Vaccine News

CSL Seqirus today announced it was selected by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to complete the fill-and-finish process of the pre-pandemic vaccine for the U.S. government as part of the National Pre-Pandemic Influenza Vaccine Stockpile program.

Under the terms of the agreement revealed on May 30, 2024, CSL Seqirus will deliver approximately 4.8 million doses of a pre-pandemic vaccine well-matched to the H5 of the currently circulating H5N1 strain.

This acquisition of a pre-pandemic vaccine will increase BARDA's vaccine stockpile to support the U.S. government's pre-pandemic response. It is the fourth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza activity.
 
"The U.S. CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners," said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, in a press release.

"This agreement, building upon prior agreements with BARDA, will help support the U.S. government's ability to respond swiftly if the current avian flu situation changes."

On April 1, 2024, the U.S. Food and Drug Administration (FDA) Dr. Peter Marks informed the media that the U.S. stockpile of avian flu-specific vaccines would work well if deployed.

As of May 2024, FDA-approved avian influenza vaccines are not commercially available in the U.S. The FDA says annual flu shots are unlikely to protect people during avian influenza (bird flu, cow flu) outbreaks. 

In Europe, the European Commission (EC) signed a framework contract on July 28, 2022, for the joint procurement of GSK's Adjupanrix, a pandemic influenza vaccine. That contact enables EC Member States to purchase up to 85 million vaccine doses during an influenza pandemic.

BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

CSL Seqirus is a business of Australia-based CSL.

NanoViricides, Inc. today elaborated on its development of a first-in-class, broad-spectrum antiviral agent that could revolutionize the treatment of viral infections, including RSV, Influenza, and other viruses.

Over 90% of human pathogenic viruses are known to use one or more "landing sites" in the Sulfated Proteoglycans ("SPG") family. NanoViricides says a successful host-mimetic nanoviricide drug using SPG as the key feature to attracting viruses could theoretically attack most, if not all, such viruses.

NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy. 

For example, in a recent RSV study, extended orally administered NV-387 was compared with a high dose of ribavirin. Two doses were given on the first day of dosing, followed by one daily dose for the next nine days (11 doses). NV-387 given by this dosing regimen led to complete survival of the mice beyond the 21-day study period, with no signs of pathology apparent on the last day of observation.

"An antiviral agent with an extra-ordinary broad spectrum of antiviral activity, coupled with strong safety, is a 'holy grail' of antiviral medicines," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, in a press release on May 29, 2024 

"Our host-mimetic, direct-acting, nanoviricide™ platform technology capable of destroying virus particles has made this possible, we believe. NV-387 is now ready for Phase II studies towards the goal of regulatory approvals worldwide."

He further commented, "If and when approved, NV-387 could be as revolutionary an antiviral agent as penicillin was as an anti-bacterial agent."

The U.S. Centers for Disease Control and Prevention (CDC) today announced an outbreak of chikungunya in Malé and Hulhumalé regions of Maldives.

Crisis24 recently reported 389 total cases from March to May 11, 2024.

On May 28, 2024, the CDC Level 2 Travel Health Advisory recommended that adults traveling to a destination with a current chikungunya outbreak be vaccinated.

The U.S. FDA recently approved Valneva SE's IXCHIQ® monovalent, single-dose, live-attenuated chikungunya vaccine.

Furthermore, the CDC says if you are pregnant, reconsider travel to Maldives, particularly if you are close to delivering your baby. Mothers infected around the time of delivery can pass the virus to their baby before or during delivery.

According to the CDC, newborns infected in this way or by a mosquito bite are at risk for severe illness, including poor long-term outcomes.

Additionally, people can protect themselves from chikungunya infection by preventing mosquito bites, including using insect repellent, wearing long-sleeved shirts and pants, staying in places with air conditioning, or using window and door screens.

Increased rates of sexually transmitted infections (STIs) are reported globally, and new interventions are needed, wrote researchers in a recent article published by The Lancet Infectious Diseases.

STIs continue to pose significant public health challenges, causing 2.5 million deaths each year, according to a new World Health Organization report.

On May 23, 2024, these France-based researchers wrote, 'We aimed to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of chlamydia or syphilis (or both) and whether the meningococcal group B vaccine (4CMenB) could reduce the incidence of gonorrhea in this population.

Results from the ANRS 174 Doxyvac phase 3 clinical trial concluded Doxycycline PEP strongly reduced the incidence of chlamydia and syphilis.

These researchers said it did not show the efficacy of the 4CmenB vaccine for gonorrhea.

Still, doxycycline PEP should be assessed in other broader populations, and its effect on antimicrobial resistance carefully monitored.

A new framework was recently released by the World Health Organization (WHO) that will guide health authorities, communities, and other stakeholders in preventing and controlling mpox outbreaks, eliminating human-to-human transmission of the disease, and reducing spillover of the virus from animals to humans.

Mpox is a viral illness caused by the monkeypox virus (MPXV).

There are two different clades of the MPXV: clade I and clade II. Clade I outbreaks are deadlier than clade II outbreaks. 

In the United States, clade II cases were reported to have a fatality rate of .002%.

A significant outbreak of the clade I virus in the Democratic Republic of the Congo (DRC) continues today, where cases have been detected for decades. Since the beginning of 2024, over 6,500 cases and 345 deaths have been reported in the DRC.

This data reflects a fatality rate of .05%.

As of May 26, 2024, most U.S. mpox cases continue to be in people who are not vaccinated or have only received one dose of the JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine. The U.S. CDC recommends that persons at risk for mpox exposure complete the 2-dose  vaccination.

In the U.S., the JYNNEOS vaccine is offered at clinics and pharmacies in select cities.

The U.S. Centers for Disease Control and Prevention (CDC) recently reported that three additional measles cases were confirmed in 2024.

As of May 23, 2024, the CDC confirmed a total of 142 measles cases were reported by 21 jurisdictions: Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, New York State, Ohio, Pennsylvania, Vermont, Virginia, Washington, West Virginia, and Wisconsin.

Recently, the city of Philadelphia reported another measles case after managing an outbreak earlier in 2024.

About 44% of these cases are in unvaccinated children under five years of age, with 63% hospitalized.

Ten measles outbreaks (3+) were reported in 2024, compared to four outbreaks in 2023.

Globally, about 50 countries have reported measles outbreaks in the past year.

The CDC says it is uncommon for someone fully vaccinated to develop measles. In 2024, the number of breakthrough infections (approximately 5%) was consistent with previous years' reports.

Two doses of MMR vaccine are 97% effective at preventing measles, and one dose is 93% effective. Measles vaccines are available at most clinics and pharmacies in the U.S.

The Inflation Reduction Act (IRA) eliminated cost sharing for vaccines covered by Part D beginning in January 2023 to improve the affordability of vaccines for Medicare beneficiaries.

To help determine if the impact matches the IRA's intent, a team led by Dima Qato—Hygeia Centennial Chair and Associate Professor at the USC Mann School of Pharmacy and Pharmaceutical Sciences—evaluated the policy removing patient out-of-pocket costs for the uptake of shingles vaccinations, the most commonly administered vaccine covered by Part D.

A Research Letter published by the JAMA Network evaluated the association of this zero cost-sharing policy on the use of shingles vaccinations, which account for more than 90% of Part D vaccinations.

Following the implementation of the new policy, total Part D shingles vaccinations dispensed increased by 46%.

Between January 2022 and December 2023, 16.3 million shingles vaccines (8.3 million to individuals with Part D and 8 million to those with commercial insurance) were dispensed at retail pharmacies.

These researchers wrote, 'The implementation of the IRA policy eliminating out-of-pocket costs for Part D–covered vaccinations was associated with substantial increases in shingles vaccinations dispensed to Part D enrollees compared with commercially insured individuals at retail pharmacies.'

"Policy matters," said Qato in a press release on May 23, 2024, who also directs the Mann School's Program on Medicines and Public Health and is a senior fellow at the USC Schaeffer Center for Health Policy & Economics. "And when these policies eliminate the costs, they remove barriers in accessing essential medications and preventive services, including vaccinations."

Recently, a long-term study revealed that the leading shingles vaccine delivers extensive value.

In April 2024, GSK plc announced that data from a long-term follow-up phase III trial showed that the Shingrix® vaccine, also known as Recombinant Zoster Vaccine, remained effective against shingles for more than a decade in adults over 50.

As of May 24, 2024, the Shingrix vaccine is available at most pharmacies in the U.S.