Daily Archives: June 5, 2020

Novavax Awarded Department of Defense Contract for COVID-19 Vaccine

  • $60 million funding for manufacturing of NVX-CoV2373
  • 10 million doses to be delivered to DoD in 2020

GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

JPEO-CRBND-EB through funding provided by the Defense Health Program, has agreed to fund up to $60 million to support Novavax in its production of several components of the vaccine that will be manufactured in the U.S. The agreement includes a 2020 delivery of 10 million doses of NVX‑CoV2373 for DoD that could be used in Phase 2/3 clinical trials or under an Emergency Use Authorization (EUA) if approved by the U.S. FDA.

“We are genuinely honored at the opportunity to protect our military personnel and their families who have devoted themselves to the needs of U.S. citizens and others worldwide,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Importantly, this award will allow Novavax to significantly expand its U.S. production capacity of NVX-CoV2373, a critical step in our ability to provide vaccine support to the COVID-19 pandemic.”

As part of the contract, Novavax will work with a U.S.-based biologics contract development manufacturing organization (CDMO) to manufacture the antigen component of NVX-CoV2373 for at least 10 million doses of vaccine. Novavax will also collaborate with U.S.-based CDMOs to scale up production and manufacture of the Matrix-M adjuvant component of the vaccine.

About the JPEO-CBRND

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions. JPEO Enabling Biotechnologies (EB) is an organization established for the purpose of providing medical solutions, during a crisis, against future threats.

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. 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. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX‑CoV2373.

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

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 recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. 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.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Trahan
ir@novavax.com
240-268-2022

Westwicke
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Brandzone/KOGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659

102 regions readied for commencing safe productive activities

 

Jakarta Chief of the Task Force for COVID-19 Handling Doni Monardo confirmed that 102 districts and cities were readied to begin safe productive activities amid the novel coronavirus disease (COVID-19) pandemic.

“Based on the report we received, regional leaders in 102 districts and cities have responded positively to the policy,” Monardo noted in a statement here on Friday.

The task force chief revealed that the program will solely be conducted in regions on the COVID-19 green zone list where no COVID-19 cases were reported.

The local administrations will be authorized to conduct pre-conditioning and build communication with all stakeholders before commencing productive activities while staying safe from the COVID-19 pandemic.

“The rate of (COVID-19 transmission) in some regions has declined, although some other regions have yet to show significant improvement,” he noted.

Monardo suggested that prior to commencing public activities, the authorities should take into account some issues, including the timing, sectors that must be prioritized, strong coordination between central and local governments, monitoring, and evaluation.

As of Thursday, the number of confirmed COVID-19 cases had risen by 585 to reach a total of 28,818, with the number of recoveries climbing by 486 to 8,892.

South Kalimantan, Jakarta, East Java, South Sulawesi, and North Sumatra registered the highest increase.

A total of 19 provinces reported less than 10 new cases, while 11 provinces recorded no new cases.

President Jokowi had recently called on the public at large to remain productive and safe while concurrently adapting to coexistence with the COVID-19 pandemic.

The head of state highlighted the World Health Organization’s information that the coronavirus may never go away, though the transmission curve could have been flattened.

 

Source: ANTARA News

Jakarta emergency hospital treated 614 COVID-19 inpatients on June 5

Jakarta The Wisma Atlet Emergency Hospital, Kemayoran, Central Jakarta, treated 614 inpatients on Friday (June 5), a decline of 11 people, from 625 on the previous day, Marine Colonel Aris Mudian, the COVID-19 hospital’s spokesman, stated.

“The number of inpatients dropped by 11 people, from 625 people (on Thursday) to 614 people (on Friday). The 614 inpatients comprised 364 male patients and 250 female patients,” he noted in a written statement.

“The number of confirmed COVID-19 patients decreased by two, from 567 to 565 people. The number of patients under surveillance (PDP) went down by nine, from 58 people to 49 people. There were no patients under monitoring (ODP),” he remarked.

The Wisma Atlet Kemayoran Jakarta Emergency Hospital has not recorded inpatients categorized as ODP since June 1, 2020.

The emergency hospital registered 4,218 patients during the period from March 23 to June 5, 2020. Of that figure, 2,499 were discharged from hospital after recovering from COVID-19.

Meanwhile, the hospital has referred 127 patients to other COVID-19 referral hospitals in Jakarta. The hospital recorded that three patients had, so far, succumbed to the disease.

The Wismta Atlet emergency hospital was formerly an athlete village that was constructed to accommodate athletes participating in the 2018 Asian Games co-hosted by Jakarta and Palembang, South Sumatra Province.

The athlete village was converted into a temporary hospital for COVID-19 treatment and was officially inaugurated by President Joko Widodo on March 23, 2020.

Indonesia announced its first two confirmed COVID-19 cases on March 2, 2020.

 

Source: ANTARA News

Two siblings killed in landslide in Solok, West Sumatra

 

Arosuka, West Sumatra A landslide claimed two lives, inflicted injuries to two others, and buried one house in the Andaleh area, Sariak Ateh Village, Solok District, West Sumatra Province, on Friday morning at around 2 a.m. local time.

“The victims are Melsa Gustia Putri, 20, and Rafki Aulia Zikra, 14, the children of Tarmizi, 46, and Padri Yeni, 45, who owned the home hit by the landslide,” Armen, head of the Solok disaster mitigation office (BPBD), reported here on Friday.

Tarmizi and his wife, Padri Yeni, suffered injuries in the natural disaster, he revealed.

The four victims were asleep when the landslide struck.

 

Source: ANTARA News

Indonesia to register six traditional scripts with ICANN

 

Jakarta After registering the Hanacaraka Javanese script as an internet domain name, Indonesia will pursue the same for six other traditional scripts with the international domain management of Internet Corporation Assigned Names and Numbers (ICANN).

The Internet Domain Name Management in Indonesia, or PANDI, is currently making preparations for the registration of Sundanese, Balinese, Bengkulu’s Rejangnese, Bataknese, as well as Buginese and Makassarese scripts.

“This follow-up action to register all Indonesian traditional scripts as Internationalized Domain Name (IDN) is part of cultural preservation in the digital world,” Yudho Giri Sucahyo, the PANDI chair, noted in a statement received on Friday.

The administration process for these six scripts will likely be easier since they have been added to the Unicode standard, Sucahyo added.

PANDI claimed that several communities keen on preserving traditional scripts have shown support, with the Sundanese and Balinese communities currently ready for a collaboration. In the meantime, the organization awaits ICANN’s response to registration of the Javanese script.

 

Source: ANTARA News