LOVELAND MAGAZINE

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Tag: children under 5

  • FDA greenlights emergency use of COVID vaccines for kids under 5

    FDA greenlights emergency use of COVID vaccines for kids under 5

    BY: JENNIFER SHUTT –  Ohio Capital Journal

    WASHINGTON — The U.S. Food and Drug Administration on Friday authorized emergency use of two COVID-19 vaccines for children under 5, moving the country one step closer to having shots for all age groups.

    The decision leaves just one hurdle, a recommendation from the Centers for Disease Control and Prevention, before parents can begin getting babies and toddlers vaccinated against the virus. That CDC decision was expected this weekend.

    “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert M. Califf said in a statement.

    “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

    The FDA’s decision to grant emergency use requests for a two-dose Moderna shot and a three-dose Pfizer vaccine came two days after its outside panel of advisers unanimously voted on Wednesday to recommend use of the two vaccines.

    White House COVID-19 Response Coordinator Ashish Jha said earlier this month that the federal government would begin shipping the vaccines to states as soon as the FDA granted the emergency use authorization.

    He expects shots can begin next week as long as the CDC issues its recommendation over the weekend.

    The Biden administration made 10 million doses of vaccine for kids under 5 available for states during a two-week pre-ordering period that closed Tuesday.

    States, tribes, territories, pharmacies and other federal partners ordered 2.5 million Pfizer doses, about 50% of those available, and 1.3 million Moderna doses, about 25%, according to a spokesperson for the U.S. Department of Health and Human Services.

    “Jurisdictions will have an opportunity to order additional doses if and when the vaccines are authorized by FDA and recommended by CDC,” an HHS spokesperson said in a statement.

    Florida vaccination distribution in question

    Florida remains the only state not to have placed any pre-orders.

    White House press secretary Karine Jean-Pierre said Thursday that some pharmacies and community health centers in the state would have COVID-19 vaccines for kids under 5 through federal distribution. But those options are limited for parents wishing to vaccinate their kids, she said.

    “By being the only state, this is Florida, not pre-ordering … pediatricians, for example, in Florida will not have immediate ready access to vaccines,” Jean-Pierre said.

    “Some pharmacies and community health centers in the state get access through federal distribution channels, but those options are limited for parents. We encouraged Florida on several occasions to order vaccines. We’ve been aware of this, and we will continue to do so.”

    Florida not pre-ordering, Jean-Pierre said, will “make it harder” for parents to get their children vaccinated.

    “That’s why we continued to, on several occasions, encourage Florida to do this,” she said.

    The Florida Department of Health said in a statement Thursday that its officials have “made it clear to the federal government that states do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies.”

    “Doctors can order vaccines if they are in need, and there are currently no orders in the Department’s ordering system for the COVID-19 vaccine for this age group,” the statement continued.

    Florida Gov. Ron DeSantis said Thursday that “there’s not going to be any state programs,” to vaccinate babies and toddlers against COVID-19.

    “That’s not something that we think is appropriate and so that’s not what we’re going to be utilizing our resources in that regard,” DeSantis said.

  • Federal OK sought for two-dose COVID vaccine for kids under 5

    Federal OK sought for two-dose COVID vaccine for kids under 5

    BY: JENNIFER SHUTT – Ohio Capital Journal

    WASHINGTON — Pfizer and BioNTech on Tuesday asked the federal government to begin the approval process for a two-dose COVID-19 vaccine for children under 5.

    The companies said in a joint statement they began the rolling submission process for an emergency use authorization at the request of the Food and Drug Administration “in response to the urgent public health need in this population.”

    While the approval process is underway for the two-dose regimen, the company will continue researching a third dose that would likely be given at least eight weeks after a child receives the second dose.

    Pfizer Chairman and Chief Executive Officer Albert Bourla said in the statement that increasing infections and hospitalizations of young children led the two companies to begin the approval process.

    “As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Bourla said.

    “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”

    Bourla said that if the FDA authorizes the two doses, that would allow parents to begin vaccinating their young children while waiting on approval of a third dose.

    The submission announcement on Tuesday comes sooner than previously expected.

    In mid-December, Pfizer and BioNTech announced they were modifying their trial to include a third dose of the vaccine for children between 2 and 4 years old after the two-dose approach didn’t lead to the type of immune response researchers sought. The trial did, however, produce the levels desired in children between six months and 2 years old.

    The company said at the time that if the three-dose trial was successful, it would likely submit its emergency use request to the federal government in the first half of 2022.

    Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, then said last week that parents needed to be patient in waiting for approval of the vaccine for younger children.

    “I don’t think we can predict when we will see an [emergency use authorization] with that because the company is still putting the data before the FDA,” Fauci said during a White House briefing on the pandemic.

    A poll released Tuesday by the Kaiser Family Foundation indicated about 31 percent of parents would get their small children vaccinated immediately.

    Another 29 percent said they would wait and see while 12 percent said only if required and 26 percent of respondents said they definitely would not give their young child the vaccine.