Vaccine News

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® to include the treatment of human immunodeficiency virus type 1 (HIV-1) infection in children weighing 10 kg or more.

As of July 28, 2023, a parallel Marketing Authorization application was submitted to the European Medicines Agency to support a type II variation and line extension for expanded pediatric use in Europe.

If the new applications are approved, EDURANT could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.

“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC, in a related press release. 

“These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”

EDURANT is not a preventive vaccine but is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. 

As of August 2, 2023, the FDA has not approved an HIV vaccine.

The U.S. Department of State officially launched the Bureau of Global Heath Security and Diplomacy.

The Bureau’s overarching mission is to fortify the global health security architecture to effectively prevent, detect, control, and respond to infectious diseases, including HIV/AIDS, wrote the Secretary of State on August 1, 2023. 

By leveraging and coordinating U.S. foreign assistance, the Bureau aims to foster robust international cooperation, enhancing protection for the United States and the global community against health threats through strengthened systems and policies.

To ensure U.S. leadership is sustained moving forward, the Bureau will provide a unified voice of leadership on global health security and diplomacy, combining strengths, functions, personnel, and resources from various offices.

Ambassador-at-Large Dr. John N. Nkengasong will lead the Bureau.

This new Bureau will seamlessly integrate global health security as a core component of U.S. national security and foreign policy, underscoring the Department of State’s commitment to advancing human health worldwide, wrote the State Department.

The State Department also issued security notices for most countries, found at this link.

Merck & Co. today announced its human papillomavirus (HPV) vaccines sales increased 47% to reach $2.5 billion, and if you exclude the Impact of Foreign Exchange, sales actually grew by 53%.

Merck's GARDASIL 9® is a vaccine indicated in men and women, 9 through 45 years of age, to prevent cancers caused by the HPV. It has been available in the United States since late 2016.

The original GARDASIL® vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18. is available in other countries.

According to the World Health Organization, HPV vaccination programs that began pre-pandemic reached the same number of women in 2022 as in 2019, with mean coverages reaching 67% in high-income countries and 55% in low- and middle-income countries.

Millions of men and women aged 27–45 may still benefit from HPV vaccination, says Merck.

"We continue to make great progress as we advance our broad and deep pipeline, raise the bar of innovation, and bring forward leading-edge science to save and improve lives around the world," said Robert M. Davis, chairman, and chief executive officer of Merck, in a press release issued on August 1, 2023.

HPV is a double-stranded DNA virus that belongs to the Papillomaviridae family. There are over 100 subtypes of HPV, characterized as high-risk or low-risk. And it is the most common sexually transmitted infection worldwide.

From a clinical perspective, HPV vaccinations reduce anal HPV infection and anal intraepithelial neoplasia (AIN).

A study published on May 31, 2023, concluded there is strong evidence for high vaccine efficacy against anal HPV infection and AIN in HIV-negative individuals vaccinated at age ≤26 years.

The U.S. Fish and Wildlife Service (FWS) Incident Command Team recently confirmed implementing conservation strategies to help California condors in light of the Highly Pathogenic Avian Influenza (HPAI) bird flu outbreak.

As of July 28, 2023, over twenty-one Condors have died related to HPAI infections this year.

In May 2023, the United States Department of Agriculture's Agricultural Research Service announced the emergency use of a HPAI vaccine candidate to prevent additional deaths of California Condors.

The California Condor Vaccination Trial continued will continue into September 2023. 

Blood samples from 13 birds will be collected at 21 and 42-days following vaccination to evaluate the immune response from two different vaccination approaches. 

The first sample will be collected on August 8.

From a recovery perspective, three condors were transferred to the release site in Arizona to reacclimate to their home. A release date will be determined based on their behavior and weather.

The fourth bird that survived also has immunity to HPAI and will be released later as he is currently re-growing molted flight feathers. 

The California Condor Recovery Program continues to implement standard operations, and we are hopeful this will include the release of juveniles in 2023. However, due to the dynamic nature of HPAI outbreaks and logistics around potential future vaccinations, adjustments will be made accordingly, wrote the FWS.

The ongoing bird flu outbreak reached Europe, Asia, and Russia in 2023.

Furthermore, the U.S. government has already approved one bird flu vaccine (Audenz™) for people and invested in vaccine candidates should a pandemic occur.

60 Degrees Pharmaceuticals Inc. today announced that the Canadian Intellectual Property Office issued a patent on using novel tafenoquine regimens for malaria prevention in malaria-naive individuals, and it will remain valid until December 2, 2035.

The Company was issued a similar U.S. patent in 2019.

Tafenoquine is the active molecule in the Company's U.S. Food and Drug Administration-approved regimen for malaria prevention, ARAKODA®.

ARAKODA, an oral tablet containing 100 mg of tafenoquine base, is an anti-malarial indicated for malaria prevention in individuals 18 years and older.

As of July 31, 2023, travelers or individuals at risk of contracting malaria are prescribed 2 x 100 mg tablets once per day for three days (the loading phase) before travel, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

Travelers from, and residents of, Canada and the United States, are usually malaria naive because they have not previously contracted malaria and thus lack immunity to the disease.

During July 2023, malaria outbreaks have been reported in Florida and throughout Central America in countries such as Costa Rica. And numerous African countries have confirmed malaria outbreaks.

The bite of an infective female Anopheles mosquito spreads malaria. The disease can cause fever, chills, and flu-like illness. If it is not treated, it can cause severe complications and death, says the U.S. CDC.

Typically, about 2,000 malaria cases are diagnosed in the United States yearly.

In Africa, there are two malaria vaccines currently being administered.

And on April 26, 2023, the United States Patent and Trademark Office issued 60 Degrees a patent covering the use of tafenoquine as a treatment for COVID-19 disease. 

The World Health Organization (WHO) recently reported circulating vaccine-derived poliovirus type 2 (cVDPV2) cases in Africa.

The WHO confirmed on July 28, 2023, the United Republic of Tanzania reported the country's first cVDPV2 case and Kenya its first of 2023.

Tanzania's Ministry of Health notified the WHO the cVDPV2 virus was isolated from a case of acute flaccid paralysis (AFP) in the Rukwa region. Gene sequencing of the isolated virus has indicated close linkage with cVDPV2 currently circulating in South Kivu, Demographic Republic of the Congo.

According to the WHO-UNICEF estimates of national immunization coverage, the oral polio vaccine third dose (OPV3) and the inactivated polio vaccine first dose (IPV1) was 88% in Tanzania last year.

And on July 11, 2023, the WHO received an official report regarding detecting a cVDPV2 in two AFP cases and two asymptomatic healthy children community contacts in Kenya.

The genetic sequencing analyses showed that all four isolates are genetically linked to the cVDPV2 circulating in Banadir, Somalia.

Vaccine-derived poliovirus is a well-documented strain mutated from the strain originally contained in OPV.

OPV contains a live, weakened form of poliovirus that replicates in the intestine for a limited period, thereby developing immunity by building antibodies. On rare occasions, when replicating in the gastrointestinal tract, OPV strains genetically change and may spread in communities that are not fully vaccinated against polio, especially in areas with poor hygiene or overcrowding.

The lower the population's immunity, the longer this virus survives and the more genetic changes it undergoes.

In sporadic instances, the vaccine-derived virus can genetically change into a form that can cause paralysis, as does the wild poliovirus – this is what is known as a vaccine-derived poliovirus (VDPV).

The detection of VDPV in at least two different sources and at least two months apart that are genetically linked, showing evidence of transmission in the community is classified as cVDPV2.

In both countries, the WHO assesses the overall risk at the national level to be high due to the sub-optimal surveillance performance in some districts, sub-optimal vaccination coverage resulting in low population immunity, and the ongoing population movement across neighboring countries.

To alert international travelers, the U.S. CDC reissued its Level 2 - Practice Enhanced Precautions, Travel Health Advisory regarding the global polio outbreak on July 28, 2023.

The CDC says before any international travel, make sure you are up to date on your polio vaccines, and adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of polio vaccine.

The nOPV2 vaccine is offered in Africa in July 2023. Approximately 670 million doses have been administered in more than 31 countries worldwide.

In the U.S., various polio vaccines are available at health clinics and community pharmacies.

Dallas County Health and Human Services (DCHHS) today reported two new human cases of West Nile Virus (WNV) infection in Dallas County for 2023.

The patients are two male residents of the 75228 and 75204 zip codes in the City of Dallas. Both patients were diagnosed with West Nile Neuroinvasive Disease (WNND.)

Due to privacy and confidentiality reasons, DCHHS does not disclose additional information about the patient.

As of July 28, 2023, there are four total human cases this year. 

There were 42 cases of WNV in Texas and seven deaths in 2022. Over the last five years, Texas has had 485 cases and 65 deaths. 

"Mosquito activity continues in our community, and we're now reporting two additional human cases of West Nile Virus. WNV is transmitted to humans by the bite of an infected mosquito, and people should be careful when going out outside to enjoy outdoor activities," said Dr. Philip Huang, DCHHS Director. "Please follow the 4 Ds to do everything you can to avoid mosquito bites," in a press release.

As of July 28, 2023, there were seven new mosquito sample pools: in Dallas, 75218, 75241, and 75243 (2 pools); Mesquite, 75150 (3 pools).

WNV is transmitted through the bite of infected mosquitoes, says the Texas Department of State Health Services (DSHS).

Most people exposed to the virus don't get sick, but about 20% develop symptoms like headache, fever, muscle and joint aches, nausea, and fatigue.

In a tiny proportion, less than 1%, the virus affects the nervous system, leading to the more severe WNND that can cause neck stiffness, disorientation, tremors, convulsions, paralysis, and even death.

"It's important for people to be aware that there are many diseases transmitted by mosquitoes found in Texas," said DSHS Commissioner Jennifer Shuford, MD, MPH, in a press release on July 11, 2023.

 "Most of these diseases cause mild illness, but in rare instances, diseases like dengue or Zika can cause severe illness."

"We've even had a locally acquired malaria case in Texas this year, which underscores the importance of taking precautions to prevent mosquito bites."

As of July 2023, the U.S. FDA has not approved a WNV vaccine.