By: The Epoch Times
U.S. authorities are preparing to ship out millions of doses of Pfizer’s COVID-19 vaccine by the end of February if drug regulators authorize the shot for children under 5.
President Joe Biden’s administration has secured enough doses to vaccinate all 18 million children in the country who are 4 or younger. Officials are telling health care providers to pre-order shots.
“Jurisdictions should plan their ordering strategy now and identify priority locations to vaccinate children ages 6 [months]–4 years,” the Centers for Disease Control and Prevention (CDC) told providers in a planning guide.
“The planning process is well underway. CDC is working with states to help them prepare,” Jeffrey Zients, coordinator of the White House COVID-19 response team, told reporters in a briefing.
Every American 5 and older can get a COVID-19 vaccine, and some parents and health experts are pushing the Food and Drug Administration (FDA) to grant emergency use authorization to Pfizer’s shot for the youngest age group.
FDA officials in late December 2021 made the unusual move of asking Pfizer to submit data on a clinical trial it’s conducting testing lower doses on young children. The ask came shortly after Pfizer and its partner BioNTech announced that interim results of the trial showed the vaccine didn’t trigger an adequate immune response for children aged 2 to 4 and that they would expand the trial to test a three-dose regimen in the youngest kids.
Based on the FDA’s request, Pfizer asked the agency on Feb. 1 to give an EUA for two doses of its vaccine for children as young as 6 months, even though the ultimate plan is to receive clearance for a three-dose series.
Even some ardent vaccine backers have expressed skepticism on the process.
“The last data we’ve seen wasn’t particularly compelling,” Andy Slavitt, Biden’s former senior adviser for COVID-19, said on his podcast.
The FDA’s vaccine advisory panel is meeting on Feb. 15 to discuss the latest data, which the agency says includes more recent data.
Based on the endpoints of the trial, “it may be tough for the FDA and the FDA advisory committee” to decide to authorize the shot, Slavitt said. “I expect it to be controversial.”
Multiple panel members declined requests for interviews and the FDA has not yet posted the data, which it plans to make public “no later than 2 business days before the meeting.”
“I don’t think that anyone has seen the complete dataset so it’s difficult to draw any conclusions at this point,” Dr. Eric Rubin, a member who serves as editor-in-chief of the New England Journal of Medicine, told The Epoch Times in an email.
Rubin is one of several members who won’t be at the meeting.
The panel gives advice to the FDA, which can accept or reject the recommendations. The last time the panel went against the agency, rejecting in the fall of 2021 a push for boosters for all American adults, the FDA accepted its advice.
Children are the least at-risk age group from COVID-19 and critics say rushing the clearance process isn’t necessary, pointing to the low number of deaths and hospitalizations among the population. On the other hand, some parents and experts say the vaccines are safe and effective enough in other groups that granting an EUA for two shots for young children makes sense, because a booster, or third dose, can’t come for at least five months following the second shot.
“If they do approve it now, it does allow providers to actually start the vaccination process so that some children could actually be ready to get a third dose soon after a third dose is approved,” Julie Morita, a pediatrician and executive vice president of the Robert Wood Johnson Foundation, told Slavitt.
The slow uptake among other groups of children has frustrated the Biden administration and polls indicate that most parents with children under 5 will not immediately take their children to get the vaccine if it’s authorized.
Sixty-nine percent of such parents responding to a Kaiser Family Foundation poll in January said they’d “wait and see,” and only get their child vaccinated if it were required, or “definitely” would not get their child vaccinated.
Asked about the results, Dr. Anthony Fauci, Biden’s chief medical adviser, told reporters that the FDA will not authorize the shot unless “the data show clear efficacy and safety.”
If the FDA does clear the jab, packing and shipping doses will start almost immediately.
Providers started ordering the shots on Feb. 7, according to the CDC document. The earliest orderers will get shipments on Feb. 21.
“We will be prepared for those parents that are eager to get their kids vaccinated,” Zients said.
If authorization is granted, the CDC’s advisory panel will likely convene to discuss whether all children between 6 months and 5 years should get the shot, or just certain subsets of the population. The CDC’s director, Dr. Rochelle Walensky, would make the final decision; administration of the shots is not supposed to begin until the CDC makes its recommendation.