Vaccine News

The U.S. Food and Drug Administration (FDA) today announced it approved the nasal influenza vaccine FluMist® for self- or caregiver-administration by adults. This innovative flu shot is sprayed into the nose and has been used safely and effectively for many years.

It is the first influenza vaccine that does not need to be administered by a healthcare provider. 

FluMist has been FDA-approved for preventing influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age for two decades. It was initially approved by the FDA in 2003. In 2007, the FDA approved using FluMist to include children 2 through 5.

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies, AstraZeneca, said in a press release, “The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza."

The vaccine may be administered by a health care provider in a health care setting (including a pharmacy) or by the vaccine recipient or a caregiver who is 18 years of age or older. Vaccine recipients and caregivers who administer FluMist will receive the vaccine, the Prescribing Information, Information for Patients and their Caregivers, and Instructions for Use. 

“Today’s approval of the first influenza vaccine for self- or caregiver administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility, and accessibility for individuals and families,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on September 20, 2024.

FluMist remains available at various clinics and pharmacies for the 2024-2025 flu season.

AstraZeneca markets FluMist® under the Fluenz® Tetra brand internationally.

The U.S. Centers for Disease Control and Prevention (CDC) recently reported that Respiratory Virus (RSV) activity remained low but is expected to increase.

In the U.S., the annual RSV season usually begins in Florida and then migrates to the southeast, later to the north and west regions. 

As of September 17, 2024, week #37, the Florida Department of Health reported increasing RSV positivity rates, decreasing hospital admissions, and no RSV outbreaks.

A recent study found that over the past few years, about 53% of children were infected with RSV during infancy, and 2.8% were hospitalized. 

Unlike previous RSV seasons, the U.S. is well prepared to reduce the impact of this respiratory disease.

As of September 20, 2024, three RSV vaccines have been approved, and the CDC recommends a passive immunization (Beyfortus™ (Nirsevimab-alip) for most infants. Based on each state, these U.S. FDA-approved products are offered at health clinics and pharmacies. 

GSK plc recently announced topline Phase 3 clinical trial data for a combination regimen of two of its vaccines: the RSV vaccine Arexvy and Shingrix, a market-leading shingles shot.

While GSK did not provide specific clinical trial (NCT05966090) data in its September 18, 2024 announcement, the company did confirm that co-administering Arexvy with Shingrix resulted in a “non-inferior immune response” compared with inoculation with the vaccines at separate visits.

The vaccine combo was also well-tolerated with an “acceptable” safety profile, according to GSK.

This is essential news as both RSV and shingles pose significant health risks to older adults, and these risks only increase with age as the immune system declines.

“With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles,” Led Friedland, GSK’s vice president of scientific affairs and public health, said in the statement.

Results from this trial will be submitted for peer-reviewed scientific publication and used to support regulatory submissions to the U.S. FDA, the European Medicines Agency, and other regulators.

According to the Times of India, 267 chikungunya cases were reported in Mumbai, India, between July and September 14, 2024. This data indicates India may exceed last year's 200,000 reported chikungunya cases.

BMC's health update on September 16, 2024, stated that doctors have confirmed that patients with mosquito-borne diseases, dengue, and chikungunya are being admitted to the Mumbai hospital with complaints of very high fever, vomiting, and severe body aches.

"Patients with chikungunya are literally bedridden due to debilitating joint pain and high temperatures,'' Dr Gautam Bhansali from Bombay Hospital informed the TOI.

The public health concern is that this viral disease may spread within Mumbai's 12 million residents.

Chikungunya disease was initially reported in India in 1963, and as of September 2024, every part of the country has become endemic.

The U.S. CDC stated in 2024 that the Chikungunya vaccination may be considered for certain visitors in India. The CDC recommends prospective travelers to India speak with a travel vaccine expert about Valneva SE's IXCHIQ® single-dose, live-attenuated chikungunya vaccine, at least one month before departure.

About 1.3 million U.S. travelers visited India last year.

IXCHIQ is available at various health clinics and pharmacies in the U.S.

Based on today's announcement by Valneva SE, adolescents may soon have access to the only approved chikungunya vaccine. This is essential news as the chikungunya virus (CHIKV) has now been identified in over 110 countries in Asia, Africa, Europe, and the Americas. 

On September 18, 2024, Valneva submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its approved chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada.

The Canadian label extension application also includes two-year antibody persistence data, a key differentiator for IXCHIQ® that was already included in the initial EMA filing.

Valneva expects to submit data to the U.S. Food and Drug Administration (FDA) in 2024 to support potential label extensions in the U.S.

IXCHIQ is currently approved in the U.S., Europe, and Canada to prevent disease caused by mosquito-spreading CHIKV in individuals 18 and older.

In the U.S., the commercial launch is underway, as IXCHIQ is available at health clinics and pharmacies.

First sales in Canada and Europe are anticipated in the fourth quarter of 2024.

In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access.

The Company expects a marketing authorization in Brazil in the second half of 2024 and recently expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access to the vaccine in Low Middle-Income Countries, post-marketing trials, and potential label extensions in children, adolescents, and pregnant women.

CEPI previously confirmed it will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s Horizon Europe program.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups."

"This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness, which is currently spreading in areas that were previously unaffected."

"The durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.”

EMA and Health Canada’s label extension applications are based on positive six-month adolescent Phase 3 data the Company reported in May 2024. These data showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents and that the vaccine was generally well tolerated. 

The Lancet Infectious Diseases also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 28 days after a single injection, regardless of previous CHIKV infection.

In addition to the adolescent data, Health Canada’s label extension application included IXCHIQ®‘s antibody persistence data, which showed that 97% of participants sustained the vaccine’s immune response for 24 months and was equally durable in younger and older adults.

Valneva expects to publish 36 months of persistence data later in 2024.

According to an analysis from the U.S. Centers for Disease Control and Prevention (CDC) and published by NEJM Evidence on September 13, 2024, SIGA Technologies, Inc. mpox treatment tecovirimat (TPOXX®) safety and effectiveness against the monkeypox virus clade 2 virus can't be determined from data.

CDC researchers evaluated data from over 7,100 patients prescribed tecovirimat, a virostatic antiviral drug, from May 29, 2022, through July 10, 2023.

They wrote, 'Although relatively few serious adverse events (SAEs) were reported, because of the passive nature of reporting, we cannot definitively conclude that tecovirimat treatment was always safe. Similar to data from case reports and other published observational studies, our data, in the absence of comparison data from untreated patients, cannot be used to infer clinical effectiveness, or lack thereof, of tecovirimat treatment.'

Overall, 223 SAEs and 40 deaths were reported. Most events were among patients who were severely immunocompromised.

Despite the inclusion of many patients with severe disease for whom the CDC was consulted, outcomes were favorable for most of the treated patients in this cohort.

This analysis did not review the current mpox clade 1 outbreak impacting countries in Africa.

With over 723 deaths from different mpox outbreaks in 14 countries of the African Region, the World Health Organization (WHO) has expanded access to one mpox vaccine.

On September 13, 2024, the WHO announced Bavarian Nordic A/S's MVA-BN (JYNNEOS®) vaccine is the first vaccine against mpox to be added to its prequalification list.

“The WHO prequalification of the MVA-BN vaccine will help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi and Unicef to help communities on the frontlines of the ongoing emergency in Africa and beyond,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, in a press release.

While MVA-BN is currently not licensed for persons under 18, this vaccine may be used “off-label” in infants, children, adolescents, pregnant women, and immunocompromised people. This means vaccine use is recommended in outbreak settings where the benefits of vaccination outweigh the potential risks.

Additionally, the WHO also recommends single-dose use in supply-constrained outbreak situations. 

Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “We are progressing with prequalification and emergency use listing procedures with manufacturers of two other mpox vaccines: LC-16 and ACAM2000."

The escalating mpox clade 1 outbreak in the Democratic Republic of the Congo and other countries was declared an emergency by the WHO Director-General on August 14, 2024. 

As of mid-Agust 2024, the United States has not reported mpox clade 1 cases, but the JYNNEOS vaccine is commercially available at select clinics and pharmacies.