(CNN) – In a long-awaited announcement, Pfizer said Monday that a Phase 2/3 trial has shown its Covid-19 vaccine to be safe and generated a ‘robust’ antibody response in children ages 5 to 11 years.
These are the first such results published for this age group for a U.S. Covid-19 vaccine, and the data has yet to be peer reviewed or published. Pfizer said it plans to submit to the United States Food and Drug Administration for emergency use authorization shortly.
The trial included 2,268 participants aged 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. These trials used a 10 microgram dose – smaller than the 30 microgram dose used for ages 12 and older.
“The 10 microgram dose has been carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years old,” Pfizer said in a press release.
The participants’ immune responses were measured by examining the levels of neutralizing antibodies in their blood and comparing these levels to a control group of 16 to 25 years old who were given a two-dose regimen with the highest dose of 30 micrograms. . Pfizer said the levels compared well to those of older people who received the highest dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”
“Additionally, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those seen in participants aged 16 to 25,” the company said.
A Pfizer spokesperson also confirmed that there were no cases of myocarditis, a type of heart inflammation that has been linked to mRNA vaccines.
Pfizer said this data will be included in a “short-term submission” for the EUA and that the companies will continue to accumulate the data needed to seek FDA approval for people aged 5 to 11.
The Pfizer / BioNTech vaccine is currently approved for people 16 years of age and older, and cleared for use in people 12 to 15 years of age.
Pfizer said it expects test data for children as young as 6 months “as early as the fourth quarter of this year.”
“Since July, pediatric cases of COVID-19 have increased by approximately 240% in the United States, underscoring the public health need for immunizations. These trial results provide a solid basis to seek authorization for our vaccine for children aged 5 to 11, and we plan to submit them urgently to the FDA and other regulators, ”said Albert Bourla. , chairman and chief executive officer of Pfizer, in a statement. the statement.
Dr Scott Gottlieb, former FDA commissioner and current Pfizer board member, said a vaccine for children ages 5 to 11 could be available by Halloween.
Acting FDA Commissioner Dr Janet Woodcock and Dr Peter Marks, director of the FDA’s Biologics Research and Evaluation Center, said in a statement this month that the agency would review the data of a vaccine for young children “as quickly as possible, probably in a matter of weeks rather than months,” once it has been submitted for authorization.
“However, the agency’s ability to quickly review these submissions will depend in part on the quality and timeliness of submissions by the manufacturers,” they wrote.
Calls for a Covid-19 vaccine for young children have increased in recent months as cases increase in children.
Coronavirus infections have increased “exponentially” in children across the United States and now account for nearly 29% of all reported cases nationwide, the American Academy of Pediatrics reported last week.
Still, U.S. health officials have stressed that children aren’t just little adults, and even those approaching the age of 12 shouldn’t be given the highest dose of vaccine available to the elderly.
“We don’t want children to have side effects. Granted, we want them to be able to get the vaccine as quickly as possible, but let’s do it right, ”FDA Marks said in a fireside chat hosted by the ResearchAmerica Alliance last week.
“There is a difference here because they don’t just get the same dose as someone 12 and over. They should be given a reduced dose. And that’s why it’s not a good idea for doctors to take matters into their own hands at this point.
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How to prevent the spread of the COVID-19 coronavirus
The COVID-19 coronaviruses transmitted from person to person. It is a virus that resembles the common cold and the flu. So, to prevent it from spreading:
- Wash hands frequently and thoroughly with soap and water for at least 20 seconds.
- Wear a mask.
- Don’t touch your face.
- Keep children and people with weakened immune systems away from someone who is coughing or sneezing (in this case, at least six feet)
- If there is an outbreak near you, practice social distancing (stay home, instead of going to the movies, sporting events, or other activities.)
- Get the flu shot.
- To get vaccinated.
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