With the FDA's emergency authorization of Pfizer's COVID-19 vaccine granted Dec. 12, health systems around the country are preparing to receive the first doses and quickly vaccinate their workers, who were determined by the CDC to be first in line.
Michael Parry, MD, chair of infectious diseases at Stamford (Conn.) Health, recently spoke with Becker's about his health system's plans once they receive their allotment of COVID-19 vaccines, how they will prioritize their workers and the need for more studies on the vaccine's long-term effects.
Stamford's vaccine prioritization plan
Stamford is set to initially receive just shy of 1,000 doses of the vaccine during the first round of distribution. Dr. Parry said the system is aiming to have vaccines on site by Dec. 15 and start administering vaccinations within a day or two.
The health system has been talking to the state of Connecticut at least once a week, often several times a week, to create its vaccine distribution plans, Dr. Parry said. The plan is to prioritize hospital staff who come in direct contact with COVID-19 patients or those who are potentially infected, particularly emergency room and ICU staff, respiratory therapists, physicians and nurses.
All hospital employees are at relatively high risk, however, and Dr. Parry said he believes that within the first three weeks of a vaccine being on the market the health system will receive enough doses to vaccinate almost all workers who want to be vaccinated.
How to make sure people come back for their second vaccine dose
Pfizer's vaccine requires two doses given three weeks apart. It's essential for patients to come back for a second dose, and Stamford will try to ensure they do by using the Vaccine Administration Management System, or VAMS, software created by the CDC.
VAMS will send patients a reminder to get their second vaccine and allow the health system to track patients.
"Multiple vaccines require more than one dose, such as hepatitis, HPV and many pediatric vaccines, so we're used to tracking multiple-dose vaccines," Dr. Parry said.
VAMS software can also be used to create a scheduling system for patients to come get their vaccines as well as a reporting system for adverse events and an inventory system for vaccines.
People receiving the vaccine will also be given an app for their smartphones created by the CDC through which they can report any adverse reactions they may have to the vaccine.
"I think there will be very robust adverse reporting through multiple modes," Dr. Parry said.
The need for more vaccine durability data
Because of the expedited timeline vaccine developers have had to create a COVID-19 vaccine, researchers don't know how effective the vaccines are beyond a few months. It will be critical to monitor patients to see what immunity levels are at six months, 12 months and two years after the second dose, Dr. Parry said.
But it may be hard to do so by continuing clinical trials. Once a vaccine is authorized, it may be considered unethical to continue a placebo arm of trials and deny those people a vaccine.
"Ethically, you don't want to withhold vaccines from those who got a placebo if they want to get a vaccine," Dr. Parry said.
Instead, researchers may have to rely on population data to track the vaccine's effectiveness. They will have to conduct observational studies over time to see the vaccine's effects, Dr. Parry said.