Pfizer Requests Clearance from FDA for Covid-19 Vaccines for Children Ages 5 to 11
Suzanne Biju, Grade 12
Pharmaceutical corporation Pfizer has formally submitted an appeal to the United States Food and Drug Administration (FDA) to approve the distribution of the Covid vaccine to kids between the ages of 5 to 11 (Li, 2021). This is the first step in the process of making the Covid vaccines available for children.
A clinical trial was conducted consisting of 2,268 children from the ages 0f 5 to 11 who were given a third of the dose-a 10 microgram dose instead of the usual 30 that is given to everyone else (Gumbrecht, 2021). Two doses of the shot were provided, with 21 days between the first and the second dose. The results from the trial led Pfizer to declare that the Covid-19 vaccine was safe for children to receive.
How exactly did they reach this conclusion? Details reveal that the children’s bodily responses to the Covid dose were determined by analysing the levels at which the antibodies were neutralized. In comparison to the levels of older participants in ages 12 to 25, it was determined that the children had developed immunity that was tantamount to that observed in older adults who received stronger shots (CBC, 2021).
The side effects of the vaccine were also reported to correspond with those that older individuals experienced-for example, sore arms and fatigue. However, the study was not extensive enough to be able to determine the possibility of more serious and/or rare side effects.
Pfizer has since submitted data from their trials to the FDA. If it is found to be concrete, the vaccine can be sanctioned in weeks, as stated by a FDA official (Gumbrecht, 2021). The evidence from the trials will also be examined by CDC vaccine advisers who will make the final verdict.
Come mid-October, Pfizer also has plans to submit a request for authorization of the vaccine for children in Canada. As an influx in cases have been reported since the reopening of schools in Canada, the vaccine will provide a sense of surety to concerned parents across the country.