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Israel waits for FDA nod to vaccinate teens

Israel is welcoming the statement from Pfizer that its COVID-19 vaccine is safe, effective and produces robust antibody responses in 12 to 15-year-olds.

Pfizer Chief Executive Albert Bourla his company is seeking expanded emergency authorization from the United States Food and Drug Administration (FDA) “in the coming weeks and … (from) other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”

Shortly after the data was released, Israel – which is leading the world in vaccination rollout – said it would start administering the shot to adolescents as soon as it has been approved.

“The Pfizer announcement is terrific news,” said Israeli Minister of Health Yuli Edelstein on social media. “There is nothing more in order now than a speedy approval of more vaccine procurements (by Israel), so we can be poised to vaccinate immediately upon FDA approval.”

6,214 Israelis have died of the disease. There have been 833,281 reported cases, including 7,200 active cases in which 385 patients are considered to be in serious condition.

Since midnight last night, 5,244,481 Israelis have been inoculated with one dose of the COVID-19 vaccine, while 4,785,534 people have received both.

The immunization of younger ages is considered a critical step toward reaching “herd immunity” toward containing the pandemic. As of today, 2,930,627 people worldwide have died from COVID-19 and 129,594,382 others have been infected.

Pfizer says there was 100% efficacy in preventing the illness in the trial administration of its vaccine to 2,260 children between the ages of 12 and 15. 18 of the participants who received a placebo caught the disease, while none of those who were given the actual doses did. The group also tolerated the inoculations well, with side effects consistent with their peers in the 16 to 25 trial. While those symptoms were not detailed in the latest statement, side effects in the adult study were found to be generally in the mild-to-moderate range, including injection-site pain, headaches, fever and fatigue.

Asymptomatic infections and the suffering of less severe symptoms of the coronavirus makes young people more likely to unwittingly transmit the disease to their elders.

“Asymptomatic spread is what you are most concerned about,” said Onisis Stefas, chief pharmacy officer at New York-based hospital system Northwell Health told Reuters, adding that, “Those are the people who are most apt to spread.”

The Pfizer/BioNTech two-shot vaccine has already authorized for administration for use in people as young as 16. The new study reveals the first evidence that it is also effective in younger adolescents.

Pfizer’s clinical trial puts the drugmaker in the lead ahead of other Western developers in the quest to protect children. Moderna is still gathering data on its own study of children aged six months to less than 12 years launched in March, while Johnson & Johnson only recently authorized to use its vaccine for adults and has yet to test children. After being linked to a very rare form of blood clotting in the brain, AstraZeneca removed children from a mid-to-late-stage trial of its COVID-19 vaccine in in December.