Opinion | Parents of little kids might be disappointed, but the FDA was right to delay vaccine authorization – The Washington Post

Despite my disappointment, I believe the FDA made the right decision to choose caution over expediency. Authorizing vaccines without meeting the endpoint for effectiveness could have worsened vaccine hesitancy. The FDA’s pause — especially in the face of many advocates urging quick approval — gives me even more confidence in its thorough and careful process.

Developing safe and effective vaccines for younger children was never a guarantee. Kids are not little adults, and one can never assume that something that works on adults will have similar results in children. Thankfully, studies have proved that two doses of the Pfizer vaccine are very safe and highly protective for 5-to-11-year-olds.

Vaccine trials for children under 5 used a smaller 3-microgram dose, compared with 10 micrograms for children 5 to 11 and 30 micrograms for people 12 and older. Unfortunately, Pfizer reported in mid-December that while this lower dose elicited a robust immune response in children 6 to 24 months old, it did not meet the efficacy threshold in 2-to-4-year-olds. Instead of applying for authorization right away, the company said that it would test a third dose of the vaccine with the hope that three doses would induce sufficient protection.

This news came as the omicron tsunami hit the United States, infecting record numbers of children. Many parents asked why they couldn’t start with two doses now. After all, if two doses are safe and children need to get two doses before the third, doesn’t the potential benefit outweigh the harm?

It’s possible that this external pressure contributed to federal officials making the unusual call on Feb. 1 to request that Pfizer submit its two-dose data for authorization. FDA advisers scheduled the meeting for Tuesday, but they canceled it last minute after the agency reversed course.

Had the FDA gone ahead to review data on the two doses for children under 5, I think there could have been a split decision by the advisers, resulting in public confusion and setting up a dangerous precedent. Our regulatory agencies are supposed to wait until there is clear evidence before giving the green light. How would it make sense to allow little kids to get the first two doses when they aren’t effective enough and we don’t yet have evidence that a third dose will be? The data reportedly showed no safety concerns in this age group, but vaccines can still cause minor side effects, such as fever and body aches. These side effects are definitely preferred to contracting covid-19, but how can we accept this risk unless we know that the vaccines work?

The confusing messaging is of particular concern given the existing level of vaccine hesitancy among parents. Only 23 percent of 5-to-11-year-olds are fully vaccinated. For more than a year, I and other physicians have been telling patients that when federal health officials recommended the coronavirus vaccines, they hadn’t taken any shortcuts and were certain that they are safe and effective. How could we continue providing this reassurance if the vaccine for our youngest children is authorized with an asterisk — that its efficacy is pending further studies?

In addition, circumstances have changed. Omicron has peaked in most of the country, and we now know that it is milder than previous variants. The risk-benefit calculus has shifted, and there is less urgency than two months ago.

Don’t misunderstand me: I’m extremely frustrated that my kids remain unprotected. Their risk of contracting covid-19 will become higher as restrictions are lifted. Our family, and millions of others with young children or immunocompromised relatives, will have to keep taking additional precautions as others return to their pre-pandemic lives.

I do not begrudge others of their much-deserved normalcy, even as we can’t have the same. We are still not flying to see our extended family because my daughter, who’s not yet 2, is unable to mask. We are still limiting our 4-year-old’s playdates to the outdoors. My husband and I will keep wearing our N95 and KN95 masks in indoor, public places and limiting our social contacts to others who are also vaccinated and boosted.

Parents of young children are tired of waiting, but we have waited this long. We can wait a couple of months more for the science to catch up to our expectations.

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