Home Updates FDA plans to approve Moderna’s COVID-19 vaccine

FDA plans to approve Moderna’s COVID-19 vaccine

Vaccine advisers to the United States Food & Drug Administration voted quickly to recommend the emergency use authorization to COVID-19 vaccine of Moderna. Top FDA officials said a few hours later that they planned to move forward quickly with the emergency use authorization.

FDA Commissioner Dr Stephen Hahn and director of the FDA’s Center for Biologics Evaluation & Search, Dr Peter Marks said in a joint statement that following the positive advisory committee meeting conclusion about the Moderna coronavirus vaccine, the United States Food & Drug Administration informed the sponsor that it would instantly work toward completion and issuance of an emergency use authorization.

FDA also informed CDC and Operation Warp Speed so that they can implement their plans for timely COVID-19 vaccine distribution. The Vaccines and Related Biological Products Advisory Committee vote 20-0 with one absence to approve emergency use authorization for the Moderna vaccine – having similar design, composition, efficacy and safety to Pfizer/BioNTech’s vaccine. That was the only one query facing the committee – whether to recommend EUA.

Committee members show their confidence on the Moderna vaccine

Dr Steven Pergam, the committee member of the University of Washington & Fred Hutchinson Cancer Research Center, recommends the vaccine before voting by expressing no doubt in his mind about the efficacy of the vaccine. Further, he said that it looks like the benefits of the Moderna vaccine outweigh the risks.

However, that didn’t stop the collection of academics, public health specialists, physicians and others from getting into a prolonged debate about whether Moderna should offer the coronavirus vaccine to citizens of the United States who got saline shots. It is something that may have the effect of reducing enduring statistics on how well and securely the vaccine saves people from the virus.

FDA plans to approve Moderna’s COVID-19 vaccine
FDA plans to approve Moderna’s COVID-19 vaccine
Source: Web

An infectious disease specialist, Dr Arnold Monto, who chairs the panel said after the vote that academics get involved in details, and they did it for the last eight to nine hours by going over the details. Arnold noted that the vote cast one-sided this time contrary to last week’s vote to recommend Pfizer/BioNTech’s vaccine, which approved with 17-4 votes, with one abstention.

The technology of Moderna vaccine

Moderna uses similar technology in its vaccine to Pfizer/BioNTech’s: mRNA or messenger RNA. The genetic material in the vaccine prompts the human body to generate compounds that look like the outside of the COVID-19, and in return that creates an immune response that protects the body against infection. Each vaccine is almost ninety-five percent effective in preventing symptomatic sickness, with few negligible side effects.

Moderna says that it will continue its efforts to gather safety statistics on the vaccine. Chief Executive Officer of Moderna, Stephane Bancel, stated that they look forward to getting their vaccine to the United States public to help address the deadly public health emergency.

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