Pfizer may ask to extend Covid vaccine expiration date

With about 2 million doses close to expiration in stock, the Ministry of Health is counting on extending the shelf life of the Pfizer vaccine. THE Sheet found that the minister had already been informed that it would be possible to extend the validity from 12 to 15 months.

In a note sent to the report on Monday (20), the company said that “new stability data should be available for potential analysis by regulatory authorities soon”.

The extension of the validity period depends on the approval of Anvisa (National Health Surveillance Agency). In April of last year, the agency authorized the validity to be extended from 9 to 12 months, both for the adult and pediatric vaccines.

“Pfizer maintains studies on the stability of the ComiRNAty vaccine to assess the validity period of the immunizers. The extension of the validity period before Anvisa follows all regulatory procedures and only becomes effective after the approval of the organ”, said the laboratory.

As revealed to Sheet, the Ministry of Health has 1.92 million doses of Pfizer purchased at R$ 128 million valid between July and August. Each dose cost R$ 66.89. The data, kept confidential by the folder, were collected by the TCU (Union Court of Auditors).

According to the same report, 26 million Astrazeneca units also expire in the next two months. The amount reaches R$ 1.09 billion, which is equivalent to R$ 41.83 per dose.

The discovery was made by auditors from the Department of External Health Control (SecexSaúde) of the court, in inspection of the Dlog (Department of Health Logistics) of the Ministry of Health in May this year — 24 million vaccines expire between September and December.

“Having news that we are about to lose more than 28 million doses of vaccine in the next two and a half months, in a loss of almost R$ 1.23 billion, is at the very least astonishing”, said TCU minister Vital do Rêgo in dispatch on Wednesday (15).

The expiration date of vaccines against Covid-19 is also a matter of concern in municipalities. THE Sheet found that municipal health secretaries came to discuss internally whether or not they should receive doses with an expiration date of less than 30 days because of logistical difficulties.

City halls say that, as a rule, they look for doses in state warehouses, which takes time. With the end of the so-called Public Health Emergency, decreed by the ministry in April, the assessment is that it would be difficult to justify the eventual waste of immunizations.

Even with doses in the ministry’s stock, many municipalities complained of shortages at Pfizer this year. The immunizer is the only one authorized for the vaccination of children aged 5 years and is the most suitable for the vaccination of pregnant women, postpartum women, immunocompromised people and young people aged 12 to 17 years.

During the announcement of the release of the fourth dose – or second booster dose – for people aged 40 or over, this Monday (20), the Secretary of Health Surveillance, Arnaldo Medeiros, stated that Brazil has already managed to apply 2 million of vaccines in a single day.

“The ministry is increasingly looking to distribute these doses. [A pasta] is doing all the work so that no dose is missed”, he declared, after being asked about the doses that are about to expire.