PM to limit Green Pass to those who’ve received 3rd jab despite FDA move to only give shot to Americans over 65 and high-risk; Israel FDA panelist explains its decision
By TOI STAFF 18 September 2021, 9:52 pm
Prime Minister Naftali Bennett speaks ahead of receiving his third COVID-19 vaccine shot at Meir Medical Center in Kfar Saba, on August 20, 2021.
In his first public comments on an FDA panel’s decision on Friday to approve booster shots of Pfizer’s COVID-19 vaccine only for older Americans and those considered high-risk, Prime Minister Naftali Bennett predicted Saturday night that the United States will gradually begin to offer the shot more widely after being presented with scientific data from Israel.
“The FDA decided to follow in Israel’s path,” he asserted on Twitter, referring to the decision by the US regulator.
“I estimate that the FDA will gradually approve the extension of the vaccine to more age groups, as has happened in Israel, as the effectiveness of the second vaccine continues to decline even among younger age groups,” he said.
Dr. Sharon Alroy-Preis, head of public health services at the Health Ministry, said on Saturday that she too believes the US will make the third dose more widely available with time. “We are ahead of them by about three months,” she explained to Channel 12 news, in reference to the highly contagious Delta wave, which began hitting Israel in June, and the rolling out of the booster shots.
She reiterated that the vaccines “lose their effectiveness over time and it’s not dependent on age, which is why we wanted to vaccinate everyone [over 12].”
While Israel initially made the booster shot available only to those over 60, all Israelis over the age of 12 are currently eligible to receive a third shot once five months have passed since their second dose.
Discounting Israeli data and expert testimony, the committee of outside experts who advise the FDA on Friday rejected boosters for most by a vote of 16-2. Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.
Then, in an 18-0 vote, it endorsed the extra shot only for select portions of the US population — namely, those most at risk from the virus.
Israeli Health Ministry official Dr. Sharon Alroy-Preis and Prof. Ron Milo of the Weizmann Institute address a FDA panel that is weighing whether approve booster shots of the Pfizer-BioNTech vaccine in the United States, on September 17, 2021. (Screenshot/YouTube)<
>
<
>
Officially, despite the panel appearing to reject Israeli data presented to the FDA that shows vaccine effectiveness wanes after around six months, the Israeli Health Ministry welcomed the rulings, saying that they validated Israel’s decision to offer 3rd shots to everyone aged 12 and over.
“With the FDA board’s unanimous decision on giving boosters to those above 65 and in danger, and also to health workers — exactly as we began doing here — the FDA has validated the booster program initiated in Israel,” the ministry said in a statement.
In an opinion piece published in The Economist on Friday, before the FDA decision, Bennett said that some experts in Israel had been reluctant to endorse booster shots, but that ultimately the decision was made to inoculate the population with a third dose amid a fourth wave of the Delta variant of the virus.
“The studies so far show the third dose is sufficient to boost resistance back to the level after the first two. Waiting too long to administer the third dose risks squandering gains already made thought vaccination and eroding public trust,” Bennett wrote.
According to a Channel 12 news report Saturday night, despite the FDA recommendation, Bennett has decided to push ahead with a plan requiring Israelis to get the third shot in order to receive a Green Pass allowing them to enter some public spaces and events.
The report, however, also quoted unnamed cabinet sources saying that they want to weigh delaying the planned October 1 start of the new rules for those under 40, due to lower rates of booster shot intake among them.
Figures aired by the network show that 61 percent of those eligible for the booster between 40-49 have done so. That figure drops to 47% of people between 30-39; 40% between 20-29; and 37% between 16-19.
Officials have said that they now fear greater wariness about the 3rd vaccine and potential legal challenges over its mandating a third shot as part of the Green Pass policy.
Responding to the FDA recommendation and the Saturday night reports, Labor MK Gilad Kariv, chair of the Knesset Consitution and Law Committee, called “to postpone the date of the Green Pass with a third vaccine for the ages 12-16.”
Israeli on panel explains FDA thinking
Speaking to Channel 12 Saturday night, Dr. Ofer Levy of Boston Children’s Hospital, the only Israeli member of the FDA advisory panel, defended the decision not to approve extra doses for anyone over 16.
“We went over a lot of data, a lot of documents, we did complicated work yesterday, but in my opinion it came out the right way,” Levy said.
Asked why he voted against administering booster shots more widely, he said, “There are a lot of figures that show us that a third dose will help and it’s safe, but in our opinion… we need to see more data concerning youths before we vote in favor of a third dose.”
Levy said that he “felt some sort of pride” in seeing Israeli researchers present the panel with data in favor of booster shots, which Israel offers to all those over the age of 12, and that their presentation “really helped all the people on our committee.”
He added that all Israelis eligible to get booster shots should do so, despite his vote yesterday.
“They definitely need to get vaccinated… there’s no doubt that the vaccine effectively protects against the worst effects of the coronavirus,” he said. “We’re in a much different situation here in the United States.”
Latest Israeli figures
Updated Health Ministry figures released Saturday night showed over 10,000 new coronavirus cases have been confirmed this weekend — 4,863 on Friday and another 5,344 since midnight.
The number of serious cases rose to 717, after falling below 700 at the start of the month. Of those in serious condition, 195 were on ventilators.
The death toll stood at 7,507.
In total there are 84,527 active cases in Israel and 1,219,374 infections have been confirmed since the pandemic began.
Ministry figures also showed the R-rate — the number of new cases stemming from each coronavirus infection — falling below 1 again. Any figure above 1 signals the spread of the virus is accelerating, while any reading below 1 indicates morbidity is receding.
According to the ministry, 6,061,244 Israelis have received at least one coronavirus vaccine dose, 5,574,359 have received two doses and 3,031,423 have received a booster shot.
Sick man