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Novavax, Inc. today announced its financial results and operational highlights for the second quarter ended June 30, 2024. The Company confirmed it achieved total revenue of $415 million in the second quarter of 2024 and ended the period with $1.1 billion in Cash.
John C. Jacobs, President and Chief Executive Officer of Novavax, commented in a press release on August 8, 2024, "We intend to drive future value for the business through not only the Sanofi partnership but also through our late-stage combination and influenza assets."
"We plan to unveil a new and expanded clinical pipeline by the end of this year and leverage the pipeline and our proven technology to drive additional partnerships and deals and ultimately drive significant, long-term value for our shareholders."
Additionally, Novavax has taken steps to enable a successful operationalization of the collaboration and license agreement with Sanofi Pasteur Inc.
Effective January 1, 2025, Sanofi will assume primary commercial responsibility for Novavax's updated 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) in the U.S., Europe, and select major markets not currently subject to Novavax Advance Purchase Agreements or existing partnership agreements.
Furthermore, the Company expects to deliver its updated 2024-2025 formula protein-based COVID-19 vaccine to the market by the start of the season, and it has advanced retail pharmacy contract negotiations to enhance access for the 2024-2025 vaccination season.
The COVID-19 vaccine was created using Novavax's nanoparticle technology, Matrix-M™, an adjuvant that enhances immune responses and stimulates high levels of neutralizing antibodies.
In the U.S. market, Novavax submitted an Emergency Use Authorization (EAU) amendment to the U.S. Food and Drug Administration (FDA); doses will be ready to ship upon receipt of the EUA. The FDA accepted the Biologics License Application for Novavax's COVID-19 vaccine with a Prescription Drug User Fee Act date of April 2025.
However, the U.S. FDA has not approved the trade name Nuvaxovid™.
Bavarian Nordic A/S today announced that it had received a new order valued at USD 156.8 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to manufacture additional bulk product for JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®), the company’s smallpox/mpox vaccine.
The new BARDA contract will help replenish the inventory of bulk vaccines required for future manufacturing and supply of freeze-dried vaccines.
The bulk product, representing $139.7 million of the contract value, will be manufactured and invoiced in 2024 and will partly replenish the inventory used to manufacture vaccines in response to the global mpox outbreak that began in May 2022.
Replenishment of the bulk inventory is necessary to fulfill the company’s existing contract to supply a next-generation, freeze-dried version of the vaccine for U.S. smallpox preparedness.
Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine.
The vaccine was approved by the U.S. FDA in 2019 under the trade name JYNNEOS®, which is indicated for preventing both smallpox and mpox infection.
In real-world studies, JYNNEOS effectiveness against mpox disease adjusted vaccine effectiveness estimates ranged from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two doses.
Before FDA approval, Bavarian Nordic had supplied nearly 30 million doses of the liquid-frozen version to the U.S., with the vast majority being delivered for emergency use - and now expired.
“Our smallpox/mpox vaccine represents a key component in the U.S. biological preparedness, as demonstrated during the 2022 mpox outbreak," said Paul Chaplin, President & CEO of Bavarian Nordic, in a press release on August 8, 2024.
"JYNNEOS was also the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear agents through public-private partnerships."
"We applaud the U.S. government’s steadfast commitment to maintaining a robust preparedness and are proud to continue providing vaccines to protect its citizens against current and future public health threats,” added Chaplin.
The new BARDA contract also includes approximately $17 million for additional services in 2025-2027, including storage of vaccine doses in the U.S.
BARDA has supported the development of a freeze-dried version of the vaccine with a longer shelf life to replace the stockpile and awarded the company a ten-year contract for the supply of freeze-dried vaccines in 2017.
On March 14, 2024, the U.S. CDC's Agam Rao, MD CAPT, U.S. Public Health Service, stated, 'JYNNEOS vaccination is expected to be effective regardless of mpox clade.'
As of August 2024, the JYNNEOS vaccine is commercially available in the United States. Healthcare providers in the U.S. administer JYNNEOS for no charge, regardless of any administration fee. The CDC does not endorse booster doses (3rd).
According to Avian Flu Diary's report on August 6, 2024, Finland is offering bird flu vaccination to qualifying adults over 18 who, due to work or other circumstances, have an increased risk of contracting it.
Finland has received 20,000 doses of the H5N8 bird flu vaccine, enough to vaccinate 10,000 people with two doses.
The batch of vaccines received in Finland expires at the end of September 2024, so those at risk of infection should take the first vaccine dose in August.
So far, there are no human bird flu infections in Finland. Taking the bird flu vaccine is voluntary in Finland.
On July 15, 2024, a U.S. government spokesperson confirmed in an emailed statement, 'Avian influenza vaccination has not been recommended for any segment of the population, and the U.S. government continues to monitor the situation.'
As of August 7, 2024, the U.S. vaccine stockpile has access to various avian influenza vaccines, such as Audenz.
Vaxcyte, Inc. today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
“We continue to make significant strides toward building the potentially best-in-class pneumococcal conjugate vaccine (PCV) franchise and expect to announce the VAX-31 adult Phase 1/2 study topline safety, tolerability and immunogenicity data in September,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release on August 6, 2024.
“Our clinical program assessing VAX-31, the broadest-spectrum PCV in the clinic today, will provide significant insights into the full potential of this vaccine candidate across the adult population."
"Following the VAX-31 adult data readout, we plan to advance either VAX-24 or VAX-31 into Phase 3 clinical development in adults.”
Mr. Pickering continued, “Additionally, we look forward to delivering the topline data from the primary immunization series of the VAX-24 infant Phase 2 study by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025."
"We believe VAX-24 has a potential best-in-class profile for this vital population and is designed to cover more serotypes than any infant pneumococcal vaccine on-market today.”
The Company also confirmed cash, cash equivalents, and investments were $1,851.9 million as of June 30, 2024, compared to $1,242.9 million as of December 31, 2023.
Nipah virus infection is an emerging serious zoonotic disease without a preventive vaccine. This virus is transmitted to humans through infected animals (fruit bats) or food contaminated with excretion and secretions from bats.
Vaccine research is essential since the case fatality rate is estimated at 40% to 75%.
Phylex Biosciences announced today its new mRNA nanoparticle vaccine against the Nipah virus achieved positive results in an immunogenicity study conducted in collaboration with scientists from the U.S. Centers for Disease Control and Prevention (CDC).
The vaccine elicited a robust neutralizing antibody response, with neutralizing titers markedly higher than with several other Nipah vaccine designs and efficient neutralizing even with a single dose. In virus neutralization assays, neutralization titers of Phylex vaccine-elicited sera against Nipah virus were 3-fold the average titers of 14 individuals in Bangladesh who survived a Nipah virus infection.
The Phylex mRNA vaccine encodes for a nanoparticle displaying 60 copies of the antigen-based upon the head domain of the G protein of the Nipah virus.
On August 5, 2024, the company published a preprint of a research article on the immunogenicity of its Nipah mRNA nanoparticle vaccine.
"We are grateful to our co-authors at the CDC for their contribution in assessing our vaccine against this difficult pathogen," said Pascal Brandys, co-founder and CEO of Phylex Biosciences, in a press release.
"The results confirm the strong advantage of our mRNA vaccine encoding for a highly immunogenic nanoparticle, as compared with a variety of other technologies."
"Our vaccine combines the advantages of mRNA for speed of manufacturing and development and a nanoparticle for efficacy after one dose," Brandys continued. "We will aggressively pursue the clinical development of our vaccine candidate to initiate clinical trials with exposed individuals on a compassionate basis and save lives as soon as possible."
The Nipah virus is a pathogen that causes encephalitis and acute respiratory distress in humans. Recent outbreaks have occurred in Bangladesh, India, Malaysia, the Philippines, and Singapore, and the fatality rate is over 50%.
The virus's natural hosts are large fruit bats, which are present across South Asia, including India and Bangladesh.
To assist countries, a Technical Brief was developed In February 2024 as an interim document to guide countries in the readiness planning for a Nipah virus event, especially in countries that have not reported a Nipah virus event.
The CDC has not approved a vaccine or therapeutics against the Nipah virus.
The news agency PTI today reported at least 66 cases of Zika virus infection have been reported in Pune, India, over the last two months. The mosquito-transmitted Zika virus has been reported in India's 16 different states/union territories since 2016.
On August 6, 2024, a senior health official told PTI those infected in Pune, a city of about 7 million, also included 26 pregnant women.
According to the World Health Organization (WHO), there is scientific consensus that Zika infections can cause microcephaly, Guillain-Barré syndrome, and other central nervous system malformations. Additionally, the WHO advises pregnant women to avoid visiting Zika outbreak areas.
As of August 2024, the Region of the Americas has reported over 24,684 ZIka cases in countries such as Brazil, Bolivia, Costa Rica, and Puerto Rico in 2024.
While several Zika vaccine candidates are conducting human clinical trials, no vaccine has been approved.
The African country of Mozambique today reached an important milestone in malaria prevention by introducing the R21/Matrix-M™ vaccine. This innovative vaccine brings the number of African countries offering malaria vaccines to eleven.
This vaccination program is essential since malaria is endemic in Mozambique, with a prevalence of 32% in children.
Through Gavi, the Vaccine Alliance, and co-financing from the Government of Mozambique, the country will vaccinate around 300,000 children through the country’s Expanded Programme on Immunization.
“The malaria vaccine, which is being rolled out initially in Zambezia today, is one of the latest approaches in the fight against the disease,” said Hon Dr Armindo Tiago, Minister of Health, in a press release on August 5, 2024.
“The choice of Zambezia as the launch site is due to the province's high burden of the disease. The vaccine will be administered in four doses to reduce the severe malaria illness and death.”
The World Health Organization (WHO) recommended that the malaria vaccine be administered in a 4-dose schedule, with the first dose covering children aged 6 to 11 months. A more extensive malaria vaccine rollout is expanding access to prevent additional disease.
Previously, the R21/Matrix-M™ malaria vaccine was launched in Côte d'Ivoire.
John Jacobs, Novavax Inc.'s President and CEO, said in a press release on July 15, 2024, ".... marks a breakthrough in the fight to protect vulnerable children against a leading cause of death across the region while reinforcing our mission to create innovative vaccines that improve public health."
As of August 6, 2024, malaria vaccines are not offered in the United States. However, the majority of travel-related malaria cases diagnosed in the U.S. originate from African travelers.
