New FDA rule could delay Covid vaccine rollout for healthy adults and kids

The COVID vaccine was shown to not help with outcomes of those that contracted COVID-19, especially when looking at hospitalizations and deaths,

Atieh, who goes by @diaryofacrunchymom on Instagram, told Newsweek

It's really unfortunate to see the Trump administration and FDA approve and push the COVID vaccine, especially to those who already have preexisting health conditions,

Atieh told Newsweek on Tuesday

While I still have high hopes of [Health and Human Services Secretary Robert F. Kennedy, Jr.] stepping in and changing the system to highlight risks associated with vaccines, here is a prime example of just how influential Big Pharma still is,

she said

Paul Offitdr

Is the pharmacist going to determine if you’re in a high-risk group?”

asked Dr Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia told the Associated Press

Although the rapid development of multiple Covid-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment, the benefit of repeat dosing – particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both – is uncertain,

Makary and Prasad wrote

For lower-risk individuals, the goal has always been less clear, as protection against infection is transient and they don't have a high risk of severe disease,

he told AFP

Any use, say in a healthy 35-year-old, would be considered off-label, and you wonder whether an insurance company would pay for it,

he told AFP

Survey after survey shows trust in institutions like the FDA and scientists in general, it's rock bottom,

Prasad said during the roundtable

The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,

they wrote

While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,

the health leaders wrote in the New England Journal

We have to admit to ourselves that America is deeply divided on the policy issue of repeat COVID 19 vaccine doses or boosters,

he said

This is overly restrictive and will deny many people who want to be vaccinated a vaccine,

Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email

C.D.C. is the agency that really has the expertise in that area,

Dr. Jamieson said

The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,

the officials wrote

We need to also include the role of observational data and the role of the C.D.C. in continuously monitoring vaccine safety and efficacy,

Dr. Jamieson said

At-risk Americans can be reassured that they will be covered by such approvals,

Dr. Prasad said

Now we are back in line with the rest of the world,

Dr. Prasad said

I think that changes like this will lead to more unnecessary deaths.”

Dr. Daniel Griffin, a physician in New York who has treated thousands of Covid patients, said

What they’re really doing is they’re very slowly reducing vaccination in the country,

he said

You buy yourself four to six months of protection from mild-to-moderate disease, which is not trivial,

he says, especially as more data suggests that repeated bouts of COVID-19 could contribute to more intense and lasting symptoms of Long COVID