What parents should know about Covid vaccines for children under 5

The U.S. Food and Drug Administration is considering Moderna’s emergency use application for its vaccine in this youngest age group, and will soon be reviewing Pfizer’s as well.

Meanwhile, Covid-19 cases are surging across the country, driven by the highly contagious subvariant of Omicron known as BA.2.12.1, according to new data from the US Centers for Disease Control and Prevention.

What Should Parents and Caregivers Know About Pfizer and Moderna’s Data to Date? What is the projected timetable for when young children can be vaccinated? And what can parents and carers do in the meantime to reduce the risk of contagion for their families?

To help answer these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management in the School of Public Health at George Washington University’s Milken Institute. She is also the author of Lifelines: A Doctor’s Journey in the Fight for Public Health and a mother of two young children.

CNN: Many parents have been eagerly awaiting the news of the vaccine for children under the age of 5. Based on what you’ve seen from the Pfizer studies so far, are you optimistic?

dr Leana Wen: Yes, I am. As a reminder, Pfizer first tested two injections of the 3 microgram dose in this youngest age group (6 months to 5 years). This dose is one tenth the dose for adults (30 micrograms) and less than one third the dose for children aged 5 to 11 years (10 micrograms).

Two shots of that lower dose were safe, the initial studies found, but they didn’t produce an adequate immune response. Because of this, Pfizer has started testing a three-dose version of the vaccine, as other age groups have needed at least three doses to boost protection. In fact, the FDA has approved a third dose of the Pfizer vaccine for everyone ages 5 and older, and the US Centers for Disease Control and Prevention has recommended that course.
Pfizer just announced top-line data from a study of nearly 1,700 children who received a third dose during the period when the Omicron variant was predominant. The antibody levels measured one month after the third dose were similar to the response seen in young adults aged 16 to 25 years.

The company also reported that the vaccine was over 80% effective against symptomatic Covid-19 in children aged 6 months to 5 years. However, these figures are considered interim results and are not final.

Overall, I find these results promising. I look forward to the final study results and to Pfizer submitting its data for FDA regulatory review.

CNN: How do Pfizer’s results compare to Moderna’s?

Whom: It’s difficult to compare them directly, so let me explain what Moderna’s results showed. Moderna was testing a two-dose version of its vaccine. This dosage was 25 micrograms, which is a quarter of the dose of the adult version (100 micrograms). The researchers found that the vaccine’s effectiveness in children aged 6 months to 5 years was similar to that in older age groups: specifically, the vaccine is 51% effective at preventing symptomatic infections in children aged 6 months to under 2 years and 37 years % effective in preventing symptoms in children aged 2 to 5 years.

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Moderna’s studies also found, similar to what Pfizer had announced, that its vaccine elicited a robust antibody response in young children that was similar to that in older individuals. The research team also found that the vaccine was safe.

I’m optimistic about these results. Moderna’s results have already been submitted to the FDA, and the agency is currently reviewing this data.

CNN: What’s the schedule at this point? When can parents expect their children to be vaccinated?

Whom: The FDA just announced a meeting of its External Advisory Committee for June 15th. Agency officials have said they will discuss Moderna and Pfizer’s applications for younger children that day.

If consultants recommend the vaccines for approval, depending on the outcome of the meetings, the FDA could issue an emergency use authorization immediately after it is convened, and the CDC could meet and make its recommendation shortly thereafter. With this kind of schedule, it’s possible for parents to start getting their young children vaccinated as early as the week of June 20th. If both vaccines are approved, parents have the choice of having their children vaccinated with one of Pfizer’s three-dose vaccine or the two-dose Moderna vaccine.

CNN: Do you already know which vaccine you would give your children?

Whom: Either vaccine, if and when approved, will be available first. I trust the very thorough regulatory process and believe that if and when both of these vaccines are approved by the FDA and recommended by the CDC, they will be safe and effective. I am committed to providing my young children aged 2 and 4 with the excellent protection that everyone aged 5+ is currently entitled to.

CNN: In the meantime, with Covid-19 cases rising, what can parents do to protect their unvaccinated children?

Whom: Parents need to decide how important it is to them to continue avoiding the coronavirus. Some may decide this is less important, especially if the entire family has recently been infected with Covid-19. Others may decide that if a child is immunocompromised, for example, it is crucial.

There are many methods that can help reduce the risk. Outdoor gatherings are still much safer than indoor gatherings. Consider holding playdates, birthday parties, and other gatherings outdoors instead of indoors. If you have an indoor event, ask everyone to take a quick test at home before arriving. Masking indoors in public places can also reduce the chance of contracting the coronavirus.

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