Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials

FDA to limit future Covid-19 shots to older people and those at risk of serious infection

Metaculus

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The Food and Drug Administration (FDA) announced a shift in COVID-19 vaccine approval policy on Tuesday, limiting routine access to those 65 and older and people with underlying health conditions, while requiring additional clinical trials for healthy younger Americans.

New England Journal of Medicine

The Food and Drug Administration (FDA) announced a shift in COVID-19 vaccine approval policy on Tuesday, limiting routine access to those 65 and older and people with underlying health conditions, while requiring additional clinical trials for healthy younger Americans.

Under the new framework, vaccine makers must conduct randomized, placebo-controlled trials lasting at least six months to demonstrate effectiveness before gaining approval for healthy individuals aged 6 months to 64 years.</span

MedPage Today

Under the new framework, vaccine makers must conduct randomized, placebo-controlled trials lasting at least six months to demonstrate effectiveness before gaining approval for healthy individuals aged 6 months to 64 years.

The FDA will continue using immunogenicity data to approve shots for adults over 65 and those with risk factors like obesity, diabetes, mental health conditions, and other medical issues that increase vulnerability to severe COVID-19.</span

The FDA will continue using immunogenicity data to approve shots for adults over 65 and those with risk factors like obesity, diabetes, mental health conditions, and other medical issues that increase vulnerability to severe COVID-19.

The policy change aligns U.S. practices with other high-income nations that limit COVID-19 vaccine recommendations to older adults and high-risk groups, moving away from the previous universal recommendation approach.</span

STAT

The policy change aligns U.S. practices with other high-income nations that limit COVID-19 vaccine recommendations to older adults and high-risk groups, moving away from the previous universal recommendation approach.

FDA officials estimate that between 100 million to 200 million Americans will still have access to updated COVID-19 vaccines through the high-risk qualification criteria.</span

StreetInsider

FDA officials estimate that between 100 million to 200 million Americans will still have access to updated COVID-19 vaccines through the high-risk qualification criteria.

The announcement comes as vaccine uptake has declined, with less than 25% of Americans receiving boosters in recent seasons, including less than 10% of children and under 50% of adults over age 75.</span

The announcement comes as vaccine uptake has declined, with less than 25% of Americans receiving boosters in recent seasons, including less than 10% of children and under 50% of adults over age 75.

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This overly restrictive policy will unnecessarily limit vaccine access for people who want protection, potentially leaving millions of healthy Americans vulnerable. The extensive safety and effectiveness data already collected from hundreds of millions of doses should be sufficient, and requiring new placebo-controlled trials raises ethical concerns given COVID-19's continued threat of hospitalization and death.

This overly restrictive policy will unnecessarily limit vaccine access for people who want protection, potentially leaving millions of healthy Americans vulnerable. The extensive safety and effectiveness data already collected from hundreds of millions of doses should be sufficient, and requiring new placebo-controlled trials raises ethical concerns given COVID-19's continued threat of hospitalization and death.

New York Times

New York Times #

F.D.A. Poised to Restrict Access to Covid Vaccines

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FDA Limits COVID Shots to High-Risk Groups, Elderly

The new framework represents a balanced, evidence-based approach that ensures timely access for vulnerable populations while demanding rigorous scientific proof of benefit for low-risk individuals. This policy shift will help restore public trust in vaccines by requiring gold-standard data and acknowledging that a one-size-fits-all approach may no longer be appropriate given widespread immunity from prior vaccination and infection.

The new framework represents a balanced, evidence-based approach that ensures timely access for vulnerable populations while demanding rigorous scientific proof of benefit for low-risk individuals. This policy shift will help restore public trust in vaccines by requiring gold-standard data and acknowledging that a one-size-fits-all approach may no longer be appropriate given widespread immunity from prior vaccination and infection.

FDA Limits COVID Shots to High-Risk Groups, Elderly

FDA Limits COVID Shots to High-Risk Groups, Elderly

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FDA Limits COVID Shots to High-Risk Groups, Elderly

FDA Limits COVID Shots to High-Risk Groups, Elderly

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