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The COVID-19 pandemic brought mRNA to global prominence by developing highly effective vaccines by Moderna and Pfizer-BioNTech. The Expanding Role of mRNA in Cancer Therapy One of the most exciting applications of mRNA therapeutics lies in cancer treatment, where leveraging the immune system to target tumors offers a novel approach.
The halting of AstraZeneca’s COVID-19 vaccinetrial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Trials have resumed in the UK, Brazil and South Africa, but US trials remain on hold. Matt Fellows. Source link.
Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccinetrial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.
The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,
In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV.
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
EMERYVILLE, Calif.
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial.
The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.
Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,
29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,
New Phase 1/2 on Novavax’s COVID-19 vaccine candidate NVX?CoV2373 CoV2373 has shown that the therapy generated “robust antibody responses” when used with or without the company’s Matrix?M tolerated COVID-19 vaccine with a robust immunogenicity profile,” explained Dr Gregory Glenn, President of Research and Development at Novavax.
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Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine.
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.
The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.
30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit.
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Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ).
The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week.
Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine ( NYTimes ) ( WSJ ) ( Endpoints ) ( Reuters ).
This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.
–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(
FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S.
In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.
Astellas”) today announced that they have entered into an agreement whereby Affinivax has reacquired the exclusive worldwide rights to ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. We believe ASP3772 has significant potential to address unmet needs in this important vaccine category. Source link: [link].
Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials.
In addition, this will meet Clover’s Phase 2/3 clinical production plan and commercial readiness once its vaccine candidate is approved.
SHANGHAI , Nov.
SHANGHAI , Nov.
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children.
The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.
billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization.
BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date.
by the middle to end of December 2020. participants are 56-85 years of age.
The UK Government has signed a new deal with Johnson & Johnson and Novavax to secure 90 million orders of their vaccine candidates to protect against COVID-19 infection. . S, the COVID-19 vaccine candidate developed by Janssen, the pharmaceutical subsidiary of J&J, for not-for-profit emergency pandemic use. Matt Fellows.
The BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within 3 days after the infection. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. and Germany. Jansen, Ph.D.,
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.
Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.
Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,
The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
25, 2021 — Giving melanoma patients a “personalized” vaccine can prompt an anti-tumor immune response that lasts for years, an early study finds. So researchers gave them an experimental vaccine called NeoVax. Unlike traditional vaccines, it is not a one-size-fits-all jab. MONDAY, Jan.
Pfizer and BioNTech today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18?years years of age and older.
The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.
As the pharma community continue to research and develop hundreds of potential therapies to combat the Covid-19 pandemic, very few initiatives are yet to cross the finishing line into the commercial market. McKesson supports OWS to centralize distributor of future Covid-19 vaccines.
government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country.
Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. This press release features multimedia. View the full release here: [link].
• Submission based on real-world safety and efficacy data from Israel • Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster.
If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. . The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. and Europe.
These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. ” Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, “In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. .”
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