School is back in session! Preparing for the new school year can be challenging as parents shop for new school clothes or supplies to ensure their children are ready for the year. It is important to also consider how to prepare them to stay healthy during the school year. Children are exposed to germs, illnesses and accidents, and parents can prepare for the year by ensuring prescriptions are refilled and accurate, and vaccines are up to date.
Neffy - Intranasal Epinephrine
Children are exposed to many foods and other allergens at school that may result in an anaphylactic reaction. Anaphylaxis is a severe, life-threatening allergic reaction that may be the result of ingestion or exposure to milk, peanuts, eggs or non-food allergens like insect stings. Life-threatening anaphylaxis reactions result in 500,000 emergency room visits each year. For decades, the only treatment for anaphylactic reactions was an epinephrine autoinjector injection. These are marker- sized dosage forms that require the user to inject themselves into the muscle of their thigh. However, in August, a new dosage form called Neffy was approved. Rather than an autoinjector, this device administered epinephrine via a nasal spray. Approval was based on studies showing comparable epinephrine levels in the blood to injectable forms, with similar effects on blood pressure and heart rate.
Neffy is the first non-needle epinephrine dosage form for severe allergic reactions and the first new delivery method for epinephrine in more than 35 years. Neffy is administered as a single dose into one nostril, with a second dose if needed. Currently, Neffy is approved for children and adults who weigh at least 66 pounds. The product became available on the market in September. The manufacturer of Neffy, ARS Pharma, is also seeking approval from the FDA for a lower dose product for children who weigh 33-66 pounds by the end of 2024.
This novel dosage form of epinephrine offers multiple benefits. Neffy uses the same spray device as Narcan, a nasal spray for opioid overdose. The nasal spray reduces barriers to quick treatment, particularly for needle-phobic patients, including children. Another benefit is the extended shelf life of the nasal spray. Neffy has a shelf life of 30 months — much longer than the autoinjectors which typically last 18 months. Users of epinephrine must remember to check the expiration date and replace their devices before they expire to ensure they always have access to their life-saving medication. The extended shelf life of Neffy reduces the frequency of replacing epinephrine products. In addition, the nasal product can tolerate more extreme temperatures. It can withstand higher temperatures, up to 122 degrees, making it a potentially effective treatment if left in a car or outside for any length of time. If accidentally frozen, Neffy can be thawed and administered. However, a major drawback of Neffy is the associated cost. A two-pack of the medication is about $710 compared to the autoinjector which is $150.
ARS Pharma expects Neffy to be widely adopted, similar to Narcan’s uptake, due to the ease of administration. Medical professionals express optimism, noting that Neffy could save lives by providing a safer, easier-to-use option for treating anaphylaxis, particularly for needle-phobic patients. It may also be included in emergency kits for public places like airplanes and restaurants.
Vaccines - Influenza and COVID-19
Importance of Childhood Vaccines
Vaccines are critical in protecting children and the community against circulating diseases. For years, the country has benefited from herd immunity, which is when a large part of the population of an area is immune to a specific disease. However, in order for an area to benefit, at least 95% of the population must be vaccinated. The country is facing a challenge because parents are choosing not to vaccinate their children against diseases like measles, mumps, rubella, whooping cough, chicken pox, meningitis and the flu. Most parents still support childhood vaccinations. However, kindergarten exemptions rose to a median of 3.3% nationally during the 2022-2023 school year compared to 2.7% the year before. This hesitancy may stem from the fear of the long-term effects of vaccinating at a young age, religious reasons or just ease of opting out.
The consequences of a lower vaccination rate are evident in the most recent measles outbreak in Oregon, the largest measles outbreak in the state since 1991. If the vaccination rate continues to decline, the country may be faced with further outbreaks, so it is important to continue to educate the population on the risks.
Influenza
The US Centers for Disease Control and Prevention (CDC) recommends that every person aged six months or older should receive an influenza and COVID-19 shot annually. Flu vaccines stimulate antibodies in the body about two weeks after vaccination, which offer protection against the influenza virus. Each season new flu vaccines are manufactured based on which strains made people sick the previous season, the extent those viruses are spreading prior to the upcoming flu season, the efficacy of the previous season’s vaccine and the ability of the vaccine to provide cross-protection against a range of flu strains. Since the 2013-2014 season, flu vaccines have been quadrivalent, meaning they protected against four groups of influenza: flu A(H1), flu A (H3), flu B/Yamagata lineage virus and flu B/Victoria lineage virus. For the first time in over a decade, this 2024-2025 flu season will not be quadrivalent. This year, the vaccines will be trivalent, only protecting against three strains: flu A (H1), flu A(H3), and the flu B/Victoria. Based on the most recent data, the FDA determined the flu B/Yamagata strain no longer poses a public health threat and, therefore, should be removed from the vaccine formulation.
Flu season changes every year but can start as early as October and peaks between December and February. Vaccination against the flu is ideally in September or October but continues throughout the year if the flu is circulating. Flu vaccines are widely available at physician offices and at local pharmacies and can be administered by both providers. These vaccines are typically $0 to the member and cost the plan $20-$30 for the ingredient cost plus a $20 administration fee.
COVID-19
The COVID-19 vaccines share a few similarities with influenza vaccines. Like the flu vaccines, the CDC recommends everyone aged six months or older receive this season’s COVID-19 vaccine to protect against the COVID-19 virus. COVID-19 vaccines are also manufactured each year based on the circulating strains. Last year, COVID-19 vaccines protected against Omicron XBB.1.5. However, this year the prominent lineage is JN.1, which has several variants, including the KP.2 strain. Both Moderna and Pfizer-BioNTech will contain the specific KP.2 strain, whereas Novavax targets the JN.1 lineage. Receiving any COVID-19 vaccines will help prevent infection from the circulation strains and reduce the chance of long COVID-19, which can reoccur following an acute infection and remain for an extended duration.
Previously, COVID-19 vaccines fell under the Public Health Emergency (PHE). The ingredient cost was covered by the government and plans only had to cover a $40 administration cost. Once PHE expired on May 11, 2023, COVID-19 vaccines were required to be covered under insurance plans. Now the average ingredient cost is $130-$150 plus a $20 administration fee.
Sources:
- Tina Reed. “Vaccine Hesitancy Eats into Back-to-School Shots,” Axios, 2024.
- CDC Newsroom. “CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season,” CDC, 2024.
- FDA News Release. “FDA Approves First Nasal Spray for Treatment of Anaphylaxis,” FDA, 2024.
- Amy Isler. “After 35 Years, the EpiPen Gets a Needle-Free Alternative,” Verywell Health, 2024.