A group of members of Congress is pressing the U.S. Food and Drug Administration (FDA) for answers before the regulator decides whether to authorize COVID-19 vaccines for young children.
All Americans aged 5 and older can get a COVID-19 vaccine. The FDA is scheduled to meet with its advisory panel on June 15 to discuss whether to grant emergency use authorization (EUA) for the Moderna and Pfizer vaccines for children aged 6 months to 4 years old.
A bicameral group of members of Congress, led by Sen. Ted Cruz (R-Texas) and Rep. Bill Posey (R-Fla.), are questioning whether an EUA makes sense, given how little risk COVID-19 poses to young children and how the vaccines have plunged in effectiveness against infection as new virus variants have emerged during the pandemic.
“The broad approach of the CDC and FDA to date has been a one-size fits all policy—get the vaccine regardless of age, risk factors, the underlying health of the individual, or previous infection,” the members wrote to FDA Commissioner Robert Califf and members of the advisory panel in a June 7 letter obtained by The Epoch Times. “Yet, to date there remain many unanswered questions about these EUA-approved COVID-19 vaccines and only a small percentage of the safety data about these vaccines that are in the possession of the FDA and the manufacturers has been released for review.”
The members noted that nearly 70 percent of children aged 1 to 4 have recovered from COVID-19, according to the Centers for Disease Control and Prevention (CDC). That recovery gives the children a level of protection against re-infection that studies show is better than the protection from the vaccines. The members also pointed out that children who contract COVID-19 have a high survival rate and have little risk of experiencing severe disease.
The group asked the FDA to answer a series of questions before issuing its decision on the EUA requests from Moderna and Pfizer. They want to know, among other details, the cardiac risk factor for children getting the vaccines; whether the FDA will commit to sticking with a 50 percent effectiveness threshold it outlined in 2020; and whether there is a possibility children who get the vaccines will face higher risk from future variants of the virus that causes COVID-19, known as SARS-CoV-2 or the CCP (Chinese Communist Party) virus.
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FDA Letter Asking COVID Vaccine Question Regarding Vaccines For Children Under 5 PDF
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