Covid vaccine rollout for healthy kids and adults is likely delayed by a new FDA rule

New England Journal of Medicine

An Evidence-Based Approach to Covid-19 Vaccination

MedPage Today

FDA Officials Detail Plan to Limit COVID Shots

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

STAT

FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say

France 24

US to limit Covid boosters to over-65s or those at high risk

StreetInsider

FDA sets new COVID booster guidelines requiring trials for approvals for healthy adults

CBS News

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

Daily Wire

FDA Will No Longer Approve Annual COVID Vaccine For Younger, Healthy Patients

Metaculus

Will there be two or more COVID-19 hospitalization waves in the United States in at least one of the 2028 and 2029 respiratory disease seasons?

<span>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

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>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.

<span>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

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>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

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>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.

<span>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.</span>

The New York Times

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

FDA Limits COVID Shots to High-Risk Groups, Elderly

FDA Limits COVID Shots to High-Risk Groups, Elderly

FDA toLimits limitCOVID futureShots Covid-19 shots to olderHigh-Risk peopleGroups, and those at risk of serious infectionElderly

The Spin

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FDA Limits COVID Shots to High-Risk Groups, Elderly

FDA toLimits limitCOVID futureShots Covid-19 shots to olderHigh-Risk peopleGroups, and those at risk of serious infectionElderly

The Spin

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