The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. An additional trial could further delay AZ’s efforts to earn an EUA in the U.S., James Miessler.

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The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. Overall, the vaccine protected against symptomatic disease in 70% of cases, according to a team led by researchers from Oxford University in England. TUESDAY, Dec. 8 in The Lancet.

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

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The Pharma Data

DECEMBER 22, 2020

CanSino Biologics has enrolled more than 20,000 participants in a global phase 3 study of its COVID-19 vaccine candidate, Ad5-nCoV, co-developed with a research arm of the Chinese military. The trial is being conducted in Argentina, Pakistan, Russia, Mexico and Chile. Source link.

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The Pharma Data

NOVEMBER 30, 2020

Novavax said it will begin a delayed phase 3 trial in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, “in the coming weeks” and that its 15,000-person late-stage trial in the UK is now fully enrolled. The new study aims to enroll up to 30,000 participants. Source link.

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The Pharma Data

DECEMBER 9, 2020

The University of Oxford has attempted to clarify the dosing error it and AstraZeneca (AZ) made in a clinical trial assessing COVID-19 vaccine AZD1222, following divergent reports between the two of what exactly transpired. Chief among them, can the vaccine fight asymptomatic infections? percent ( DID , Dec. Jason Scott.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.

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The Pharma Data

DECEMBER 20, 2020

Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. AstraZeneca is leading the phase 3 U.S.

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The Pharma Data

DECEMBER 10, 2020

Moderna has started dosing adolescent participants in a phase 2/3 trial evaluating vaccine candidate mRNA-1273, planning to enroll 3,000 U.S. volunteers aged 12 to 17.

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The Pharma Data

DECEMBER 11, 2020

The Australian government has scrapped a supply deal with CSL for 51 million doses of its COVID-19 vaccine co-developed with the University of Queensland, after trial participants falsely tested positive for HIV. Source link.

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MAY 6, 2021

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. This press release features multimedia. View the full release here: [link].

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MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

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The Pharma Data

JULY 21, 2021

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial.

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The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon. based Dynavax Technologies to boost the vaccine’s efficacy. Jason Scott. Source link.

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The Pharma Data

JUNE 25, 2021

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.

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NOVEMBER 18, 2020

19, 2020 /PRNewswire/ — OBI Pharma, Inc. These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients. Session Date and Time: Friday, November 20, 2020.

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APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen’s COVID-19 Vaccine Candidate.

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The Pharma Data

NOVEMBER 23, 2020

Third COVID-19 Vaccine Shows Effectiveness. 23, 2020 — On Monday, AstraZeneca announced that late-stage clinical trials of its COVID-19 vaccine showed it to be 70.4 The trials were conducted in the United Kingdom and Brazil in collaboration with the University of Oxford. © 2020 HealthDay. Professional.

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NOVEMBER 12, 2020

German drugmaker Curevac says its COVID-19 vaccine candidate, CVnCoV, can remain stable for at least three months at 41 degrees Fahrenheit (5 degrees Celsius), making it easier to distribute than some competitors’ vaccines. The company hopes to launch a phase 3 trial by year’s end. Source link.

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The Pharma Data

DECEMBER 8, 2020

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent effective “at least 14 days” following the second injection.

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The Pharma Data

DECEMBER 12, 2020

Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. to vaccinate on demand.

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The Pharma Data

DECEMBER 7, 2020

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon.

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The Pharma Data

DECEMBER 7, 2020

Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD). sites to assess the vaccine’s safety, tolerability and immunogenicity as a two-dose regimen. The Plymouth Meeting, Pa., The Plymouth Meeting, Pa.,

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The Pharma Data

DECEMBER 21, 2020

22, 2020 07:13 UTC. 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.,

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DECEMBER 30, 2020

Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. © 2020 HealthDay. Posted: December 2020. All rights reserved.

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The Pharma Data

NOVEMBER 18, 2020

Both Moderna’s and Pfizer’s COVID-19 vaccine candidates could receive Emergency Use Authorization (EUA) in less than a month and be ready for rollout in a matter of weeks, HHS Secretary Alex Azar said Wednesday, giving hope that high-risk patients could receive a vaccine before the year ends.

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The Pharma Data

DECEMBER 7, 2020

Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD). sites to assess the vaccine’s safety, tolerability and immunogenicity as a two-dose regimen. The Plymouth Meeting, Pa., The Plymouth Meeting, Pa.,

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The Pharma Data

NOVEMBER 13, 2020

We must collectively work to support countries and engage communities to reach everyone, everywhere with measles vaccine and stop this deadly virus.” This means ensuring we have the resources to continue immunization campaigns for all vaccine-preventable diseases, even as we address the growing COVID-19 pandemic.”

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The Pharma Data

DECEMBER 11, 2020

70 Percent Efficacy Found for Oxford COVID-19 Vaccine. 11, 2020 — The ChAdOx1 nCoV-19 vaccine has an overall efficacy of 70.4 Participants in the vaccine group received two doses containing 5 x 10 10 virus particles (standard dose; SD/SD cohort); a subset in the U.K. © 2020 HealthDay. Posted: December 2020.

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The Pharma Data

DECEMBER 10, 2020

Thursday, December 10, 2020 – . Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.

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The Pharma Data

DECEMBER 17, 2020

Advisory Committee Votes to Recommend EUA for Moderna Vaccine. 17, 2020 — The Moderna COVID-19 vaccine received recommendation from a U.S. Food and Drug Administration advisory committee on Thursday, clearing the way for it to become the second COVID-19 vaccine to be granted emergency use authorization.

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The Pharma Data

DECEMBER 9, 2020

COVID-19 Vaccine Caution Issued by U.K. 9, 2020 — People with a “significant history” of allergic reactions should not receive the new Pfizer-BioNTech COVID-19 vaccine, U.K. mass vaccination program, the Associated Press reported. mass vaccination program, the Associated Press reported.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. pivotal Phase 3 trial update. South Africa Phase 2b trial update. GAITHERSBURG, Md.,

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DECEMBER 8, 2020

FDA Review Finds Pfizer COVID-19 Vaccine Effective After First Dose. 8, 2020 — New data released Tuesday by the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee suggest that Pfizer’s two-dose COVID-19 vaccine works well protecting recipients against COVID-19.

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DECEMBER 30, 2020

Is First Country to Approve Oxford-AstraZeneca COVID-19 Vaccine. 30, 2020 — Britain became the first country to give authorization to the COVID-19 vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. © 2020 HealthDay. Posted: December 2020. WEDNESDAY, Dec.

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The Pharma Data

DECEMBER 7, 2020

7, 2020 — Scientists say they may be getting closer to creating a universal flu vaccine. In an early-stage clinical trial with 65 volunteers in the United States, an experimental vaccine triggered strong immune responses to a wide range of flu virus strains and subtypes. MONDAY, Dec.

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