Could COVID-19 vaccines soon be available for young adolescents in Stanislaus County?
On Friday, Pfizer BioNTech submitted a request for an amendment to its emergency use authorization to the U.S. Food and Drug Administration to expand the use of its COVID-19 mRNA vaccine in adolescents ages 12 to 15.
The Pfizer mRNA vaccine demonstrated 100% efficacy based upon 18 cases of COVID-19 in the placebo group and zero cases in the vaccinated group in a trial in kids 12 to 15.
The Pfizer mRNA vaccine is currently authorized for teens as young as 16. Both the Moderna and Johnson & Johnson/Janssen vaccines can be used in individuals 18 and older.
This is the first EUA requested for COVID-19 vaccines in anyone younger than 16.
“That is so great to hear,” said Kamlesh Kaur, spokesperson for Stanislaus County public health, in an email. “We haven’t heard of any plans yet for how that will roll out.”
Although children and teens generally have milder COVID-19 illness than adults, they can get infected and become seriously ill. As of April 1, nearly 3.5 million children have tested positive for COVID-19, and 279 kids have died, since the onset of the pandemic.
Teen vaccine trial
The Pfizer trial enrolled 2,260 adolescents, 12 to 15, and about half received placebo and half received two doses of the Pfizer vaccine three weeks apart, following the same regimen as the adult trial that showed more than 95% efficacy.
One month after the second dose, the average antibody responses among the vaccine recipients were higher than the antibody levels among vaccinated subjects ages 16 to 25 in the previous efficacy trial, suggesting robust immunity.
Pfizer has not shared safety data publicly, but it reported in a press release that the vaccine was well tolerated in the younger adolescents. They had reactions similar to those observed among the 16- to 25-year-old vaccine recipients, with injection site reactions being the most common.
“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination. ... It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” said Ugur Sahin, CEO and co-founder of BioNTech.
At the end of March, Pfizer BioNTech began a vaccine trial of safety, tolerability and immune responses to the mRNA vaccine in young children, in age groups of 5 to 11, 2 to 5 and 6 months to 2 years. Results are not expected until late summer or fall. Moderna and J&J are also conducting or planning trials in children and young teens.
Upon request of an EUA, FDA scientists do an independent analysis of all data submitted by the manufacturer. The agency will schedule a public meeting of its outside advisory panel, the Vaccines and Related Biologics Products Advisory Committee, to review the results.
For the three previous EUAs for Pfizer, Moderna and J&J COVID-19 vaccines, the FDA gave authorization within days of the advisory committee’s favorable recommendations. If this EUA follows a similar timeline, the Pfizer vaccine could be available for 12- to 15-year-olds in May.
The CDC guidance for safe reopening of schools does not require vaccination of school personnel or students.
This story was produced with financial support from The Stanislaus County Office of Education and the Stanislaus Community Foundation, along with the GroundTruth Project’s Report for America initiative. The Modesto Bee maintains full editorial control of this work. To help fund The Bee’s children’s health and economic development reporters with Report for America, go to bitly.com/ModbeeRFA.
This story was originally published April 10, 2021 at 6:56 AM.
