The FDA’s decision to limit COVID boosters was no snub to Israel

Shunning the boosters-for-all approach pioneered in Israel, American health officials seem to have rejected the Vaccination Nation’s wisdom.

After spending hours poring over research about Israel’s policy of universal COVID boosters, the United States Food and Drug Administration has decided not to take this path. Instead, it has recommended a far more narrow deployment of boosters, mostly focused on the elderly.

Has the era of Israeli research being used to guide and inform vaccination practices by the US and other nations suddenly come to an end? Not at all.

Though it hasn’t gone all-out with the Israeli approach, experts stress that the US regulator emulated the Jewish state by approving the booster for the entire demographic that tends to define pandemic success or failure: the elderly and at-risk.

All such US citizens aged 65-plus, as well as some others like health workers, are now to going to receive boosters, after FDA officials surveyed data from Israel which suggests that its national booster campaign has proven to be safe and helped prevent serious disease.

“The important point here is what the FDA did approve, and that, after viewing Israeli data, it acknowledged the importance of boosters,” Prof. Alon Hershko, director of internal medicine at Jerusalem’s Hadassah Medical Center, told The Times of Israel.

“It isn’t rejecting boosters, but rather addressing boosters step by step, starting with the elderly and at-risk, and planning on proceeding cautiously with others. It’s just how the FDA works — making decisions carefully based on data.”

The top infectious diseases doctor Prof. Ronen Ben-Ami, of Ichilov Hospital in Tel Aviv, takes a similar view, insisting that “the main message is that they have given backing to booster doses, not that they have restricted them.”

Indeed, FDA officials made their decision after viewing research published on Wednesday by The New England Journal of Medicine, and after briefings from Israeli officials, including Dr. Sharon Alroy-Preis, head of public health services at the Health Ministry.

The research found that 12 days after receiving a booster shot of a Pfizer-BioNTech COVID-19 vaccine, the chance of infection was 11.3 times less than among those eligible for a third shot who didn’t get one.

More importantly, the chance of suffering serious illness as a result of COVID-19 among those who had received a booster shot was 19.5 times less, the research said.

Following the FDA recommendation, many Israelis are focusing on the difference in its stance compared to that of their government, with some unsettled by the implication that the swift rollout of the boosters in Israel may have been premature.

Senior Israeli health officials are well aware of the impact the FDA decision can have on public opinion, and say that they now fear greater wariness about the third vaccine. Over 3 million Israelis have already received the third dose, about one-third of its total population.

But experts stress that while the coronavirus crisis is global, and data from one country has great relevance elsewhere, solutions are not suitable for exact replication. Israel took a decision to offer everyone boosters when the Delta variant was spreading fast and vaccine immunity waning — on levels not yet seen in the US.

Eyal Leshem, an infectious diseases specialist at Sheba Medical Center, said that the circumstances for the decision-making are very different, partly because under-65s in America tended to receive vaccines much later than Israelis, meaning that they are not yet waning.

“I think in the United States, where most people under 65 who aren’t healthcare workers received vaccines less than half a year ago, it makes sense to postpone the decision by several weeks,” Leshem said. “Whereas in Israel if we had delayed the decision by several weeks, we would probably be sitting in lockdown and facing lots of serious cases.

“With the current situation in America, the FDA deciding now not to vaccinate the entire population over 12 now is not expected to be so substantial, and the impact of postponing the decision by several weeks is not expected to be major.”

Ben-Ami said that Israel weighed the risk of its Delta wave and waning immunity against those of vaccine side effects, which are uncommon, and took a decision in July to roll out boosters which, “in retrospect saved many lives.”

America today “just is not in the same situation that Israel faced back then.”

US to eventually fully follow Israel’s lead, experts predict

The FDA hasn’t said “never” to universal boosters, but rather said that the data doesn’t yet support the move. Boosters are new, and the American scientific community hasn’t rallied behind them for all ages.

A news article in the academic journal Nature, which reacts to a study based on Israel’s national experience with the booster shot, notes that “potential biases in the data leave some scientists unconvinced that boosters are necessary for all populations.” And The New York Times quoted immunologist Marion Pepper voicing the possibility of “some risk in continuously trying to ramp up an immune response.”

But many Israeli doctors believe that as their health system generates more trustworthy data, and if America sees a sharper drop in immunity and a more serious Delta-driven outbreak, the FDA will back boosters for all.

“I anticipate that the FDA will come to approve what we’re doing here in Israel,” Hershko said. “Even if data points to some small adverse effects from boosters, the chance that these will outweigh the benefit of letting the pandemic expand is very small. All negative effects have been negligible so far.”

But he insists that FDA caution shouldn’t be criticized as feet-dragging. It is the “gold standard” in medical regulation, whose decisions set the agenda for healthcare globally, he said. The FDA has set protocols and data requirements, and doesn’t have a sense that an urgent decision is needed on under-65s.

Israel didn’t take a shot in the dark. It had a strong indication that third shots were safe. In Pfizer’s clinical trials, vaccines were given to people in various dosages. Even when people received large amounts of the vaccine in one administration, it didn’t cause negative effects. The government made a judgement call that boosters weren’t going to harm Israelis, but didn’t know how much they would help.

“By contrast FDA protocols are just very strict and structured,” Hershko said. “It’s the mentality of a superpower in health, while Israel is a small country and we’re able to move faster. Each approach has advantage and disadvantage.”

Ben-Ami thinks that, in part, the FDA is moving more slowly than Israel for strategic reasons. In America, where there is a far larger anti-vax movement, presenting the maximum possible information on side effects — even if minor — is particularly important for maintaining confidence.

“They are trying to be cautious, and think if they did what we did, they may undermine confidence for the vaccine, especially among those who have not been vaccinated,” he said.

“Also, there is still a very large unvaccinated population among the young in America, more than in Israel, and it makes sense to focus on giving under-65s initial shots rather than giving boosters to those among them who are vaccinated.”

Data will develop, circumstances will change, and the FDA will adjust its recommendations on boosters for the young accordingly, Ben-Ami predicted.

“It’s inevitable that this will become an issue, so they will have to be very dynamic on the way they view this,” he said.