FDA announces deaths of two Pfizer vaccine trial participants

The Jerusalem Post

At least 110,000 doses of the Pfizer coronavirus vaccine candidate are expected to arrive in Israel before the end of the week and the medical staff at Tel Aviv Sourasky Medical Center will likely be the first inoculated.

On Tuesday, Sourasky director-general Prof. Ronni Gamzu confirmed for The Jerusalem Post that the hospital could begin vaccination even before the vaccine receives US Food and Drug Administration (FDA) approval. He said he could administer the vaccine early because it had already been approved in Britain.

However, Health Ministry director-general Chezy Levy told the Post that beginning vaccination in any place ahead of FDA approval was forbidden. He added that the country had still not finalized the list of who would be prioritized to receive the vaccine first.

“We hope that in the coming days, there will be FDA approval,” Levy said.

The FDA advisory panel is set to review the Pfizer vaccine on December 10.

“The vaccine is safe for every person on an individual level and for us as a company at the national level,” wrote Gamzu on Twitter. “I am proud to receive this treatment first as part of the global technological advancement. I am convinced that leading by personal example will help gain public trust so all citizens take the vaccine for their health.”

Gamzu received sharp criticism from the Israel Medical Association, whose head Zion Hagay said in a statement that the move was “irresponsible” and will have the opposite of its intended effect – that it will “erode public trust.”

The exact day that the Pfizer vaccine will land in Israel is still unknown. The Hebrew website Ynet said Tuesday that the first doses could arrive as early as Wednesday. Kan News reported their arrival would be Thursday.

The vaccines are supposed to arrive on a special flight via the DHL shipping company and be directly transferred to the Teva SLE Logistic Center, where they will be stored and then distributed throughout the country.

Pfizer vaccines are made of messenger RNA (mRNA) and are required to be kept frozen at negative 70 degrees Celsius.

Israel has purchased eight million doses of the Pfizer vaccine – enough to vaccinate four million people.

Last week, Levy said during a video meeting with the country’s hospital administrators that some four million doses could arrive before the end of the month. But he said then that although they could come even before they are approved by the FDA, no one will be inoculated before approval.

Ahead of the Thursday meeting of the FDA on the Pfizer vaccine, the administration announced Tuesday that two trial participants have died after receiving the Pfizer coronavirus vaccine. One of the deceased individuals was immunocompromised.

This information was obtained from documents released on Tuesday by the FDA.

The documents were released ahead of a meeting on Thursday of outside experts who will debate whether emergency authorization for the vaccine should be granted.

The FDA also said on Tuesday that the data they’re presented with is in line with emergency use authorization, raising hopes for Thursday.

At the same time, the FDA said that there currently is not enough research to guarantee the vaccine’s safety for immunocompromised groups, pregnant women and children.

Israel’s Midaat Association responded to the report on the deaths, explaining that when vaccines are administered to at-risk populations “there may be unfortunate cases. One should not infer from this about the safety of the vaccine but welcome the transparency required from the pharma companies in the drug approval process.”

The association noted that in large trials of tens of thousands of people, death can occur without any connection to the trial, but that companies like Pfizer 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 of the control group,” said Dr. Uri Lerner, the scientific director for Midaat. “After an in-depth examination, no connection was found between the experiment and the cause of death.”

Hospitals across the country are preparing to receive the Pfizer vaccine and inoculate their staff.

“We very much hope that we have light at the end of the tunnel,” said Health Minister Yuli Edelstein during a visit to Galilee Medical Center on Tuesday, “The success of the vaccine also depends on the response of the medical staff. I hope that thanks to your effort and the efforts we make, both in bringing the vaccines and in improving the rapid testing, we will be able to get back to routine.”

Baruch Padeh, Barzilai, Wolfson and Soroka medical centers all announced that they were ready for the vaccine to arrive.
Baruch Padeh held a preparatory meeting Tuesday morning and sent the it’s 1,500 staff members a message, “We are all getting vaccinated.”
“We who are at the forefront of the war against coronavirus should be the first to be vaccinated,” said Erez Onn, director-general of Baruch Padeh, “so that we can continue to give professional and dedicated care… We are the ones who should serve as an example to the entire public.”
Wolfson’s Dr. Anat Angel said that the vaccination process for its more than 3,000 employees would be documented and carried out “immediately and without any delays.”
“Having succeeded well above average in previous years with staff vaccinations against influenza … I am sure, beyond a doubt, we will also lead in vaccinations against the coronavirus,” she said.
The hospitals said that they would receive the vaccinations and inoculate staff with their first does right away. There would be a 28 day waiting period before administering the second dose.

Getting the vaccines to the hospitals will be handled by the Teva SLE Logistic Center, which the Knesset’s State Audit Committee visited on Tuesday.
“The eyes of the entire State of Israel are here,” said committee chairman MK Ofer Shelach during the visit. “This is the most important and extensive national project since the beginning of the coronavirus crisis.”
He said that the visit left him feeling that “the company is unusually prepared and professional. I sincerely hope that it will continue like this.”
Yossi Ofek, CEO of Teva Israel-SLE, agreed and said, “there is no room for error here. We understand the magnitude of the responsibility.”
Prime Minister Benjamin Netanyahu also spoke about the vaccines again on Tuesday, stressing that although the vaccines are almost here and the country is starting to hopefully see the end of the pandemic, “as in war, when we see the end of the war, we must not lose people. People will die and will be stricken with a serious disease for no reason – it is possible to prevent this.”
He called on the country to continue social distancing, wearing masks and following the Health Ministry rules even as the first vaccines arrive in Israel.

One thought on “FDA announces deaths of two Pfizer vaccine trial participants

  1. ‘One of the deceased individuals was immunocompromised.’ It begs the question, why would there be an immunocompromised individual in a trial? I would think the healthiest people would be used in a trial so as to have the best outcome possible to convince people of the ‘safety’ of the shot.

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