FDA: Six people die during Pfizer vaccine trial

    FDA: Six people die during Pfizer vaccine trial
    © REUTERS / Dado Ruvic

    Half of those killed were over 55 years old. Two people died in the vaccinated group, four in the placebo group.

    Two people who received the COVID-19 vaccine from the Pfizer and Biontech died after being inoculated, according to documents from the US Food and Drug Administration (FDA).

    “A total of six people [two with vaccines, four with placebos], out of the 43,448 who participated [of the tests, 0.01%], died between April 29, 2020 [first participation] and November 14,” the date the tests were completed, the FDA reported in a document.

    Both vaccine recipients were over the age of 55, according to the documents.

    One patient experienced cardiac arrest 60 days after receiving a second dose of the vaccine and died three days later.

    The other patient with initial obesity and pre-existing atherosclerosis died three days after receiving the first vaccine.

    The text was released prior to a meeting of the Advisory Committee scheduled for this December 10 to discuss the authorization for the emergency use of vaccines against COVID-19.

    “A Favorable safety profile”

    However, the FDA affirmed that the nearly 38,000 clinical trials of the COVID-19 vaccine developed by the companies Pfizer and BioNTech show that it does not pose a concern that could prevent its authorization for emergency use.

    “The safety data of approximately 38,000 participants (…) with an average of two months of follow-up after the second dose, suggest a favorable safety profile, without identifying specific safety concerns that could prevent its emission”, stated the FDA in a statement.

    The FDA document, released prior to a meeting scheduled for Thursday to discuss the emergency use of the vaccine, concludes that the study “meets pre-established success criteria.”

    The document adds that vaccination can benefit people previously infected with COVID-19.

    “Previously infected people may be at risk for COVID-19 and could benefit from the vaccine,” the FDA said. 

    The FDA stated that only 3% of participants in the Pfizer and BioNTech trials had evidence of prior infection at the time of enrollment in the study and assured that additional tests showed that very few cases of COVID-19 occurred in these participants during the course of the entire study.

    Last week, the UK became the first country in the world to grant emergency use of the vaccine produced by the US drugmaker giant Pfizer and German firm BioNTech.

    In mid-November, Pfizer announced that its candidate vaccine completed phase 3 clinical trials, with a declared efficacy level of 95%.