Marathon hearings in the United States to decide the fate of COVID injections for young children

Parents eager to finally vaccinate their youngest children against COVID-19 include: Many things will happen next week.

On Wednesday, both Moderna and Pfizer will have to convince what is essentially a scientific court – advisers to the Food and Drug Administration – that their photos work well for babies, young children and preschoolers.

The FDA weighed in on Friday with its own analysis of Moderna’s vaccine, finding that the injections seemed safe and effective for children under 6 months of age. A federal review of the Pfizer vaccine for young children is expected by Monday.

Children under 5 are the only group not yet eligible for COVID-19 vaccination in the United States. If FDA counselors approve one or both vaccines for them – and the FDA agrees – there is another hurdle. Centers for Disease Control and Prevention should recommend that all young children need immunization or only those at high risk of the virus.


In addition to complexity, each company offers different dose sizes and number of injections. And the week won’t even start with a debate for the youngest child: Moderna will first ask FDA advisers to support its vaccine for older children.

Only a handful of countries, including China and Cuba, offer different types of COVID-19 vaccinations to children under 5.

Here is an example that will help you keep everything right.


Pfizer has pediatric experience – its COVID-19 vaccine is the only type the FDA allows for children of all ages. Two doses plus booster are cleared for everyone aged 5 and over. Vaccines for children aged 5 to 11 years contain one third of the dose given to teenagers and adults.

For children under 5 years of age, Pfizer and its partner BioNTech reduced the dose even further, to one tenth of the adult dose. The compromise requires three shots, the first two being three weeks apart and the last at least two months later.



Moderna is seeking FDA approval for two injections, each quarter of the adult dose, given at intervals of about four weeks for children under 6 years of age. (Moderna is testing a slightly different age than Pfizer.)

The FDA currently allows the Moderna vaccine to be used in adults only. But some countries allow two full-size doses for teens and half-size photos for children ages 6 to 11 – which Moderna also hopes to offer in the United States.


Pfizer disappointed parents back in December, when a study found that two shots were not strong enough. Thus, the researchers tested a third injection in young people aged 6 months to 4 years during the winter jump of the omicron variant.

Preliminary data from Pfizer show that after three shots, the children developed high levels of antibodies that fight viruses without any safety concerns. In addition, the vaccine has been shown to be 80% effective in preventing symptomatic COVID-19. However, this calculation is based on only 10 cases diagnosed among study participants by the end of April, and may change if more cases have occurred since then.


The Moderna study found that young children aged 6 months to 5 years developed high levels of antibodies after two of the shots. But while there were no severe cases of COVID-19 during the trial, the vaccine was only about 40% to 50% effective in preventing milder infections.

In their review, FDA researchers noted that the study was too short to determine how long the vaccine would last effective. They also said a booster was likely to be needed, based on adult experience.

Moderna recently added a booster dose to the tot study – and revealed in a presentation at Wednesday’s meeting that it also plans to enable participants to help test a booster aimed at the omicron.


If the FDA approves one or both injections – a decision expected soon after its advisory committee meeting – all eyes are on the CDC. This agency recommends how to use vaccines. Which young children should be vaccinated against COVID-19 will be an important debate, as the coronavirus does not make children as sick as adults, but nearly 500 deaths have been reported in children under 5 in the United States.


The CDC’s own vaccine advisers are due to meet next Friday and Saturday, and the final decision by the CDC’s director, Dr Rochelle Valenski, is due shortly.

If all these steps are implemented, vaccinations can begin in many areas on June 21.


Pediatricians, other primary care physicians and children’s hospitals are expected to vaccinate most of the youngest children. Limited drugstores will offer them for at least part of the group under 5 years – parents should check the local availability for different ages. The Biden administration says it is also working with various other groups, such as children’s museums, to offer pop-up clinics and reach even more young people.


About three-quarters of children of all ages are thought to have been infected at some point during the pandemic. This is a question that is sure to arise as CDC counselors make recommendations for the youngest children, so stay tuned.


For older adults, the CDC recommended vaccination anyway to reduce the chances of re-infection. There are no definite guidelines on how long to wait; The CDC said people can wait up to three months.


There are approximately 18 million children under the age of 5, and many parents are eager to vaccinate their young. But it is unclear how much they will do in the end, given the frustrating vaccination of older children.

According to the CDC, only 29% of children aged 5 to 11 received two doses and about 60% of 12- to 17-year-olds.


On Tuesday, FDA advisers will review Moderna’s photos for older children, ages 6 to 17, a solution that could alleviate some parental confusion. The FDA review released on Friday also includes an analysis of the company’s photos for this age group.

The FDA has kept the Moderna teen vaccine for months while investigating a rare side effect, inflammation of the heart. This is especially a risk for teenagers and young men, and it can happen with the Pfizer vaccine. The FDA review said that a recent analysis of myocardial reports in both the United States and other countries found no convincing evidence of a difference in risk between Moderna and Pfizer vaccines.



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Marathon hearings in the United States to decide the fate of COVID injections for young children

Source link Marathon hearings in the United States to decide the fate of COVID injections for young children

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