Allows Pfizer's COVID-19 Vaccine Use For Booster Doses For Children 12-15 Years Old, This Is FDA Consideration

Illustration of a COVID-19 vaccination. (Wikimedia Commons/US Secretary of Defense)

JAKARTA - The United States Food and Drug Administration (FDA) on Monday authorized the use of the third dose of Pfizer and BioNTech COVID-19 vaccines for children ages 12 to 15, and narrowed the interval for booster injection eligibility to five months from previously. six months.

In addition, the agency also allows a third injection for immunocompromised children aged 5 to 11 years.

The regulatory decision comes as COVID-19 cases soar due to the Omicron variant, as well as the sheer number of workers and schoolchildren returning from holiday holidays, raising the health system's extraordinary prospects. Some businesses and schools are closed on Mondays due to sick staff.

"Based on the FDA's assessment of currently available data, booster doses of currently authorized vaccines could help provide better protection against Delta and Omicron variants," said Peter Marks, director of the FDA's Center for Biological Evaluation and Research.

The US government has urged vaccinated Americans to get a booster and for the unvaccinated, who are at much higher risk of COVID-19 and severe death, to be inoculated.

An advisory panel for the US Centers for Disease Control and Prevention (CDC) will meet on Wednesday to discuss the changes, according to the agency's website.

New COVID-19 infections in the US have doubled in the past seven days to an average of 418,000 per day, according to a Reuters tally. So far, 62 percent of the eligible US population is considered to have been fully vaccinated with a third of them also having received a booster dose.

In making its decision, the FDA said it reviewed real-world evidence from Israel, including safety data from more than 6,300 people aged 12 to 15 years who received a booster dose of Pfizer-BioNTech vaccine, at least 5 months after primary completion. two-dose vaccination series.

Two injections of the mRNA vaccine were about 35 percent effective against infection from the Omicron variant, but a booster dose restored effectiveness to 75 percent, according to the CDC, based on data from South Africa and the UK.

The FDA will weigh boosters for children ages 5 to 11 after more children receive two doses, Marks said.

"Last I looked, only about 25 percent of eligible 5 to 11 year olds had been vaccinated. So it would be great to get a bigger percentage of those vaccinated and then we'll see how many months later we need to get it scaled up, " he told the media.

The FDA says giving injections at 5 months instead of 6 may provide better protection sooner against Omicron. The agency said the interval between the second dose of Moderna (MRNA.O) and the booster remained unchanged at six months.

Separately, Eric Topol, director of the Scripps Research Translational Institute in La Jolla, Calif., said a third shot is essential for protecting against Omicron for severe disease.

"The good thing here is the change in booster time to five months instead of six. That's a big step for this country, which has been resistant to data," he explained.

To note, countries including the UK and Israel have narrowed their windows for giving the booster, from six months to three or four months after the second injection.

Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security, said she doesn't believe a booster is necessary for most people because two doses of the vaccine have been effective in preventing hospitalization and severe illness in everyone except the elderly.

"When I worked at the hospital, I didn't see patients there because they didn't have a booster. I saw patients because they lacked the first and second doses," Adalja said.