According to newly released documents, the US Food and Drug Administration (FDA) has acknowledged deviating from its usual process for approving vaccines in relation to Pfizer’s COVID-19 vaccine, The Epoch Times reports.

In June 2021, Christopher Joneckis, the FDA’s associate director for review management, wrote a memo authorizing the release of a Biologics License Application (BLA) number for the vaccine, despite the fact that regulators were still considering whether to approve the BLA.

In the memo, Joneckis explained that this deviation from the normal process was made “to facilitate product labeling and distribution and is consistent with other Center practices to facilitate vaccine delivery during the declared Public Health Emergency.”

He added that the decision was partly based on the FDA having previously granted Emergency Use Authorization (EUA) for the vaccine in late 2020, meaning that the agency was already “familiar with and has reviewed much of the information provided in the BLA application.”

It should be noted that EUAs can be granted if the FDA determines that it is “reasonable to believe” that a vaccine or other product “may be effective” in addressing a disease or condition caused by a public health threat, while BLAs require a higher level of evidence to demonstrate that a product is “safe, pure, and potent.”

The documents were released by the Informed Consent Action Network (ICAN), which obtained them through a lawsuit and Freedom of Information Act requests.

In a statement to The Epoch Times, Aaron Siri, a lawyer representing ICAN, said that the new documents provide “another piece of evidence that supports that licensure of this product quickly became a foregone conclusion.”

The FDA granted a BLA for the vaccine to individuals aged 16 and over on 23 August 2021, and it was later approved for children as young as six months of age.

The agency has also authorized or approved multiple booster shots due to the vaccine’s reduced effectiveness against new variants.