On February 11, the FDA announced that it would be postponing the authorization of the Pfizer COVID-19 vaccine for children aged 6 months – 4 years to analyze new data from the ongoing clinical trial. This is a crucial part of the authorization process that ensures all COVID vaccines adequately protect without compromising safety and effectiveness.

The currently approved COVID-19 vaccines are only eligible for people five years and older. More than 252 million people have been safely vaccinated with at least one dose of the vaccine.

Pfizer has an ongoing clinical trial to test the effectiveness of a smaller dose of their vaccine on children under five years old. The results from the trial showed that two smaller doses of the vaccines did not adequately protect children between 2 and 4 years (though they did seem to protect those between 6 months and two years old).

Based on this information and the need to carefully review and authorize vaccines by considering the risks and benefits to each age group, the FDA is waiting to analyze the new data for the third dose before deciding. The third dose result is likely to be available in April 2022.

It is common for young children to need multiple doses of a vaccine to get enough benefit. Examples include the hepatitis B vaccine, which is given to children in three doses, and the diphtheria, tetanus, and pertussis (DTaP) vaccine typically requires five doses.

It is recommended that children older than two years continue to practice other preventive measures such as mask-wearing and social distancing to protect them.

We do not know how many doses children under five years will need to reach a high level of protection.