Pharmacists Get Ready: One Dose J&J COVID-19 Vaccine Is Shipping
With emergency use authorization granted in late February to the first single-dose COVID-19 vaccine, pharmacists and other healthcare professionals have another weapon in their fight against the pandemic. Johnson & Johnson was already shipping product by the beginning of March and planned to deliver more than 20 million doses by the end of the month. Here is more information.
NEW BRUNSWICK, NJ -- Johnson & Johnson has begun shipping its single-dose COVID-19 vaccine, developed by its subsidiary Janssen Pharmaceutical Companies. The company says it expects to deliver enough doses by the end of this month to enable full vaccination of more than 20 million people in the United States.
During the first half of this year, 100 million single-shot vaccines will be delivered here, according to a Johnson & Johnson press release. As with the other vaccines, doses will be distributed by the federal government and the states.
The Food and Drug Administration granted emergency use authorization for the vaccine in late February. Shortly thereafter, the national Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the vaccine for adults 18-years-old and older.
The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the spike protein found on the surface of the SARS-CoV-2 virus that causes COVID-19, according to a National Institutes of Health press release, which explains that adenoviruses are a group of viruses that cause infections in the respiratory and gastrointestinal tracts. The adenovirus vector used in the Janssen COVID-19 vaccine has been modified so it no longer can replicate in humans and cause illness, according to the NIH.
Johnson & Johnson points out that is product is compatible with standard vaccine storage and distribution channels and will allow ease of delivery to remote areas. In a press release, the company reports that the vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The product will be shipped using the same cold chain technologies the company uses to transport treatments for cancer, immunological disorders and other medicines; the Janssen COVID-19 vaccine is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F). Pharmacists and other distributors of the vaccine are cautioned not to refreeze it thawed.
“The Janssen COVID-19 vaccine is a very welcome addition to the arsenal of COVID-19 vaccines and other prevention strategies,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “When tested among 45,000 volunteers, the single-injection vaccine proved 77 percent effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85 percent effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. The vaccine was approximately 67 percent effective in preventing moderate-to-severe/critical COVID-19 disease occurring at least 14 days after vaccination and 66 percent effective in preventing moderate-to-severe/critical COVID-19 disease occurring at least 28 days after vaccination.”
Fauci says it is especially important that “the vaccine was 100 percent effective in protecting against death from the disease everywhere it was tested. In addition to meeting the expectations of safety and effectiveness to support emergency use authorization, the Janssen vaccine has the advantage of requiring only a single injection and can be easily transported and stored without special refrigeration requirements.”
In a fact sheet, Johnson & Johnson provides some critical information about dosage and administration. Among the information is that:
- Prior to first puncture of the vaccine vials, unpunctured multi-dose vials of the Janssen COVID-19 vaccine should be stored at 2°C to 8°C (36°F to 46°F) and protected from light. They should not be stored frozen.
- A later revision notes that the vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.
- If vaccine is still frozen upon receipt, it can be thawed at 2°C to 8°C (36°F to 46°F). If needed immediately, it can be thawed at room temperature (maximally 25°C/77°F).
- The company advises that, at room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 2 hours to thaw, and an individual vial will take approximately 1 hour to thaw but should not be refrozen.
- After the first dose has been withdrawn, the vial can be held at between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. As with the other vaccines used, it must be discarded if vaccine is not used within these times.
- The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL). Each dose is 0.5 mL, and each vial contains five doses.