FDA Comments on Death of 6 Patients during Pfizer’s Vaccine Trial Stage

A total of six people,  who received the COVID-19 vaccine from the Pfizer and Biontech during the trial stage of the COVID-19 vaccines, died after being inoculated, according to a statement of the US Food and Drug Administration (FDA).

The FDA commented that both vaccine recipients were over the age of 55, one of them 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.

It confirmed the vaccine was, as reported by Pfizer, 95 per cent effective at least seven days after the second injection.

The statement 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.

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.

“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 drug maker 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%.