Pfizer COVID vaccine FDA approval for young teens: What you should know

The Jerusalem Post answers all your question.

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
The US Food and Drug Administration earlier this week approved administering the Pfizer COVID-19 vaccine for children between the ages of 12 and 15. Now, Israel has to prepare for its own rollout – if and when it happens.

The Jerusalem Post asked a team of health experts what’s next when it comes to vaccinating adolescents.

When can Israeli kids start getting the shot?

There are discussions under way in the Health Ministry about the exact process that should take place, now that the FDA has given approval to the Pfizer vaccination, and those could take days or even weeks, according to Tzachi Grossman, chairman of the Israeli Pediatric Association.

He told the Post that “FDA approval is not automatic approval in Israel” and that the vaccine’s use with kids 12-15 would “still undergo some regulatory approval here.”

Why should children get vaccinated?

While very few Israeli children died from COVID-19, more than 1,000 children were hospitalized with the virus, including about 150 kids who were in serious condition, half of whom required treatment in the intensive care unit, explained Cyrille Cohen, head of the immunotherapy laboratory at Bar-Ilan University.
Moreover, 10% to 15% of kids develop long COVID, according to multiple studies – symptoms that last for more than 12 weeks. These symptoms can range from fatigue and shortness of breath to depression and anxiety or changes to the senses of smell or taste.

A small percentage of youth also develop paediatric inflammatory multisystem syndrome (PIMS-TS), temporally associated with COVID-19, which is similar to Kawasaki disease or toxic shock syndrome. These children suffer from fever and inflammation, and some have rashes, abdominal pain, vomiting or diarrhea. Although respiratory involvement has been reported in less than half the cases, it does occur.

What are the concerns?

“We are not under any emergency regarding the vaccines, so ‘should we or should we not recommend vaccination for a population that is usually less affected by COVID-19?’ is the question right now,” Cohen explained.

He said that the vaccines appear to have a very safe biological profile, but that a recent report by the ministry indicated that in rare cases, younger vaccine recipients between the ages of 18 and 30 developed myocarditis – inflammation of the heart.

Currently, a committee is examining the data, and the results of their findings will “be a crucial element of regulatory approval here,” Grossman said.

The ministry’s interim analysis report showed that during the first three months of Israel’s vaccination campaign, some 62 cases of myocarditis or pre-myocarditis were reported, mostly in younger people.

“The topic of myocarditis is often cited by people who oppose the vaccine,” Grossman said. “The ministry will examine the topic before giving approval.”

How do we know the vaccine really works for young people?

The FDA granted approval for use in 12- to 15-year-olds based on a Pfizer study of 2,260 participants between those ages. The study was a randomized, placebo-controlled clinical trial conducted in the United States. 
Some 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. No cases occurred among the vaccinated and 16 cases occurred among the placebo.

“The main point proven in the vaccine trial was the high-level immunogenic response – and based on this finding, we can quite surely assume that the actual protection will be as it was in the adult vaccination rollout,” Grossman said.

He added that the ministry will monitor the protection of younger people, as it has with adults, but he noted that “since the level of disease is really very, very low in all sections of the population, we might not see a big difference in the immediate period.”

Do adolescents receive the same doses as adults?

Yes. Youth will get two 0.3 ml. doses, three weeks apart.

Are there any different side effects that adolescents might experience?

The main side effects reported by Pfizer were pain at the site of injection, fever and weakness that lasts a couple of days, which Grossman said are probably the same side effects Israeli kids will experience and that mirror the symptoms experienced by adults.

“We are not expecting any surprises,” he said.

Will kids need their parents’ permission to get the jab?

While no formal announcement has been made and the ministry told the Post that all details of how the country’s adolescent vaccination campaign will look are still under discussion, both Cohen and Grossman said it can be assumed that these kids will get vaccinated the same way their older peers did.

Teens got the jab at their local health funds accompanied by one of their parents. They were asked to bring with them their health fund and national ID cards. If a parent could not accompany them, then they had to bring a signed letter, including ID number and a parent’s signature.

Those over the age of 18 do not require a parent chaperon or consent.

Grossman said there is also discussion about vaccinating kids at school.

Will vaccination be mandatory for any specific activities and will youth get a Green Pass?

These steps are the topics that are currently being discussed by the ministry committees and no decisions have been made.

When will children under age 12 be eligible to get the COVID-19 vaccination jab?

Likely not until closer to the end of the year. Pfizer is conducting a clinical trial in lower age groups that is supposed to conclude around September 2021, and the results will need to be sent to the FDA for review.

“Only in the winter might we talk about the possibility,” Cohen said.