Paxlovid's expiration date has been extended

6,000 prescriptions a day

While the expiration date of Pfizer's COVID-19 treatment Paxlovid has been changed from 12 months to 18 months, experts said that a six-month extension is reasonable for the volume purchased after approval.

 

According to the minutes of the Central Pharmaceutical Review Committee recently released by the Ministry of Food and Drug Safety, there was a feasibility consultation on the extension of the validity of Paxlovid, and all members agreed to increase the validity of medical field distribution.

 

At the meeting, the Korea Centers for Disease Control and Prevention explained that 1.7 million COVID-19 treatments were introduced as of the end of October last year, leaving 500,000 people in stock, of which Paxlovid accounts for 400,000 to 450,000.

 

Based on the stability test data in December 2021, Paxlovid has been recognized for 18 months as a previous submission data in August last year after initial approval with a validity period of 12 months.

 

However, if the expiration date of the emergency use approved product is extended, the product imported before the change approval is not retroactively applied, so Celltrion submitted additional data on the amount that was suitable for up to 12 months at the time of Paxlovid import.

 

The Korea Centers for Disease Control and Prevention said, "The amount purchased after the approval of the change has an expiration date of 18 months, but the previous purchase is applied to 12 months, so we need a six-month extension," adding, "As of the end of October last year, 380,000 people need to be extended." Currently, about 4,000 pharmacies and medical institutions are storing Paxlovid in a packaged state by tablet, and the Korea Centers for Disease Control and Prevention said it has conducted a full document survey and on-site inspection of pharmacies to see if it is properly stored and managed.

 

When asked by the committee whether it is possible to purchase a new product with an 18-month validity period instead of extending the validity period of Paxlovid, the Korea Centers for Disease Control and Prevention said, "It is important to prevent budget waste with expensive drugs.

 

If there is no safety problem, we will reduce disposal." The Korea Centers for Disease Control and Prevention said, "If a re-test is necessary to extend the validity period, we will proceed with the test as much as possible," adding, "However, there is a concern that the test will take a lot of time and cannot be extended." In response, a member of the committee said, "The key is what data to replace the appropriateness of the storage of on-site supplies," and stressed, "There should be sufficient explanation for the public afterward." The Korea Centers for Disease Control and Prevention said, "If it is extended, we will check the storage condition again, and if the storage is appropriate, we will label the expiration date and check whether it is working." The Commission agreed that the validity period of medical field distribution can be extended by applying the requirements for detailed submissions under the Pharmaceutical Affairs Act to extend the validity period of crisis-responsive medical products.