Monday, October 3, 2022

Why children under 5 still can’t get the COVID-19 vaccine

Although vaccines have restored some semblance of pre-pandemic life for most people in the United States, one group is still waiting: children under the age of five who are yet to be eligible for COVID-19 vaccines. are not. This has been particularly frustrating for their parents, who must decide which activities are safe for their uninfected children – and who are often scrambling to close schools and daycares.

Compared to adults, children in this age group have a lower risk of severe COVID-19. But the Omicron version of the coronavirus is currently increasing in pediatric hospitals – more than double compared to the previous peak in the fall – because it is more transmissible than earlier strains.

Elizabeth Lloyd, a pediatrician at the University of Michigan Health CS Mott Children’s Hospital, says it is difficult to tell how many children were hospitalized for COVID-19 for other reasons. “But from my experience, we’re definitely seeing more kids who are sick and who sometimes need ICU-level care,” she says. “It’s something we’re looking forward to [children’s] The vaccine is preventable.”

Emerging evidence suggests that vaccines may help prevent complications that children may develop such as prolonged COVID, or a rare multisystem inflammatory syndrome. And giving shots to under-fives will almost certainly reduce the number of unvaccinated children who can spread the virus in their communities, pose a threat to vulnerable adults and create nightmares for daycare centers and parents. can.

Children older than early November are eligible for the Pfizer-BioNTech vaccine. At the time, there was hope that suitable vaccines for young children would soon arrive.

Those hopes were dashed in mid-December when Pfizer and BioNTech revealed that their clinical trials had yielded disappointing results. The companies decided to add a third dose to the vaccination series for this age group, which pushed back the timeline for authorization.

So where do things stand now? White House adviser Anthony Fauci said on January 19 that he expected authorization “may not come within the next month or so.” But Fauci acknowledged that the availability of the vaccine will depend on how quickly the regulatory process moves. In the meantime, Moderna says it won’t have study data on vaccines for children between the ages of two and five until March. And neither Moderna nor Pfizer-BioNtech have released any data yet.

Despite all these uncertainties, Lloyd says parents can be reassured of one thing—that is, delays don’t mean vaccines aren’t safe, only that companies are still taking them as effective. working to make.

Here’s what Lloyd and other experts say about the process of approving vaccines for children under five — and how to keep them safe in the meantime.

1. Why was the Pfizer vaccine delayed?

Pfizer and BioNTech began testing their vaccine in the spring of 2021 in children aged six months to five years — there is reason to believe all children may be eligible for the vaccine by the end of the year. After a small dose-finding study showed that older children received more side effects from a 10-microgram dose than those in the younger group, the companies eventually decided to give two smaller doses 21 days apart.

“We weren’t hearing about any serious adverse events,” says Kristin Moffitt, a pediatric infectious disease specialist at Boston Children’s Hospital. “But you might think that parents would consider the side effects from these vaccines very carefully when deciding whether to vaccinate their children under the age of five.”

As recently as last fall, Pfizer CEO Albert Boerla said that preliminary data for children under the age of five could be available by the end of October. But October came and went. Finally, in December, Pfizer and BioNTech announced that the vaccine did not produce as strong antibody protection in children between the ages of two and five as it did in the older population.

While the low dose reduced the adverse effects of the vaccine in young children, Moffitt says it appears to have weakened the immunity produced by the two-dose vaccine.

Rather than file for emergency use authorization, Pfizer and BioNTech said they would expand their clinical trials to see if a third dose would improve results. While it’s hard to know how far along the immune response was without looking at the data, Lloyd suggested that “they must have realized it was bad enough that if they took that data to the FDA it wouldn’t proceed.”

2. Why did they expand clinical trials to infants and toddlers as well?

However, many parents are left scratching their heads, which is why Pfizer and BioNTech also scaled up clinical trials for infants and toddlers between the ages of six months and two years. According to the companies’ December statement, the low-dose vaccine was safe and Did Generate an adequate immune response for children under two years of age.

It is not clear why the companies did not comply with emergency use authorization for this age group. Pfizer declined an interview request for this article and referred National Geographic To your December statement for the latest updates on your pediatric trials.

Moffitt says it’s possible that companies have decided on trials because of vaccine hesitation. For every parent who is looking forward to getting their child vaccinated, there is a parent who is concerned about possible side effects. Moffitt estimates that Pfizer and BioNTech will want to wait until there are more safety and efficacy data in a population of two to five years before seeking authorization for young children.

“As a provider who has had a lot of conversations with families about the safety of vaccines,” she says, “I can tell you these are very easy conversations when you have hundreds of thousands to millions of children who have have safely obtained the vaccine, compared to a few thousand that we usually get from clinical trial data.”

3. What dosage regimen are Pfizer and Moderna trial now?

Pfizer and BioNTech are now evaluating a third three microgram dose to be given at least two months after the second dose. This rule “reflects the companies’ commitment to carefully selecting the right dosage to maximize the risk-benefit profile,” he said in a statement.

The companies did not explain why they are testing a third dose, instead conducting another dose-finding study to determine whether there may be a single sweet spot between three and 10 micrograms. Lloyd says it may be in the interest of getting the data back faster or it may be related to the recent discussion about whether three doses is really the right regimen for mRNA vaccines.

Meanwhile, Moderna is testing higher doses of its vaccine for children in this age group. Last March, the company said it would first test two doses of 50 or 100 micrograms over 28 days in addition to children aged two to 12. For babies and infants aged six months to two years, the company will also test 25-microgram doses. After an interim analysis, the company will select the best dosage and expand the study. But it’s not clear where those tests stand now.

“We’re all looking forward to hearing more,” Moffitt says. She explains that Moderna has slowed its efforts to seek authorization for older children after safety signs pointed to a higher risk of heart inflammation in young men ages 18 to 29. “I think the latter has caught up to all age groups,” she says.

In late December, William Hartman, principal investigator of the University of Wisconsin’s Modern Pediatric COVID-19 vaccine trial, told local news station WSAW that the vaccine appeared to be safe for children under the age of five and the results of that trial were finally can come. January. However, the University of Wisconsin referred National Geographic to Moderna, which did not respond to a request for information.

4. The earliest a vaccine can be authorized?

Fauci has said he expects the Pfizer-BioNTech vaccine to be approved before March. But Moffitt believes the assessment is optimistic. If you look at the example set for older children, she says, it’s typically taken three to four weeks for the FDA and CDC to consider emergency use authorization for the Pfizer-BioNTech vaccine. So even if the companies submitted their data to the FDA yesterday, it could still take a month.

And there’s no indication when that data will be available for submission. Moffitt says clinical trial investigators will typically wait another month after the third dose has been administered to measure antibody responses and compile the data. She says Fauci will certainly have the best information on when Pfizer and BioNTech expect that data, but how long it takes, “we can see until late winter or even early spring.” Huh.”

In the meantime, Moderna has said it expects to report the data for children between the ages of two and five in March and can “go ahead” with seeking emergency use authorization later. Following the precedent set by Pfizer, Moffitt says this could mean the shot will be available as early as April.

But Moderna may have a quicker road to climb than Pfizer, Moffitt says. She points out that Pfizer has been able to quickly secure authorization for younger age groups because the company has already collected a substantial amount of security data from older groups. For example, by the time Pfizer sought authorization for children ages five to 11, it was already clear to regulators that the vaccine was safe and effective for teens ages 12 to 15.

“So I’m concerned that the lack of authorization for Moderna in 12- to 17-year-olds will potentially further delay a decision,” Moffitt says.

5. Will the Children’s Vaccine Contain Omicron?

In short, no. Although there has been discussion about adjusting mRNA vaccines to specifically target the Omicron variant, Moffitt says the clinical trial data being evaluated by the FDA and CDC are the same formulations used to target the older population. Vaccines received are similar—only in lower doses. And since clinical trials began before the Omicron variant emerged, there will be no clear information about how well the vaccine works against the variant.

6. What should parents do in the meantime?

While parents of young children continue to wait for a vaccine, Lloyd says one thing they can do to protect their children is to make sure everyone else in the household is vaccinated and promoted , if eligible. Meanwhile, everyone in the household must follow standard COVID-19 guidelines on hand washing, social distancing and wearing masks.

Moffitt says that the best mask is one with multiple layers that fits well and can be worn for a long time. She recommends upgrading to surgical masks or KN95 and N95 masks. He agrees with Lloyd’s that these steps are not just for those who are not vaccinated.

“If everyone can wear a mask when they leave the house, especially when they are going indoors in public places, it could go a long way towards protecting those who are not yet in a home. Not eligible for vaccination.”

Nation World News Desk
Nation World News Desk
Nation World News is the fastest emerging news website covering all the latest news, world’s top stories, science news entertainment sports cricket’s latest discoveries, new technology gadgets, politics news, and more.
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