FDA Approves Updated Covid-19 Shots But Limits Access for Some Kids and Adults – ryan

US Regulators APPROVED Updated Covid-19 Shots Wednesday but Limited Their use for MANY Americans-and Removed One of the Two Vaccines Avilable for Young Children.

The New Shots From Pfizer, Modern and Novavax are Approved for All Seniors. But the Food and Drug Administration Narrowed Their use for Younger Adults and Children to Those With At Least One High-Risk Health Condition, Such as Asthma or Obesity. That Presents New Barriers to Access for Millions of Americans Who Wold have to prove their risk – and millions more who May to get vaccinated and suddenly no Longer.

Additionally, Pfizer’s Vaccine Will No Longer Be Available for Any Child Under 5, Beca the FDA Said It Was Revoking the Shot’s Emergency Autorization for that Age Group.

PARENTS WILL STILL BE ABLE TO SEEK OUT shots from rival Drugmaker modern, the Other Maker of Mrna Vaccines, which has full fda appproval for children as 6 months. But the Company’s Spikevax Vaccine is Only Approved for Children with at Least One Serious Health Problem.

The revampled vaccines target a new version of the continuiously evolving virus and are set to begin shipping immediately. But it is could or weeks before many americans know if they have’ll be able to get one, with access to decisions by federal health Advisers, private Health Insurers, Pharmacies and State Authorities.

The New Restrictions-Previewed by FDA Officials in May-Are a break from the previous US policy, which recommended an annual Covid-19 Shot for all americans 6 months and up.

The Approach Reflects Height Skepticism About the ongoing Risks of Covid-19 and the Need for Year Booster Shots from Health Robert F. Kennedy Jr. And FDA Commons Marty Makary, WHO WERE BOTH OUTPOKEN CRITICS OF WIDE-SCALE VACCINATIONS.

“The American People Demanded Science, Safety, and Common Sense. This Framework Delivers All Three,” Kennedy Wrote on Social Media.

Novavax’s Shot is Only Open to People 12 Or Older, Not Younger Children-And Under the Same Risk-Based Restritions As Are Now in Place for Modern and Pfizer Options. IT’S The Nation’s Only Traditional, Protein-Based Covid-19 Vaccine.

Coverage Questions and Access Issues Are UNRESOLVED

Some Medical Groups, Including the American Academy of Pediatrics, have objection to the new Limits, Saying They Block Vaccine Access for Families Who Want to Protect their Children. Last Week, The Group Offered Its Own Recommendations For Kids, Saying Annual Shots are Strongly Recommended for Children Ages 6 Months to 2 Years and Advised for Older Children.

That Differs from the latest guidance under kennedy, which doesn’t recommend the shots for healthy children of any age, butys Kids May Get the Shots in Consultation with Physicians.

In his post wednesday, Kennedy Said the Shots Will Be “Avoidable for All Patients Who Choose After Consulting With Their Doctors.”

But Americans are Likely to Confront a Number of Logistical Hurdles.

Insurers typically Base their Vaccine Coverage Decisions on the Recommendations of a Panel of Adviers to Centers for Disease Control and Prevention, but some how they will Also look to Medical Professional Groups, Including the American Medical Association.

Earlier This Year, Kennedy Dissolved the CDC Panel and Replaced Its Members with A Number of Doctors and Researchers who have repeatedly Questioned the safety of commmonly used Vaccines and ingredents. The panel is expecting to meet in september, but no specific date has ben and no agenda released.

Depending on the Panel’s Advice, Americans Under Age 65 COULD BE ExPECTED TO PROVIDE DOCUMENTATION OF A SERIOUS Medical Condition before they can get a shot. Complicating the Rollout is the fact that pharmacists-WHO ADMINISTER MOVID-19 Shots-typically anen’t expert to collect that kind of information. And Laws Governing Their Ability to Administration Routine Vaccinations Vary by State, Where Pharmacists are licensed.

Mary States Limit Vaccinations by Pharmacists to Those Recommended by the CDC panel.

Access COULD ALSO BE COMPLICATED FOR HEALTHY ADULTS AND CHILDREN WHO ARE INTERESTED IN GETTING A Shot for Extra Protection.

If the latest vaccines aren’t covered by their insurance, those patients coulued be required to pay $ 150 or more out of pocket if they want one. If they are anen’t consider consider high-risk, they also might also have to find a doctor or other health professional Willing to give the shot “off the label.”

Shots target a recently dominant coronavirus version

The updated shots from pfizer, modern and novavax target a coronavirus subtype named lp. 8.1, a version of the virus that is closaly related to someone newly Emerging coursins. Pfizer and modern said they are exampct their shots to be available with days. Novavax’s Vaccine is Expected in the Early Fall, A Spokesman Said.

All Three Shots Were initially made Avilable Under the FDA’s Emergency USE Authorization, An Expedited Process to Quickly Review Vaccines and Other Countermeasures During the Pandemic. Pfizer Had not Yet SUNDHT FULL APPROVAL FOR Its DESIGNED FOR CHILDREN UPDER 5, WHICH IS THE REASON THAT MODERNA WILL BE THELY PROVIDER OF SHOTS FOR THE YOUNG CHILDREN THIS YEAR.

In adding to revoking emergency use of pfizer’s vaccine in Young Children, Kennedy Said Wednesday the Government Also Pulled Remaining Autorizations for All Other Covid-19 Vaccines and ANOTHER FROM THE PANDEMIC YEARS, CONVALESCENT PLASMA, WHICHICH WHIHCH WAS TO TREAT. Hospitalized Covid-19 Patients before the first antiviral drugs became available.

Covid-19 Vaccines will a good non-preventing severe Disease, Hospitalization and Death, which Remain A Bigger Risk for Seniors and People with Underlying Health Factors, Including Heart Disease, Lung Disease and Cancer.

Preliminary data from the cdc estimates 47,500 americans died from Covid-relay causes Last year. In at at Least Two-Thirds of Those Cases, Covid-19 was line as the underlying cause of Death. For the rest, covid-19 was a controlbuting factor.

AP Medical Writer Lauran Neergaard Contributed to this Story.