Vaccines

Akston Biosciences Announces Positive Top-Line Data From Phase II Study of COVID-19 Vaccine in the Netherlands

01/04/2022

Two 45 μg doses and single 90 μg of protein subunit vaccine AKS-452 were generally well-tolerated and showed robust neutralizing antibody titers Primary immunogenicity endpoints were met Vaccine is shelf stable for at least 6 months at 25° C (77° F) Phase II/III trial starting in India Excerpt from the Press Release: BEVERLY, Mass.–(BUSINESS WIRE)–Akston…

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Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron

12/22/2021

Cross-reactivity will be assessed using samples from Phase II clinical participants and in a parallel animal challenge study Oral tablet’s immunogenicity profile suggests it may provide cross-protection against SARS-CoV-2 variants, including Omicron Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (NASDAQ: VXRT) said today it plans to…

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NRx Pharmaceuticals and Hungarian Health Officials Agree on Pathway for ZYESAMI® and BriLife COVID-19 Vaccine Trials

12/14/2021

NRx and Hungary Agree on Regulatory Path for Emergency Use of ZYESAMI Hungary to Serve as First European Nation for the Registrational Phase 2b/3 BriLife COVID Vaccine Trial Excerpt from the Press Release: BUDAPEST, Hungary, Dec. 09, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP) today announced the conclusion of high-level meetings in Hungary that are expected to…

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Canada gives full approval to J&J’s single-shot COVID-19 vaccine

11/30/2021

Excerpt from the Press Release: Nov 24 (Reuters) – Johnson & Johnson (JNJ.N) said on Wednesday Canada gave full approval to its single-shot COVID-19 vaccine for people aged 18 years and older, making it the first full approval for the vaccine globally. The vaccine was previously authorised by the country under an interim order. (https://refini.tv/30Zd5TR) Canada, which…

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A different type of COVID-19 vaccine is about to roll out around the world

11/30/2021

Excerpt from the Press Release: Whatever happened to Novavax and Sanofi’s COVID-19 vaccines? Many people thought at the beginning of the pandemic that these were the two most likely vaccines to succeed. AUDIE CORNISH, HOST: A new kind of COVID-19 vaccine is about to roll out around the world. It’s called a protein subunit vaccine.…

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UK data shows good safety of COVID-19 vaccines in pregnancy

11/30/2021

Excerpt from the Press Release: COVID-19 vaccination is safe for pregnant women and not associated with higher rates of complications, data released by the UK Health Security Agency showed on Thursday, as officials urged pregnant women to take up the offer of shots. The real-world data from the rollout of COVID-19 vaccines in Britain support other studies around the…

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Aiming to make Covid vaccines easier to take, East Bay company pushes forward with microneedle patch

11/23/2021

Excerpt from the Press Release: An East Bay company formulated a Covid-19 vaccine candidate to load onto a patch of 2,000 microneedles, one of several efforts globally to make it easier to take drugs and vaccines to combat the pandemic. Zosano Pharma Corp. (NASDAQ: ZSAN) of Fremont did not disclose the name of the vaccine,…

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Moderna Files for Authorization of its COVID-19 Vaccine with Health Canada to Include Children Ages 6-11 Years

11/22/2021

Submission based on Phase 2/3 study of SPIKEVAX in children ages 6 to 11 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization with Health Canada for the evaluation of a 50 µg two-dose series…

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Ocugen Statement Regarding Publication of COVAXIN™ (BBV152) Phase 3 Study Results in The Lancet

11/19/2021

Excerpt from the Press Release: We are pleased that The Lancet, a trusted source of clinical, public health and global health knowledge, published Phase 3 data showing the COVID-19 vaccine candidate, COVAXIN™ (BBV152), has 93.4% efficacy against severe COVID-19 disease. COVAXIN™ (BBV152), a whole virion inactivated COVID-19 vaccine candidate, uses the same technology that is safely and effectively applied in the production of Bharat…

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Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

11/10/2021

COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines,…

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