Category: COVID-19

by Laura Olson, Kansas Reflector

Washington — Smaller needles. Redesigned shipments to ease the storage needs in pediatricians’ offices. And enough vials of the COVID-19 vaccine to inoculate the 28 million U.S. children between ages 5 and 11.

Those are among the plans announced by the White House on Wednesday as federal and state officials prepare for a regulatory decision to be made on the COVID-19 shot that Pfizer reformulated for younger children.

A long-awaited decision on a vaccine for that age group is expected in the coming weeks. A Food and Drug Administration advisory panel is set to consider authorizing the shot on Oct. 26, and after the FDA’s green light, the Centers for Disease Control and Prevention then will issue its guidelines for use.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group,” said Jeff Zients, the White House’s COVID-19 response coordinator, during a briefing Wednesday morning. “And should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms.”

Making another age group eligible for vaccines could be significant in preventing another spike in infections this winter.

The rate of infections and deaths has been falling after a summer surge caused by the delta variant, but colder weather and the winter holidays will lead to more indoor gatherings, where the virus that causes COVID-19 can spread quickly.

“If we can get the overwhelming majority of those 28 million children vaccinated, I think that would play a major role in diminishing the spread of infection in the community,” said Anthony Fauci, President Joe Biden’s chief medical adviser.

Shipments to states

If the FDA authorizes Pfizer’s shot for kids, 15 million doses will begin to ship to states, so providers will be ready to launch the next phase of the vaccination campaign as soon as the CDC weighs in.

The doses for children between 5 and 11 will be different from the ones approved for those 12 and older.

Pfizer has sought authorization for that younger age group to receive one-third of the amount given to adults and teens, and the vials will have a different color cap to distinguish them from the adult version.

Instead of the larger shipments of the adult version that initially were sent out, spurring concerns about potentially wasted doses in areas with fewer residents or less demand, the cartons shipping to pediatricians will include just 10 vials with 10 doses each. Those doses can be stored for up to 10 weeks at standard refrigeration temperatures.

The shipments also will come with all the supplies needed to administer shots to kids, the Biden administration emphasized in a memo outlining its operational plans. That includes needles designed for smaller arms.

Once the shipments go out to states, the doses will be distributed to providers, including pediatricians, children’s hospitals, pharmacies, and community health centers.

Zients said officials are seeking to ensure parents and children can go to a trusted and familiar site to get their vaccine. More than 25,000 pediatric and primary care provider sites will provide vaccinations, he said.

The administration also is working with state and local officials to set up vaccination sites at schools, and with children’s hospitals and other sites to host clinics during evenings and on weekends to inoculate kids at times that don’t require missing work or school.

State reimbursements

States can receive reimbursement through the Federal Emergency Management Agency to cover their costs related to setting up vaccination sites, buying supplies, and conducting outreach campaigns.

The White House’s planning efforts also include ways to ensure parents are receiving scientifically sound information about the vaccines amid waves of misinformation, and to create forums for them to ask questions.

A third of parents, or 34%, say they will vaccinate their 5-to-11-year-old child “right away” once a vaccine is authorized for that age group, according to a September survey by the Kaiser Family Foundation.

Another third say they will “wait and see” how the vaccine is working, and one in four say they definitely won’t get their children in that age group vaccinated.

Kansas Reflector stories, www.kansasreflector.com, may be republished online or in print under Creative Commons license CC BY-NC-ND 4.0.

See more at https://kansasreflector.com/2021/10/20/kids-ages-5-to-11-next-in-line-for-covid-19-vaccines-as-white-house-rolls-out-plans/

by Laura Olson, Kansas Reflector

Washington — Millions of Americans who received Moderna’s two-shot COVID-19 vaccine are expected to be eligible soon for booster shots, after a federal advisory panel on Thursday recommended a third dose for older and higher-risk adults as well as certain workers.

The unanimous recommendation from the Food and Drug Administration vaccine panel came a few weeks after federal health officials authorized a booster dose of Pfizer’s vaccine, to be given at least six months after an individual gets a second shot.

Unlike the Pfizer booster, the additional Moderna shots will be half doses, 50 micrograms compared to the 100 micrograms in the first and second Moderna shots that are given four weeks apart. The smaller dose resulted in fewer side effects while still boosting immune-system antibodies, according to company officials.

The FDA panel’s Moderna recommendation is for people who are 65 and older, as well as those between 18 and 64 who are at high risk of developing severe COVID-19 or who live or work in situations that increase their risk. The same population groups are eligible for the Pfizer booster.

As with Pfizer, the Moderna boosters are intended to be given six months after the second shot.

That matching eligibility was by design. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said at the beginning of Thursday’s meeting that he hoped the panel would seek to “harmonize” who is getting boosters across the different vaccines in order to reduce confusion.

The next step for the Moderna booster shot is the granting of emergency authorization by the FDA, and then action by the Centers for Disease Control and Prevention on who should receive the boosters. A CDC panel will meet next week to debate those specifics.

The same FDA panel that made Thursday’s recommendation will meet Friday to consider an additional dose of the one-shot Johnson and Johnson vaccine.

The vaccine panel also will be reviewing data on the potential to mix and match different brands of COVID-19 vaccines. That would give more flexibility to state and local officials overseeing vaccination campaigns and to providers administering shots.

Some who received the J and J shot also have sought approval to receive a follow-up dose of either the Pfizer or Moderna vaccines, which studies have shown to have higher efficacy against infection.

The approval of booster shots was initially bumpy, with some federal vaccine officials frustrated by the Biden administration’s aggressive timeline for approving additional shots. Several longtime FDA officials announced their departure from the agency.

The FDA remains led by an acting commissioner, though that may soon change: The Washington Post and Politico reported Thursday that former Food and Drug Administration commissioner Robert Califf, currently a professor of cardiology at Duke University School of Medicine in North Carolina, is expected to be tapped to head the agency.

The advisory panels weighing the Pfizer shot also expressed unease about the broad categories proposed for boosters, questioning whether health care workers, teachers and others really needed another dose due to potential exposure to the virus at their workplace. The eligibility categories were pared back after a contentious committee hearing, and later expanded in the CDC’s recommendation.

Kansas Reflector stories, www.kansasreflector.com, may be republished online or in print under Creative Commons license CC BY-NC-ND 4.0.
See more at https://kansasreflector.com/2021/10/14/fda-panel-recommends-booster-shot-of-modernas-covid-19-vaccine/