Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine

GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M™ to enhance the immune response.

Novavax is currently conducting late-stage clinical studies to demonstrate the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This includes two large pivotal Phase 3 clinical trials in the United States/Mexico (the PREVENT-19 trial) and in the United Kingdom, as well as a Phase 2b trial in South Africa.

“The continued increase in significant COVID-19 transmission in virtually all parts of the world underscores the need for multiple safe, efficacious vaccines in enormous quantities to stop the pandemic,” said Stanley C. Erck, Novavax President and Chief Executive Officer. “We appreciate the confidence of the Australian government and the opportunity to play a role in ensuring that its citizens will have access to a protein-based vaccine that can be distributed using existing distribution channels, should it receive regulatory approval.”

Novavax will work with Australia’s regulatory agency, the Therapeutics Goods Administration (TGA), to obtain product approvals upon demonstrating efficacy in clinical studies. The company aims to deliver initial doses by mid-2021. As part of the agreement, Australia will have the option to purchase up to an additional 10 million doses.

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  1. China ramped up its vaccination rollout and warned about a possible winter spike in infections as people travel and gather for holidays. In Japan, a state of emergency may expand to the nation’s second-biggest metropolitan region.

    U.S. daily fatalities surpassed 4,000 for the first time and President-elect Joe Biden said he’ll distribute more of the available vaccine doses. New York state will begin to expand eligibility for the shots and Utah’s new governor signed an order to speed distribution. Los Angeles County and Maine broke records for deaths.

    London’s mayor declared an emergency as the U.K. reported record fatalities. Germany also reported the most daily deaths since the start of the pandemic.

  2. The U.K. cleared Moderna Inc.’s Covid-19 vaccine, adding a third shot for emergency use against the pandemic as infections surge.

    Britain’s medicines regulator said Friday that it has authorized the U.S. company’s vaccine, confirming an earlier report by Bloomberg. As the country ramps up immunizations against the fast-spreading coronavirus, the Covid death toll now stands at more than 78,000 across Britain.

    More Than 17.5 Million Shots Given: Covid-19 Vaccine Tracker

    The U.K. also ordered an additional 10 million Moderna doses, bringing the total to 17 million, with delivery beginning in the spring. The regulator approved the shot on a two-dose regimen, given four weeks apart, after authorizing a longer gap for other vaccines.

  3. Maryland-based biotechnology company Novavax specializes in “protein subunit” vaccines. They use virus-like nanoparticles as a base and cover them with genetically engineered pieces of the coronavirus spike protein.
    This is also a tried and true vaccine approach. A hepatitis B vaccine given to newborns is a protein subunit vaccine, as is the human papillomavirus or HPV vaccine and FluBlok, Sanofi’s influenza vaccine.
    Novavax uses an insect virus called a baculovirus to get the coronavirus spike protein into moth cells, which then produce the protein. This is harvested and mixed with an adjuvant — an immune booster –based on saponin, found in soap bark trees.

  4. Novavax’s South Africa-based Phase IIb trial investigating its COVID-19 vaccine NVX-CoV2373 has results likely to be revealed within the next fortnight, a source familiar with the trial said. The company completed its data entry in the past several days, he added.

    NVX-CoV2373 belongs to the second wave of COVID-19 vaccines which are yet to garner any regulatory authorisation. Other second wave vaccines include those by Johnson & Johnson and CureVac. Although a Novavax spokesperson said detailed progress of the Phase IIb trial is not publicly available, the trial is on schedule. According to a presentation from the JP Morgan Annual Healthcare Conference this month, preliminary data are expected early 1Q21.

    But multiple 2020 company media releases state timelines depend on local illness rates. In the Phase IIb, 23–50 infection events would trigger efficacy analysis. The 4,422-participant trial started recruiting volunteers in August and completed its enrolment in November, according to a 30 November media release. The study includes 245 medically stable, human immunodeficiency virus (HIV)-positive volunteers. The Phase IIb trial is valuable as it is specific for South Africa, and it would shed light on the vaccine’s efficacy in HIV-positive patients, the source explained. Immunogenicity and safety are the primary endpoints in HIV-positive participants.

    NVX-CoV2373 is a two-dose protein subunit vaccine with the second shot administered after 21 days. The Phase IIb is an event-driven trial, with primary endpoints in HIV-negative patients looking into safety and number of symptomatic mild, moderate or severe COVID-19 infections seven days after the second dose, states. In the HIV-positive cohort, these event-driven measures are secondary endpoints.

    South Africa’s existing regulatory, consent and ethics frameworks around HIV vaccine trial investigations helped with regards to quick initiation and straightforward progress of COVID-19 vaccine trials in the country, the source said. Clinical trial site staff are proactive in ensuring volunteers understand the study process, like the importance of the second shot, he added. Volunteers who might have to travel long distances are reimbursed, he noted.

    NVX-CoV2373 is in two Phase III trials. The UK-based Phase III trial was announced as having completed its 15,000-participant enrolment target in the aforementioned 30 November media release. This trial, which will serve as the basis for licensure in the UK, European Union, and other countries, has interim data expected early 2021.

  5. Long Island physician Benjamin Luft began receiving urgent calls from his elderly clinical trial subjects almost as soon as New York followed numerous other states last week and announced it would begin vaccinating anyone 65 or older with one of two authorized coronavirus vaccines, those made by Pfizer and Moderna.

    The subjects wanted to get out of the clinical trial Luft is helping oversee of an experimental vaccine made by another company, Novavax.

    They wanted to be “unblinded” and find out if they had received a placebo in the Novavax study, and, if so, try to get the Pfizer and Moderna vaccines, which have already been proved to be about 95 percent effective at preventing coronavirus infections.

    “The number who have been calling me has been significant, and the numbers are increasing,” Luft, an infectious-disease expert at Stony Brook University Hospital, said in an interview. Fresh recruits also have begun to dry up, he said: “As we are doing our recruitment, all of a sudden the people over 65 became less interested.”

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