WASHINGTON, D.C. – The Food and Drug Administration (FDA) authorized emergency clearance on Thursday for two new COVID-19 vaccines that are able to be administered to children as young a 6 months of age; previously, COVID vaccinations were only available to U.S. youngsters who were age 5 and older.
The new “bivalent” vaccines, produced by pharmaceutical giants Pfizer and Moderna respectively, target the original strain of COVID as well as several of the Omicron-based variants that have popped up.
The new vaccines are intended to be used as a third-dose booster for children who have already received the initial two-dose inoculation; however, unlike the Moderna jab, the Pfizer vaccine requires three doses for full vaccination in children, with the company’s new drug being considered acceptable to use as the third dose.
FDA Commissioner Robert Califf said that granting emergency clearance for the new Pfizer and Moderna vaccines to be used on toddlers was a matter of protecting their health and well-being.
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“As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families, and public health by helping prevent severe illnesses, hospitalizations, and deaths,” he said in a statement.
Currently, neither Moderna or Pfizer are able to provide any clinical efficacy data for their new, updated vaccines, saying that they were basing their safety findings on the initial versions of the vaccines; this has led to backlash from drug safety advocates such as Kim Witczak.
“Looks like @US_FDA just authorized the MRNA injections for babies 6 mos and older,” she tweeted. “How can any doctor look at parents and insist this is ‘safe’ for their babies when it was never tested on people?”
This follows the recent release of an Italian study, which found that older participants who received a booster shot of the updated Omicron-targeting vaccines displayed almost no additional protection whatsoever against COVID infection after two-to-four months, and that the vaccine had become only 30 percent effective against preventing severe illness.