When might Covid-19 vaccines be available for the youngest? An expert intervenes

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This is news that many parents have been eagerly awaiting – but what exactly does that mean for when vaccines might be available for this age group? What about children under 5? Should parents try to immunize their young children now? And with the news that some older, high-risk Americans may be getting booster shots soon, should parents try to get themselves a booster dose?

To answer these questions, we spoke with CNN medical analyst Dr. Leana Wen. Emergency physician and visiting professor of health policy and management at the George Washington University Milken Institute School of Public Health, she is also the author of a new book, “Lifelines: A Doctor’s Journey in the Fight for Public Health” , and the mother of two young children.

Dr. Léana Wen: The Covid-19 vaccine is currently only authorized for children 12 years of age and older, but studies are underway for the vaccine in younger people. On Monday morning, Pfizer announced the first results for children aged 5 to 11. In a study of 2,268 participants aged 5 to 11, they found that the vaccine is, first of all, safe. Side effects are similar to those seen in older groups. In addition, they found that the vaccine induces a strong antibody response. This is very important because a lower dose is used – 10 micrograms compared to 30 micrograms for older groups.

The study does not show that the vaccines prevent infections or serious illnesses in young children. These data are still being collected. However, based on what we have seen in the older age groups, the antibody response correlates well with immune protection.

It is also important that no one in the study group contracted myocarditis, an inflammation of the heart muscle considered a rare side effect of the vaccine, especially in adolescents and young men. This side effect is so rare that it would be unlikely to occur in a study of 2,268 participants. If this happens, it may not be until hundreds of thousands, if not millions of people in this age group are vaccinated.

CNN: Are these results important?

Magnifying glass: Yes. These are the first results to date in this 5-11 age group, and they show great promise. Many parents have been eagerly awaiting these results because we are eager to vaccinate our children. This is especially critical given where we are in the pandemic.

Almost 30% of new Covid-19 infections concern children. Nearly half a million children have been infected with the coronavirus in the past two weeks. Many children are returning for in-person schooling in places that have failed to implement necessary preventive measures, such as requiring indoor masking. Parents are eager to protect their children, and obtaining this first round of results gives hope that vaccines may soon be licensed for younger children.
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CNN: What’s next – when will the vaccine actually be licensed for children aged 5 to 11?

Magnifying glass: Pfizer has not yet submitted its data for clearance to the United States Food and Drug Administration. This is the next step, for Pfizer to formally seek emergency use authorization for this younger group. The FDA will then review all of the company’s data, convene an independent committee of advisers, and make a decision on whether or not to approve the vaccine for this group of children aged 5 to 11.

Note that the authorization is not acquired in advance. It’s possible that the FDA will also come back to Pfizer and request more data or only allow it for a subset of that group – for children with underlying medical conditions, for example. So far we only have one earnings announcement from the company and we have to wait for full data release by Pfizer.

Dr Scott Gottlieb, former FDA commissioner and current Pfizer board member, said the FDA may clear the vaccine for the 5-11 age group as early as late October. This means that, in the best-case scenario, some shots could take up arms by Halloween.

CNN: And what about young children – when will vaccines be available to them?

Magnifying glass: Studies are underway for children as young as 6 months old. Pfizer said it expects these results to be achieved by some time this year. Assuming it takes an additional three to six weeks for the FDA to review the data, I predict that we will not have vaccines for children aged 4 and under until early 2022. This is something that I do not expect. ‘look forward to myself, because the mom of a 1 year old and a 4 year old.

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CNN: What questions should parents ask themselves now when deciding whether to immunize their youngest children?

Magnifying glass: Children 12 and older are already eligible to be vaccinated, and I urge parents to get their children in this age group vaccinated now. About half of children 12 and over have already received a dose of the vaccine, and we know it is safe and effective in this age group. For the younger ones, I would say wait until we see the data from Pfizer and the FDA reviews it. We want to make sure our federal health officials are doing their job to make sure the vaccine for 5 to 11 year olds is safe and effective.

CNN: I’ve heard of some parents claiming their youngest children are 12 to get them vaccinated earlier. Should they do this?

Magnifying glass: No, and in fact the FDA has explicitly warned against this move. Note that younger children are tested with a lower dose of vaccine than older children. Also, I think it’s only a matter of weeks before people in the 5-11 age group have access to the vaccine. I really urge parents to wait until there is clearance for the younger group. In the meantime, let’s continue to protect our children through other measures, including sticking to outdoor gatherings only with unvaccinated people and adhering to indoor masks in schools.

CNN: Now that booster shots are available to some Americans, should parents of unvaccinated young children try to get them?

Magnifying glass: The FDA advisory committee has recommended that booster doses of the Pfizer vaccine be available for those who have received the Pfizer vaccine and are 65 years of age and older, as well as for those at risk of serious consequences from Covid- 19. In addition, third doses are available for Pfizer and Moderna vaccine recipients who are moderately or severely immunosuppressed.

The reason why boosters are to increase immune protection against breakthrough infections and against serious infections. There is no data yet to suggest that a third dose will reduce the transmission of Covid-19. The U.S. Centers for Disease Control and Prevention will determine later this week what exactly constitutes these risk factors.

Some parents who are, for example, front-line workers or who have serious underlying issues themselves may be eligible for recalls, but I don’t think being a parent of young children can, in and of itself, qualify someone. This is because we do not yet know whether receiving a reminder will reduce the likelihood that they will pass to others, including their children.

Having said that, if parents or other family members are not yet vaccinated with their first doses, they really need to be vaccinated now, to protect themselves and their family.

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