#ugursahin

[biglisbonnews]

As Covid-19 shot sales dwindle, BioNTech doubles down on cancer vaccines BioNTech is over covid. Or looking past it, at least, planning to invest the company’s pandemic windfall into the development of oncology products.Read more... https://qz.com/as-covid-19-shot-sales-dwindle-biontech-doubles-down-o-1850267976

[intellectures]

Innovation gibt es nicht umsonst

Springer-Unternehmer Christoph Keese hat ein Buch über visionäre Erfinder geschrieben, die mit marktwirtschaftlichen Instrumenten die Grenzen des Möglichen verschieben. Anhand von Beispielen aus den Bereichen Energie, Kommunikation, Mobilität, Gesundheit und Bildung zeigt er auf, wie technologischer Fortschritt und digitale Innovation Mensch und Gesellschaft voranbringen können. Read the full article

[mensfactory]

Alfa Romeo Nivola concept,

Designed by Ugur Sahin

[rheinsiegmagazin]

Biontech stellt Impfung für Schulkinder ab Juni in Aussicht

Biontech stellt Impfung für Schulkinder ab Juni in Aussicht

Biontech-Chef Ugur Sahin gibt Eltern Hoffnung: Ab Juni könnten die ersten Schulkinder gegen Corona geimpft werden. Eine Zulassung für alle Altersklassen wird für September geplant.

[newzradar]

Europe will reach herd immunity by August, says BioNTech chief

[alperkulpro]

Gurur . #biontech #derspiegel #pandemic #gurur #özlemtüreci #ugursahin #vaccine #pfizer #albertbourla https://www.instagram.com/p/CJjQat4s5Bt/?igshid=9dw1oqigw6qh

[scienza-magia]

La corsa verso il vaccino contro il Covid-19 si fa sempre più serrata.

Un vaccino solo, che protegge da 10 ceppi virali: primi test clinici entro l'anno. La corsa per mettere a punto un vaccino a livello mondiale si fa sempre più serrata. Funziona su topi, ratti e macachi il vaccino cinese PiCoVacc, basato su una forma purificata e inattivata del virus SarsCoV2. Un vaccino "jolly", perché protegge da 10 ceppi virali isolati in diversi Paesi (Svizzera inclusa), inducendo una massiccia produzione di anticorpi, che nei topi è 10 volte superiore a quella dei pazienti guariti da Covid-19. I risultati, che aprono ai test sull'uomo entro l'anno, sono pubblicati su Science dal gruppo di ricerca cinese coordinato dall'azienda Sinovac Biotech con sede a Pechino. L'equipe guidata da Qiang Gao ha isolato diversi ceppi di coronavirus da 11 pazienti ricoverati in Cina, Italia, Svizzera, Spagna e Gran Bretagna. Un ceppo in particolare è stato selezionato, purificato e reso innocuo per poter sviluppare il vaccino. Il prodotto è stato quindi somministrato a topi e ratti, che a distanza di tre settimane sono stati infettati con gli altri dieci ceppi virali: come risultato, PiCoVacc è riuscito a neutralizzarli tutti.

keystone-sda.ch (Pool) Nei topi, in particolare, ha indotto una produzione di anticorpi diretti contro la proteina S del virus (usata per attaccare le cellule umane) che è dieci volte superiore a quella misurata nei pazienti guariti da Covid-19. Non è ancora possibile dire se un risultato simile si possa ottenere anche nell'uomo, ma secondo i ricercatori questo dato fa pensare che la risposta immunitaria indotta sia comunque massiccia. Dopo questo primo successo la sperimentazione è passata sui macachi, a cui sono state somministrate tre dosi di vaccino (da 1,5 microgrammi o 6 microgrammi) nel corso di due settimane. Quelli che avevano ricevuto le dosi da 6 microgrammi hanno sviluppato una protezione completa contro il virus e senza manifestare nel breve termine quel temuto effetto paradosso (chiamato Ade, Antibody-Dependent Enhancement) che induce la produzione di anticorpi non neutralizzanti capaci di favorire l'ingresso del virus nelle cellule. «Messi insieme, questi risultati indicano la strada verso lo sviluppo clinico del vaccino per uso umano», concludono i ricercatori, che intendono cominciare i primi test clinici entro l'anno. Corsa sempre più serrata - Si fa sempre più serrata a livello mondiale la corsa per mettere a punto un vaccino contro il Covid-19. Varie sperimentazioni sull'uomo sono state avviate e ora entrano nel vivo anche i test clinici per il vaccino Usa-Germania messo a punto dalla multinazionale Pfizer e dalla tedesca BioNTech, che conta di avere il vaccino «per l'autunno» e milioni di dosi entro la fine del 2020. La somministrazione del vaccino al primo campione in Germania è stata completata la scorsa settimana e sono cominciati i test sull'uomo anche negli Stati Uniti, con l'annuncio che si punta a produrre milioni di dosi già entro il 2020. L'ampiezza di questo programma, annunciano le due aziende, «dovrebbe consentire la produzione di milioni di dosi di vaccino nel 2020, aumentando a centinaia di milioni nel 2021». Nei test del vaccino avviati in Usa, i primi a farsi iniettare sono stati cinque volontari all'università del Maryland e al centro medico Grossman della università di New York. I ricercatori utilizzeranno sui volontari ben 4 diverse versioni del potenziale vaccino. Inizialmente la sperimentazione riguarderà volontari tra i 18 e i 55 anni e successivamente saranno inclusi anziani sino agli 85 anni. La sperimentazione in Usa arruolerà fino a 360 soggetti. Pfizer prevede di attivare la sua vasta rete di stabilimenti e d'investire 'a rischio' nella produzione di un vaccino COVID-19 approvato, per «renderlo disponibile il più rapidamente possibile per coloro che ne hanno più bisogno in tutto il mondo». Il programma di sviluppo Pfizer-BioNTech comprende dunque 4 vaccini candidati (a diversa combinazione di formato di mRNA e antigene bersaglio): la sperimentazione consente la valutazione simultanea dei vari candidati vaccini, al fine d'identificare il candidato più sicuro e potenzialmente più efficace in un numero maggiore di volontari, in modo da facilitare la condivisione dei dati con le autorità regolatorie in tempo reale. «Siamo ottimisti sul fatto che portare avanti più vaccini candidati nelle sperimentazioni umane ci consentirà d'identificare le opzioni di vaccinazione più sicure ed efficaci contro il Covid-19», ha affermato il CEO e cofondatore di BioNTech, Ugur Sahin. Complessivamente, sono 90 i candidati vaccini contro il Covid-19 allo studio in tutto il mondo e 6 hanno cominciato i test sull'uomo. Read the full article

[cool-emreaytekin-blog]

Yılmaz Kuruca ve Arkadaşları

Yılmaz Kuruca , Ümit Kuruca, Uğur Şahin , Özkan Mamati, Emre Ertüzün

[haberder]

#BioNTech CEO’su Prof. Dr. #UgurSahin, yıl sonuna kadar 5-11 yaş arasındaki çocuklara aşı uygulanması için gerekli prosedürün tamamlanacağını tahmin ediyor.

[expatimes]

KUWAIT SAID TO SIGN CONTRACT FOR PFIZER VACCINE

Pfizer-BioNTech in vaccine success

■ Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis

■ Analysis evaluated 94 confirmed cases of COVID-19 in trial participants

■ Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; safety and additional efficacy data continue to be collected

■ Submission for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November

■ Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

NEW YORK/MAINZ, Germany, Nov 9, and KUNA: Pfizer Inc (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on Nov 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases.

Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 percent, at seven days after the second dose.

This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned.

The data will be discussed with regulatory authorities worldwide. “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID- 19,” said Dr Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.

With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.” “I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof UgurSahin, BioNTech Co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve.

Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.” The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of Nov 8, 2020.

Approximately 42 percent of global participants and 30 percent of US participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID- 19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.

In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus. Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on supply projections, we expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

About BioNTech: Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Based on its deep expertise in mRNA vaccine development and inhouse manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech. de. Meanwhile, the State Audit bureau (SAB) has reached an agreement with the Health Ministry on the signing of a contract with Pfizer to procure the COVID-19 vaccine at a total cost of $24,900,000, reports Al-Anba daily quoting sources.

Sources disclosed the bureau has asked the Ministry of Health to take all the necessary measures to guarantee the availability of the vaccine on the agreed dates in order to fully benefit from this contract. Sources said the bureau informed the ministry about the need to set a timetable with the Pfizer to ensure that Kuwait will obtain the required quantities at the beginning of each quarter.

The post KUWAIT SAID TO SIGN CONTRACT FOR PFIZER VACCINE appeared first on ARAB TIMES - KUWAIT NEWS.

#kuwait Read full article: https://expatimes.com/?p=13662&feed_id=15565

[yourmassivecollectionballoo-blog]

[tremendouslyuniquebasement-blog]

Dikkat! Bu kişiler vatan haini FETÖ terör örgütüyle bağlantılıdır:

Özkan Mamati ve Uğur Şahin

[metruksehir-blog]

Cumhuriyet çalışanları 9 ay sonra hâkim karşısında: Hakikat / Foksmedya, son dakika, haberler

UĞUR ŞAHİN ugursahin@birgun.net @uugurs“FETÖ, DHKP-C ve PKK propagandası yaptığı” iddiasıyla tutuklanan Cumhuriyet gazetesi Kaynak : Cumhuriyet çalışanları 9 ay sonra hâkim karşısında: Hakikat

[haberder]

BioNTech Üst Yöneticisi (CEO) ve kurucu ortağı Prof. Dr. #UgurSahin, 3. doz BioNTech aşısının koruma oranlarını açıkladı.