FDA supports third dose over 65, but questions raised about need to give it to children

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Israel has just found itself in the strange situation of getting a pat on the back from the most important medical regulatory agency in the world, while at the same time feeling the heavy weight on its shoulders for being among the first to decide to give its citizens a third dose of the COVID-19 vaccine.

Israel has received professional and scientific backing for the daring pioneering step that it took beginning in late July to begin administering a third dose to the Israeli population. But the step has also raised the question of the need to give the dose to children – something being asked not only in Israel but by scientists and doctors around the world.

Currently, Israeli children 12 and over are entitled to be vaccinated, but parents have been given limited public information at this stage about the booster shot. There has been considerable information about the safety and effectiveness of the first two doses of the vaccine, as well as information on the third dose administered to groups of young children who received it for various medical reasons. Consequently, the members of the public committee overseeing the vaccination program in Israel feel certain about administering a third booster shot to children.

Some parents who have themselves gotten a third dose are nevertheless not at ease with their children being the first in the world to receive the third dose – a dose that wasn’t part of the trial protocol of Pfizer – the manufacturer of the vaccine that is being administered in Israel. Nor has it been approved by the U.S. Food and Drug Administration for children.

If the FDA’s professionals had also recommended at this stage that children be vaccinated based on the Israeli data, it would have been a valuable stamp of approval, encouraging Israelis to get their children vaccinated. It’s difficult to explain to Israelis that the FDA is an American regulatory agency that considered the issue based on the circumstances in the United States, which are different from those in Israel. For years, the Israeli public has gotten used to the FDA being the regulatory standard when it comes to approval for use in Israel of various medications and medical technologies, even though that hasn’t entirely been the case.

Medical staffer administering the COVID vaccine Ohad Zwigenberg

Israeli Health Ministry officials say they are convinced that the decision to inoculate children was the correct one, pointing out that the same mechanism that causes the immunity provided by the vaccine to wane in the population as a whole applies to children as well – and there is no justification to wait to give children the booster shot. As the Israeli officials see it, a 12-year-old who got their second dose eight months ago is just as contagious as a 30-year-old in a crowd, if infected with the coronavirus. And since Israel has been several months ahead of the United States in its vaccination campaign, the officials say the United States will soon follow suit and expand its vaccination program to include the younger population.

Demographically, Israel is a young country. Children up to the age of 18 constitute about a third of the country’s population. Since the beginning of the pandemic, children have been at the lowest risk for developing serious illness from the coronavirus, however. Prior to the era of the vaccine, fewer than one percent of the children infected with COVID-19 required hospitalization. In many instances, they were simply under observation.

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The position of doctors is that children should be protected from COVID so long as there are effective and safe means to do so. But the most significant reason to do so is to collectively lower the incidence of the disease in the country and to boost the overall vaccination rate in order to halt the pandemic. (Also, the effects of the pandemic on children go beyond the illness itself.)

Close to a million Israelis who are entitled to the vaccine have not gotten it at all. Israeli experts believe that the decision to vaccinate children was a correct decision in order to manage the current risks in a situation of uncertainty. In fact, a quest for total certainty and safety in such a situation is destined for failure or a heavy loss of life.

Medical staffer administering the COVID vaccine Hadas Parush

Israel is not a clinical trial lab. The coronavirus vaccine has been proven effective and safe and has been approved for use and about 30 percent of the world’s population has been vaccinated with various coronavirus vaccines. Israel is working to increase the level of protection that its population has from the vaccine and to halt the pandemic. It’s very possible that that’s the correct step. Many Israeli experts are certain that it has spared Israelis from illness and death.

Nevertheless, the fact that the FDA prefers to have Israel vaccinate additional children with a third dose before it decides to give American children the third shot doesn’t bolster Israeli parents’ confidence in the system. The Israeli Health Ministry and the Israeli government as a whole should therefore rethink how to act with regard to the roughly 30 percent of the population aged 18 and under whose vaccine effectiveness will wane in the coming months.