The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. JUNE 22 , 2021. 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.

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DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology.

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MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021.

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OCTOBER 22, 2020

Moderna has completed enrollment of 30,000 participants for its phase 3 study evaluating COVID-19 vaccine candidate mRNA-1273. The randomized, placebo-controlled trial is being conducted in partnership with the NIH’s National Institute of Allergy and Infectious Diseases and HHS’ Biomedical Advanced Research and Development Authority.

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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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SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September.

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NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

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JANUARY 31, 2021

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.

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JANUARY 20, 2021

-based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger-RNA technology designed to combat future variants of the coronavirus.

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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. The Cambridge, Mass., Source link.

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JANUARY 25, 2021

In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Initial efficacy data are anticipated in the first quarter and the phase 2/3 trials are expected to wrap up in May.

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SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J.,

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JANUARY 13, 2021

Brazil’s Butantan Institute has reported that Sinovac’s COVID-19 vaccine, CoronaVac, demonstrated an overall efficacy of only 50.38 percent in a phase 3 trial, putting it barely over the World Health Organization’s 50 percent efficacy threshold for approval.

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JANUARY 31, 2021

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.

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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 17, 2020

Gavi, the Vaccine Alliance welcomes latest pledges in support of the Gavi COVAX AMC , a financing mechanism that will support 92 low- and middle-income economies’ access to safe and effective COVID-19 vaccines. Nine candidate vaccines are currently being supported by CEPI; eight of which are currently in clinical trials.

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FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.

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NOVEMBER 23, 2020

As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. Food and Drug Administration (FDA) and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today. The prices for the vaccines are moving targets, dependent upon the amount ordered.

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MAY 3, 2021

Posted 03 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . EMA. . . .

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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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JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . Testing Therapies, Antivirals and Vaccines. By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . Other Industry News.

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JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

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MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).

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MAY 4, 2021

Posted 04 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review. . CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. EMA. . . . . .

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JANUARY 29, 2021

29, 2021 — Interim phase 3 data show that the COVID-19 vaccine developed by Janssen Pharmaceuticals of Johnson & Johnson is 66 percent effective in preventing moderate-to-severe COVID-19 in adults, the National Institutes of Health announced today. The vaccine, known as Ad.26.COV2.S, The vaccine, known as Ad.26.COV2.S,

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JANUARY 4, 2021

4, 2021 — The mRNA-1273 vaccine has 94.1 from Brigham and Women’s Hospital in Boston, and colleagues conducted a phase 3 randomized trial at 99 centers across the United States. per 1,000 person-years), resulting in vaccine efficacy of 94.1 © 2021 HealthDay. Posted: January 2021. MONDAY, Jan.

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JANUARY 11, 2021

Two Billion COVID-19 Vaccine Doses From BioNTech Expected This Year. 11, 2021 — A boost in manufacturing should enable Germany’s BioNTech to produce 2 billion doses of its COVID-19 vaccine this year, the company says. BioNTech and partner Pfizer developed the first COVID-19 vaccination to be brought to market.

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JANUARY 29, 2021

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.

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JANUARY 29, 2021

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.

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NOVEMBER 30, 2020

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. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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FEBRUARY 22, 2021

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above.

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SEPTEMBER 4, 2020

Dr Moncef Slaoui, the leading doctor involved with Operation Warp Speed, has said it is unlikely a vaccine for the US will be ready by November. . But Slaoui did say that he believes a vaccine will be available by the end of the year, and could possibly vaccinate between 20 and 25 million people.

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JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

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NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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JANUARY 13, 2021

COV2-S Vaccine Seems Safe, Immunogenic for SARS-CoV-2. 13, 2021 — A candidate vaccine, Ad26.COV2.S, 13, 2021 — A candidate vaccine, Ad26.COV2.S, “Our interim analysis indicates that vaccine candidate Ad26.COV2.S “Our interim analysis indicates that vaccine candidate Ad26.COV2.S

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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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