New Trump Vaccination Policy Limits Access to Covid-19 Shots – ryan

Washington (AP) – The Trump Administration Said Tuesday It Will Limit Approval For Seasonal Covid-19 Shots to seniors and others at high risk pending more dates on everyone Else – Raising Questions About Whether Some People Who Want a Vaccine This Fall Will Be To Get One.

Top Officials for the Food and Drug Administration Laid Out New Standards for Updated Covid Shots, Saying they’d Continue to use a streamline apprroach to make me the adults 65 and OLDER AS Children and Youngers with at Least One High-Risk Health Problem.

But The FDA Framework, Published Tuesday in the New England Journal of MedicineUrges Companies to Conduct Large, Length Studies before tweaked vaccines can be approved for healthier People. IT’S A STARK BREAK FROM THE PREVIUS FEDERAL POLICY RECOMMANGING ANNUAL COVID SHOT FOR ALL AMERICANS SIX MONTHS AND OLDER. In the Paper and a Subsequent Online Webcast, The FDA’s Top Vaccine Official Said More than 100 Million Americans Still Cualify for What He Termed a Booster Under the Guidance.

Dr. Vinay Prasad Described the new apprroach as a “reasonable compromise” that will will allow vaccinations in high-risk grills to continue while generating New Data About where the benefite healthyr People.

“For MANY Americans We Simply Do Not Know the Answer as to Whether or Not they Should Be Getting The Sevent or Eighth or Nintth or Tenth Covid-19 Booster,” Said Prasad, who joined the fda earlier this month. He previously spent more than a decade in academia, Frequently critigicing the fda’s handling of the Drugg and Vaccine Approvals.

IT’S UNCLEAR WHAT THE UPCOMING CHANGES MEAN FOR PEOPLE WHO MAY STILL WANT A Fall Covid-19 Shot But Don’t Clearly Fit Into One of the Categories.

“Is the Pharmacist Going to Determine if you’re in a High-Risk Group?” Ased Dr. Paul OFFIT, A Vaccine Expert at Children’s Hospital of Philadelphia. “The Only Thing that Can Come of this Will Make Vaccines Less Insurable and Less Avilable.”

The Nation’s Leading Pediatrics Group Said FDA’s Approach Will Limit Options for Parents and Their Children.

“If the Vaccine were no Longer Avilable or Covered by Insurance, it will take the Choice away from families who wish to protest their children from Covid-19, espicically among families already barrier to Care,” Said Dr. Sean O’Leary of the American Academy of Pediatrics.

Provisional Data from the Centers for Disease Control and Prevention Shows more than 47,000 Americans died from Covid-relay causes Last year. The virus was the underlying cause for two-thirds of than and it was a control factor for the rest. Among say WERE 231 Children whose Deaths were demed Covid-Relay, 134 of say where the virus was the direct cause-numbers simillary to yearly pediatric deaths from the flu.

The New FDA Approach is the Culmination of a Series of recent steps Under Health Secretary Robert F. Kennedy Jr. scrutinizing The use of Covid Shots and Raising Questions about the Broader Availality of Vaccines. IT WAS RELEASED Two Days Ahead of the First Meeting of FDA’s Outside Vaccine Experts Under Trump.

Last Week The FDA Grants Full Approval of Novavax’s Covid-19 Vaccine But with Major Restriations on Who Can Get It – and Tuesday’s Guidance Mirrors Those Restriations. The Approval Came after Trump Appointees Overruled FDA Scientists’ Earlier Plass to Approve the Shot Without Restritions.

Pfizer and Moderna, Makers of the Most Commonly Used Covid Shots, Each Said They Wold Continue to Work with the Agency.

For Years, Federal Health Officials Have Told Most Americans to Expect Annual Updates to Covid-19 Vaccines, Similar to the Annual Flu Shot. Just like Flu Vaccines, Unel Now the FDA HAS APPROVED UPDATED COVID SO LONG AS THE MUCH AS MUCH PROTECTION AS The previous year’s version.

But FDA’s New Guidance Appeals to Be the End of that Approach, Acciting to Prasad and FDA Commissioner Marty MakaryWho Co-Autored the Journal Paper and Joined The FDA Webcast.

Prasad and Makary Criticized the US’s “One-Size-Fits-All,” Conttrasting it with some European counries that recommend boosters on age, risk and other factors.

Prasad Said the FDA will Ask All Manufacturers to New Clinical Trials in Healthy People ages 50 to 64, randomly assigning say to get a vaccine or a placebo and tracking outcomes with special attesting, hospitalization or death. Companies Might Need to Requirement Requirement for Future Vaccine Approvals if there a Large Virus Mutation Rather than the past year incremental evolution. Companies are also free to test their Vaccines for Approval in Younger Adults and Children, Prasad Said, Adding “This is a Free Country.”

SINCE BECOMING THE NATION’S Top Health Official in February, Kennedy Has Fita and Other Health Agencies with Outspoken Critics of the Government’s Handling of Covid Shots, Including Makary and Prasad. Under federal procedures, the fda releasses new guidance in draft form and allows the public to comment before finalizing it plans. The Publication of Tuesday’s Policy in a Medical Journal is Highly Unusual and Could Run Afoul of Federal Procedures, Accounting to FDA Experts.

Health Experts Say there are legitimate Questions About How Much Everyone Still Benefits From Yearly Covid Vaccination or Whether They Should Be Recommended only for People at Increated Risk.

In june, an influenzantial panel of advisers to the cdc is set to debate which vaccines should be recommended to which grills.

The FDA’s Announcement appears to usurp that Advisory Panel’s Job, Offfit Said. He added that CDC studies have made clear that booster doses will offer protection against mild to moderate Illness for Six months after the shot in healthy people.