Pfizer vaccine doses received by DoH can be used with confidence
Pago Pago, AMERICAN SAMOA — The US Food and Drug Administration has informed the local Health Department that the 3,900 dose shipment of the Pfizer COVID-19 vaccine — which arrived last month and raised local concerns over the quality of doses — are good to be used.
Meanwhile, the Pfizer vaccine will be given to LBJ Medical Center to be used for vaccinations there, while DoH will utilize the Moderna vaccine at its Tafuna Community Health Center, where this week, the next group to get the first dose began on Monday for those 65-years and older.
Local and federal health officials have said that the Pfizer vaccine requires a minus 70 Celsius temperature during transporting and storage.
And when American Samoa received its first shipment of the vaccine, there were two separate shipments and one has 3,900 doses, but the temperature didn’t meet the required temperature while the other shipment was ok for use.
DoH contacted the manufacturer and was given the okay for its usage. It also contacted US FDA, whose official Dr. Philip Krause responded in a Jan. 7, 2021 letter to acting Health director Motusa Tuileama Nua, clarifying some aspects of temperature exposure of the Pfizer vaccine.
Dr. Krause noted that the vaccine received in American Samoa was exposed to temperature of minus 93 Celsius temperature during shipping and stakeholders in the territory raised concerns about the quality of the vaccine handled outside the range of minus 60 degrees Celsius and minus 90 degrees Celsius as stated on the fact sheet.
“I can assure you that FDA reviewers have carefully evaluated the data provided by Pfizer on product that has been exposed to temperature as low as minus 95 degrees Celsius and can state that there are no concerns about the quality of the product or of the ability of the vial to maintain integrity during this temperature excursion,” Dr. Krause wrote to Motusa.
Additionally, FDA is aware of other shipments with exposure to temperatures colder than the fact sheet specific range. Furthermore, FDA will work with the company to make sure that the fact sheets include the information needed to facilitate vaccine use and delivery, and this may include extension of the temperature range.
But, “in the meantime, American Samoa can use these vaccines with confidence,” Dr. Krause concluded.
Speaking at last Thursday’s DoH news conference providing update on the vaccination and repatriation program, DoH Pharmacist, Dr. Francine Amoa told the news media that there have been questions about the Pfizer vaccines “that we have received and had experience a temperature excursion” — referring to the 3,900 doses.
“We have received word from both Pfizer and FDA that those are safe to use. So we have confidence in moving forward in releasing those vaccines for the community at large,” she said and points out that all of those Pfizer vaccines will be taken to the LBJ team for them to administer, and for any Moderna vaccines received by DoH, will be administered at the Tafuna Community Health Center.
“And the purpose of separating it that way, is for ease of use — both on the medical side and less confusion on the community side,” she said
According to health officials, another shipment of Moderna vaccine arrived last Saturday on the weekly cargo flight.
For information on vaccination call 219 or 633-5871. DoH is also putting out daily updates on its Facebook page.