The Ministry of Public Health (MSP) clarified this Friday that the extension of the expiration date of vaccines and medicines “it is a common practice” in the portfolio and is done through a process “regulated and with the maximum guarantees”.
The clarification arises after some users warned that the vials of the Pfizer vaccines against covid-19 that are being administered in Uruguay had written on the expiration label: “09/2022”.
In a statement, from the portfolio they say that the vaccines against covid-19 supplied in Uruguay “are submitted to registration” before the Department of Medicines of the MSP “with stability studies”. These studies must be approved by international reference regulatory authorities such as the FDA (Food and Drugs Administration) and the EMA (European Medicines Agency).
That is to say: the laboratory carries out its studies and presents the documentation to the regulatory agencies. The latter analyze the samples, carry out their own independent studies, and validate the vaccines in periods of six months “to certify their efficacy, safety, and useful life.”
In the case of vaccines against covid-19, the Pfizer laboratory had obtained a first validation with six months of expiration. Later, she achieved a second certification for one year. And in December it was extended to a year and a half (18 months).
“The most important thing is that the stability of the biological is studied with absolute rigor,” he explained to The Observer Gabriel Peluffo, director of Immunizations of the MSP.
How does the MSP extend expiration dates?
The extension of expiration dates is achieved when Pfizer submits to the Department of Medicines of the MSP “new stability studies and certificates of approval” from the EMA and the FDA.
Uruguay does not carry out its own trials, but rather relies (as with the rest of medicines and vaccines) on international reference agencies.
Since Pfizer complied with these requirements, the batches of the vaccines that are administered (including the booster that is being given to the population over 50 years of age), have the new expiration date for 06/30/2023 and 07/30/2023.
In this sense, the official statement concludes: “The Ministry guarantees the population that the anti-covid-19 vaccines that are being administered have the technical endorsement that enables their use and guarantees their safety and efficacy.”
Despite the modification of the date, it is prohibited the change in the label of the bottles (vials). Happens that The regulations do not allow overprinting on medicines and vaccines, even though their administration is authorized. In this case, the validity of the vaccines administered in Uruguay (that is, the verification that they are still on date to be supplied) is controlled by the Laboratory of the Fight against Tuberculosis and Prevalent Diseases.
