bianco negli studi di prova del produttore.

...Il fatto che ora lo sappiamo è merito dei "Pfizer Files". Un gruppo di cittadini ha ottenuto con successo da un tribunale del Texas che i documenti degli studi di prova della "vaccinazione" fossero divulgati. Pfizer, in collaborazione con le autorità statunitensi, aveva cercato invano di ottenere 75 anni di segretezza. Ora è possibile leggere ciò che è realmente accaduto durante la fase di sperimentazione, ciò che l'azienda sapeva e come questo contraddica ciò che è stato detto alle persone nelle campagne di vaccinazione in tutto il mondo.

Effetti sull'organismo

I risultati più importanti delle 300.000 pagine sono stati riassunti nel libro "Pfizer Documents Analysis Reports". La coeditrice Naomi Wolf scrive nella prefazione: "La cosa più inquietante è il riconoscibile attacco a tutto campo alla capacità riproduttiva umana". La vaccinazione potrebbe causare danni in termini di numero di spermatozoi, testicoli, motilità degli spermatozoi, ovaie, cicli mestruali e placenta.

Pfizer ha riportato innumerevoli "eventi avversi" durante la serie di test con 40.000 partecipanti. Tra questi, aborti spontanei e morti al parto. La stessa azienda ha parlato anche di "disturbi riproduttivi". Ma al momento del lancio del "vaccino" non c'era nulla di tutto questo. Al contrario: le prime indicazioni di un'influenza negativa sulla fertilità sono sempre state liquidate come teorie cospirative.

Questo vale anche per gli effetti sull'organismo femminile. Nelle prime dodici settimane dopo l'inizio della "vaccinazione", le madri che allattano si sono lamentate con il produttore di paralisi parziale, mancanza di latte materno o emicrania. Nei neonati, tra i sintomi segnalati vi erano vomito, febbre e infiammazioni cutanee. Pfizer ha dovuto assumere 2.400 persone in più per far fronte alla mole di feedback, ma ha mantenuto la sua decisione: il "vaccino" deve essere somministrato anche alle donne in gravidanza e in allattamento. Le autorità preposte al rilascio delle licenze nei vari Paesi, tra cui la Svizzera, hanno approvato questa raccomandazione senza problemi.

In molti casi, tuttavia, la gravidanza probabilmente non si è nemmeno verificata. I documenti che il produttore ha voluto tenere nascosti dimostrano che la fertilità maschile potrebbe risentire del "vaccino". Pfizer non ha approfondito la questione perché era "sotto pressione" e voleva accelerare lo sviluppo del "vaccino".

___________

Vedi maternità surrogata, malati cronici e depopolamento. Non creano mai qualcosa per un solo fine.

[reportsofawartime]

今日の話題：「PBS緩衝液（Comirnatyが保存されている液体）は、BioNTech SEが特許番号：US2023/0414747A1で保存に適さないと特定した製品Comirnatyに適さない」。 この特許は "Topic today "で言及されているが、Comirnaty製品の保存をPBS緩衝液からいわゆるTris緩衝液に変更する根拠を開示している。 レシピ変更に関するプレスリリースに伴い、2021年10月��緩衝液もいわゆるTris緩衝液に変更されたと推測される。 https://cdn.pfizer.com/pfizercom/2021-10/EMA_Tris_Sucrose_Statement_10.18.21_FINAL.pdf… Modernaは最初からTris緩衝液を使っていたので、Modernaにとってこの疑問は生じない。 PBSバッファーで保存する場合とTrisバッファーで保存する場合の違いは何でしょうか？ BioNTech社は、PBSバッファーがLNP中に極めて安定した折り畳まれたRNA構造を作ることを問題視した。製品がほぼ1年間この問題を抱えたまま移動した後、Tris緩衝液に置き換えることで解決した。 しかし、この特許出願の日付は2020年11月18日であるため、バイオエヌテックは承認時に意図的に間違った緩衝液で市場に出すことを知っていたことになる。 言い換えれば、この特許は、バイオエヌテックが高度に安定な折り畳みRNA構造を人体に放出することに伴うリスクを認識していた証拠である。 製品文書とEMA文書（https://docs.google.com/document/d/1K-dWmwzH-gbsPstj3bTfYgS1DUTEqIn1uA2T5-4jZr0/edit#bookmark=id.gjdgxs…）によれば、この問題は製造中には発生せず、完成品にのみ発生する。 特許そのものでは、序文[1023]から[1026]にバイオエヌテック自身が認識している問題が明記されている。 医薬品の文書では、バイオエヌテックは「コンフォメーション的に折り畳まれた、あるいは可逆的に凝集したRNA」と述べているが、この特許ではバイオエヌテックは「高度に安定的に折り畳まれたRNA」と述べている。 RNAの構造は、リボソームがスパイクタンパク質武漢1の折りたたみ計画をどのように読み取り、正しく認識するかという点で、決定的に重要である。RNAの構造は、コドンの最適化によって形成されるタンパク質のフォールディングプランを変えることが知られている。このような背景から、強く折り畳まれたRNAもまた、形成されるタンパク質の結果に影響を与える可能性があると推測できる。 また、この変更が製造工程中にしか行われなかったという事実は、変更が必要なほど問題が深刻であったことを示唆している。そうでなければ、バイオテック社はおそらく放置していただろう。 日本の弁理士 パテント・サン が親切にも製造中に指摘してくれた。ありがとうございました。 ガブリエレ・セガッラ博士 https://ijvtpr.com/index.php/IJVTPR/article/view/68/185… によると、オリジナルの緩衝液には、一般的な塩で希釈すると脂質ナノ粒子が凝集するという問題がすでにあった。https://patentimages.storage.googleapis.com/de/67/95/27ec2ea27a32d9/US10485884.pdf… ガブリエレ・セガッラ博士は上記の特許を参照した。 私の側からのコメント： これは製造と開発における欠陥の別の側面であり、現段階の製品が人体に適さないこと、そして同社が発売前にこのことを知っていたことを示している。 #欠陥#製品の欠陥#特許#バイオNTech#LNP#貯蔵#応用#バッファー#PBS#トリス#RNA#EMA#PEI

[covid-safer-hotties]

New COVID Variant XEC May Outpace Others This Fall - Published Sept 18, 2024

"The virus is always going to be mutating away from what it was in order to get more efficient at infecting individuals," Adalja said. "So I think this really highlights the fact that a universal COVID vaccine, or some vaccine with different technologies, perhaps a nasal vaccine and using mucosal immunity, all of those things are important."

What if, get this, we prevented covid cases by improving ventilation, mandating air filtration, and wearing masks in public? Wouldn't that accomplish the same goal right now? Every mutation takes us further away from the current scientific fantasy of a universal covid vaccine. We have to stop cases to make this dream a reality.

by Sophie Putka

The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said, but will not prompt a meaningful change in symptoms or vaccine response.

So far, the CDC's variant proportions tracker has not registered enough cases of XEC in the U.S. to report it. (The agency's projected estimates for the 2 weeks ending in September 14 currently show KP.3.1.1 and KP.2.3 as the leading variants, with 52.7% and 12.2% of national cases, respectively.) Another estimate using data from the variant tracker GISAID has XEC at 1.11% of U.S. cases as of September 15, with around 48 sequences reported.

First detected in Germany in June, it's been found mostly in Central Europe, representing 10% of cases, according to the U.K.'s Science Media Centre.

"XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters," like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.

Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.

XEC is a "recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has," Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. "But it doesn't really change anything, just like the last variant didn't change anything, or the one before that, one before that, or the one before that."

Currently available COVID vaccines target slightly different subvariants. The updated mRNA shots aimed at KP.2 from Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax), as well as Novavax's vaccine targeting the JN.1 variant lineage, are still protective against the most serious consequences of COVID infections, experts said.

"If this becomes a dominant variant, it will decrease the efficacy against infection of the updated vaccines, but the updated vaccines will still be durable against severe disease [and] hospitalization, and that's what is really the primary function of our current, first-generation COVID vaccines," Adalja said.

Still, he emphasized, the rapid mutation of the virus underscores a need for a different kind of vaccine than those currently available if the goal is to protect against infection rather than just severe disease.

"The virus is always going to be mutating away from what it was in order to get more efficient at infecting individuals," Adalja said. "So I think this really highlights the fact that a universal COVID vaccine, or some vaccine with different technologies, perhaps a nasal vaccine and using mucosal immunity, all of those things are important."

[moneypuzzleexchanger]

I was just a normal boy before I got the 2023-2034 moderna spikevax covid-19 monovalent booster but now I have breasts and soft skin well let me tell you I doubt I'd have this same debilitating response to the comirnaty formulation but that's all that needs to be said about that.

[normal-with-adhd-is-a-joke]

Hello, it's me, the COVID vaccine test subject! I'm always first in line to get new COVID vaccines because I have long COVID and I'm not trying to make it worse. Here are some things of note about the new (as of 9/25/2023) COVID vaccine from Pfizer based on the experience of me and my mom who just got it on Sunday.

General info:

The vaccine is usually called Comirnaty or "The 2023-2024 Covid Vaccine" when you're signing up to get it. It's generally not referred to as a booster. All Pfizer vaccines fall under the name "Cormirnaty" so make sure you're getting the latest one, it's always good to ask the office, clinic, or pharmacy you're scheduling with if you're unsure.

According to the pharmacist who administered my shot, it wasn't supposed to be out for a few weeks so some insurances, including Pennsylvania Medicaid, won't cover it yet. It's $190 out of pocket. I would recommend getting in contact with your insurance company or the place you're getting vaccinated to ensure that you're not going to have to pay for it.

The vaccine is FDA approved and uses MRNA technology, the same as the original Pfizer vaccine.

Side effects (I received the flu and covid vaccines at the same time in the same arm, my mom received only the covid one, will update if/when my dad and sibling get it):

I had very manageable arm soreness and swelling. I've gotten this with every vaccine I've gotten, some are worse than others, this was one of the less severe ones. The swelling isn't interfering with my arm movements at all, it's just certain movements are painful.

I also had extreme sleepiness today, I fought to keep my eyes open for most of the morning and ended up skipping class and just going back to bed for most of the day. There are several factors that could play into this. I went to the ren faire on Saturday and my big crashes are sometimes delayed by a day. I also got both vaccines at the same time which can sometimes cause worse side effects. I wanted to mention it because it could be related to the COVID vaccine alone. I would plan to get the vaccine on a day where you don't have work or another big event going on.

My mom had more severe arm pain and limited range of motion. She struggled to move for the first day. She, like me, often gets a bump and/or pain following shots. She (by her own admission) forgot there were things she could do to reduce the swelling so that might have contributed to her having such a hard time with it.

Tips:

Keep your arm relaxed as much as possible during the shot. Tensing the muscle causes the shot to hurt more.

Move your arm a bit after the shot to reduce pain, but don't do anything strenuous.

If you're able to, take a pain medication with anti-inflammatory properties shortly after getting the shot.

Use a cold compress if the swelling becomes bothersome.

If fear is a barrier to getting a shot, it's perfectly acceptable and actually good to talk to a doctor about taking an anti-anxiety medication beforehand. I use weed or CBD, but you might also be given one dose of a sedative like Ativan or Xanax.

[gusty-wind]

BioNTech Faces Lawsuit Over COVID-19 Vaccine Side Effects

In a landmark development, BioNTech SE, the German biotechnology company that partnered with Pfizer Inc. to produce one of the first COVID-19 vaccines, is now facing its first legal challenge in Germany over vaccine side effects.

In an unprecedented case that could potentially spark hundreds of similar claims across Germany, the plaintiff – a woman who has chosen to remain anonymous due to Germany’s privacy laws – is suing BioNTech for a minimum of €150,000 ($161,500) in damages.

According to Reuters, she cites “damages for bodily harm as well as compensation for unspecified material damage,” as detailed by Hamburg’s regional court and the law firm representing her, Rogert & Ulbrich.

Side effects listed in the suit include upper-body pain, swollen extremities, fatigue, and sleeping disorders attributed to the BioNTech Pfizer vaccine.

The landmark case’s first hearing will take place on Monday.

Conservatives Are Looking For Ways To Boycott and Move Spending Away From Woke Corporations -- Here Is One Way To Do It

More lawsuits are coming in Germany. Rogert & Ulbrich reports filing about 250 cases for clients seeking damages for COVID-19 vaccine side effects. Another law firm, Caesar-Preller, claims to represent 100 cases, collectively covering almost all such cases in Germany. A few similar cases have been filed in Italy.

Reuters reported:

Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile.

German pharmaceutical law states that makers of drugs or vaccines are only liable to pay damages for side-effects if “medical science” shows that their products cause disproportionate harm relative to their benefits or if the label information is wrong.

BioNTech, which holds the marketing authorisation in Germany for the shot it developed with Pfizer , said it concluded after careful consideration that the case was without merit.

“The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well characterised,” the biotech firm said, referring to the vaccine’s brand name.

It noted about 1.5 billion people had received the shot across the world, including more than 64 million in Germany.

The European Medicines Agency (EMA) also claimed that BioNTech’s Comirnaty, the most prevalent vaccine in the Western world, is “safe for use.”

EMA claimed that vaccines have helped save almost ’20 million lives globally’ in the first year of the pandemic alone. While acknowledging a ‘rare’ risk of myocarditis and pericarditis, two types of heart inflammation, primarily in young males post-vaccination, the EMA affirms that safety monitoring was not compromised during fast-track assessments.

Reuters reported that the liability issue remains uncertain, especially regarding who would pay legal costs or compensation if the plaintiff wins. EU’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, reportedly contain full or partial liability waivers for legal costs and potential compensation, which could force EU governments to bear some costs.

Germany, like many countries, has a no-fault compensation program for individuals who suffer permanent harm from vaccines. However, participation in this program does not preclude an individual from seeking damages separately.

In contrast, the United States has granted manufacturers immunity from liability for COVID vaccines receiving regulatory approval.