Why parents have to wait for children under the age of 5 to get the COVID-19 vaccine

A recent report said the FDA had to wait for data on how well the third shot works for the youngest age group. Press release..

Pfizer will get the data by early April.

according to PfizerDrug studies in children aged 6 months to 4 years have not been completed, and pharmaceutical companies continue to share data with the FDA on the first two doses of this age group.

“Cases continue to accumulate according to the research protocol, and especially with the recent surge in Omicron, more data is being generated as the infection rate and illness remain high in children of this age,” Pfizer explains. Did. statement..

According to the company, the study’s independent data monitoring committee (DMC) helped continue the study, and the data collected so far show that the vaccine is “tolerable and a potential three-dose regimen.” Is supported. “

“We have a responsibility to consider these vaccines very seriously,” said Dr. Peter Markes, director of the FDA Center for Biologics Evaluation and Research, recently. Media call..

“Looking at these data, parents can rest assured that we have set the standard. If we don’t meet the standard, we can’t move on,” he said.

Peter PittsThe director of the Public Interest Medical Center and former Vice-Chairman of the FDA said the Commission would be able to act swiftly when data on vaccine efficacy for children under the age of 5 became available.

He said the CDC would hold an Advisory Committee on Immunization and Implementation (ACIP) meeting and vote on the same issue if the FDA voted to approve a vaccine for children under the age of five. Vaccines may then be available to infants within a few days of these decisions.

“I believe that if Pfizer could share more and more positive data by the end of the month, that would mean that the vaccine could be available before St. Patrick’s Day,” he said. Told.

Pitts pointed out that vaccination rates for children over the age of 5 remain low even before the vaccine is approved for infants.

Pitts calls immunization rates for children under the age of 12 “disastrous,” and says immunization rates need to be improved in order to move from a pandemic to a “more controllable endemic reality.” Said.

Dr. Joel BloombergA clinical associate professor of pediatrics at the University of Houston School of Medicine, explained that vaccines can reduce the risk of infection and provide significant protection for children’s serious illness and hospitalization.

In addition, sick children can spread the illness to others and prolong the pandemic.

“Many children are still infected with COVID-19 and may act as mediators to others at risk of more serious infections, such as school teachers and grandparents. There is, “he said.

“Immunization can send children to school, protect their families, and reduce their spread in the community,” Bloomberg said. Said.

For parents who are planning to have children Vaccinated professionals over the age of 5 were advised on what to expect and how to prepare their children.

Mary Uncle TermesPharmD, Director, said the safety and quality of medicines from the American Association of Health Systems Pharmacists (ASHP) can help parents explain vaccines to their children so they are not afraid.

Parents need to start by telling their children that Shot keeps their children healthy and “protects them from a disease called COVID that can make them and adults sick.”

Kliethermes has suggested several ways to relieve stress in children. For example, tell them to receive a “quick little poke” or say that sitting still like a statue helps.

“Or, bring your favorite stuffed animal, hug it, and give it courage,” she said.

Kliethermes said during clinical trials, no cases of myocarditis occurred in vaccinated children aged 5 to 11 years.

However, there are potential side effects that parents should be aware of.

“There may be pain, redness and swelling at the injection site,” she said. “Children can also experience fatigue, headaches, muscle aches, chills, fever, and nausea.”

Kliethermes added that in the case of babies, this can manifest itself as hypersensitivity, loss of appetite, and lethargy.

When approved, parents asked where young children could be vaccinated, Kliethermes said, and said it varies from country to country and may vary by state and local implementation plans.

She said that this is the same process used for the COVID-19 vaccine aged 5 to 11 years, with each state, tribe, and region being assigned the vaccine and uniquely distributing the vaccine to residents. I explained that I made a plan. Their jurisdiction.

“The federal government has added pharmacies, community health centers, and tribal distributions to ensure that vaccines are distributed fairly,” Kliethermes said. Said.

She pointed out that 60 percent of children in the age group of 6 months to 4 years live in poorly serviced areas.

“Therefore, there may be more distribution to groups that can reach these areas, such as community health centers, healthcare systems, pharmacies, and large groups of doctors,” Kliethermes said.

The Centers for Disease Control and Prevention (CDC) has announced plans to distribute millions of COVID-19 vaccines to young children, while the Food and Drug Administration (FDA) has approved it on February 15. I suddenly canceled the vote.

According to the FDA, authorities have decided to wait for more data from Pfizer before making a decision. According to experts, once the drug is approved, the distribution will be similar to that used for children over 5 years old.

They also say that vaccination of children under the age of 12 is important to end the pandemic and prevent serious illness in that age group.