Israeli Health Minister ‘pleased’ as FDA approves Pfizer COVID-19 vaccine

Coronavirus commissioner calls on public to go and get vaccinated.

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020 (photo credit: REUTERS/DADO RUVIC/ILLUSTRATION/FILE PHOTO)
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020
Israelis could begin getting vaccinated as early as this week, after the US Food and Drug Administration said it authorized the use of Pfizer Inc.’s COVID-19 vaccine on Friday, marking a turning point in the United States’ and Israel’s war against the pandemic, where it has killed almost 300,000 people.
“I am pleased that Pfizer’s vaccine has undergone a critical phase with FDA approval,” said Health Minister Yuli Edelstein on Friday, just after the FDA’s Vaccines and Related Biological Products Advisory Committee voted in support of the agency granting Emergency Use Authorization (EUA), which paved the way for the vaccine’s approval. “This is a huge message for Israeli citizens as well.”
He said that he instructed his ministry’s staff to review the approval and submit their recommendations in the coming days so that vaccinations could start before the end of the month.
The Health Ministry, the health funds and Magen David Adom, along with representatives of Israel’s senior living centers and likely the Home Front Command, are all preparing for mass vaccination of the Israeli population.
Inoculation was expected to begin in two weeks on December 27, but the Health Ministry said it is considering moving it up as early as this week.
Cyrille Cohen, who sits on the Advisory Committee for Clinical Trials of Coronavirus Vaccines through the Health Ministry, told The Jerusalem Post that “the FDA awarding an EUA is definitely a step in the right direction as far as the approval in Israel is concerned.” But he cautioned that Israel’s Health Ministry is the only one that can grant an approval of the same type for the vaccine to be used in the country.
Last week, Health Ministry director-general Chezy Levy said that the ministry was working to “reduce bureaucracy, but we will not compromise on the safety of the vaccine.”
Dr. Boaz Lev, the ombudsman for medical professions at the Health Ministry, revealed that the first to be inoculated would be medical personnel, senior citizens and those with pre-existing medical conditions that put them at risk for a serious case of COVID-19.
However, he said during a Thursday briefing that the ministry is considering opening the vaccination at the beginning to more groups to encourage more people to agree to receive the shots.
More than 100,000 doses of the Pfizer vaccine arrived in Israel last week and more are expected to come before the end of December. Israel ordered a total of eight million doses of the Pfizer vaccine, enough to vaccinate four million Israelis.
“It is very important to vaccinate against coronavirus,” Coronavirus commissioner Prof. Nachman Ash said over the weekend during visits to Arab towns and neighborhoods. “This is our chance to get out of this pandemic. Everyone: Go out to get vaccinated.”
Ash noted that he had reviewed the data published about the vaccine’s efficacy and safety, as was published last week in the New England Journal of Medicine. “The data is very good,” he said. “The vaccine is effective.”
He also noted that after tracking side-effects for four months, no serious incidents had arisen.
“I am personally positively considering getting vaccinated against COVID-19,” Cohen told the Post.
Ran Balicer, chairman of the COVID-19 national experts team, also said he would get vaccinated.
“My fear of the disease is greater than that of the vaccine,” he said Saturday night in an interview with Channel 12.
And FDA head Stephen Hahn said he was ready for a vaccination as soon as it is available.
Hahn, speaking during a press conference, defended the fastest-ever vaccine process, saying the agency did not sacrifice safety in return for speed. He also described as inaccurate press reports that said President Donald Trump’s administration had threatened to fire him if the FDA did not approve the authorization by a certain date.
The FDA granted an EUA for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in preventing the disease in a late-stage trial.
The FDA said the vaccine can be given to people aged 16 and older.
“The first vaccine will be administered in less than 24 hours,” US President Donald Trump said in a video posted on Twitter. “I am proud to say we have made sure this vaccine will be free for all Americans.”
The US government has said it will begin distributing the vaccine around the country immediately after FDA authorization and that the first inoculations would happen early next week.
Millions of Americans could begin getting vaccinated this month, especially if a second vaccine from Moderna Inc. is quickly approved.
The Pfizer/BioNTech vaccine was first approved in Britain earlier this month, and UK residents began receiving the shots on Tuesday. Canada also authorized the vaccine and expects to start inoculations this week. Mexico and Bahrain have also approved the vaccine.
The EUA comes at a time when infections, hospitalizations and deaths are soaring to record levels in the United States, which has so far failed in its coordinated effort to slow the spread of the virus.
The one-day COVID-19 death total topped 3,000 this past week, while hospital intensive care units across the country are nearing capacity, threatening to overwhelm healthcare systems.
“The EUA was anticipated and it is one step in a sequence of steps that will bring this pandemic to an end,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
“I’m not going to feel that there is an EUA tomorrow when I’m taking care of COVID-19 patients,” he said. “A lot of people will be infected, a lot will be hospitalized and a lot will die before the vaccine is able to have a meaningful impact on spread.”
At the same time, infection is rising in Israel.
There were 1,818 people diagnosed with coronavirus on Friday, the Health Ministry reported Saturday evening, with 2.4% of those screened testing positive. Some 331 people were in serious condition, including 123 who were intubated. The death toll stood at 2,979.
Others with vaccines in advanced development include Moderna, which could win emergency US authorization as soon as this week; AstraZeneca Plc. with Oxford University; and Johnson & Johnson.
Israel has contracts with both Moderna and AstraZeneca.
SPEAKING LAST week during a visit by Edelstein and Prime Minister Benjamin Netanyahu to the Teva Pharmaceutical Industries Ltd. unit Teva Israel-SLE – which signed an exclusive agreement with the state to distribute COVID-19 vaccinations in Israel and is preparing to store millions of vaccine doses in special cooling conditions – a representative of the company said that four million Pfizer and three million Moderna vaccine doses were expected to arrive at the center by January 1.
BioNTech began developing the vaccine in January, using a technology called synthetic messenger RNA (mRNA) that had yet to produce an approved product. The technology uses a chemical messenger to instruct cells to make proteins that mimic part of the new coronavirus, which the immune system learns to recognize as an invader. BioNTech struck a development deal with Pfizer in March.
The vaccine comes with complex distribution challenges as it must be shipped and stored at -70°C, requiring specialized ultra-cold freezers or supplies of dry ice.
Moderna’s vaccine employs the same technology but does not need to be stored at sub-Arctic temperatures.
The health funds are establishing hundreds of vaccination complexes and plan to contact those eligible for vaccination via text message, similar to how they reached out to people this year for their flu vaccine.
Both Pfizer’s and Moderna’s vaccine require two doses each to maximize efficacy. There is a 21-day window between the two doses of the Pfizer vaccine; it is still unclear how the health funds will ensure that people come back for their second dose.
The prime minister is expected to visit a Maccabi health fund drive-in vaccination complex in Tel Aviv today and to speak more about the process.