FDA Panel's Decision on COVID Booster Shot Poses Challenge for Israel

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A vaccine clinic in Tel Aviv, this week.
A vaccine clinic in Tel Aviv, this week.Credit: Hadas Parush

The U.S. Food and Drug Administration advisory panel recommended Friday that the COVID-19 vaccine booster only be administered to those 65 or higher and high-risk populations, just as Israel announced that 3 million of its citizens had received one.

News of the recommendation will likely renew debate over Israel’s decision to provide the so-called green passport only to those who have received a booster shot, starting on October 1. We can also expect it to affect Israeli parents’ willingness for their children to receive a booster shot.

The head of Israel’s public health services, Dr. Sharon Alroy-Preis, said the panel made a similar decision as Israel when the health ministry first considered administering booster shots. “The U.S. is three months behind us in terms of the vaccine campaign,” she said. “On April 15 this year, the rate of people who had received two doses in the U.S. was 25 percent. In Israel, it was 50 percent at the time, and therefore they are just not seeing the same trend that we observed.”

According to Alroy-Preis, “We also made a decision in the beginning to do things gradually, and [the panel] is now making the decision that we made in July, and is even expanding the vaccine [booster] to groups that came later for us, like workers who are at high risk of infection at work.”

She further said that “When we published figures about a decrease in the vaccine’s effectiveness in preventing infection up to a level of 60 percent, everyone attacked us, experts and journalists claimed that this was different from the numbers in other places in the world … At first, the decrease was felt only in the effectiveness in preventing infection, and after some time also in preventing serious illness. We started seeing more people in serious condition who had been vaccinated with two doses.”

Dr. Sharon Alroy-Preis at the Knesset, in August.Credit: Noam Moskovitz

Alroy-Preis added that she does not believe the panel’s recommendations will affect Israel’s green passport regulations. “As soon as we realized that there is a weakening of the vaccine and that it wanes – there’s nothing to wait for,” she said. “It can be done gradually, but the process is clear. The vaccine wanes among all ages.”

Israel’s booster shot campaign began in August after the Health Ministry observed a significant reduction in the level of protection provided by the first two shots. The decision to provide a third vaccine dose – without clear protocol or backing from the World Health Organization – was a significant precedent. Less than a month after the campaign began, it was expanded to anyone aged 12 and up, if at least five months had passed since the second dose was given.

According to Health Ministry figures, 1,011 people have died of the coronavirus in Israel since July. Of these, 536 (54 percent) had received two doses of the vaccine, and 402 (about 40 percent) were not vaccinated at all. Another 28 were in the process of being vaccinated, and 35 had received a booster shot a week earlier (without it being clear whether they had been infected before that.)

The FDA's position isn’t having a direct effect on Israel’s policy regarding booster shots, despite the fact that Israel usually sees the body as providing a crucial stamp of approval for new medications and technology. The situation changed during the pandemic, in which response time is a matter of life and death for many patients.

The Health Ministry responded rapidly to the panel’s recommendation on Friday. “The U.S. Food and Drug Administration unanimously decided this evening to recommend giving booster shots to people over the age of 65 and those at risk, as well as to healthcare workers – just we did here at first,” the ministry said. “The FDA has thus validated the booster shot campaign that began in Israel, followed by Canada, Austria, Germany, France and other countries. In Israel, it was decided to act responsibly and rapidly to address rising infections, and this is proven by data confirming the high effectiveness of the booster shot, which renews protection from the coronavirus.”

Despite the fact that Israel's health ministry representatives presented the findings of the booster campaign to the American experts, the FDA was not convinced that there was sufficient data that supported administering a third vaccine to the younger population.

A vaccination center in Tel Aviv, last week.Credit: Hadas Parush

Israel's decision to vaccinate younger demographics was based on several reasons: evidence of declining immunity across all ages, data supporting the safety and effectiveness of the third dose among older patients and Israel's desire to curb the recent wave as rapidly as possible.

The Health Ministry stressed that the FDA fully supports administrating the third jab to older age groups. However, Israel's haste to give the booster to children and teenagers, who are less likely to become seriously ill, may prove to have been premature. Israel may appear to have made a rash decision, even though most Israeli experts still believe it was the best choice, and that its benefits will outweigh the harms.

In actuality, most children and teenagers in Israel have not yet gotten the third dose, as it is only permitted five months after the second dose. So far, around 95,000 teens aged 16-19 have received the third shot, around 17 percent of their age group.

In an article published on Friday in The Economist, Prime Minister Bennett wrote that "The high proportion of Israelis who had had their two doses early in the vaccination campaign were also more vulnerable to the new strain when their defenses started to weaken." He added that "paradoxically, people with two doses can be at increased risk, because they think and act as if they’re fully protected, even when that protection may be waning."

The Israeli study about the third dose, which was presented to experts by Alroy-Preis, included data collected from more than a million vaccinated and used several methods of analysis. Its focus, however, is only on older patients. Since the vaccine was originally given to older groups first, researchers could see the decline in immunization most clearly in this age group. They were also the first to be given the third dose, meaning the largest amount of available data is focused on older demographics. Therefore, FDA felt that there was insufficient data about the effectiveness of the third dose on younger age groups and that a month was too brief a period for observation.

Professor Gili Regev-Yochay, the director of the Infectious Disease Epidemiology Unit at Sheba Medical Center, who is researching the efficiency of the vaccine says she doesn't think the decision was rash. "We also proceeded carefully, approving the third dose to people over 60 first. It's a shame our early findings about antibodies were not presented; they could have provided answers to some of the questions that followed." According to Regev-Yochay, "The fact that we see a bigger rise in antibodies after the third shot, as opposed to after the second shot, indicates that immunity could last longer; in which case, everyone should receive it." When it comes to children, Regev-Yochay said that there's no rush. "At this point I think the third dose should be approved for age 16, or 18, and up," she added.

Meanwhile, Professor Ran Balicer, chief innovation officer at Clalit Health Services said that the FDA decision was looking at a much broader range of people than in Israel because "it takes into account any person at risk of serious illness. According to the American definition that includes every single pre-existing condition." Balicer explains that "the situation in the U.S. is different: serious illness affects non-vaccinated people more than it does in Israel. There has been less of a decline in effectiveness because they started vaccinating later."

"Israel is smaller, quicker, and more willing to take risks - that's totally legitimate," said Professor Hagai Levine, former head of the Israeli association of Public Health Physicians. He added that "despite the FDA's decision it is very likely that the third shot provides better protection for younger people as well." However, Levine noted that the FDA decision may still have implications for the conditions surrounding Israel's green passport. "Israel has debated having the green passport for the age of 12 and up. Considering the FDA's decision, this question will surely have to be discussed again."

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