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Following any infection, your immune system will create antibodies to defend itself and store these blueprints for later in case they are needed again. Many of our vaccines attempt to replicate this response without the detrimental effects of actually contracting the virus. Inactivated vaccines, like the quadrivalent flu shot, take bits and pieces of virus particles that are grown in eggs (that is why they always ask if you have an egg allergy) and these stimulate the immune response.
The MRNA covid vaccines exploit this same principle but instead of inactivated virus particles, it contains small bits of RNA that are taken up by our own cells. Then much like how the virus itself replicates, our cellular machinery copies the code and makes the virus spike particle which causes the immune response. All this just to aid our bodies in learning how to fight off the infection.
What if we just had Covid-19 antibodies that we could give as an effective therapeutic? Turns out we do and they are called monoclonal antibodies. We know what covid antibodies look like that is how we test for them after all so we can most certainly just make them in a lab. While it is not quite that simple, it is possible and Regeneron has accomplished this feat.
Initially referred to as the Regeneron Cocktail, a 50/50 mix of casirivimab and imdevimab (brand name REGEN-COV) has proven to be very effective, likely saving the previous president’s life to the pleasure and dismay simultaneously of half the country. It does carry a hefty price tag at around $1,250 a dose but the government has already put it on their tab so it will be no cost to the patient for the drug. That does not include administration fees and other associated costs that come with IV or Subcutaneous infusion the patient may be liable for. Competitors have also entered the playing field with Glaxo Smith Kline and Vir agreeing to distribute their drug sotrovimab under the brand name Xevudy in Australia where it has approval for almost $2,000 a dose. They obtained emergency use authorization from the FDA as well in May. Eli Lilly also has received FDA emergency use approval for two of its antibody drugs, bamlanivimab and etesevimab.
REGEN-COV has been available in the United States under an emergency use authorization since last November. Recently though, it has been back in the news as use has spiked in certain states. In response, on September 3, HHS made changes to the ordering and distribution process. In what they are calling “A temporary change” to “promote optimal and equitable use of the available supply”. In the same statement, they also say “It remains the goal of the federal government to ensure the continued availability of these drugs for current and future patients.” The following actions were taken to achieve these goals.
- Limiting immediate orders and shipment only to administration sites with HHSProtect accounts and current utilization reporting
- Reviewing all orders for alignment with utilization, currently estimated at 70% of orders
In order to ensure the continued availability of this life-saving product, the government has put a halt to some orders and shipments and placed additional roadblocks in the way of obtaining the medication. Direct ordering of the product because you need it will no longer occur and how much you get will be decided by the HHS in coordination with state and local officials. You can check your state’s allocation here: State/Territory-Coordinated Distribution of COVID-19 Monoclonal Antibody Therapeutics (September 21, 2021) (phe.gov)
The idea of having some strategic stockpile for whatever reason has never made much sense to me. We can make more of the medication and if we used every dose to potentially save a life, why should that be frowned upon? What good does it do to have some extra doses sitting on a shelf until they expire? Meanwhile on the ground, these actions can have real consequences as local restrictions may result in fewer patients obtaining therapy. As a workaround, Florida has announced its intention to purchase the GSK product sotrovimab to help offset its reduced availability of REGEN-COV thanks to their new allocation.
Jacob Hyatt, Pharm D.
Father of three, Pharmacist, Realtor, Landlord, Independent Health and Medicine Reporter
Further Reading and References:
An EUA for casirivimab and imdevimab for COVID-19. Med Lett Drugs Ther. 2020 Dec 28;62(1614):201-202. PMID: 33451174.Published in