FDA Says “Working Round The Clock” To Assist Approvals For Youngsters Underneath 12 Years Outdated

Justing Concepcion, 12, receives a dose of Pfizer BioNTech’s Coronavirus Disease (COVID-19) vaccine from Registered Nurse Angela Nyarko during a vaccination event for local teenagers and adults outside the Bronx Writing Academy school in the Bronx. New York City, June 4, 2021.

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The Food and Drug Administration said Friday that US regulators are working “around the clock” to help approve Covid-19 vaccines for children under the age of 12.

So far, the Pfizer BioNTech coronavirus vaccine has been approved by the FDA for people ages 12 and older, while Moderna and Johnson & Johnson’s vaccines have been approved for adults.

Federal regulators are “eager to have our children and grandchildren vaccinated against COVID-19 as soon as possible,” said acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, the agency’s supreme vaccine agency, in a joint statement. “We have to be guided by science and data.”

To ensure safety, clinical trials testing the vaccines are expected to include a monitoring period of at least two months after half of the participants receive the injections, they said.

“Once manufacturers have completed the relevant portion of their clinical trials, they need to finish analyzing the data from the trials to understand how safe the vaccine is and how well it works on the clinical trial participants,” they said.

The testimony from top health officials comes as many parents say they are careful to get their children vaccinated, especially as schools reopen and the highly contagious Delta variant continues to spread. The exposure has led to an increase in hospital admissions in the United States, including young children who are currently unable to be vaccinated.

President Joe Biden on Thursday detailed a comprehensive plan to fight the virus, pressured private employers to immunize their workforce, and mandated the shots for federal employees, contractors and healthcare workers.

Marks said last month the agency would approve admission for children under the age of 12 as “soon” as possible once companies submit data. “Studies are ongoing and the agency will have to wait for the company to submit the data for these studies,” he said. “We definitely want to make sure we’re getting it right.”

The German drug manufacturer BioNTech announced on Friday that, according to a report, it would apply for worldwide approval for the use of its Covid vaccine in children aged 5 and over in the next few weeks.

Dr. Scott Gottlieb, a Pfizer board member, has told CNBC that he expects U.S. drug regulators to clear the Pfizer BioNTech Covid vaccine for emergencies in children ages 5-11 in late fall or early winter this year.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of Norwegian Cruise Line Holdings ′ and Royal Caribbean’s Healthy Sail Panel.

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