Vaccine Breaking News

The U.S. Centers for Disease Control and Prevention (CDC) Technical Report issued on March 17, 2023, stated that despite the geographic spread of highly pathogenic avian influenza (HPAI) A(H5N1) viruses, only a small number of 'bird flu' cases in people have been identified.

The CDC stated all reported human cases since 2022 have been associated with poultry exposures.

And no bird flu cases of human-to-human transmission have been identified, says the CDC.

However, because of the potential for influenza viruses to evolve rapidly, continued sporadic human infections are anticipated.

To date, more than 6,300 people in 52 jurisdictions have been monitored since 2022, and only one human case in Colorado has been identified.

However, there has been an upsurge in various mammals dying from bird flu in Canada and the U.S. during 2023.

The CDC presented some good news regarding bird flu vaccines.

An H5 candidate vaccine virus (CVV) produced by CDC is nearly identical or, in many samples, identical to the hemagglutinin (HA) protein of recently detected clade 2.3.4.4b HPAI A(H5N1) viruses in birds and mammals and could be used to produce a vaccine for people. 

This H5 CVV is available and has been shared with vaccine manufacturers.

One manufacturer, CSL Seqirus Inc., has already produced a U.S. FDA-approved vaccine, Audenz™.

Audenz is a monovalent, adjuvanted, cell-based inactivated influenza (H5N1) subunit vaccine designed to protect people from bird flu.

GSK plc recently announced positive results from a phase 3 clinical trial evaluating its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years.

GSK's MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).

All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response.

In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.

Tony Wood, Chief Scientific Officer at GSK, commented in a press release on march 14, 2023, "These statistically significant phase III data are a very encouraging step toward reducing the incidence of meningococcal disease."

"In the U.S., routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease's incidence peak, could drive significant public health impact."

Invasive meningococcal disease (IMD), a significant cause of meningitis and septicemia, is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents.

Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases worldwide.

Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. 

As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine.

Currently, in the U.S., two separate vaccines needing four injections are required to protect against all five serogroups.

This immunization regimen and low awareness of the disease can lead to sub-optimal immunization coverage rates, particularly for MenB, with an estimated coverage of only about 31% of adolescents in the U.S.

GSK works closely with regulators to review the complete phase III data set, including the supplemental Biologics License Application for Bexsero.

This clinical trial was the confirmatory trial for Bexsero and the phase III trial for MenABCWY.

Detailed results from this phase III trial will be presented in a peer-reviewed publication and at upcoming scientific meetings.

The U.S. Food and Drug Administration (FDA) presented some good news last week regarding influenza vaccines. The FDA confirmed this season's influenza vaccination provided substantial protection against inpatient, emergency department, and outpatient illnesses among all ages.

On March 7, 2023, Lisa Grohskopf, MD, MPH, with the U.S. Centers for Disease Control and Prevention (CDC), presented to the FDA's Vaccines and Related Biological Products Advisory Committee updated vaccine effectiveness (VE) information through January 2023.

Dr. Grohskopf's presentation highlighted influenza vaccination significantly reduced disease by the following:

• 39% (95%CI: 31, 45) against adult hospitalizations,
• 44% (95%CI: 41, 47) against adult ED or UC visits, and
• VE was observed across age groups and immunocompromised.

Furthermore, this flu season's estimates are higher than VE estimates against hospitalization (25%) and ED or UC visits (25%) from the 2021–22 season.

As of March 15, 2023, the CDC says various flu shots remain available at most clinics and pharmacies in the U.S., and late-season vaccinations are advised for certain at-risk people.

Over 173 million influenza vaccines have already been distributed this flu season.

A recent Lancet Lancet Infectious Diseases analysis concluded that a single dose of Modified Vaccinia Ankara (MVA-BN, Jynneos®) vaccine was very protective against mpox.

Published on March 13, 2023, Dimie Ogoina, with Niger Delta University and colleagues, wrote the 78% vaccine effectiveness reported suggests that a single dose of Jynneos is considered protective against symptomatic mpox only after 13 days post-vaccination.

Furthermore, this analysis and other studies suggest that using a single dose of Bavarian Nordic's Jynneos as pre-exposure prophylaxis is preferable to post-exposure prophylaxis to guarantee protection against symptomatic mpox.

And because people living with HIV have been shown to have a higher risk of breakthrough COVID-19 infections post-vaccination, identifying four of eight breakthrough mpox infections among people living with HIV is noteworthy.

However, the Jynneos vaccine has previously been shown to be immunogenic among adults with a history of AIDS.

Since there are no approved HIV vaccines, co-administration data is unavailable.

Additional Mpox outbreak news is posted at MpoxToday.

Eisai Co., Ltd. today announced that the U.S. Veterans' Health Administration (VHA) is providing coverage of LEQEMBI™ to veterans living with early stages of Alzheimer's disease (AD).

As of March 13, 2023, VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA's standards and the U.S. Food and Drug Administration's (FDA) current label.

The FDA-approved LEQEMBI under the accelerated approval pathway in January 2023, and was launched in the U.S. on January 18, 2023.

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ),

Treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology, the population in which treatment was initiated in clinical trials.

After the first infusion, 38% of LEQEMBI-treated patients had transiently decreased lymphocyte counts to <0.9 x109/L compared to 2% on placebo, and 22% of LEQEMBI-treated patients had transiently increased neutrophil counts to >7.9 x109/L compared to 1% on placebo.

Furthermore, there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

LEQEMBI is not a vaccine but is therapeutically administered via infusion.

In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered. 

The FDA has not approved an Alzheimer's disease vaccine as of March 2023.

The U.K. National History Museum recently reported sea lions in Peru are among the latest victims of a version of the highly pathogenic avian influenza (HPAI) known as bird flu.

The HAPI virus has killed about 3,500 South American sea lions in Peru as of March 9, 2023.

The Peruvian government has reported that since November 2022, around 3% of the country's sea lions have died due to HPAI infections.

Peru, like many South American countries, believes HAPI was brought south by pelicans before jumping into the marine mammals. 

In the Northern Hemisphere, Canada and the United States have reported multiple mammalian fatalities related to bird flu infections.

The United States Department of Agriculture and the World Animal Health Information System reported during March 2023, over 131 HAPI H5N1 detections of wild striped skunks, black bears, raccoons, and red foxes.

• The California Department of Fish and Wildlife received confirmation on February 15, 2023, that an adult bobcat died from the Eurasian strain of HPAI H5N1.
• The Colorado Parks and Wildlife confirmed on February 9, 2023, several cases of HPAI in free-ranging wildlife (black bear, skunk, mountain lion).
• The Montana Department of Fish, Wildlife, and Parks confirmed on January 17, 2023, three juvenile grizzly bears tested positive for HAPI.

While there are no vaccines that protect birds or mammals from H5N1 infections, there are bird flu vaccines for humans.

In the U.S., the Food and Drug Administration authorized CSL Seqirus' Audenz™ vaccine on January 31, 2020, and RAPIVAB® in 2022.

And the U.S. government has financially supported the development of newer bird flu vaccines for people.

Furthermore, the government reminds everyone that annual flu shots are effective against certain types of influenza, but they are not effective against bord flu viruses.

The U.S. Centers for Disease Control and Prevention (CDC) today announced about 8.9% of the deaths that occurred last week were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 2,172 PIC deaths reported by the National Center for Health Statistics Mortality Surveillance on March 9, 2023, 1,274 listed pneumonia as an underlying or contributing cause of death on the death certificate, 876 had COVID-19, and 22 listed influenza.

While everyone is aware of COVID-19 and flu shots, most people don't know pneumonia is also a vaccine-preventable disease.

The CDC also confirmed the proportion due to influenza increased from October through mid-December 2022, decreased for seven weeks, and has been stable at low levels for the past five weeks. 

Unfortunately, the CDC confirmed on March 10, 2023, a total of 125 influenza-associated pediatric deaths occurred during the 2022-2023 flu season. Previous data indicate about one-third of these children were vaccinated.

While the flu season is fading in most areas of North America, the CDC reminds international travelers a second flu shot this year may protect them when visiting at-risk countries in the Southern Hemisphere.

The World Health Organization published Influenza Update N° 400 on March 6, 2023, stating in the temperate zones of the Southern Hemisphere, influenza activity remained at interseasonal levels.

In the U.S., there were about 173 million flu shots distributed during 2022-2023.

And many health clinics and community pharmacies offer vaccination services in March 2023.