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Home Special Coverage Coronavirus Outbreak

Israel to discuss Pfizer vaccine for children aged 5 to 11 following FDA approval

With FDA approval expected in coming weeks, Israeli Pediatric Association president says proving efficacy and safety of vaccine in this age group critical for protection of children and the end of the pandemic.

by  Maytal Yasur Beit-Or , Assaf Golan , AP and ILH Staff
Published on  09-22-2021 12:45
Last modified: 09-22-2021 12:10
Israel to discuss Pfizer vaccine for children aged 5 to 11 following FDA approvalAP / David Goldman

a droplet falls from a syringe after a person was injected with the Pfizer COVID-19 vaccine at a hospital in Providence, Rhode Island, United States, Dec. 15, 2020 | File photo: AP / David Goldman

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Israel's coronavirus infection rate stands at 4.7% as 4,800 of the 108,797 people who tested for the virus Tuesday were found to have COVID-19, according to Health Ministry data released Wednesday. The reproduction rate is 0.83.

There are 74,898 active cases of the virus. There are 723 people in serious condition, 172 of whom are on ventilators.

Although 1,161,949 Israelis have recovered from the virus since the outbreak of the pandemic, 7,582 have died.

Pharmaceutical giant Pfizer announced Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek US authorization for this age group soon – a key step toward beginning vaccinations for youngsters.

The vaccine made by Pfizer and its German partner BioNTech is already available for anyone 12 and older.

For elementary school-aged kids, Pfizer tested a much lower dose – a third of the amount that's in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president said.

Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.

Israeli Pediatric Association President Professor Zachi Grossman welcomed the announcement, saying, "Proving the efficacy and safety of the vaccine in this age group is critical for the protection of children and the end of the pandemic."

He said Israel would wait for FDA approval that is set to come in a few weeks, and following a discussion by the Epidemic Management Team's Vaccination Monitoring Committee, we will start vaccinating.

"I am optimistic and believe that through the right, targeted public outreach among both medical staff and parents, we will reach high levels of vaccination," he said.

Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data "hopefully in a matter of weeks" to decide if the shots are safe and effective enough for younger kids.

Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune "bridging" study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo – something that might offer additional evidence.

The study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA's Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer's Gruber said once the vaccine is authorized for younger children, they'll be carefully monitored for rare risks just like everyone else.

A second US vaccine maker, Moderna, is also studying its vaccine in elementary school-aged children. Pfizer and Moderna are studying even younger tots as young as six months old. Results are expected later in the year.

A demonstration by medical workers at the Red Cross Emergency Ambulance Station in Washington during the influenza pandemic of 1918 (Library of Congress via AP)

The announcement comes as the Associated Press reported COVID-19 has now killed about as many Americans as the 1918-19 Spanish flu pandemic did – approximately 675,000.

The US population a century ago was just one-third of what it is today, meaning the flu cut a much bigger, more lethal swath through the country.

Like the Spanish flu, the coronavirus may never entirely disappear from our midst. Instead, scientists hope it becomes a mild seasonal bug as human immunity strengthens through vaccination and repeated infection. That could take time.

While the delta-fueled surge in infections may have peaked, US deaths are running at over 1,900 a day on average, the highest level since early March, and the country's overall toll topped 675,000 Monday, according to the count kept by Johns Hopkins University, though the real number is believed to be higher.

The 1918-19 influenza pandemic killed 50 million victims globally at a time when the world had one-quarter the population it does now. Global deaths from COVID-19 now stand at more than 4.6 million.

The Spanish flu's US death toll is a rough guess, given the incomplete records of the era and the poor scientific understanding of what caused the illness. The 675,000 figure comes from the US Centers for Disease Control and Prevention.

In many ways, the 1918-19 flu, which was wrongly named Spanish flu because it first received widespread news coverage in Spain, was worse.

Spread by the mobility of World War I, it killed young, healthy adults in vast numbers. No vaccine existed to slow it, and there were no antibiotics to treat secondary bacterial infections. And, of course, the world was much smaller.

Yet jet travel and mass migrations threaten to increase the toll of the current pandemic. Much of the world is unvaccinated. And the coronavirus has been full of surprises.

Tags: COVID-19Modernapfizervaccine

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