#Nuvaxovid

[allthecanadianpolitics]

Health Canada has authorized an adapted vaccine from Novavax to prevent COVID-19 in people age 12 and older.

Novavax's product — Nuvaxovid XBB.1.5 Omicron subvariant COVID-19 vaccine — uses a more traditional approach to defend the body against severe infection, hospitalization and death.

It is also authorized as a booster for those 18 and older, according to Health Canada's webpage.

Novavax said it expects to have doses available across the country. 

Novavax's first vaccine to protect against COVID-19, known as Nuvaxovid, was authorized for use in Canadians 18 and over by Health Canada in February 2022. [...]

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Tagging: @politicsofcanada

[covid-safer-hotties]

Also preserved on our archive

Nuvaxovid vaccine targets JN.1 variant

Health Canada said Thursday it has authorized Novavax's updated COVID-19 vaccine for those aged 12 years and up.

The product, called Nuvaxovid, is a protein-based vaccine.

Health Canada said the vaccine was updated to target the JN.1 variant, an offshoot of Omicron. Nationally, the JN.1 group is currently the main lineage in Canada. The variant set off a massive wave of infections worldwide in November 2021.

Guidance from the National Advisory Committee on Immunization (NACI) strongly recommends updated COVID-19 vaccinations starting this fall for high-risk groups:

All adults 65 and older. People living in long-term care and other group settings. People with underlying medical conditions that put them at higher risk of severe illness. Individuals in or from First Nations, Métis and Inuit communities. Members of racialized and other equity-deserving communities. Those who are pregnant. People who provide essential community services. All other individuals aged six months and older may also receive COVID-19 vaccines, NACI recommended.

Doctors advise fresh vaccines because the virus that causes COVID-19 continues to mutate to avoid being recognized by our immune system and to better bind for entering human cells.

Earlier this week, Health Canada also approved Moderna's updated mRNA vaccine for rollout in fall immunization campaigns.

Health Canada has said it anticipates issuing a decision about Pfizer's updated mRNA vaccine for COVID-19 over the next few weeks.

[decentralvaccine]

Health Canada Approves Updated Novavax Covid 19 Vaccine

Health Canada has authorized an adapted vaccine from Novavax to prevent COVID-19 in people age 12 and older.

Novavax's product — Nuvaxovid XBB.1.5 Omicron subvariant COVID-19 vaccine — uses a more traditional approach to defend the body against severe infection, hospitalization and death.

It is also authorized as a booster for those 18 and older, according to Health Canada's webpage.

[thebusinesspress]

EU Authorizes Nuvaxovid XBB.1.5-adapted COVID-19 Vaccine: A Crucial Step in Battling the Pandemic

In the ongoing fight against the COVID-19 pandemic, the European Commission has authorized the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine developed by Novavax. This groundbreaking feat marks the first protein-based adapted vaccine authorized for the autumn and winter season, representing a significant stride in our collective efforts to combat the disease. In this blog post, we delve into the…

[delectablywaywardbeard-blog]

Covid, la Commissione Ue autorizza il nuovo vaccino aggiornato Novavax

La Commissione europea ha autorizzato Nuvaxovid, il vaccino Novavax contro il Covid adattato alla sottovariante XBB.1.5. Ieri era arrivata la raccomandazione dell’Agenzia europea del farmaco. Si tratta del primo vaccino adattato a base proteica autorizzato per questa stagione autunnale e invernale. L’autorizzazione della Commissione è avvenuta con procedura accelerata, in modo che gli Stati…

[gadgetsforusesblog]

Click to read NVAX shares plummet on 'substantial uncertainty' as Covid admissions ease | Investor's Business Daily

Novavax (NVAX) reported lower-than-expected Q4 sales of its Covid vaccine late Tuesday and NVAX shares crashed. X During the December quarter, Novavax sales grew 61% to $357 million. But that fell short of expectations for $383 million, according to FactSet. The company said growth in sales of its Covid vaccine, Nuvaxovid, was offset by declining revenue from grants, royalties and other…

[visionblue-info]

Fragen mit Fakten zu den Covid-19-Impfstoffen

Die Impfpflicht soll nach einem Gesetzentwurf von über 200 Bundestagsabgeordneten noch im März 2022 im Bundestag beschlossen werden. Frau Rechtsanwältin Dr. Brigitte Röhrig, Fachanwältin für Medizinrecht, hat in ihrem Telegramkanal ein Informationsschreiben veröffentlicht, in welchem den Entscheidungsträgern, sprich den Bundestagsabgeordneten, faktenbasierte Fragen zu den  COVID-19 Impfstoffen…

[covid-safer-hotties]

Moderna's updated COVID-19 vaccine is coming to Alberta, but Novavax shots are not - Published Sept 23, 2024

By Jennifer Lee

Health Canada's decision on new Pfizer formulation is expected soon

With the approval of Moderna's updated COVID-19 vaccine, doctors are hoping the shots will be available soon and Albertans will opt to roll up their sleeves to get one.

Last week, Health Canada announced it had authorized Moderna's new formulation, which targets the recent KP.2 subvariant, and that shipments would arrive within days.

A decision on Pfizer's new formulation is expected in the next few weeks.

"To get better protection and protection also against getting more sick, because it's miserable, it would be advised to get the updated vaccine," said Dr. Lynora Saxinger, an infectious diseases specialist at the University of Alberta.

"A lot of people I speak with are actually surprised to hear that we are seeing severe COVID still. It is still a thing."

No Novavax vaccine Health Canada also approved the protein-based Novavax vaccine (Nuvaxovid) last week.

It's designed to target JN.1, which is the dominant lineage in Canada at the moment.

But it will not be available to Albertans.

The federal government, which procures the vaccines on behalf of the provinces, said it won't be providing the Novavax shots.

"Canada's current contract with Novavax only provides access to domestically manufactured vaccines, which Novavax has been unable to confirm for the 2024-25 season," a Health Canada spokesperson said in an email.

"Provinces and territories may choose to procure independently from Novavax from supply produced in India for their fall vaccination campaigns."

When asked by CBC News whether it would order its own doses, a spokesperson for the province said the Novavax vaccine would not be available through the publicly funded program and there would be no stock for those who wished to pay out of pocket.

"Due to Novavax's inability to honour their contract with the federal government to provide domestically manufactured vaccines, the Nuvaxovid vaccine will not be included in the fall immunization program," the email said.

"As confirmed by Novavax, Nuvaxovid will not be available on the private market, and there will be no option for Albertans to purchase the vaccine."

Dr. Noel Gibney calls the situation "unfortunate," given the level of vaccine hesitancy in Alberta.

"Novavax is a traditional protein-based vaccine so that for those individuals, those Albertans, that are more reluctant to get an mRNA, Novavax presents an ideal option for protection," said Gibney, professor emeritus of critical care medicine at the University of Alberta.

In a statement emailed to CBC News, Novavax said doses of its updated vaccine can be made available based on supply, demand and a government's level of need.

"Novavax is prepared to deliver its updated protein-based 2024-25 COVID-19 vaccine to Canada, in line with federal public health recommendations, should the Canadian government or provinces place an order," the statement said.

Saxinger said uptake for that particular shot has been low in the past, despite calls for its availability.

"I think there could be a rationale for getting at least a small supply for people who have had a contraindication to mRNA vaccination based on their prior experience with it or other medical issues," she said.

Meanwhile, Gibney said it's particularly important for high-risk Albertans to plan on getting vaccinated, including seniors and people with underlying health conditions such as heart and lung problems as well as diabetes and high blood pressure.

"COVID hasn't gone away, and individuals who are older and more susceptible to serious illness are at risk of getting seriously ill still."

The provincial government wouldn't say when COVID-19 shots will be made available.

Pharmacists have been told to prepare for the vaccination campaign to launch, for the general public, on Oct. 15.

[decentralvaccine]

Covid Vaccine Maker Novavax May No Longer Be A Going Concern

Novavax, which makes the Nuvaxovid vaccine used to treat Covid-19, posted huge sales gains for the past three years during the height of the pandemic. But the company is now facing serious financial challenges — and has even warned it may not be able to survive.

The Gaithersburg, Maryland-based company said its forecast "is subject to significant uncertainty," particularly with regard to future sales and funding from the US government, the company said in its latest earnings report after the closing bell Tuesday.

"Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern," the company added.

[zoranphoto]

U Hrvatsku stiže novo cjepivo protiv korone. Stručnjaci su podvojeni, a ovo su odgovori na ključna pitanja

Do kraja veljače u Hrvatsku bi trebalo stići peto cjepivo protiv covida-19, Nuvaxovid američke tvrtke Novavax.   Prof. dr. sc. Mirjana Kujundžić Tiljak, ravnateljica Škole narodnog zdravlja 'Andrija Štampar' Medicinskog fakulteta sveučilišta u Zagrebu, u četvrtak je na HTV-u kazala da je riječ o potpunom novom cjepivu s nekoliko nepoznanica. 'O njegovoj učinkovitosti na nove sojeve ne znamo ništa. Ne znamo još ni koliko dugo će trajati zaštita. To tako i piše u službenom opisu lijeka', rekla je Kujundžić Tiljak gostujući u emisiji 'Dobro jutro, Hrvatska'     S obzirom na to da je Europska agencija za lijekove (EMA) amenovala Nuvaxovid još u prosincu, kao prvo proteinsko cjepivo odobreno za primjenu u Europskoj uniji, dosta toga ipak je poznato. Uz europske zemlje, za novim cjepivom već je posegnuo Izrael, naručujući prošlog tjedna prvih pet milijuna doza i prije nego što je cjepivo u toj zemlji službeno odobreno. 'Ovo cjepivo bit će još jedna alternativa onima koji ne mogu ili ne žele primiti mRNA cjepivo', poručilo je izraelsko ministarstvo zdravstva. Istovjetnu poruku odaslao je u subotu irski ministar zdravstva Stephen Donnelly, priopćivši da se Nuvaxovid pokazao 'visoko učinkovitim' u sprječavanju umjerenih i teških oblika bolesti. Stoga je pozvao one malobrojne koji se još nisu cijepili da to učine kad prve doze stignu u Irsku. Hrvatska je još u rujnu, temeljem sporazuma Europske komisije i Novavaxa, naručila 198.000 doza Nuvaxovida, a početkom prosinca dr. Dragan Primorac izjavio je za RTL Direkt da to cjepivo 'iznimno učinkovito' djeluje na omikron. Cjepivo Nuvaxovid primjenjuje se u dvije doze u razmaku od tri tjedna. Za razliku od mRNA cjepiva (Pfizer, Moderna), koje se služi dijelom genetskog koda koronavirusa, te vektorskih cjepiva (AstraZeneca, Johnson&Johnson) s bezopasnim, genetski modificiranim virusom za prijenos dijela DNK koronavirusa, proteinska cjepiva sadrže fragmente proteina jedinstvenog za koronavirus. Ti su fragmenti dovoljni da tijelo odgovori stvaranjem prirodne obrane od zaraze, a Novavax se u proizvodnji cjepiva služi i stanicama insekata. Izvor: Društvene mreže / Autor: youtube Tehnologija proteinskih cjepiva nije nova, dapače - na istom principu nastala su i cjepiva protiv hripavca i hepatitisa B. Takvo cjepivo ne mora se skladištiti na niskim temperaturama, što je osobito važno za zemlje u razvoju. Rezultati dvaju glavnih kliničkih ispitivanja s više od 45.000 ispitanika pokazali su da je Nuvaxovid siguran i djelotvoran u prevenciji covida u osoba u dobi od 18 i više godina. Prvo ispitivanje, provedeno u Meksiku i SAD-u, pokazalo je smanjenje broja simptomatskih slučajeva zaraze u osoba koje su primile cjepivo Nuvaxovid od 90,4 posto sedam dana nakon primjene druge doze. Drugo kliničko ispitivanje, provedeno u Ujedinjenom Kraljevstvu, pokazalo je djelotvornost cjepiva od 89,7 posto. Valja napomenuti da su ta istraživanja provođena na 'starim' varijantama koronavirusa, prije pojave omikrona, no Novavax je u međuvremenu objavio da njihovo cjepivo također stvara imunološki odgovor na omikron.

Najčešće nuspojave bile su blagog do umjerenog karaktera te su prolazile za nekoliko dana. Uključivale su bol i osjetljivost na mjestu primjene cjepiva, umor, bolove u mišićima, glavobolju, opću slabost, bolove u zglobovima te mučninu ili povraćanje.

Očekivano djelovanje cjepiva

Nuvaxovid je proteinsko cjepivo s laboratorijski uzgojenom verzijom proteina šiljka koji je prisutan na površini virusa SARS-CoV-2. Cjepivo također sadrži 'adjuvans', tvar koja pomaže pojačati imunološki odgovor na cjepivo, priopćio je HALMED.     Kada se cjepivo primijeni, imunološki sustav osobe identificirat će protein kao strani te će protiv njega stvoriti prirodnu obranu, odnosno antitijela i T-stanice. U slučaju zaraze imunološki će sustav prepoznati protein šiljka na virusu i biti spreman za napad. Protutijela i imunološke stanice zajednički djeluju na ubijanju virusa, sprječavanju njegova ulaska u stanice tijela i uništavanju zaraženih stanica, čime pomažu u zaštiti od bolesti covid-19. Novavax Covid jab approved by UK drugs regulator https://t.co/vu1tBeC4HR — CR Health Platform (@cr_health) February 3, 2022 U nastavku donosimo odgovore EMA-e na nekoliko dodatnih pitanja o cjepivu Novovaxa.

Mogu li se osobe koje su preboljele covid cijepiti Nuvaxovidom?

Nije bilo dodatnih nuspojava u osoba koje su primale Nuvaxovid u kliničkim ispitivanjima i prethodno su imale covid-19. Nije bilo dovoljno podataka iz ispitivanja da bi se zaključilo koliko dobro Nuvaxovid djeluje na osobe koje su već imale covid-19.

Mogu li se trudnice i dojilje cijepiti Nuvaxovidom?

Studije na životinjama ne pokazuju nikakve štetne učinke u trudnoći, međutim podaci o primjeni Nuvaxovida tijekom trudnoće su ograničeni. Iako ne postoje studije o dojenju, ne očekuje se rizik. Odluku o primjeni cjepiva u trudnica treba donijeti u bliskoj konzultaciji sa zdravstvenim djelatnikom nakon razmatranja koristi i rizika.

Mogu li se djeca cijepiti Nuvaxovidom?

Nuvaxovid se trenutno ne preporučuje osobama mlađim od 18 godina. EMA se s Novavaxom dogovorila o planu za kasnije ispitivanje cjepiva na djeci. Tportal.hr Read the full article

[sondakikabu]

İngiltere Covid-19 aşısına daha onay verdi

İngiltere Covid-19 aşısına daha onay verdi

İngiltere, merkezi ABD’de bulunan Novavax firmasının koronavirüse karşı geliştirdiği “Nuvaxovid” adlı aşıyı onayladı. Bu, İngiltere’nin onay verdiği 5’inci aşı oldu. İngiltere, koronavirüse karşı bir aşıya daha onay verdi. İngiltere İlaç ve Sağlık Ürünleri Düzenleme Kurumundan (MHRA) yapılan açıklamada, gerekli güvenlik, kalite ve etkinlik standartlarını karşılayan aşının yetişkinlerde birinci ve…

[globalhappenings]

Vaccines: Fvg, from March 1st it is possible to book Novavax

Vaccines: Fvg, from March 1st it is possible to book Novavax

(ANSA) – TRIESTE, 26 FEB – “From 12 on 1 March in Friuli Venezia Giulia it will be possible to book, through the usual channels, for the administration of the vaccine for Covid-19 Nuvaxovid (Novavax). The vaccinations will be carried out starting from March 3 in the vaccination centers of all health authorities in our region “. This was announced by the deputy governor of the Fvg with…

[firewalker]

Vaccino Novavax

Leggo il foglietto illustrativo di Nuvaxovid, il nuovo vaccino Novavax che è stato appena approvato, e noto che - ovviamente - ha un adiuvante, ovvero un componente che migliora la risposta immunitaria alla proteina S, che poi è il "principio attivo".

Cose interessanti:

L'adiuvante è una certa Matrice M, ricavata da una pianta, la Quillaja saponaria, anche noto come "albero della corteccia del sapone", perché la corteccia contiene saponina e viene usata proprio come sapone, dato che produce anche schiuma (oltre ad altri usi medicamentosi)

La proteina S (la spike, per capirci) è il risultato dell'infezione di un Baculovirus artificialmente mutato che ha infettato cellule chiamate Sf9, cellule derivate da tessuto ovarico di un insetto, la Spodoptera frugiperda, una falena.

Mi aspetto quindi che, presto, avremo i complottari che grideranno che il vaccino ci avvelena col sapone e feti di insetti morti.

[vanadio00]

Finalmente è arrivato Novavax ed è sparito dalla tabella dall’allegato E della nota tecnica EMA il riferimento ai termini di sperimentazione legati all’efficacia e alla sicurezza. 😓 Giusto per essere pronti a firmare sereni il consenso informato. 👍 Quindi ufficialmente e al più tardi la sperimentazione di questo vaccino termina il 31 gennaio 2023. 👏🏻👏🏻👏🏻

https://www.ema.europa.eu/en/documents/product-information/nuvaxovid-epar-product-information_it.pdf