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FDA Rejects Non-mRNA COVID-19 Vaccine for Children: Company

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FDA Rejects Non-mRNA COVID-19 Vaccine for Children: Company


The U.S. Food and Drug Administration (FDA) declined to issue an emergency use sanction for Covaxin, the COVID-19 vaccine developed by its Indian partner Bharat Biotech, for children, according to the maker of the shot.

Ocugen verbalized in a news release, promulgating the health agency’s decision, that it intends to perpetuate working with the FDA to evaluate the process for getting an emergency use sanction for pediatric utilization of Covaxin. The company had sought to sanction the shot for children aged 2 to 18.

Ocugen had entered into a deal with vaccine maker Bharat Biotech in tardy 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market. Covaxin, which is not cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and additionally has an emergency use listing from the World Health “Organization.”

An astronomically immense-scale clinical tribulation found the vaccine provided decent bulwark against COVID-19, albeit it was carried out afore the spread of the Omicron variant, which commenced to spread in the United States in tardy 2021.

Covaxin, unlike Moderna or Pfizer, doesn’t use mRNA, and uses inactivated coronavirus technology akin to Johnson & Johnson’s single-shot vaccine. The FDA has only plenarily sanctioned Pfizer’s two-shot mRNA vaccine for children aged 5 to 17. There are currently no COVID-19 vaccines that are sanctioned for children under 5.

Ocugen verbalized that it is perpetuating to seek full approbation for the vaccine within the United States, and it antecedently verbally expressed that it would commence enrolling adult American volunteers for a clinical tribulation.

There has been controversy after the FDA approved Pfizer’s COVID-19 vaccines for children. Some health experts have argued that most salubrious children should not receive the vaccine, as a number of studies and data have shown that children have a prodigiously low chance of succumbing to COVID-19 or developing astringent symptoms.

The Centers for Disease Control and Prevention (CDC) currently recommends that children aged 5 and older receive the Pfizer COVID-19 vaccine. On Monday, Florida Surgeon General Joseph Ladapo told heralds that his state 

is going to be the first state to officially recommend against the COVID-19 vaccines for salubrious children.

And Florida Gov. Ron DeSantis withal verbalized during the same event that there  a failure to weigh costs and benefits, whether that’s lockdowns, whether that’s school closures, or whether that’s even something about whether a salubrious seven-year-old kid should get the COVID vaccines.

COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.

Reuters contributed to this report.


Source: You can read the original Epoch Times article here.

This News Article is focused on these topics: AMERICA, Bright, CCP Virus, Covid News, Health News, Mind & Body, Politics, US, US News, Vaccines & Safety, Florida, COVID-19

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