Vaccine News

Pfizer Canada announced the Health Canada approved its bivalent Respiratory Syncytial Virus (RSV) vaccine ABRYSVO™ Vaccine.

ABRYSVO is indicated for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older by active immunization, and the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant women.

"Vaccines are considered to be the most effective tool in public health for preventing illness and can help reduce the stress on our healthcare system and professionals, including nurses, doctors, and others on the frontline," said Dr. Darine El-Chaâr, Maternal Fetal Medicine physician at The Ottawa Hospital, in a press release on January 4, 2024. 

"Vaccines administered through maternal immunization can also help play a critical role in decreasing the gap of vulnerability in the first few months of an infant's life, as well as helping to protect their mothers, who may be at increased risk of severe disease compared with non-pregnant women."

RSV is a common respiratory virus that causes mild disease with cold-like symptoms in the fall and winter months.

In more vulnerable populations, like adults 60 and over, an RSV infection can be severe, especially among those with underlying respiratory or cardiac conditions.

For infants, RSV infection can result in respiratory distress, especially in those less than six months of age and those with higher risk factors such as congenital heart or lung disease or prematurity.

Pfizer Canada is currently assessing the availability timeline for ABRYSVO and is committed to bringing a supply of this vaccine to Canadians as quickly as possible.

As of January 5, 2024, RSV vaccines and monoclonal antibody therapy that deliver passive immunization to infants are approved for use in the United States.

Sanofi Canada recently announced the National Advisory Committee on Immunization's annual Statement on Seasonal Influenza Vaccine for 2024-2025 continues to recommend Fluzone® High-Dose Quadrivalent among the preferential influenza vaccines to protect adults 65 years of age and older against influenza.

Delphine Lansac, General Manager, Vaccines Canada, Sanofi, commented in a press release on January 3, 2023, "This long-standing recommendation as a preferential influenza vaccine for adults 65 years of age and older speaks to the science that Fluzone® High-Dose Quadrivalent is built on and demonstrates our continued leadership in vaccines."

"It's been a groundbreaking year, where over 50% – more than one in two – seniors who received influenza vaccines in Canada were immunized with Fluzone® High-Dose Quadrivalent Influenza Vaccine."

Fluzone® High-Dose Quadrivalent Influenza Vaccine is designed to protect seniors with four times the active component dosage of a standard flu shot.

To date, Fluzone® High-Dose is available in more than 20 countries, including the United States, Canada, and Germany.

As of December 23, 2023, over 155 million flu shots had been distributed in the U.S. this season. 

ImmunityBio, Inc. announced today a recent capital raise that provides significant financial resources to accelerate the Company's commercialization efforts and expand its pipeline within the broader urological cancer space.

The Company's pipeline is based on broad immunotherapy and cell therapy platforms designed to attack cancer and infectious pathogens by activating the innate and adaptive branches of the immune system in an orchestrated manner.

On January 2, 2023, the Company confirmed up to $320 million royalty financing and equity investment by Oberland Capital, with $210 million of gross proceeds received at closing on December 29, 2023.

The proceeds will also fund ongoing business operations and clinical trials expanding Anktiva® (N-803) indications into multiple solid tumors.

ImmunityBio's commercialization efforts are in anticipation of potential U.S. Food and Drug Administration ("FDA") approval of Anktiva in combination with Merck's Bacillus Calmette-Guérin (BCG) vaccine for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 disease.

The Company announced on March 26, 2023, that the FDA had set a user fee goal date for Anktiva's Biologics License Application resubmission of April 23, 2024. 

Anktiva® (N-803) is an investigational therapy, and no safety or efficacy has been established by any Health Authority or Agency, including the FDA.

"This transaction raises significant capital for the Company to support important growth plans, yet with limited equity dilution and with a cap on total payments tied to the initial investment," said Richard Adcock, Chief Executive Officer and President of ImmunityBio, in a press release.

"Besides providing a capital source at a key inflection point for ImmunityBio, this investment demonstrates strong confidence by Oberland Capital in our future, and in particular in the potential value of Anktiva in bladder cancer, as well as the direction of our clinical pipeline."

In aggregate, $850 million in capital was raised in 2023, with $320 million from institutional investors and $530 million from its founder, Patrick Soon-Shiong, M.D.

The investment from Oberland Capital takes the form of a $300 million Revenue Interest Purchase Agreement ("RIPA") that is non-dilutive to current investors, of which $200 million was funded at closing, and $100 million is to be funded contingent upon FDA approval of the Company's BLA for Anktiva in combination with BCG for NMIBC, and subject to other terms and conditions as outlined in the RIPA. 

Under the terms of the RIPA, Oberland Capital will have a right to receive initially tiered single-digit royalty payments on net sales of the Company's products, which are capped at a multiple of their investment. In addition, the Company has entered into a purchase agreement with Oberland Capital for the private placement of 2,432,894 shares issued at closing, representing $10 million of gross proceeds based on the trailing 30-trading days VWAP. Oberland Capital can also purchase an additional $10 million of common stock at a future date.

In connection with the RIPA, the Company and Nant Capital entered into amendments to extend the maturity dates of certain existing promissory notes with an aggregate principal amount of approximately $505 million from December 31, 2024, to December 31, 2025, and to allow Nant Capital to convert up to an aggregate of $380 million of principal, plus accrued and unpaid interest, into shares of common stock at a price per share equal to a 75% premium to the closing market price on January 3, 2024. Nant Capital and the RIPA Purchaser Agent also concurrently entered into a Subordination Agreement, pursuant to which the Notes were subordinated to the Company's obligaCompany'sthe Purchasers under the RIPA.

Inventprise Inc. today announced the completion of vaccination in their Phase 2 dose-ranging study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in young adults.

On January 2, 2023, the company stated that this Phase 2 study is essential in developing an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV). This vaccine candidate is designed to help prevent pneumococcal disease caused by serotypes not covered in the current PCVs.

“PCVs are the world’s most complex vaccines, and increasing the number of serotypes (25) and manufacturing capacity has been challenging since conjugate vaccines were first developed,” commented Yves Leurquin, President & CEO of Inventprise, in a press release.

As of 2024, several approved PCVs and vaccine candidates are conducting research. However, some do not include critical disease-causing serotypes.

“This study was designed to evaluate safety and antibody responses following single doses of three different formulations of IVT PCV-25 in young adults to pave the way for future studies in infants and older adults. In Canada, as well as elsewhere in the world, there continues to be significant rates of disease due to serotypes not covered in licensed vaccines so we are very interested in the potential for broader coverage,” says Dr. Joanne Langley, the study’s principal investigator at the Canadian Center for Vaccinology.

As a leading cause of deadly childhood pneumonia, sepsis, meningitis, and debilitating middle-ear infections, the pneumococcus bacterium is responsible for an estimated 300,000 deaths per year in children less than five years of age worldwide.

Inventprise is producing the IVT PCV-25 vaccine at its automated manufacturing facilities in Washington State. Funding for the development of IVT PCV-25 has been achieved with support from the Bill & Melinda Gates Foundation.

The last report of the Polio Eradication Initiative (GPEI) confirmed additional vaccine-derived poliovirus type 2 (cVDPV2) cases.

The west African country of the Islamic Republic of Mauritania confirmed its first cVDPV2 case in Nouakchott Nord, the first one in 2023.

And Indonesia's confirmed one cVDPV2 case was reported this week in Jawa Tengah. There have been four cVDPV2 cases this year and one case in 2022.

Indonesia Ministry of Health previously completed two rounds of immunization for children below five years of age with the nOPV2 vaccine, regardless of their prior vaccination status. The first round was implemented in April 2023.

The nOPV2 vaccine is a modified version of the type 2 monovalent OPV and is genetically more stable.

The administrative coverage of the bivalent oral polio vaccine between 2018 and 2022 in West Java ranged from 88% to 102%, while coverage of inactivated polio vaccine ranged from 26% to 106%. 

Vaccine-derived poliovirus is a strain mutated from the strain initially contained in the oral polio vaccine (OPV).

OPV vaccines contain a live, weakened form of poliovirus that replicates in the intestine for a limited period, thereby developing immunity by building up antibodies, says the World Health Organization (WHO).

On rare occasions, when replicating in the gastrointestinal tract, OPV strains genetically change and may spread in communities not fully vaccinated against polio.

According to the GPEI's data, as of December 31, 2023, about 1 billion nOPV2 vaccinations have been completed globally.

WHO's International Travel recommendations include .... that all travelers to the 35 polio-affected areas should be fully vaccinated against polio.

Mexico's president recently announced a "super pharmacy" that will help patients nationwide access medicines and vaccines.

According to VOA reporting on December 29, 2023, President Andrés Manuel López Obrador's solution is a centralized warehouse on the outskirts of Mexico City intended to complement local health facilities.

If a patient can't get needed medications at a local hospital, the patient's doctor or pharmacist could have it delivered from the 40,000-square-meter warehouse.

"The pharmacy is going to be big, big, big, and it is going to have all the medications used in the health system," López Obrador said.

The question is whether Mexico can overcome its history of being bad at regulating the pharmaceutical industry, buying medicines, storing them, and distributing them. Extreme centralization also hasn't helped Mexico much in the past in many areas, wrote VOA/AP.

The U.S. Centers for Disease Control and Prevention (CDC) recently updated its Mexico Yellow Book for 2024, identifying numerous endemic diseases such as dengue, varicella, and measles.

And the CDC issues Travel Health Alerts regarding specific disease outbreaks in Mexico and advises that all travelers should be updated on their routine immunizations and travel vaccinations.