Kids’ COVID Vaccine May Be Approved By Halloween Former FDA Head

Kids’ COVID Vaccine May Be Approved By Halloween Former FDA Head NEW BRUNSWICK, NJ — Former Food and Drug Administration commissioner Dr. Scott Gottlieb predicts that the FDA could approve the Pfizer vaccine for children ages 5 to 11 by the end of October — by Halloween, in fact.

Gottlieb, who made his prediction on CBS’ “Face the Nation” on Sunday, currently sits on Pfizer’s board of directors.

“In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween,” Gottlieb said. “If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they’ve collected.”

At the start of summer, Pfizer and Moderna both said it was extremely unlikely a coronavirus vaccine for children would be approved in time for kids headed back to school in September. And the FDA has long said it expects a vaccine for children to be approved on a “fall or winter timeline.”

However, Gottlieb’s Halloween prediction is the most specific timeline yet. As of last Tuesday, 2,396 children were hospitalized with COVID-19 across the nation, according to CNN. That is a record high.

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In total, the Pfizer-BioNTech vaccine will be tested on approximately 4,644 children at trial sites in the United States, Finland, Poland and Spain. In early May, it was announced that one of those sites was Rutgers University’s New Brunswick campus.

But what hasn’t been reported yet is that when Rutgers medical school first put out a call for children volunteers, it received so much interest that parents had to be turned away, the university said.

“The number of people who expressed interest in the study in children was greater than 1,200 and we plan to enroll about 100,” said Dr. Simon Li, a pediatrics professor at Rutgers Robert Wood Johnson Medical School, who is helping run the trial.

Rutgers had this public sign-up page for the trial but had to close it, writing “Due to tremendous response the study has closed for new referrals.”

Currently, Rutgers has 100 children ages 5 to 11 enrolled in the Pfizer-BioNTech trial. It is the only Pfizer COVID-19 clinical trial site for children in New Jersey.

Just like adults, each child will be given two shots of the vaccine. Alternately, some of the children will be given a placebo. Over the next two years, Rutgers researchers said they will track whether those who were vaccinated have lower rates of infection with moderate to severe symptoms than kids who got the placebo.

A secondary trial is planned to take place at Rutgers for 100 additional, younger children: 50 children each from the age groups 2 to 5 years and 6 months to 2 years.

Dr. Minh-Tu Do, a pediatric ER doctor who lives in New Jersey, told NJ Spotlight why he decided to enroll his sons, ages 9 and 4, in the Rutgers trials. He said his 9-year-old son, Justin, has been asking his parents when he can get the vaccine.

“Knowing how devastating this disease can be, I also wanted to make sure our children were protected not only for themselves but also for others,” he told NJ Spotlight. “I’ve seen a lot of patients who were diagnosed with COVID-19. I’ve seen the best and the worst.”

To some, 4,644 in Pfizer’s childhood trial may seem low. Pfizer said in a Patch article in May that its initial adult vaccine study enrolled more than 44,000 people worldwide, and that that study gave it an indication of the vaccine’s safety for teens and children.

Moderna is currently testing its coronavirus vaccine on 12,000 children across 100 sites in the United States.

Moderna is not doing any child coronavirus trials at Rutgers or anywhere else in New Jersey.

This is the third time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. Last fall, it conducted trials for Moderna and Johnson & Johnson. Rutgers college students participated in the Johnson & Johnson trial.

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