World Health Organization Updates Emergency Use Listing for Novavax Nuvaxovid COVID-19 Vaccine as a Primary Series in Adolescents and as a Booster in Adults

GAITHERSBURG, Md., Nov. 29, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series of two doses in adolescents aged 12 through 17 and as a booster in adults aged 18 and older.

“Today’s updated Emergency Use Listing from the WHO allows us to offer our protein-based vaccine as a primary series to adolescents and as a booster for adults around the world,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “WHO member countries now have a vaccine option for these indications developed using an innovative approach to traditional technology that can also be stored in standard refrigeration, making it easy to transport.”

Novavax LogoPrimary Series in Adolescents
The updated EUL for Nuvaxovid as a primary series in adolescents aged 12 through 17 was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,232 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.

Booster in Adults
The updated EUL for Nuvaxovid as a booster in adults aged 18 and older is supported by data from Novavax’ Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the United Kingdom (U.K.)-sponsored COV-BOOST trial. As part of the Novavax Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a meaningful antibody response when used as a heterologous third booster dose.

In the Novavax-sponsored trials, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, often seen with increased immunogenicity. Medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

In the 12 through 17-year-old population, Novavax’ vaccine has been authorized in more than 10 markets including the U.S., the European Union (EU), and the U.K. The vaccine has also been authorized as a booster in the U.S.EUJapanAustraliaNew Zealand, and Switzerland, and a number of other countries have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose. Novavax’ vaccine is actively under review in other markets for both indications and has ongoing trials to further explore its efficacy and safety as a booster.

The WHO previously granted EUL for Nuvaxovid in adults aged 18 and older in December 2021.

Trade Name in the U.S.
The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA).

Important Safety Information: WHO

  • Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
  • Events of anaphylaxis have been reported with administration of Nuvaxovid. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
  • Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
  • Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
  • Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
  • The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
  • Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
  • The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
  • Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
  • The most frequent adverse reactions in clinical trials in individuals 12 years of age and older were headache, nausea or vomiting myalgia, arthralgia, injection site tenderness, injection site pain, fatigue, and malaise.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

About Nuvaxovid™ (NVX-CoV2373)
Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.

About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials
The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations in the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the U.S., compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S. Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.

About Matrix-M™ Adjuvant
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 biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S. FDA, the European Commission, and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza Combination (CIC) vaccine candidate in a Phase 1/2 clinical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, NVX-CoV2515 and a bivalent Omicron-based / original strain based vaccine, the CIC investigational vaccine candidate, a quadrivalent influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety, intended utilization, and expected administration of NVX-CoV2373, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, 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
Erika Schultz | 240-268-2022
ir@novavax.com

Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com

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WHO recommends new name ‘MPOX’ for monkeypox disease

GENEVA— Following a series of consultations with global experts, WHO will begin using a new preferred term “mpox” as a synonym for monkeypox. Both names will be used simultaneously for one year while “monkeypox” is phased out.

 

When the outbreak of monkeypox expanded earlier this year, racist and stigmatizing language online, in other settings and in some communities was observed and reported to WHO. In several meetings, public and private, a number of individuals and countries raised concerns and asked WHO to propose a way forward to change the name.

 

Assigning names to new and, very exceptionally, to existing diseases is the responsibility of WHO under the International Classification of Diseases (ICD) and the WHO Family of International Health Related Classifications through a consultative process which includes WHO Member States.

 

WHO, in accordance with the ICD update process, held consultations to gather views from a range of experts, as well as countries and the general public, who were invited to submit suggestions for new names. Based on these consultations, and further discussions with WHO’s Director-General Dr Tedros Adhanom Ghebreyesus, WHO recommends the following:

 

Adoption of the new synonym mpox in English for the disease.

Mpox will become a preferred term, replacing monkeypox, after a transition period of one year.

This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak. It also gives time to complete the ICD update process and to update WHO publications.

The synonym mpox will be included in the ICD-10 online in the coming days. It will be a part of the official 2023 release of ICD-11, which is the current global standard for health data, clinical documentation and statistical aggregation.

The term “monkeypox” will remain a searchable term in ICD, to match historic information.

Considerations for the recommendations included rationale, scientific appropriateness, extent of current usage, pronounceability, usability in different languages, absence of geographical or zoological references, and the ease of retrieval of historical scientific information.

 

Usually, the ICD updating process can take up to several years. In this case, the process was accelerated, though following the standard steps.

 

Various advisory bodies were heard during the consultation process, including experts from the medical and scientific and classification and statistics advisory committees which constituted of representatives from government authorities of 45 different countries.

 

The issue of the use of the new name in different languages was extensively discussed.  The preferred term mpox can be used in other languages. If additional naming issues arise, these will be addressed via the same mechanism. Translations are usually discussed in formal collaboration with relevant government authorities and the related scientific societies.

 

WHO will adopt the term mpox in its communications, and encourages others to follow these recommendations, to minimize any ongoing negative impact of the current name and from adoption of the new name.

 

Source: NAM NEWS NETWORK

Russia Donates 260,000 Tons of Fertilizer to Africa

Russia has donated 260,000 metric tons of fertilizer it produced that was sitting in European ports and warehouses for use by farmers in Africa, the United Nations said Tuesday.

“This will serve to alleviate humanitarian needs and prevent catastrophic crop loss in Africa, where it is currently planting season,” U.N. spokesman Stephane Dujarric told reporters, welcoming the announcement.

He said a ship chartered by the World Food Program left the Netherlands on Tuesday carrying 20,000 tons of the fertilizer destined for the southeastern African nation of Malawi. Dujarric said it would take about a month to reach Beira, in Mozambique, and then would be transported overland to Malawi, which is a landlocked country.

“It will be the first of a series of shipments of fertilizer destined for a number of other countries on the African continent in the coming months,” Dujarric added.

Fertilizer crunch

Since Russia’s invasion of Ukraine on February 24, world fertilizer prices, which were already inflated due to the COVID-19 pandemic, surged further, in part due to quotas Moscow imposed on its fertilizer exports, saying it wanted enough for its own farmers.

The U.N. said fertilizer prices have risen a staggering 250% since before the pandemic in 2019.

Russia is a top global fertilizer exporter. The disruptions, shortages and price increases that its quotas have contributed to have made fertilizer unaffordable for some smaller farmers. This could dramatically decrease their harvests, which could potentially lead to food shortages next year.

The World Food Program’s chief economist told VOA that developed and developing countries are dependent on fertilizer for half of their food production.

“Right now, with all that is happening, we are looking at essentially a shortfall of about 66 million tons of staple foods because of shortage of or unaffordability of fertilizer,” Arif Husain said. “I am talking about crops like wheat, corn, rice. Now, that 66 million tons of food, that is enough to feed 3.6 billion people for one month.”

Russia has complained that Western sanctions are to blame for its decrease in fertilizer exports. But Western nations repeatedly stress that they do not sanction food or fertilizer products from Russia.

But some shippers, banks, insurers and other companies involved in the transport or purchase of Russian grain and fertilizer have been reluctant to do business with Moscow, fearing they could run afoul of the sanctions.

Diplomacy continues

A package deal signed in Istanbul on July 22 has made it possible for more than 12 million metric tons of Ukrainian grain to get to market from three of its Black Sea ports, while working to build confidence with the private sector in order to return to pre-invasion export levels of Russian fertilizers and grain.

“The U.N. is continuing intense diplomatic efforts with all parties to ensure the unimpeded exports of critical food and fertilizers from both the Russian Federation and Ukraine, that are exempt from sanction regimes, to the world markets,” Dujarric told reporters.

The deal, known as the Black Sea Grain Initiative, was renewed on November 17 for an additional four months.

 

 

 

Source: Voice of America

EYES ON IRAN ART ACTIVATION FACES THE U.N. IN NEW YORK

AN EVENT MARKED THE OPENING FEATURING HILLARY RODHAM CLINTON, GISSOU NIA,SHEIDA SOLEIMANI, SHIRIN NESHAT with SPECIAL PERFORMANCE BY JON BATISTE

NEW YORK, Nov. 28, 2022 (GLOBE NEWSWIRE) — Iranian artists Sheida Soleimani, Aphrodite Désirée Navab, Z, Icy and Sot, Shirin Neshat, Mahvash Mostala, Sepideh Mehraban, and Shirin Towfiq, alongside artists Hank Willis Thomas and JR, activate New York’s FDR Four Freedoms State Park with a provocative multi-day and multi-media art installation facing the United Nations entitled Eyes on Iran, November 28, 2022 – January 1, 2023.

Timed for the U.N. initiative, 16 Days of Activism Against Gender-Based Violence, the installations are focused on the power of collective sight, with eyes facing the U.N., signifying the world’s eyes on Iran. ‘Eyes in the Sky’ flying billboards featuring artworks by Thomas and Mostala will fly on December 3 in New York City and on November 28 and 30 in Miami. An interactive installation by artist JR will take place on December 4. Eyes on Iran aims to amplify the mission of Woman, Life, Freedom, a campaign demanding that the Islamic Republic of Iran is removed from the Commission on the Status of Women.

The New York installation was unveiled at an event featuring former U.S. Secretary of State Hillary Rodham Clinton, Human Rights Lawyer and Director of the Strategic Litigation Project at the Atlantic Council Gissou Nia, artists Sheida Soleimani and Shirin Neshat, actor and singer Sepideh Moafi and more at FDR Four Freedoms State Park with a performance by Grammy award-winner Jon Batiste. 

“We are calling on the world to take more action, starting at the United Nations. We must remove Iran from the U.N.’s Commission on the Status of Women. The fact that Iran is a member is a bitter irony,”  said Clinton. “What we are seeing is a revolution led by young women who are just not willing to live with the loss of freedom being imposed upon them.”

November 28 is significant because it is the anniversary of the 1943 Tehran Conference where Allied leaders, Franklin D. Roosevelt, Winston Churchill and Joseph Stalin met in Tehran to coordinate the Allied military strategy and also stated a shared desire for the maintenance of the independence, sovereignty, and territorial integrity of Iran. Today, Woman, Life, Freedom shares the call for human rights for the people of Iran.

“The world’s eyes have been focused on the courage of Iranian citizens in their quest for freedom, in the face of increasingly grave danger,” said human rights activist Nazanin Afshin-Jam Mackay. “The Islamic Republic has censored them and attempted to blind the world to the potential of this movement. ‘Eyes on Iran’ is our response to their call for a free Iran.”

“When we say that we must keep our ‘Eyes on Iran,’ we mean that what is happening deserves not only our attention but our vision. In solidarity with the courageous Iranians who are risking their lives to express their human rights, many artists throughout the diaspora and beyond are bringing our vision to bear to ensure international audiences and institutions remain aware of what is happening in Iran, in their eyes and in their hearts, and feel moved to respond,” says artist Shirin Neshat.

An interactive installation by artist JR will take place on December 4 at FDR Four Freedoms State Park. Eyes on Iran aims to amplify the mission of Woman, Life, Freedom, a campaign demanding that the Islamic Republic of Iran is removed from the Commission on the Status of Women. Additional artists featured online including Emily Elise, Mahdis Nikou, Priscillia Kounkou Hoveydam, Ernesto Yerena, Hourdad, Golnar Adili, and Anonymous Artists.

In October, the campaign published a two-page ad in The New York Times with a petition signed by women leaders from more than 14 countries, including Clinton, demanding the U.N. Member States remove the Islamic Republic of Iran from the Commission on the Status of Women. Within days, Prime Minister Jacinda Ardern of New Zealand, Canadian Deputy Prime Minister Chrystia Freeland, and Foreign Affairs Minister Melanie Joly, along with nearly 100,000 others, signed the petition.

The Woman, Life, Freedom campaign is a partnership between artist collective For Freedoms, a coalition of Iranian women leaders and Vital Voices Global Partnership, a non-profit elevating women leaders.

Key Links:

Press Images

Woman Life Freedom Website 

Press Release: Open Letter Calling for the Immediate Expulsion of the Islamic Republic of Iran from the UN Commission on the Status of Women

About Our Partners:

For Freedoms is an artist collective that centers art and creativity as a catalyst for transformative connection and collective liberation.  By wielding the power of art, we aim to deepen and expand our capacity to interrogate what is and imagine what could be.  Together, we seek infinite expansion.
www.forfreedoms.com

Vital Voices Global Partnership celebrates 25 years of directly investing in more than 20,000 women leaders across 184 countries since 1997. Driven by the universal truth that women are the key to progress in their communities and nations cannot move forward without women in leadership positions, Vital Voices has provided early support for leaders who went on to become Nobel Peace Prize Laureates, U.S. Youth Poet Laureates, prime ministers, award-winning innovators, pioneering human rights defenders, and breakthrough social entrepreneurs.
www.vitalvoices.org

Four Freedoms Park Conservancy (FFPC), founded in 2011, operates under a Friends Agreement with New York State Parks to produce and curate public programs at Franklin D. Roosevelt Four Freedoms State Park. The park, designed by American modernist architect Louis Kahn, is among the greatest architectural masterpieces in New York City. By leveraging this spectacular architecture and the unique location of the park, the Conservancy produces events, installations,public art, and partners with local organizations that, together, serve a singular purpose: igniting the conversation around the Four Freedoms and the legacy of President Franklin D. Roosevelt.
www.fdrfourfreedomspark.org

The New York State Office of Parks, Recreation and Historic Preservation oversees more than 250 parks, historic sites, recreational trails, golf courses, boat launches and more, which are visited by more than 78 million people annually. For more information on any of these recreation areas, visit www.parks.ny.gov, download the free NY State Parks Explorer mobile app or call 518.474.0456. Also, connect on Facebook, Instagram and Twitter.

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