Millions of doses of unused vaccines. AIFA moves the expiration date

Fedaisf editorial staff

May 30, 2022

L'who let it be known that a new supply of serums would appear to be ready for October, updated to the new variants of the virus, but the problem of unused vaccines remains, which affects all regions from north to south.

As also stated by the Senator of the Brothers of Italy Francesco Zaffini in aparliamentary question to the Minister of Health, the 90% of the Italian population over 12 has completed the vaccination cycle: a percentage that corresponds to 51 million people.

Despite the large numbers vaccine doses are in surplus: overall, in fact, almost 142 million had been delivered to the regions, then administered only 137 and a half million.
We therefore find ourselves with a deficit of almost 4 and a half million vaccine doses which, to date, are not updated with the new variants of the virus but above all in correspondence with the deadline. This is certainly due to a lack of rush to the third and fourth dose which, lately, thanks to the lowering of infections and the dangerousness of the virus, has not happened.

The expiration date of the remaining doses is between June and August 2022, which is why the regions have raised an alarm. In response, Aifa, at the suggestion of the pharmaceutical company PfizerBiontech, he decided to extend the shelf life of the drug: from six months to nine months. The old expiry date was therefore moved up by three months.

The government has remained silent on this, so much so that there is no trace of this news in any newspaper: the purpose of the'interrogation of Sen. Sapphires è proprio in questa direzione infatti chiede di sapere: “come il Governo intenda collocare le migliaia di dosi prossime alla scadenza; se e quante dosi di vaccino siano state ad oggi distrutte in Italia, perché scadute prima che potessero essere inoculate; in quale modo intenda proseguire la campagna vaccinale e quantificare l’approvvigionamento necessario“.

Source Bianca Leonardi, 29 maggio 2022 – N.Porro

AIFA. LIST OF COMIRNATY BATCHES SUBJECT TO THE EXTENSION OF THE VALIDITY PERIOD FOR FROZEN VIALS (Valid as of May 23, 2022) Ed: 12 months

Legislatura 18ª – Atto di Sindacato Ispettivo n. 3-03343

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St vizzera. Covid-19, al macero 620’000 dosi di vaccino

Note:

Pfizer and BioNTech presented a swissmedic, the pharmacovigilance authority of Switzerland, an application to change the shelf life and make it of 12 months, instead of 9 months, for the Comirnaty, the preparation a mRna used in the vaccination campaign against Sars-Cov-2.

The institute, after reviewing the application, approved the extension of the drug's expiration date. The extended period may apply retroactively, and is therefore valid immediately for all lots currently available and for future ones.

The formulation and the storage conditions of the anti Covid vaccine remain unchanged after the Institute had approved on 30 March 2021 the preservation at temperatures between -25° and -15° C, and on 2 June 2021 that of unopened and thawed vials at controlled temperatures between 2 ° and 8° C, up to one month.

It is assumed that behind the request to the Swiss regulator there is a supply of 400 thousand doses of expiring Pfizer and BioNTech vaccines, which would have ended up in the trash without a measure from Swissmedic.

It is not the first time that a drug agency has extended the validity of the preparation. It also happened last September throughout theEuropean Union, with the EMA approving an extension of 3 months compared to the 6 initially foreseen, moving the deadlines for the last supplies from March 2022 to June 2022.

Only in Italy there would be at least 10 million doses of the Comirnaty vaccine not used, also due to the slowdown in administration due to the extraordinary participation of the population in the vaccination campaign against Covid, despite the fact that many have decided not to undergo the third dose.

It is conceivable that also in our country, and in the rest of the European Union, an extension of the drug's expiry date will be opted for, with its validity thus increasing from the current 9 months to 12 months to avoid wasting unused doses , which in any case should be destined for the countries of the Third World and in trouble.

È da considerare che l’iniziale periodo di validità del farmaco era stato ipotizzato quando ancora non erano disponibili dati a sufficienza per determinare una data di scadenza più corretta. Oggi sono disponibili più studi che giustificano un’estensione della data di scadenza.

Source: Here Finance

Editor's note: None of the companies that completed the development of Western-licensed Covid-19 vaccines could know how long they would remain stable. There was not enough experience to guarantee a duration of three years, as is generally the case for most vaccines, so very close expiration dates were initially indicated, often as low as three months.