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Hundreds of San Diego State University students vaccinated against meningococcal B-type meningitis at Viejas Arena on October 5 and 8 must receive replacement vaccines after Walgreens Inc. has determined that doses delivered had been manipulated incorrectly.
In a brief statement, the company said "to have realized that the temperature of the vaccine at the time of administration was not optimal" for 350 students vaccinated by staff of the pharmacy chain during two mass vaccination clinics, triggered by a three-case survey. outbreak that the county declared in September.
The company said it believed that a new vaccination was needed to ensure "full vaccine effectiveness", but assured the students and their families that receiving an off-temperature vaccine "poses no associated safety risk." ".
Dr. Wilma Wooten, San Diego County Public Health Officer, said Friday morning that Walgreens claims were accurate. The studies, she said, did not reveal any safety concerns when the vaccines are not kept in the appropriate temperature ranges.
"The loss of efficiency is the main problem that can occur when the proper temperature is not maintained," Wooten said.
A research paper published in 2018 by the US Centers for Disease Control and Prevention reviewed five years of data from the National Vaccine Adverse Event Reporting System and discovered 476 reports of vaccines used after being kept out of range recommended temperature.
The researchers found that 32 of these reports involved patients who had adverse reactions to the vaccine. Minor "local reactions", such as swelling and pain or redness at the injection site, were the most common consequences of administering an off-temperature vaccine.
Many different vaccines, and all those targeting meningococcal disease, require refrigeration to maintain their effectiveness.
Inserts approved by the US Food and Drug Administration indicate that Bexsero and Trumenba, the only two Type B vaccines on the market, must be refrigerated at all times and kept between 36 and 46 degrees Fahrenheit.
In general, on-site vaccinations, such as those at Viejas Arena, use special coolers equipped with digital "recorder" thermometers to maintain vaccine temperature during transport. These special temperature indicators must have formal accuracy certifications that allow public health investigators to verify that vaccines have always been stored at the appropriate temperature.
This is a chain of custody that has presented additional complexity during the recent vaccination campaign against hepatitis A from the county's Department of Health, which sent small teams of health nurses public, paramedics and other health personnel in camps of different locations to give more than 100,000 doses. At all times, all persons doing this work should be trained in the correct use of temperature measuring equipment in order to maintain the supply of vaccines within the specified temperature range, even when working outdoors during hottest months of the year.
Wooten said all county employees who handle the vaccines, including herself, must undergo annual training on proper handling procedures.
On Friday morning, it was unclear whether Walgreens employees had received similar training or how long the vaccines in question had been kept outside the appropriate temperature range. A spokesman for the company said that this additional information was not available.
Wooten said the county health department was not investigating such incidents, which fall under the jurisdiction of the California Department of Public Health.
In addition to Walgreens, Kaiser Permanente nurses and county public health nurses attended the two vaccination events in early October in the Viejas arena. Wooten stated that about 3,000 doses were administered by the three organizations during the event and that all doses given by Kaiser or county nurses met the temperature requirements.
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Twitter: @paulsisson
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