Zika Breaking News

Vaxcyte, Inc. announced today that the U.S. Food and Drug Administration (FDA) had cleared the Company's infant Investigational New Drug (IND) application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte stated it plans to initiate the infant Phase 2 study in the second quarter of 2023, with data expected by 2025.

The infant study design will include a primary immunization series consisting of three doses followed by a subsequent booster dose.

"The clearance of the VAX-24 infant IND application marks an important step in expanding the development of our lead, broad-spectrum PCV candidate in this important and vulnerable population," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release on February 21, 2023.

"Based on the positive data from our Phase 1/2 proof-of-concept study in adults, we believe VAX-24 has the potential to deliver a best-in-class profile with broader coverage and better immune responses relative to the standard-of-care for both the adult and pediatric populations."

"We remain focused on advancing our VAX-24 clinical programs and look forward to the anticipated initiation of the infant study and announcement of the topline results from our Phase 2 study in adults aged 65 and older in the second quarter of this year."

Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under.

The burden of disease in the pediatric population underscores the need for a broader-spectrum vaccine.

Precision Vaccinations post additional pneumococcal disease vaccine and candidates news.

Pakistan's Polio Eradication Programme recently stated it is focused on eliminating polio in 2023 by continuing to conduct extensive vaccination programs.

Pakistan launched its first nationwide anti-polio campaign in 2023 to immunize children under the age of five against the crippling disease.

Pakistan has repeatedly come close to eradicating polio, but long-running propaganda in conservative rural areas that the vaccines cause sterility in children has set back the mission, reported VOA in January 2023.

This goal is within reach as only 20 wild poliovirus type 1 cases were reported in the Khyber Pakhtunkhwa province in 2022.

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

For a summary of polio-related activities in Pakistan for the last two weeks, take a look at the latest National Emergency Operations Centre newsletter.

Pakistan is included in the U.S. CDC's Alert - Level 2, Practice Enhanced Precautions polio travel advisory issued in 2023.

Tonix Pharmaceuticals Holding Corp. recently announced that it is obtaining an exclusive license from Columbia University in New York for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prevention of SARS-CoV-2 infection.

The Company believes that murine mAbs, such as TNX-4100, have the potential to generate high-affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.

This is because mice have a different repertoire of antibodies than humans.

The technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach, and screening platform.

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, commented in a press release on February 13, 2023, "Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes."

"We believe there is a need for second-generation mAb treatments and prophylactics to protect this population."

Although five mAb products containing seven distinct mAbs received emergency use authorization from the U.S. Food and Drug Administration for either treatment or prevention of COVID-19, none have remained useful or available in the U.S. since January 26, 2023.

Other mAbs news is posted at Coronavirus Today.

GC Biopharma announced today that the World Health Organization (WHO) granted prequalification for BARYCELA, a varicella vaccine.

BARYCELA is a live attenuated varicella virus vaccine containing MAV/06 strain, a virus exclusively attenuated by GC Biopharma.

While containing a higher amount of virus, this new vaccine, compared to its previous product (Suduvax), shows higher product stability.

BARYCELA has also proved non-inferior in immunogenicity with an equivalent level of safety to Merck's Varivax®, an existing prequalified vaccine in the market.

In addition, BARYCELA is being produced in a state-of-the-art aseptic condition from cell culture and virus infection to purification to make it the world's single-only varicella vaccine produced without antibiotics.

WHO prequalification decision has made BARYCELA eligible for procurement by the United Nations agencies for national immunization programs. 

With the WHO's prequalification decision, MAV/06 strain has moved closer to being registered in the WHO Technical Report Series and the previously listed OKA strain.

According to the U.S. CDC, Varicella, known as chickenpox, is an acute infectious disease.

It is caused by the varicella-zoster virus (VZV), which is a DNA virus that is a member of the herpesvirus group. Primary infection with VZV causes varicella.

After the primary infection, VZV stays in the body as a latent infection.

Reactivating latent infection causes herpes zoster (shingles), and approved vaccines are available.

"We hope BARYCELA will continue our contribution to reducing the world's social and economic cost incurred by varicella outbreaks," said EC Huh, Ph. D., President of GC Biopharma, in a press release on February 19, 2023.

Developed in 1993, GC Biopharma's Suduvax was Korea's first and the world's second varicella vaccine.

Over 28 million doses of the vaccine have been sold worldwide.

GC Biopharma's strategy is to utilize the global supply network for Suduvax to distribute BARYCELA.

During the year since Malawi confirmed its first case of wild poliovirus patient in 30 years, more than 33 million children across five African countries have been vaccinated against the virus.

About 80 million polio vaccine doses have been administered since mid-2022.

A total of nine wild poliovirus cases have been reported, with one in Malawi and eight in neighboring Mozambique, since the declaration of an outbreak in February 2022 in Malawi.

The last confirmed case to date was in August 2022 in Mozambique.

The wild poliovirus in Malawi and Mozambique originated from Pakistan, one of the two last endemic countries.

"Southern Africa countries have made huge efforts to bolster polio detection, curb the spread of the virus and ensure that children live without the risk of infection and lifelong paralysis," said Dr. Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa, in a press release on February 17, 2023.

"We continue to support the polio control efforts across the region so that every child receives the protection they need."

And at least five more are planned for 2023 in the five countries.

Polio is highly infectious and affects unimmunized or under-immunized children.

There is no cure for polio, and it can only be prevented by immunization.

Children worldwide remain at risk of wild polio type 1 as long as the virus is not eradicated in the remaining areas where it is still circulating.

There are WHO-approved polio vaccines offered throughout Africa.

These African countries were identified in the U.S. CDC's Global Polio Alert - Level 2, Practice Enhanced Precautions alert issued in January 2023.

Although the initial response was led by a sense of urgency and crisis management, the Florida State Surgeon General announced on February 15, 2023, he believes it is critical that, as public health professionals, responses are adapted to the present to chart a future guided by data.

As such, the State Surgeon General notified the healthcare sector and public on February 15, 2023, of a substantial increase in Vaccine Adverse Event Reporting System reports issued from Florida after the COVID-19 vaccine rollout.

To further evaluate this, Surgeon General Dr. Ladap wrote a letter to the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, illustrating the risk factors associated with the mRNA COVID-19 vaccines and emphasizing the need for additional transparency.

The acting director of the Africa Centers for Disease Control and Prevention (ACDC), Ahmed Ogwell, stated he hopes Mpox vaccines will finally arrive on the continent "in another two weeks, tops" after months of seeking doses.

The AP reported on February 16, 2023, the Mpox vaccines will go first to countries with acute need and the most significant overall burden, such as Congo and Nigeria. Nigeria was listed in the U.S. CDC's Watch - Level 1, Practice Usual Precautions notice issued in November 2021.

People become infected with the mpox virus through contact with the bodily fluids of infected animals or humans.

Mpox occurs throughout Central and West Africa, often near tropical rainforests. The first human case of Mpox was identified in the Democratic Republic of Congo in 1970. 

In November 2022, the government of the Republic of Korea, through the Korean Disease Control and Prevention Agency, announced it would donate the first batch of the Mpox vaccine to Africa through the ACDC.

In the U.S., over 1.1 million doses of the Bavarian Nordic JYNNEOS® (MVA-BN) vaccine have been distributed since May 2022.

Since May 5, 2022, about 110 countries have reported 85,800 Mpox patients and 88 related fatalities.

The countries with the highest cumulative notification rates in Europe are Spain, Portugal, and Luxembourg. Additional Mpox outbreak news is posted at MpoxToday.

While the World Health Organization has maintained its multi-country outbreak notice, the U.S. recently discontinued its Mpox alert.