Two new COVID-19 vaccines on the horizon
Absolute Pharmacy prepares for vaccine distribution
There is hope on the horizon in the fight against COVID-19.
Pfizer and Moderna have both recently concluded trials and submitted their vaccine data to the FDA for review, with a request for emergency use approval (EUA). The two companies’ results are very similar and highly encouraging with 95% efficacy.
Both companies used messenger RNA (mRNA) to create the vaccine, which can trigger immune cells (antibodies) to defend against the COVID-19 virus. This is the same process used to create the SARS-CoV-2 vaccines that are considered safe and reliable. However, there is still a lot to learn about immunogenicity with COVID-19.
It is hopeful the FDA will approve a vaccine for administration in this month. The plan is to use this phase 1 vaccine for front line health care workers and residents in congregate living settings. The vaccines have the complexity of requiring cold chain management due to a short shelf life. Additionally, they require two doses 21 or 28 days apart. Planning is already occurring on how to immediately distribute and vaccinate this critical part of the population and will need to be done with a well thought out plan.
Distributing the COVID-19 vaccine
For many months Absolute Pharmacy has been a participant in “Operation Warp Speed,” a Department of Defense led vaccine committee, and we are designated as a Strike Force Unit. This means we have completed all of the requirements to participate in all phases of vaccine distribution and administration.
We are anxiously awaiting FDA approval and our opportunity to be awarded the vaccine based on an allocation schedule. At first, the vaccine will be in scarce supply and will require a detailed pre-plan to avoid waste and quickly immunize at-risk populations.
The news media reports some public apprehension regarding the vaccine. But the two companies’ early results are nearly identical – with both reporting very good, consistent data. This creates validation that lends credibility to the safety profiles. Additionally, the process of manufacturing vaccines is well established with a safe profile history.
In terms of supply, there are several other vaccines that will quickly follow phase 1, and we anticipate high availability by early summer. We believe both data and history are on our side of creating a solution that will impact this virus with a low degree of risk.
Lastly, the FDA has issued an EUA for a monoclonal antibody therapy called Bamlanivimab, made by Eli Lilly, for the treatment of mild-to-moderate COVID-19 cases in adult and pediatric patients. This drug can be used with those who are 65 years of age or older and will be covered by Medicare. It’s a one-time infusion for patients who are not hospitalized. It’s currently in short supply and being controlled by state departments of health, but production is being ramped up to bolster supplies.
There is hope and optimism in ending this pandemic; we hope to be part of the solution.