FDA Says No Safety Signals From Booster Shots After European Regulator Warning

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The Food and Drug Administration (FDA) says its experts have not seen indications of safety problems from COVID-19 vaccine booster shots after European and international officials expressed concern about how repeat boosters may impact immune systems.

“FDA is aware of the EMA report. To date, we have not seen any safety signals regarding booster shots and immune response,” a spokeswoman for the agency told The Epoch Times in an email.

The FDA cleared boosters of the Moderna, Johnson & Johnson, and Pfizer vaccines for all adults late last year, and certain immunocompromised individuals can get a second booster under current U.S. authorization. The agency has also recently allowed children as young as 12 to get a Pfizer booster, and children 5 to 11 with weakened immune systems to get an additional Pfizer shot.

Both the FDA and the Centers for Disease Control have in place surveillance systems to monitor the vaccines, the spokeswoman added, pointing interested parties to an FDA webpage on the topic.

Across both Europe and the United States, multiple booster shots are being allowed or even recommended for people because the vaccines have dropped considerably in effectiveness, especially against virus infection, over time.

A top European Medicines Agency (EMA) official told reporters this week that no data yet exists to support giving more than one booster shot and repeat boosters would potentially lead to “problems with immune response.”

“We should be careful in not overloading the immune system with repeated immunization,” said Marco Cavaleri, the official.

There are also some who say that certain populations should likely not get any boosters because of safety concerns. Young men, for instance, have a higher risk of contracting heart inflammation from a Pfizer booster than COVID-19 itself, according to one recent study.

Experts with the World Health Organization’s Technical Advisory Group, meanwhile, said in a brief around the same time as Cavaleri spoke that “a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.”

The group said vaccines must be based on strains that are similar to the variants of the CCP (Chinese Communist Party) virus. The CCP virus causes COVID-19.

All the current COVID-19 vaccines are based on early strains, which some experts say has led to the sharp decline in protection against infection and the smaller slippage in protection against severe disease.

Booster shots restore some of the lost protection against the Omicron virus variant but that restored shielding quickly drops, according to emerging data.

Still, U.S. authorities are continuing to call on people who haven’t gotten a vaccine to get one and those who have to get a booster when they’re eligible—five months after the primary regimen for those who got the Moderna or Pfizer jab, and two months for those who received the Johnson & Johnson vaccine.

“Up-to-date COVID-19 vaccination with boosters prevents severe disease and keeps you out of the hospital,” Dr. Anthony Fauci, U.S. President Joe Biden’s chief medical adviser, told a briefing this week.

Zachary Stieber

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Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.



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