Pfizer-BioNTech Covid-19 vaccine for young children to be reviewed by FDA advisors

Experts advising the Food and Drug Administration are due to meet Tuesday, including Pfizer Inc. and BioNTech SE will be considered to support a Covid-19 vaccine for use in young children.

His positive recommendation is likely to soon expand the US vaccination campaign to millions of young children.

The FDA said last week that the results of the companies’ late-stage study met criteria for an immune response in children ages 5 to 11. The agency also confirmed data from companies that showed the shot was found to be safe and 90.7% effective in preventing symptomatic Covid-19 in a study of youth.

The expert panel, called the Vaccines and Related Biological Products Advisory Committee, is expected to review scientific data about the safety and effectiveness of vaccines in children, and vote to recommend whether the FDA should Use must be authorized.

A thumbs-up from the panel could come within days of the FDA authorizing the use of pediatric shots of the vaccine.

The FDA, which regulates medical products, must clear a vaccine before it can be used outside of testing. Following the FDA’s action, the Centers for Disease Control and Prevention, which provides guidance to doctors, pharmacies and vaccination sites, will set policy for young children to receive the shots.

The FDA is not required to accept the panel’s decisions, but generally it is. Panel members—who have weighed in before the FDA’s all-important Covid-19 vaccine decisions—include infectious-disease experts, professors and practicing physicians.

The panel is likely to debate the risk of myocarditis, a heart-inflammatory condition found in a small number of young men and male adolescents who have received messenger RNA vaccines. Pfizer-BioNtech and Moderna Inc. The shots use mRNA technology. US health officials have said the risk of heart conditions appears to be highest in young men and male teens after a second dose of one of the vaccines.

According to Pfizer and BioNTech, no cases of myocarditis were found in the children’s study, although it was too small to detect a potential risk.

States and healthcare providers are on course for what is to be the largest vaccine campaign since the initial dose was made available to adults nearly a year ago. Federal and state officials say clinics are planned in pediatricians’ offices, schools, community-health facilities and pharmacies.

Children face a relatively low risk of serious illness and death from Covid-19, but have had more hospitalizations than ever before in the pandemic and as the highly contagious Delta variant has swept across the country. Doctors and physicians say it is important to get vaccinated to protect children and those around them.

The FDA’s green light would expand the vaccine’s availability to about 28 million additional children.

If the vaccine is authorized, young children will take two shots spaced three weeks apart. Each shot will contain one-third of the dose used for teens and adults.

Many parents are looking forward to vaccines, hoping to protect their children as the school year gets on and the holiday season approaches. Yet surveys also show that there are more parents who are unsure about vaccinating their children.

Pfizer and BioNTech this month asked the FDA to authorize the vaccine for young children. The vaccine is fully approved for people 16 years of age and older and for use in children 12 years of age and older.

According to the companies, in a study of 2,268 children ages 5 to 11, the vaccine was generally well tolerated and produced levels of neutralizing antibodies comparable to those seen in subjects 16 to 25 years old.

Pfizer and BioNTech are at the forefront of authorized Covid-19 vaccine companies in advancing a shot for young children.

Moderna said Monday that its vaccine was generally safe and induced immune responses in children aged 6 to 11 in a clinical trial. Johnson & Johnson has not yet studied whether the vaccine works in young children.

This story has been published without modification to the text from a wire agency feed