Phase III Trial of Novavax Vaccine Starts in UK

Covid-19 Vaccine From Novavax Begins Phase 3 Trial in U.K.

Surge in British cases offers opportunity to determine if shots works safely ahead of planned U.S. Phase 3

Source: WSJ

By Peter Loftus

Novavax Inc. NVAX 8.08% said Thursday it has started a final-stage, 10,000-person study of its experimental Covid-19 vaccine in the U.K., where a recent surge in cases could hasten an answer about whether the inoculation safely protects people from the new coronavirus.

The Gaithersburg, Md., company said the pivotal Phase 3 trial in the U.K. would track whether adults receiving its two-dose vaccine experience a lower rate of symptomatic Covid-19 compared with study subjects who get a placebo.

Novavax still plans to test its vaccine in a Phase 3 trial in the U.S. with up to 30,000 subjects, which could start in October, said Gregory Glenn, Novavax’s president of research and development.

“The U.K. trial is a different shot on goal,” Dr. Glenn said in an interview. “They look like they are going to have a big surge in disease.”

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The best of the Muslim Times’ collection for war against Covid 19:

In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.

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Coronavirus Vaccine Tracker – The New York Times

Categories: The Muslim Times, Vaccine

3 replies

  1. President Donald Trump has fanned new concerns over the politicization of coronavirus vaccine approvals, suggesting he could block stricter guidance from the U.S. Food and Drug Administration (FDA) in order to expedite a treatment to the general public.

    As the U.S. faces a second wave of COVID-19 cases ahead of the flu season, two leading vaccine candidates are making their way through late-stage clinical trials. The need for a successful cure is high, as the world’s largest economy struggles to control nearly 7 million diagnoses and over 200,000 deaths. Globally, almost 32 million have been infected and more than 677,000 have died.

    At a Senate hearing on Wednesday, FDA Commissioner Stephen Hahn repeated assurances that the agency would stick to usual standards of review of data and information in order to grant a limited emergency use authorization.

    • We should always keep in mind that the reported cases of the covid-19 are ‘reported tested cases’. Few speak of any estimates of the ‘hidden figure’ of ‘untested cases’. In villages in the ‘third world’, where clinics are few and far between, tests are hard to come by…

  2. About NVX-CoV2373
    NVX-CoV2373 is a 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 and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies, which 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 $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About ResVax
    ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

    About NanoFlu™
    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based MatrixM adjuvant.

    About Novavax
    Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

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