Novavax Plans U.S. Covid Vaccine Phase III Trial in a Few Weeks

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Source: Investor’s Business Daily

Novavax (NVAX) said Monday it’s planning to begin the U.S.-based study of its coronavirus vaccine “in the coming weeks.” NVAX stock popped on the news.

Previously, Novavax said it expected to begin Phase 3 testing in the U.S. in November. Now, the biotech company says studies in the U.S. and Mexico will begin “in the coming weeks.” NVAX stock initially fell on the news. Novavax is currently working to iron out manufacturing for its vaccine in North Carolina.

It was the second big hang-up for the biotech company’s vaccine to combat Covid-19. The Phase 3 test in the U.S. and Mexico was originally expected to begin in mid-October. Then, the company pushed the start date out to the end of November.

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Categories: Vaccine

4 replies

  1. Shares of Novavax (NASDAQ: NVAX) were 6.3% higher as of 10:56 a.m. EST on Monday after rising as much as 9.7% earlier in the day. Novavax stated that its late-stage study in the U.K. and its phase 2b study in South Africa of coronavirus vaccine candidate NVX-CoV2373 had completed enrollment. The company also said that its U.S./Mexico late-stage study is “expected to begin in the coming weeks.”

    https://www.investors.com/news/technology/nvax-stock-biotech-company-plans-coronavirus-vaccine-test/?src=A00220

  2. GAITHERSBURG, Md., Nov. 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. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

    “Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

    Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. The primary efficacy endpoints for these trials have been harmonized and reviewed by global regulatory agencies in order to facilitate regulatory approval and ensure that the results are generalizable across global populations. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

    United Kingdom (U.K.) 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. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

    Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries. More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

    South Africa Phase 2b trial update

    The Phase 2b trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.

    This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults. As in the U.K., availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

    U.S./Mexico pivotal Phase 3 trial update

    Novavax expects its pivotal Phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. More than 100 trial sites have been selected with some alternate sites in place, should they be needed.

    Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

    Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

    Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up.

    About NVX-CoV2373
    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and more than $1.6 billion from the U.S. Government’s Operation Warp Speed program.

    https://www.globenewswire.com/news-release/2020/11/30/2136318/0/en/Novavax-Announces-COVID-19-Vaccine-Clinical-Development-Progress.html

  3. The NIHR-supported Novavax Phase 3 COVID-19 vaccine trial has achieved its recruitment target just two months after opening in the UK – with 15,203 volunteers from across the country recruited in record time.

    The Novavax study is now the largest double blind, placebo-controlled COVID-19 vaccine trial to be undertaken in the UK so far.

    The pivotal phase 3 trial to determine efficacy and safety of the Novavax vaccine candidate opened in the UK on 23 September and is now closed to further recruitment having fully enrolled, ahead of schedule. The final study participant enrolled on Saturday 28 November.

    The UK Vaccines Taskforce and National Institute for Health Research (NIHR) have played vital roles in the rapid recruitment and enrollment of volunteers.

    A significant proportion of participants taking part in the study were recruited through the new NHS COVID-19 Vaccine Research Registry – an online registry of people who have signed-up to be contacted about taking part in COVID-19 vaccine studies. While the NIHR’s new National Patient Recruitment Centres also played a key role in recruiting and dosing study participants at three regionally based NHS sites across England.

    The UK was the first country in the world to undertake and deliver a phase 3 trial for the Novavax vaccine. A phase 2b trial is currently underway in South Africa – with 4,422 volunteers taking part. While Novavax expects its pivotal phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. In total, nearly 20,000 participants around the world have already been dosed.

    The Novavax trial is investigating the safety, efficacy and immunogenicity of NVX-CoV2373 – a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

    The UK phase 3 trial is a randomised, placebo-controlled, observer-blinded trial during which 50% of volunteers will be given two intramuscular injections of the vaccine candidate, 21 days apart, while the remaining will receive placebo.

    More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying medical conditions generally representative of the population.

    Interim data from this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries.

    The UK government has already secured 60 million doses of the Novavax NVX-CoV2373 vaccine, provided it meets standards on safety, effectiveness and quality following publication of results.

    Professor Paul Heath, Chief Investigator of the Novavax Phase 3 vaccine trial in the UK said:

    “The speed at which this important trial was conducted was a huge challenge but the NIHR sites stepped up and delivered this in an efficient and professional manner. We believe this is the largest randomised, double blind, placebo-controlled vaccine trial yet done in the UK and as a team we now look forward to bringing this trial to a successful conclusion.”

    Gregory M. Glenn, MD, President of R&D, Novavax said:

    “Completion of enrollment in this Phase 3 clinical trial is a significant achievement and important step in our ability to demonstrate how well NVX-CoV2373 works to prevent COVID-19.

    “We are grateful to the professional and dedicated staff across the many NHS sites for their work to advance this trial, as well as the thousands of volunteers who stepped forward to participate in this critical research.”

    https://www.nihr.ac.uk/news/novavax-phase-3-covid-19-vaccine-trial-completes-enrollment-in-two-months/26321

  4. For J.P. Morgan analyst Eric Joseph, the answer is the latter.

    “We continue to view NVX-CoV2373 as having a well-differentiated positioning in the overall COVID-19 vaccine space, both clinically and logistically, and believe current levels under-reflect its long-term commercial potential,” Joseph said.

    Joseph rates NVAX an Overweight (i.e. Buy) along with a $215 price target. The implication for investors? Upside of ~87%.

    https://finance.yahoo.com/news/coronavirus-stock-over-80-upside-005521838.html

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