On June 5, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBAC) and FDA panel met and unanimously voted for the JN.1 strain for the new fall 2024-25 COVID-19 vaccine formulation. A week later, based on updated data, the FDA asked the vaccine manufacturers to focus on the KP.2 and KP.3 strains of the JN.1 lineage as they are becoming the more dominant strains. It is anticipated that the change requested by the FDA will not cause any delays in the manufacturing of the new formulations.
The vaccine manufacturers (Pfizer, Moderna) expect the new vaccine will be available mid to late August, while Novavax anticipates a slightly later release in September but still in time to begin the fall vaccine administrations once the final approval is received by the FDA. The current COVID-19 2023-24 vaccine is still approved for administration, likely for the remainder of the summer, however, production of the 2023-24 formulation has stopped as manufacturers gear for the new formulation.
Currently, Pfizer has stopped shipping all 2023-24 from Pfizer direct. Going forward, additional doses of Pfizer and Moderna may be obtained through regular wholesalers or vendors IF they have any more stock remaining. Once the 2023-24 is completely depleted from all Vendors, facilities should wait until the new formulation is available early fall.
Facilities are encouraged to review all patients who did not receive any vaccine or dose of the 2023-24 formula and administer it as a priority for those patients. For all others who have already received at least one dose of the 2023-24 formula in recent months, it may be beneficial to wait for the new formulation at the discretion of the healthcare provider and facility protocol.
The ACIP and CDC advisory group made official recommendations on June 27, 2024, for who should get the new vaccine in the fall. They continue to support vaccination against Covid-19 with one dose of the new 2024-25 formulation in all individuals ages 6 months and older irrespective of whether they were previously vaccinated for COVID-19.
As temperatures rise and weather conditions become more unpredictable, SpecialtyRx takes proactive steps to ensure the safety, efficacy, and availability of medications across all of our facilities — especially in regions where heat and extreme weather are seasonal challenges.
Our focus is clear: to preserve medication integrity and support uninterrupted patient care, regardless of the forecast.
At SpecialtyRx, we begin preparing for the summer heat well in advance. Our pharmacy and logistics teams review and reinforce best practices for cold chain management and delivery protocols to ensure the protection of temperature-sensitive medications.
Here's how we ensure medications stay within the proper range during transport:
Temperature fluctuations can compromise the efficacy of medications and lead to waste. That’s why we remain vigilant — because patient safety is non-negotiable.
Summer weather can bring hurricanes, flash floods, and other natural disasters — especially in the southern regions we serve. SpecialtyRx maintains comprehensive emergency preparedness plans to ensure timely medication delivery and operational continuity in the event of any crisis.
Above all, we prioritize clear and proactive communication with facility teams to ensure that everyone is aligned and supported.
To help our partners stay prepared, we recommend the following actions:
May 6th was World Asthma Day, and SpecialtyRx is here to give you all the latest updates around Asthma guidelines!
The Global Asthma Initiative (GINA) has updated its guidelines for 2025. Some ofthe key changes include looking at additional biomarkers for Type 2 inflammation,additional risk factors for severe exacerbation in adults, including environmentalfactors and air quality that they are exposed to, and the impact of extreme weather.The diagnosis criteria have also been updated for clarity because variability insymptoms and expiratory airflow are two distinct characteristics of Asthma.Additionally, a reference to a calculator of peak expiratory flow variability was alsoadded.
Treatment recommendations for adults are in two treatment tracks for better clarity,and due to poor access to some preferred combination inhaled products. The mainkey difference is the medication that is used for symptom relief. Track one maintainsan"as needed" inhaled corticosteroid (ICS) - formoterol combination product such asSymbicort or Dulera as the preferred treatment approach. Formoterol substantiallyreduces the risk of severe exacerbations and systemic corticosteroid exposure ascompared to short-acting beta agonists (SABA) based regimens. Also, thecombination products provide a simpler regimen and better overall compliance.
Track 2 uses the alternative approach of “as needed” SABA or as needed ICS-SABA(ie, Airsupra -combo product or albuterol and a steroid inhaler separately), which maybe a good option for patients with controlled stable asthma and no exacerbations. Itis recommended to ensure the patient is good with medication adherence beforeusing one of these suggested products.
The U.S. Department of Veterans Affairs (VA) and Department of Defense alsoreleased updated clinical practice guidelines for Asthma in March 2025. Like the GINAguidelines, the VA also makes strong recommendations for the use of ICS incombination with a long-acting beta agonist (LABA) such as formoterol as both acontroller and reliever for those with uncontrolled asthma.
Lastly, the latest studies show that the use of Proton Pump Inhibitors (PPI) has beenassociated with increased asthma incidence. While PPIs are used to manage GERD,which itself can also worsen symptoms of asthma, the use of PPIs may not be thebest option in asthma patients. If there are residents who are on PPIs and seem tocontinue having asthma that is uncontrolled, consider switching to an H2-receptorantagonist such as famotidine or ranitidine.
Asthma is a chronic condition that can affect many residents in the nursing homesetting. Proper management by identifying triggers, educating residents and staff,and having up-to-date knowledge of new and preferred treatment options can begreatly beneficial in better controlling and reducing asthma exacerbations in theelderly.
Covid-19 Updates
On March 1, 2024 the CDC updated their guidelines. An additional dose of the Covid-19 202324 vaccine has been approved for individuals over the age of 65. This dose can be administered 4 months after the previous dose.
The FDA issued a new Emergency Use Authorization (EUA) on March 22, 2024 for Pemgarda (pemivibart). This medication can be used for the prevention of Covid-19 as a pre-exposure prophylaxis treatment.
This is the first treatment to be used a “pre exposure medication” Pemgarda is for individuals over the after of 12 or at least weighing 40kg, who are not infected with the virus AND have not had recent exposure to Covid-19. It is only to be considered for individuals that are moderate to severe immune compromised where vaccine will likely not provide adequate immune response.
Statins are the first line treatment for cardiovascular disease-atherosclerosis, more simply put, the high cholesterol. However, since these medications also have known associated risks in the elderly, the effects of it in older patients with multiple comorbidities, including dementia was not available and it was broadly recommended to avoid statins.
Recently, after extensive review in this population, the use of statins has been associated with improved mortality in the elderly, including those with dementia
The take home message is that these medications might improve the quality of life by reducing the risk for cardiovascular events in the elderly including those with dementia and this is something to consider in the nursing home setting. Perhaps it is important to look at the bigger picture of the benefit these medications can provide before recommending to de-prescribe statins.
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