Vaccine News

Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) today announced that it had received IND approval from the National Medical Products Administration in China for a novel monoclonal antibody AK0610 that was bioengineered based on a respiratory syncytial virus (RSV) infection.

AK0610 specifically targets the RSV pre-F protein.

It demonstrated potent neutralizing effects against RSV both in vitro and in vivo. With a prolonged half-life, it holds promise as a next-generation long-acting antibody for RSV prevention.  

Dr. Jim Wu, chairman and CEO of ArkBio, commented in a press release on November 23, 2023, "We are excited with the IND approval of AK0610 and its great potential in the field of RSV prevention."

"...We will strive to provide very needed RSV high-risk population and patients with efficacious prevention and treatment solutions." 

The discovery and pre-clinical characterization have been published in hLife jointly by Professor George Fu Gao and his team from the Institute of Microbiology, Professor Zhengde Xie and his team from Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, and ArkBio R&D team.

China has one of the highest rates of lower respiratory tract infection in children caused by RSV, accounting for 18-27% of all hospitalizations in children under five years old due to RSV infections.

ArkBio licensed AK0610 intellectual properties from the Institute of Microbiology, Chinese Academy of Sciences and Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, followed by further engineering and optimization at ArkBio.

Currently, there is no approved drug for preventing RSV infection in China. 

In the United States, RSV antibody passive immunization products have been U.S. FDA-approved since 1998.

Recently, AstraZeneca and Sanofi co-developed Beyfortus™ monoclonal antibody, which was approved by the FDA to protect infants through their first and second RSV season.

The U.S. Transportation Security Administration (TSA) has screened a record number of passengers in 2023 and anticipates airport security checkpoints nationwide will be busier than ever this holiday travel season.

The season kicked off with Thanksgiving travel, which concludes November 28, 203.

Historically, the Sunday following Thanksgiving will likely be the busiest travel day. The TSA expects to screen 30 million passengers this season.

TSA Administrator David Pekoske recently stated, "We are ready for the anticipated volumes and are working closely with our airline and airport partners to ensure we are prepared for this busy holiday travel season."

"We will also do our best to maintain wait time standards of under 10 minutes for TSA PreCheck® lanes and under 30 minutes for standard screening lanes."

"I am grateful for our dedicated employees who remain vigilant and focused on the mission during this holiday travel season and beyond."

The U.S. Department of State and the U.S. CDC publish notices to alert international travelers to various risks.

Furthermore, certain travel vaccinations are recommended before visiting disease outbreak areas, such as Dengue and Zika.

The World Health Organization (WHO) today announced that 331,200 doses of Mosquirix™ RTS, S/AS01, arrived in the Republic of Cameroon.

Mosquirix is a recombinant malaria vaccine with the P. falciparum circumsporozoite protein.

The delivery on November 21, 2023, is the first to a country located on the Gulf of Guinea not previously involved in the WHO malaria vaccine pilot program and signals that scale-up of vaccination against malaria across the highest-risk areas on the African continent will begin shortly.

A further 1.7 million doses of Mosquirix are expected to arrive in Burkina Faso, Liberia, Niger, and Sierra Leone in the coming weeks, with additional African countries set to receive doses in the months ahead.

Since 2019, Ghana, Kenya, and Malawi have been administering the vaccine in a schedule of 4 Mosquirix doses from around five months of age in selected districts as part of the pilot program known as the Malaria Vaccine Implementation Programme (MVIP).

More than 2 million children have been reached with the malaria vaccine in three African countries through MVIP – resulting in a 13% drop in all-cause mortality in children age eligible to receive the vaccine and substantial reductions in severe malaria illness and hospitalizations. 

Nearly every minute, a child under five dies of malaria in Africa.

In 2021, there were 247 million malaria cases globally, which led to 619,000 deaths in about 84 countries.

Of these deaths, 77% were children under five years of age.

Approximately 95% of global malaria cases and 96% of related deaths in 2021.

The U.S. Centers for Disease Control and Prevention (CDC) has issued various alerts for malaria-endemic countries, including Costa Rica.

The CDC has recently confirmed autochthonous (local) malaria cases in Florida (seven), Texas, Maryland, and Arkansas.

As of November 22, 2023, malaria vaccines are unavailable in the U.S.

JUVE Patent today reported the European Patent Office Opposition Division has revoked an essential mRNA vaccine patent.

As of November 21, 2023, a contested mRNA patent owned by Moderna Inc. was declared invalid.

Moderna believes Pfizer and BioNTech copied features of the company's patented technologies critical to the success of mRNA vaccines.

According to Reuters, BioNTech welcomed the decision, calling the patent office's decision "an important one, as we believe that this and others of Moderna's patents do not meet the requirements for grant and should never have been granted."

The legal dispute revolves around Moderna's patents EP 3 590 949 B1 and EP 3 718 565 B1, which protect "ribonucleic acids containing n1-methyl-pseudouracils and uses thereof" and "respiratory virus vaccines," respectively.

However, while both patents are concerned with mRNA vaccines, they have different applications.

EP 949 is concerned with claims concerning modified mRNA.

And EP 565 covers the "betacoronavirus mRNA-LNP vaccine," an improved substance for the prevention of contracting COVID and other respiratory diseases.

The unedited news article is posted at this link.

The journal Vaccines recently published the findings from a Texas A&M University survey that assessed parental intention to vaccinate children against respiratory viruses.

Published on November 17, 2023, these researchers found that about 40% of parents intended to vaccinate their children against COVID-19, 63% against influenza, and 71% against RSV.

Women showed lower intentions for COVID-19 and influenza. For COVID-19 and RSV, intentions were higher for those who thought vaccines were necessary.

Intention to vaccinate was consistently correlated with concerns about the disease, trust in health institutions, and previous vaccinations.

Moreover, the highlighted reasons for vaccine hesitancy include concerns about safety, necessity, and lack of information. 

Communications contact: Simon F. Haeder, Department of Health Policy & Management, School of Public Health, Texas A&M University, College Station, TX 77843.

The U.S. Food and Drug Administration (FDA) today issued a final rule to amend its regulations concerning direct-to-consumer (DTC) advertisements for human prescription drugs presented in television or radio format.

Since September 1985, the FDA has authorized pharmaceutical DTC advertising and required the advertisements to meet the same legal requirements as those directed at physicians.

Like all advertisers, pharmaceutical firms have incentives to present their products in a positive light to potential consumers.

However, the FDA says that those business incentives do not assure clear communication to consumers of the advertised drug's negative attributes.

In 2022, research data indicates that pharma companies spend about 1 billion dollars monthly.

FIERCE Pharma published a list of the top 10 pharma drug ad spenders for 2022.

Specifically, the FDA's final rule issued on November 21, 2023, implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the FDA Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.

The FDA's final rule establishes five standards that, independently and collectively, help ensure that the major statement is presented clearly, conspicuously, and neutrally. This rule does not change the content of the major statement.

As directed by FDAAA, FDA is establishing these standards.

The Global Polio Eradication Initiative (GPEI) recently confirmed six countries reported additional polio cases in 2023

These countries include Pakistan, which reported its fifth wild poliovirus type 1 (WPV1) case this year.

According to the GPEI, the other countries include Chad, the Democratic Republic of the Congo (DRC), Guinea, Nigeria, and Somalia, which reported more circulating vaccine-derived poliovirus type 2 cases.

The DRC also reported four more cases involving circulating vaccine-derived poliovirus type 1.

While it has been about three months since the World Health Organization (WHO) confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern, the WHO continues to remind Member States that the risk of the emergence of polio has increased due to low vaccination coverage. 

Polio is a crippling and potentially deadly disease that affects the nervous system. 

Most people with polio do not feel sick. In rare cases, polio infection causes permanent loss of muscle function (paralysis). Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.

To warn international travelers, the U.S. Centers for Disease Control and Prevention issued an updated Global Polio Alert - Level 2, Practice Enhanced Precautions, Travel Health Notice on September 11, 2023, regarding polio outbreaks and poliovirus detections in 31 countries.

The CDC says that before visiting any of these destinations, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of the polio vaccine.

As of November 2023, various polio vaccines are available worldwide.