Cancer Vaccine Breaking News

The World Health Organization (WHO) today announced that although encouraged by the reported progress, the Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  

As of August 25, 2023, only two genetic clusters of WPV1 were identified, compared to three in 2022 and five in 2021.

However, there have been multiple chains of transmission within these two genetic clusters, detected primarily in the endemic zones of Eastern Afghanistan and South KP of Pakistan, including an extreme orphan virus, indicating some gaps in surveillance.

And there is a large pool of unvaccinated "zero dose" children in Afghanistan, which could reintroduce wild-type poliovirus into the southern region.

The also noted suboptimal immunization coverage during campaigns in southeastern Africa, Malawi, Mozambique, Zambia, and Zimbabwe. The nOPV2 vaccine has been deployed over 700 million times in Africa.

Based on the current situation and the reports provided by affected countries, the WHO Director-General accepted the Committee's assessment. It determined that the poliovirus situation continues to constitute a PHEIC.

While poliovirus has been detected in southern New York in 2022 and 2023, no outbreak has been confirmed.

Various polio vaccines are approved and available in August 2023 in the U.S. and globally.

The Republic of Finland recently reported another H5N1 avian influenza outbreak at a fur farm involving blue foxes. This outbreak, reported by EuroNews on August 24, 2023, increases the number of 'bird flu' outbreaks at such farms to 23.

In June 2023, several outbreaks of H5N1 were identified among larids in Finland. The first cases in fur farms were detected in July.

Given these findings, the Finnish authorities decided to cull 120,000 foxes and mink on farms affected by the epidemic.

Finland is Europe's leading producer of fox fur, with around 400 fur farms. For example, FashionFinFur is owned by a fur-farming family in Vörå, Finland, that has been In the business since the 1980s.

In the northern hemisphere, bird flu outbreaks among birds, mammals, and people continue in 2023.

As of August 2023, access to bird flu vaccines is controlled by government agencies.

The U.S. Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report (MMWR) on August 25, 2023, with updated recommendations of the Advisory Committee on Immunization Practices (ACIP) for the 2023–24 Influenza Season.

The primary updates to this new MMWR include the following two topics: 1) the composition of 2023–24 U.S. seasonal influenza vaccines and 2) updated recommendations regarding influenza vaccination of persons with egg allergy.

First, the composition of 2023–24 U.S. influenza vaccines includes an update to the influenza A(H1N1)pdm09 component. U.S.-licensed influenza vaccines will contain HA derived from:

1) an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus (for egg-based vaccines) or an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus (for cell culture-based and recombinant vaccines).

2) an influenza A/Darwin/9/2021 (H3N2)-like virus (for egg-based vaccines) or an influenza A/Darwin/6/2021 (H3N2)-like virus (for cell culture-based and recombinant vaccines).

3) an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus.

4) an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus.

Second, the ACIP recommends that all persons aged ≥6 months with egg allergy should receive an influenza vaccine.

Any influenza vaccine (egg-based or non-egg-based) that is otherwise appropriate for the recipient’s age and health status can be used.

It is no longer recommended that persons with allergic reactions to eggs involving symptoms other than urticaria should be vaccinated in an inpatient or outpatient medical setting supervised by a healthcare provider who can recognize and manage severe allergic reactions if an egg-based vaccine is used.

Egg allergy alone necessitates no additional safety measures for influenza vaccination beyond those recommended for any vaccine recipient, regardless of the severity of a previous reaction to an egg.

Furthermore, all flu shots for 2023-2024 should be administered in settings in which personnel and equipment needed for rapid recognition and treatment of acute hypersensitivity reactions are available.

A summary of these recommendations is posted on this CDC webpage.

SK bioscience today announced that the company has entered into a collaboration agreement with Vaxxas to develop a second-generation typhoid conjugate vaccine.

SK bioscience’s SKYTyphoid™ vaccine will be reformulated to be ‘printed’ onto the thousands of tiny microprojections covering the Vaxxas patch to be delivered directly to the abundant immune cells just under the skin surface.

This reformulation aims to enhance access and broaden markets where traditional intramuscular delivery using needles and syringes has been employed.

Under the agreement announced on August 23, 2023, SK bioscience will supply the antigen utilized by its typhoid conjugate vaccine, SKYTyhpoid™, jointly developed by SK bioscience and the International Vaccine Institute.

Vaxxas, an Australian company, will be responsible for reformulating the SKYTyphoid antigen so that it can be applied to its proprietary HD-MAPs and then conduct preclinical studies, which, if successful, will be followed by a Phase I human clinical trial.

Jaeyong Ahn, CEO of SK bioscience said in a press release, “Typhoid fever is a dangerous disease that frequently occurs in low- and middle-income countries, but the utilization of typhoid vaccines has been limited due to the requirement for vaccines that remain stable under varying temperatures and those that can be administered without medical supervision."

This collaboration with Vaxxas provides an opportunity to overcome those challenges."

The project is expected to be completed within two years from initiation to reporting the data from the Phase I clinical trial and is supported by grant funding received from Wellcome.

According to the World Health Organization, an estimated 9 million cases of typhoid fever occur globally each year. Symptoms include prolonged high fever, fatigue, headache, nausea, abdominal pain, and constipation or diarrhea, with mortality rates up to 30%.

As of August 24, 2023, typhoid vaccines are available in the U.S. and internationally.

The Government of Hong Kong Special Administrative Region's Centre for Health Protection (CHP) of the Department of Health today announced it is closely monitoring a human case of avian influenza A(H5N6) in the Mainland.

The CHP report on August 23, 2023, says the 27-year-old woman lives in Dazhou, Sichuan, and was admitted for treatment on July 22. This report did not disclose how or where she became infected with 'bird flu' nor the outcome.

On July 23, 2023, the Alert Response Level under the Government's Preparedness Plan for an Influenza Pandemic was activated.

From 2014 to date, 86 human cases of avian influenza A(H5N6) have been reported by Chinese health authorities. A high percentage of infections (52%) lead to death.

The CHP says that travelers to the Mainland or other affected areas must avoid visiting wet markets, live poultry markets, or farms. And they should strictly observe personal and hand hygiene when visiting any place with live poultry.

The Food and Agriculture Organization of the United Nations, the World Health Organization (WHO), and the World Organisation for Animal Health urged countries in July 2023 to work together across sectors to save as many animals as possible and to protect people. 

The current outbreaks of avian influenza ("bird flu") have caused devastation in animal populations, including poultry, wild birds, and some mammals. Although primarily affecting animals, these outbreaks pose ongoing risks to humans, says the WHO.

Since the annual flu shot is not designed to be effective against bird flu viruses, the U.S. government has invested in various avian influenza vaccines.

In June 2023, the U.S. Centers for Disease Control and Prevention confirmed about 20 million H5N1 and 12 million H7N9 vaccines were available in the U.S. National Strategic Stockpile.

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) entered into an agreement with the Company to support the clinical development, clinical manufacturing, and regulatory licensure process of a next-generation COVID-19 monoclonal antibody (mAb) therapy for the prevention of SARS-CoV-2 infections, which cause COVID-19 in people.

The agreement is part of the U.S. Department of Health and Human Services (HHS) 'Project NextGen' initiative to advance innovative vaccines and therapeutics for COVID-19.

Regeneron's most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials in 2023.

For the new COVID-19 program announced on August 22, 2023, HHS will fund up to 70% of Regeneron's costs for certain clinical development activities for a next-generation mAb therapy. 

The new BARDA contract has an estimated value of up to approximately $326 million of government funding.

Regeneron's first COVID-19 mAb cocktail, REGEN-COV, was granted Emergency Use Authorization in November 2020, with nearly 3 million doses delivered to the U.S. Government between 2020 and 2022.

"We're pleased to expand our longstanding BARDA relationship, which is predicated on Regeneron's decades of investment in deep scientific research and enabling technologies," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron, in a press release.

"Although COVID-19 has moved to an endemic stage, many people – including those with immunocompromising conditions – continue to face exposure that impacts their everyday life and could cause serious health consequences."

Previously, the U.S. CDC wrote some immunocompromised people benefit from mAb therapy instead of COVID-19 vaccination.

Under the NextGen project structure, Regeneron independently invents and proposes an antibody candidate, which BARDA and Regeneron will evaluate and agree upon for further development, manufacturing, and regulatory activities.

BARDA and Regeneron have previously worked together to deliver novel medicines for Ebola.

The new program announced today falls under Regeneron and BARDA's ongoing Other Transactions Agreement initiated in 2017 to develop a portfolio of antibodies targeting up to ten pathogens that pose significant risks to public health.

Novavax, Inc. today announced that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small pre-clinical studies.

As of August 22, 2023, SARS-CoV-2 coronavirus XBB sublineage variants are overwhelmingly responsible for the majority of current COVID-19 cases in the U.S. and European Union.

"Our data have shown that Novavax's protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6," commented Filip Dubovsky, President of Research and Development, Novavax, in a press release.

Non-clinical data previously showed that Novavax's COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants.

Novavax is submitting applications for its XBB.1.5 COVID vaccine candidate to regulatory authorities globally.

Novavax COVID-19 vaccine brands (Nuvaxovid, CovoVax, NVX-CoV2373, TAK-019) have been authorized in about 40 markets.

The Novavax COVID-19 Vaccine, Adjuvanted, has not been approved or licensed by the U.S. FDA but is authorized for emergency use. Novavax vaccines are available in specific clinics and pharmacies in the U.S.