ALBANY, N.Y. (NEWS10)- Keeping on par as the first pharmaceutical company to have its COVID-19 vaccine approved for emergency use by the U.S. Food and Drug Administration (FDA), Pfizer along with partner BioNTech asked the FDA for approval to administer its vaccine to kids.
The request was made on April 9, after the companies released data showing the efficacy rate for Pfizer’s vaccine in kids proved to be greater than the efficacy rate in adults, according to the company. It was found to be 100% effective in kids aged 12-15, and 95% effective in adults 16 years and older.
The number of kids that have gotten sick from COVID-19 in the U.S has remained low, according to the Centers for Disease Control and Prevention (CDC). In New York COVID-19 has claimed the lives of 16 children between the ages of 0-19 years old, based on the state’s COVID dashboard.
Regardless of these statistics, both Johnson and Johnson and Moderna have said they intend on or are in the process of including kids in ongoing clinical trials but as of mid-April, neither has asked the FDA for approval to administer their vaccines to kids and teens.
It wasn’t long after the FDA’s emergency approval for the Pfizer COVID-19 vaccine that Moderna’s was approved for use in adults over the age of 18.
Although its administration has been halted because of concerns over the risk of a severe type of blood clot, Johnson and Johnson was the third company to get approval for emergency use of its COVID vaccine in adults 18 or older.
Pfizer got a jump on vaccinating adults with its COVID-19 vaccine and seems to have done the same with vaccinating kids as well. It was already looking ahead to vaccinating kids for COVID-19 last year when it began a three-phase clinical trial in April 2020, according to Clinicaltrials.gov.
Phase one focused on distributing the vaccine to adults but phase two and phase three were to include administration to kids between the ages of 12-15. The company announced it had finished enrolling kids 12-15 into its trial in late January 2021, according to the American Hospital Association.
The results of that trial were made public when the pharmaceutical company announced the efficacy of its vaccine in kids on March 31, seven days before asking the FDA to approve its vaccine for kids.
In addition to high efficacy rates, Pfizer said side effects in kids ages 12-15 were similar to that of those between 16-25 years old. The five most reported side effects in adults over the age of 16 were injection site pain (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), and chills (31.9%).
Clinical trials for COVID-19 vaccines
|Manufacturer||Adults||6 mos.-12 years||12-17 years|
|Johnson & Johnson||approved for 18+||no information||clinical trial in progress|
|Moderna||approved for 18+||clinical trial in progress||clinical trial in progress|
|Pfizer||approved for 16+||clinical trial in progress for kids 6 mos.- 11 years old||Pfizer asked for FDA approval to vaccinate kids ages 12-15 Apr. 9, 2021|
Moderna said the first participants in its adolescent clinical trial for ages 12-17 received their first dose of the COVID-19 vaccine in December 2020. Further information on the trial could be released soon. The company said its goal was to be able to present results this spring “that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year.”
Moderna also announced the inclusion of children ages six months to 12 years old into its trial on March 16, 2021. They are still enrolling kids into its trial and plans on accepting 6,750 kids from the U.S. and Canada, according to Moderna’s www.kidcovestudy.com.
Johnson and Johnson said its initial COVID-19 vaccine clinical trials involving kids and teens would include a small group of ages 16-17. Trials will be expanded to a larger group of kids above the age of 12 once the small group study of teens 16-17 years old has been evaluated, Johnson and Johnson said on April 2, 2021.
Johnson and Johnson began enrolling kids in its clinical trial in Spain and the United Kingdom with plans to begin enrolling for trials in the U.S. soon, they said. No mention was made by the company that they would eventually extend the trials even further to include kids younger than 12.
It may be months before either Johnson and Johnson or Moderna is far enough along in their clinical trials to ask the FDA for approval to vaccinate kids.
Should the CDC, New York State, or schools implement a policy or push to vaccinate school-aged children in an attempt to return them to the classroom, it is unclear at this time if more than just the Pfizer vaccine will be available before the beginning of the 2021-2022 school year.