Vaccine News

Recent Highly Pathogenic Avian Influenza (HAPI) outbreaks in Europe have led France to issue a 'high' alert, forcing poultry farms to keep birds indoors as of December 5, 2023.

The French government wrote, 'continuing strong dynamic of HPAI virus infection recorded in Europe, while the first contamination of a farm had been detected a few days ago in France, has now led the public authorities to place all of the territories at high-risk levels with of HPAI.'

The French Ministry of Agriculture and Food Sovereignty launched a vaccination campaign in October 2023 to reduce the spread of HAPI. The mandatory vaccination of domestic ducks applies to all of Metropolitan France (except Corsica Island).

To better inform the public, the Ministry has published 'Ten Things to Remember About HAPI Vaccination' (posted in French) on November 17, 2023.

Avian influenza, known as bird flu, is harmless in cooked food and spreads among various types of birds, mammals, and even to humans.

Furthermore, the World Health Organization report #907 confirmed sporadic influenza A(H5N1) clade 2.3.4.4b virus detections in humans. 

On September 29, 2023, the U.S. government announced that it restricted the import of poultry from France and its European Union trading partners following France's decision to vaccinate meat ducks against HPAI.

Additionally, the U.S. Centers for Disease Control and Prevention (CDC) published a Technical Report in 2023 that confirmed the overall risk to human health associated with the ongoing outbreaks of highly pathogenic A(H5N1) viruses remains low.

From an outbreak protection perspective, the CDC confirmed in June 2023 that about 20 million H5N1 and 12 million H7N9 vaccines for humans were available in the U.S. National Strategic Stockpile.

Note: This article was updated on Dec. 7, 2023.

Vaxcyte, Inc. today announced the publication of the results from the VAX-24 vaccine candidate's pneumococcal disease (PD) proof-of-concept study in the journal The Lancet Infectious Diseases.

This phase 1/2 clinical trial evaluated the safety, tolerability, and immunogenicity of Vaxcyte's investigational 24-valent, carrier-sparing pneumococcal conjugate vaccine (PCV) compared to the current standard-of-care, Prevnar 20® (PCV20, APEXXNAR), for the prevention of invasive pneumococcal disease (IPD) in healthy adults.

The study results showed that VAX-24 demonstrated a safety and tolerability profile comparable to PCV20 at all doses studied and an immunogenicity profile that met or exceeded established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2 mcg dose.

"The results from the proof-of-concept study provided the first look at the safety and immunogenicity profile of VAX-24 in adults, giving us confidence in the 2.2 mcg dose we plan to advance into Phase 3," said Dr. Jakub Simon, Chief Medical Officer of Vaxcyte, in a press release on December 4, 2023.

"We look forward to initiating our Phase 3 pivotal, non-inferiority study, designed to further establish the clinical potential of VAX-24, and announcing topline data, which we expect in 2025."

PD is an infection caused by Streptococcus pneumoniae bacteria, says the U.S. CDC.

It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis.

People can get pneumococcal disease more than once. A previous pneumococcal infection will not protect you from future infection. Therefore, CDC recommends pneumococcal vaccination even if someone has had pneumococcal disease in the past.

In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in about 150,000 hospitalizations and 5,000 deaths.

Pneumococci also cause over 50% of all cases of bacterial meningitis in the U.S.

As of December 2023, several approved pneumococcal vaccines are available at clinics and pharmacies in the U.S.

With the winter months ahead, most hikers are not focused on catching Lyme disease. However, once the snow melts, millions of people will once again not have access to a vaccine.

There are currently no approved human vaccines for Lyme disease.

To address this significant health risk, Pfizer Inc. and Valneva SE today announced that they have completed recruitment for the Phase 3 clinical trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) for Lyme disease vaccine candidate VLA15.

The VALOR trial, initiated in August 2022, has enrolled 9,437 participants five years of age and older at sites where Lyme disease is highly endemic across the U.S., Europe, and Canada.

As part of the primary vaccination series, participants receive three doses of VLA15 or a saline placebo (1:1 ratio) within the first year and one booster dose approximately one year after completion of the primary immunization.

The trial builds on previous positive Phase 1 and 2 trial results and includes adult and pediatric participants to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.

"Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long-lasting consequences," said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer, in a press release on December 4, 2023.

"If approved, a vaccine could prevent the disease and ease the burden of acute, severe, and sometimes persistent consequences in adults and children."

"We look forward to progressing the trial with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive data."

VLA15 is an alum-adjuvanted formulation administered intramuscularly and has demonstrated a strong immune response and a satisfactory safety profile in pre-clinical and clinical trials.

This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

OspA is a surface protein the bacteria expresses when present in a tick. Blocking OspA inhibits the bacterium's ability to leave the tick and infect humans.

The vaccine candidate covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species prevalent in North America and Europe.

As the multi-year Zika vaccine development process continues in late 2023, the mosquito-spreading disease is impacting more people in the Region of the Americas.

As of December 2, 2023, the Pan American Health Organization's data dashboard indicates there have been 31,780 Zika cases across the Americas, with the highest proportion of Zika cases reported in Brazil, Bolivia, Belize, Columbia, Paraguay, and Venezuela.

Brazil has reported the most Zika cases in 2023, with over 30,000 confirmed cases, primarily in high precipitation areas and low sewage network coverage.

Previous studies conducted in the states of Rio de Janeiro and São Paulo also indicated that temperature influenced the distribution patterns of Zika virus carrying Ae. aegypti and Ae. albopictus mosquitoes, consequently affecting the incidence of diseases they transmit.

While there have not been any Zika cases confirmed in the continental United States in 2023, two frequently visited destinations have reported locally acquired cases.

In the U.S. territory of Puerto Rico, week #44 shows 43 probable Zika cases as of 2023 and 20 cases during 2022.

And in Central America, Costa Rica's Ministry of Health recently confirmed there have been 27 Zika cases confirmed this year. In 2022, there were 45 Zika cases reported in Costa Rica. 

According to the U.S. Centers for Disease Control and Prevention, about 25% of infected people may develop Zika symptoms, and the illness is usually mild, lasting between two and seven days,

However, Congenital Zika-associated syndrome is seen in infants born to mothers with a history of gestational Zika fever. These children may also develop microcephaly.

As of December 2023, various Zika vaccine candidates are conducting clinical trials without any indication of pending U.S. FDA approval. These trials include DNA, modified vaccinia Ankara vector platform, and purified inactivated virus vaccine technologies.

According to the U.S. Centers for Disease Control and Prevention, influenza-related deaths increased during week #47.

As of December 1, 2023, the CDC's Weekly U.S. Influenza Surveillance Report confirmed five additional influenza-associated pediatric deaths occurring during the 2023-2024 flu season were reported to CDC last week.

The CDC's FluView has now reported a total of 8 influenza-associated pediatric deaths.

These new deaths occurred between October 28 and November 25, 2023.

Two pediatric deaths were associated with influenza A(H1N1) viruses, and three were associated with influenza B viruses with no lineage determined.

The vaccination status of these children was not disclosed.

Overall, the weekly flu-related deaths that occurred during weeks #45 (52), #46 (38), and #47 (21) were updated.

Of the deaths reported by the National Center for Health Statistics from October 2022 to September 9, 2023, 9,697 (4%) were listed as influenza. 

As we enter the month of December, the CDC recommends that everyone six months and older get an annual flu vaccine, as there are still vaccines available at clinics and pharmacies.

As of November 18, 2023, about 151 million flu shots had been distributed in the U.S.

People can choose from up to nine different influenza vaccines (nasal, egg, cell-based) for the 2023-2024 flu season.

Since the discovery of the Ebola virus disease (EVD) in 1976, more than 30 outbreaks have been reported in Africa. While Ebola vaccines have been approved for adults, infants have not been protected from the EVD.

Published by The Lancet Global Health in November 2023, this analysis concluded an Ebola vaccine combination was well tolerated and induced strong humoral responses in infants younger than one year.

Furthermore, this phase 2 study concluded there were no safety concerns related to Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo) vaccination.

And the reactogenicity profile comprised mild-to-moderate adverse events (grade 1 or 2). Within seven days of administration of either dose, there were no grade 3 solicited adverse events in the Ebola vaccine group.

The two-dose Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen induced robust antibody responses in 100% of infants 21 days after receiving dose two.

The serum antibody levels declined over the follow-up period, but 93% of the younger and 100% of the older infants were still considered responders 12 months post-dose 1.

In addition to its EMA-approved use in individuals aged one year or older, the results of the current Vaccines & Prevention B.V.-funded study could support the use of Ad26.ZEBOV and MVA-BN-Filo in infants aged 4–11 months, as recommended for off-label use in 2021.

As of November 30, 2023, access to Ebola vaccinations in the U.S. is limited. The U.S. CDC updated its Ebola Overbreak History on August 30, 2023. 

The Pan-American Health Organization (PAHO) recently issued an Epidemiological Alert following an increased number of invasive group A streptococcal (iGAS) infection cases, especially in children.

As of November 28, 2023, Argentina had reported 93 fatal cases.

About half of the 643 cases and over 38% of the deaths involved children younger than 16 years. 

Previous reports of the National Epidemiological Bulletin of Argentina had alerted about the presence of the M1UK clone and the finding of a hypervirulent M1 sublineage that is being characterized.

Based on these findings, the National Reference Laboratory, the Epidemiology Directorate, and its municipalities are implementing an intensified surveillance protocol for non-invasive Streptococcus pyogenes disease.

PAHO noted that Argentina's developments follow an increase in GAS and scarlet fever cases in Europe and Uruguay in 2022.

Streptococcus pyogenes, or GAS, are gram-positive bacteria that cause a broad spectrum of infections. GASs can lead to life-threatening complications and immune-mediated diseases with chronic sequelae.

According to the PAHO, GASs are responsible for more than 500,000 deaths per year worldwide.

According to the U.S. CDC, most people exposed to someone with a group A strep infection should not receive prophylaxis. However, in some situations, healthcare professionals may recommend prophylaxis for someone exposed to an invasive group A strep infection. 

As of November 30, 2023, there is currently no vaccine to prevent group A strep infections, although several vaccines are in development, says the CDC.