First Pfizer coronavirus vaccines expected to land on Wednesday

FDA announces deaths of two Pfizer vaccine trial participants • Vaccines expected to arrive in Israel Wednesday

A refrigerated truck leaves the Pfizer plant in Puurs, Belgium December 3, 2020.  (photo credit: YVES HERMAN/REUTERS)
A refrigerated truck leaves the Pfizer plant in Puurs, Belgium December 3, 2020.
(photo credit: YVES HERMAN/REUTERS)
The public is likely to begin vaccinating in less than two weeks, as vaccines arrive in the country and the health funds and hospitals prepare to administer them.
Health Ministry director-general Chezy Levy informed the country’s health funds on Tuesday that they should prepare for the vaccinations to begin on December 20, The Jerusalem Post confirmed.
A senior health fund official said that the hospitals and the funds will start vaccinating in small numbers at first, but are expected to begin larger-scale community vaccination right after Christmas, when a large shipment of Pfizer vaccines is supposed to arrive in Israel. 
At least 110,000 doses of the Pfizer coronavirus vaccine are expected to arrive today and medical staff at Tel Aviv Sourasky Medical Center have signed up to be the first to be inoculated.
On Tuesday, Sourasky director-general Prof. Ronni Gamzu confirmed to the Post that the hospital could begin inoculating even before the vaccine receives US Food and Drug Administration (FDA) approval. He said he could administer the vaccine because he received permission from the director-general of MASHAV, Israel’s Agency for International Development Cooperation.
However, Health Ministry director-general Chezy Levy told the Post that beginning vaccination in any place ahead of FDA approval was forbidden and added that the country had still not finalized the list of who would be prioritized to get it 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,” Gamzu wrote 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 was the target of 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 vaccines are supposed to arrive on a special flight via the DHL shipping company and will be transferred directly to the Teva SLE Logistic Center, where they will be stored ahead of countrywide distribution.
Pfizer vaccines are made of messenger RNA (mRNA) and must be kept at minus-70 degrees Celsius.
Israel has purchased eight million doses of the Pfizer vaccine – enough for four million people.
Last week, Levy said in a video meeting with the country’s hospital administrators that some four million doses could arrive before the end of the month. But he added that although they could come even before they are approved by the FDA, no one will be inoculated before approval.
Ahead of the FDA’s Thursday meeting on the Pfizer vaccine, the administration announced Tuesday that two trial participants had died after receiving it. One of the deceased individuals was  immunocompromised, meaning the person’s immune defenses were low.
The information was obtained from documents released by the FDA on Tuesday.
The documents were released ahead of a meeting on Thursday of external experts who will debate whether emergency authorization for the vaccine should be granted.
The FDA also said on Tuesday that the data they receive are in line with emergency use authorization, raising hopes for authorization on Thursday.
At the same time, the FDA said that currently there is not enough research to guarantee the vaccine’s safety for immunocompromized 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 such as 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 throughout 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 to receive the vaccine.
Baruch Padeh held a preparatory meeting Tuesday morning and sent 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 the vaccination process for its staff of more than 3,000 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 doubt, we will also lead in vaccinations against coronavirus,” she said.
The hospitals said that they would receive the vaccinations and inoculate staff with their first doses right away. There would be a 21-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 responsibility.”
Prime Minister Benjamin Netanyahu also spoke about the vaccines again on Tuesday, stressing that although they 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 for continued social distancing, wearing masks and following the Health Ministry rules even as the first vaccines arrive.
Reuters contributed to this report.

Reuters contributed to this report.