FDA: 2 Participants, 4 Controls Died in Pfizer Vaccine Trials

Israelis are awaiting the delivery of the first batch of Pfizer coronavirus vaccines, which are expected to arrive in the Jewish State before the end of this week.

The vaccine, expected to arrive Thursday, was originally going to arrive “by the end of December.” Health Ministry Director-General Professor Chezy Levy, told representatives of health insurance providers that the beginning of vaccine distribution is set for December 20.

However, an announcement Tuesday by the US Food and Drug Administration that revealed two participants died after receiving the vaccine during Pfizer’s clinical trials has raised the eyebrows of Israelis who worry about whether or not to raise their sleeves for the shot.

The information was released Tuesday in documents that were released ahead of a meeting scheduled for Thursday with outside experts who are set to discuss whether the vaccine should receive emergency authorization. It is not clear whether media remembered to mention that four others also died during the trials — and they were in the control group at the time — so they were people who did not even receive the vaccine.

One of the two people who died was an individual who was already immunocompromised before the vaccine was administered.

The scientific director of Israel’s Midaat Association notes that in large clinical trials involving tens of thousands of participants, deaths may occur with no connection to the trial, the Jerusalem Post reported.

Companies like Pfizer, said Dr. Uri Lerner, are required to report those deaths.

“According to the published data, six of the participants in the experiment died – two of whom received the vaccine, and four from the control group (which did not receive the vaccine.) After an in-depth examination no connection was found between the experiment and the cause of death.”

The website of Midaat is a member of the World Health Organization-led project Vaccine Safety Net (VSN). Midaat’s website is the most comprehensive portal on vaccines in Hebrew, said the WHO. The site contains detailed information regarding all the vaccines included in the vaccination routine in Israel for babies, children and youth, adults and travelers. This includes specific vaccination schedules.

For each vaccine, the site describes the diseases from which it protects, expected side effects, the different compositions, and more. The site caters to diverse target audiences, ranging from parents and the general public to health and education professionals.

The FDA said Tuesday in its report that the data included in the application for emergency authorization provided adequate support for the request.

FDA staff said Tuesday that data on Pfizer’s coronavirus vaccine were in line with its guidance on emergency use authorization, raising hopes it could soon be made available to Americans aged 16 and above, Reuters reported.

The comments were made in documents released ahead of Thursday’s meeting of outside experts to discuss whether the shot developed with German partner BioNTech SE should be authorized for emergency use.

The FDA is expected to decide on whether to authorize the vaccine within days or weeks. Nevertheless, the agency said at present there is not yet enough research to guarantee the safety of the vaccine for pregnant women, children and those who are immunocompromised.

Via https://www.jewishpress.com/headline/fda-2-participants-4-controls-died-in-pfizer-vaccine-trials/2020/12/08/