Decision taken in March “against manufacturers’ standards”
Portugal’s medicines authority Infarmed has been found to have authorised the use of expired Covid vaccines, going against manufacturers’ published standards.
Página Um – a journalistic project, regulated by the press regulatory authority, and funded by subscribers – has discovered at least one instance where this happened, in the Alentejo, in March.
The decision was taken between Infarmed and the regional health administration, “without legal basis” and obviously against manufacturers’ standards, says the website.
“In spite of guaranteeing the process was safe, Infarmed ended up establishing the requirement for collection of information on people who became infected” (after receiving the vaccines from see image below) “for the later evaluation of possible increases in adverse effects or reduction in vaccine effectiveness”.
“The Ministry of Health has still not commented on whether it knew of this decision, nor has it clarified whether there were further out-of-date batches used in other regions of the country”.
Explains Página Um founder Pedro Almeida Vieira, “Infarmed authorised the use in vaccination centres of the Alentejo of three batches of vaccines against Covid-19 that were out of date during the month (sic) of March and April”.
As he points out, the decision appears to have been “an unauthorised clinical experiment which doesn’t conform with minimum principles of ethics and informed consent.”
According to emails to which Página Um had access, Sandra Silva, director of the department of contracts of the Alentejo’s regional health authority (ARS) informed various “responsible entities” of the region that “taking into account the quantities of out-of-date vaccines existing in regional health authorities, Infarmed has authorised their use. At issue are an indeterminate number of phials of batches FP9632 and 1F1047A of Comirnaty/ Pfizer, with an expiry date at March 14 and March 5, respectively, and a batch of the Spikevax/ Moderna vaccine 000063A – some of the phials of which expired on February 27 and others on March 4”.
In the email of the evening of March 14, apart of saying that further more detailed information would be sent the following day, Sandra Silva copied the advice from Infarmed, consisting of two phrases written in what Página Um describes as “rather archaic Portuguese”:
“The aforementioned vaccines from batches mentioned below can be used for a further 15-30 days from the expiry date of 30 days referring to the period after thawing, under the conditions of 2ºC to 8ºC, however administration of said vaccines must be logged in the Vaccines system, mentioning expiry date and thawing date, in order to monitor adverse reactions if they exist. It is further informed that the aforementioned batches of vaccines were evaluated by Infarmed with regard to the integrity of the mRNA when released by the vaccine manufacturer”.
On the Infarmed site however there was no mention of this.
Says Página Um’s text, the last update on conditions of vaccine conservation was published on February 3 and made no mention of the possibility of extending validity periods.
Indeed Infarmed’s Infomed portal, with reference to both Comirnaty/ Pfizer vaccine and Spikevax/ Moderna, stressed that validity should “never be exceeded” beyond the dates stamped on phials.
Moving swiftly on, the next day saw an email with ‘improved explanation’ of the “authorisation” conceded the night before.
Maria Fernanda Ralha, director of Infarmed’s Inspection and Licensing department sent an email to ARS Alentejo guaranteeing that the “aforementioned batches of adult Comirnaty and Spikevax remain stable, assuming that none of the other approved storage/ transport conditions have been exceeded, (and that) they can be kept for another 15-30 days beyond their approved shelf-life as long as the vaccines are kept between 2ºC and 8ºC after thawing”.
She wrote that “due to the nature of these Covid-19 vaccines, and the stability data available for other batches” safety issues were not anticipated. But, she added nonetheless that “it is necessary to be aware of possible reports of adverse reactions in users who will receive these doses, so it is recommended that deviation from the approved conditions should be recorded on the Vaccines platform”.
As Página Um stresses, Ms Ralha essentially “assumed that there were no certainties that extending the period of validity was harmless, nor that vaccine protection might be compromised”.
Pedro Almeida Vieira adds that the decision was not prompted by any shortage of vaccines. It was down to ‘leftovers’ as a result of “poor adherence to booster doses – especially among the population under the age of 50. So much so that (Ms Ralha) recommended that “thawed vaccines, approved validity of which has passed, should be used before unfreezing vaccines for any subsequent dates, and only when existing stock has run out”.
“Página Um contacted Maria Fernanda Ralha, Infarmed’s direction of Inspection and Licensing, who did not wish to comment on this matter, telling us that she was on holiday and that all information regarding vaccines against Covid-19 should be supplied by the DGS.
“The office of health minister Marta Temido was questioned over whether it knew of this decision by Infarmed and ARS Alentejo, and on how many people had been vaccinated with the out-of-date vaccines. The health ministry was also asked if other regions had used a similar procedure (to use-up out-of-date stock), and, if so, will this procedure be maintained in future. There have been no responses up until now”.
This latest article by Página Um was published yesterday.