US Approves Pfizer-BioNTech Vaccine For Children 12-15 Years Old

US Approves Pfizer-BioNTech Vaccine For Children 12-15 Years Old

U.S. regulators on Monday cleared Pfizer-BioNTech’s COVID-19 vaccine for use in children as young as 12, expanding the country’s immunization schedule as vaccination rates slow significantly.

The vaccine is available under Emergency Use Authorization (EUA) for people as young as 16 years old in the United States. Vaccine makers said they began the full approval process for these ages last week.

The United States Food and Drug Administration has said it is amending the EUA to include the millions of children between the ages of 12 and 15.

It is the first COVID-19 vaccine to be cleared in the United States for this age group, seen as an important step in getting children back to school safely. Health Canada approved the use of the Pfizer-BioNTech vaccine for children as young as 12 years old on May 5.

US President Joe Biden has called on states to immediately make the vaccine available to young adolescents.

“Today’s action enables a younger population to be protected from COVID-19, bringing us one step closer to a return to a sense of normalcy and the end of the pandemic,” said Dr Janet Woodcock, Commissioner Acting FDA, in a statement. “Parents and guardians can rest assured that the agency has undertaken a rigorous and in-depth review of all available data, as we have done with all of our emergency use permits for the COVID-19 vaccine.”

‘A boon’

Most children with COVID-19 develop only mild symptoms or no symptoms at all. However, children are not without risk of becoming seriously ill and can still spread the virus. There have been epidemics attributable to sporting events and other activities for children in this age group.

Dr William Gruber, a senior scientist at Pfizer, said the EUA will help the United States boost its immunity and protect an age group that has not been completely spared from serious illness.

“I hear from pediatricians and members of the community saying what a godsend this is going to be for the teenage population that has been restricted in terms of sports, theater clubs and other types of things that we naturally want. they’re engaging. in, ”Gruber said.

Vaccines are essential to end the pandemic. But many health officials fear that vaccine reluctance in some adults may be even more pronounced when it comes to their children.

Parents may question the risks versus the benefits, given the unknowns about the long-term impact of vaccines on children’s development and the data on the number of young children hit hard by COVID-19.

Pfizer-BioNTech vaccine first to be approved for children up to 12 years of age in the United States (Getty Images)

100% effective in preventing disease

The companies said in March that they found the vaccine to produce robust antibody responses and to be safe and effective in children ages 12 to 15 in a clinical trial.

In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group who received a placebo and none among those who received the actual vaccine, resulting in a 100% effectiveness in preventing the disease, the companies said. at the time.

Pfizer and BioNTech asked the FDA to expand their EUA to include the younger age group in early April.

Almost 46% of people in the United States had received at least one injection of a COVID-19 vaccine on Sunday, according to data from the United States Centers for Disease Control and Prevention (CDC).

But the pace of vaccinations in the United States has slowed considerably since reaching a seven-day average of more than 3.3 million doses per day in mid-April. That average had dropped by more than a third to about 2.1 million strokes per day as of May 4, according to CDC data.

Pfizer’s vaccine is the only one licensed for 16 and 17 year olds in the United States. Nearly 2 million people in this age group have received at least one vaccine, according to CDC data. Many states did not open to non-high risk people in this age group until early April.

Broad vaccination of 12 to 18-year-olds could allow American schools to relax masking and social distancing measures suggested by the CDC.

Pfizer said it expects to have safety and efficacy data for children aged 2 to 11 in September, when it plans to seek a further extension of the EUA for this age group. .

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