A Covid-19 vaccine for children ages 5 to 11 could be authorized by early November.
A Food and Drug Administration review this week determined that Pfizer-BioNTech’s Covid-19 vaccine is safe and effective for children ages 5 to 11, paving the way for a shot to be authorized for that age group as soon as early November. Pfizer also announced on Friday that the vaccine is more than 90 percent effective at protecting school-age children from serious illness or hospitalization from Covid-19, similar to the level of protection it provides in adults. The FDA analysis looked at data from Pfizer clinical trials in four different scenarios and concluded that any risks — in particular, a vaccine-related pediatric myocarditis that typically lasts a few days — were negligible in comparison to the benefits for the age group. Previous data from Pfizer showed that young children were able to tolerate the vaccine well and produced a strong immune response, and the results of Friday’s FDA review are further confirmation of its effectiveness. The 2,268 children ages 5 through 11 in Pfizer’s clinical trials received doses a third the size of an adult vaccine dose, spaced 21 days apart. Now that the initial review is complete, there are just a few steps left before Pfizer’s coronavirus vaccine can be authorized for the approximately 28 million American children ages 5 through 11. Next week, the FDA’s panel of independent experts will examine the research and make specific recommendations to the FDA about administering the Pfizer vaccine to this age group. Much as with recommendations about booster shots, the advisory committee is able to offer specific, granular guidance about the vaccine’s safety and necessity. For example, in September of this year, after the Biden administration had planned a widespread rollout of vaccine boosters, the FDA panel recommended that only certain populations receive an additional shot. However, as Vox’s Dylan Scott points out, “the groups already okayed by the FDA and Centers for Disease Control and Prevention for booster shots are quite broad and cover much of the adult population.” The FDA panel will meet Tuesday and offer FDA leadership its assessment. The FDA typically follows the advice of its expert panel, but its guidance isn’t binding. If the advisory committee’s advice conforms with the agency’s initial review of the data, the FDA will likely authorize the vaccine soon after. After that, Pfizer then must present its data to the CDC’s Advisory Committee on Immunization Practices or ACIP. It’s a similar body to the FDA’s advisory committee — a rotating, independent panel of scientists and other experts who can make specific recommendations to the CDC about administering the vaccine. That panel is scheduled to meet November 2 and 3 to discuss pediatric vaccines, according to CNN. Then, ultimately, it’s up to CDC director Dr.
