If the US regulators agree that the vaccines are safe for this age group, babies as young as 6 month old may be eligible to receive a COVID-19 vaccination in the United States within a few weeks .
Pfizer and BioNTech, its partner, made the first step towards COVID-19 shots becoming available to children on Tuesday when they submitted data from their clinical trials to the Food and Drug Administration. Although there are many regulatory steps ahead, things could quickly move from here. The process with the 5- to 11-year olds took just under four weeks .
These are the steps that must be taken before children under 5 years can get vaccinated against COVID-19.
If the shots are authorized, it remains to be seen if parents will embrace them. A poll by the Kaiser Family Foundation Tuesday found that more than two thirds of parents with children this age say they will wait to see if their child needs vaccinations or “definitely” are not going to get it. Nearly one third of parents state that they will vaccinate their children and babies right away.
Pfizer currently stands farthest along. However, Moderna is also testing the vaccine with this age group. Moderna plans to submit data to FDA in March on 2-to-5-year-olds. Johnson & Johnson will conduct vaccine trials in the future for young children.
We provide more information on each step of the regulatory process and how it is going to affect the Pfizer vaccine.
Step 1: Drugmakers conduct clinical studies and submit data to FDA
Pfizer and BioNTech conducted a 3-phase clinical trial with children aged 6 months to 4 years. In December, the companies revealed that the two-dose series was ineffective for children under 5 years old. Many parents and public health professionals assumed this meant more waiting.
In an unusual move, however, the companies decided that they would apply for authorization to continue their research on the vaccine due to the “urgent public need.” Pfizer-BioNTech stated in a press release.
The companies submitted data on the safety and effectiveness of the two doses of vaccine in this age group, describing them as “part a three-dose principal series”, in an emergency authorization application to the Food and Drug Administration. The data on the third dose of the vaccine, which was administered at least eight weeks following the first, is still being collected.
The pediatric clinical trials for the vaccine include approximately 8,300 children aged 6-12 years. The vaccine is administered in three doses to the youngest age group — the second shot is 21 days following the first and the third eight weeks later.
Children’s dosage is lower than that of adults. The dose for children is 3 micrograms. This is a smaller amount than the 30 microgram dose for teenagers and adults. The dose for children aged 5-11 years is 10 micrograms.
Pfizer has not yet released detailed safety and efficacy data regarding children under this age group.
Step 2: Independent scientists evaluate the data
A panel of scientists from outside will review Pfizer’s safety data and efficacy data on February 15, along with an analysis by FDA scientists about the risks and benefits associated with the vaccine in different scenarios.
After discussions and presentations, the group will vote on whether or not the Pfizer vaccine is worth the risk in this age group.
Step 3: FDA officials weigh-in
Next, the FDA (the agency) will take into account the vote of the advisors on Pfizer’s smallest-dose shot to the youngest children.
After that, FDA officials will decide if the emergency Use Authorization for Pfizer’s COVID-19 vaccine should be extended to this youngest age group.
Step 4: Vote and debate with more independent scientists
Wait, there’s more. Another federal agency and its advisors must weigh in before shots can be made available — this is the Centers for Disease Control and Prevention.
It can be viewed as follows: The FDA is responsible for the what and the CDC for the who.
After the FDA’s evaluation is complete, the vaccine advisory committee of CDC will meet shortly. The group of CDC advisors will vote on whether to recommend the vaccine to all children aged 6 months to 5 years. It could also recommend limiting the vaccine to children who have underlying conditions or children who have not had a coronavirus infection in the past.
Step 5: Final recommendation by the Director of the CDC
The vote of the CDC’s advisors is not an official recommendation. It comes from Dr. Rochelle Walensky, the director of the CDC.
The advisers must be approved by her. She can alter the recommendation from the one that the committee voted on , just like she did with boosters, but she generally follows the lead of the advisers.
Only after the CDC director has issued an official recommendation, shots can be distributed to pharmacies and pediatricians around the country.
Step 6: Doses are distributed to pharmacies and providers
The availability of shots quickly became widespread after a brief delay when vaccines for children aged 5-11 years old were approved. Many pediatricians have been practicing for months administering Pfizer’s COVID-19 vaccines in older children. It’s probable that the rollout of vaccines for babies and small children will be smooth.
Experts recommend that you seek guidance from your child’s school and pediatrician about when and where shots are available. The vaccines.gov website provides information for parents on where to look to locate pharmacies that stock low-dose COVID-19 shots for children.