Emergency COVID-19 vaccine approval to require 2 months of follow-up data, FDA says

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Emergency COVID-19 vaccine approval to require 2 months of follow-up data, FDA says

The FDA told the manufacturers of the experimental coronavirus vaccines that for requesting emergency approval, they’d need to offer a follow-up data of at least 2 months post trial participants got their last injection.

The new guidelines create a timeline for the drug manufacturers to get approval by 3 November.

As a part of the newly updated requirement, the FDA cited that the drug manufacturers should follow the participants for at least 2 months post receiving their last dosage as an effort to curb any side effects prior to submitting the candidates for the EAU (Emergency Use Authorization) approval.

This information would provide adequate data to assess the benefit-risk profile of a vaccine, including the adverse events, state the guidelines.

The requirements mainly are focused at firms who are seeking quick approval via the emergency authorization approach of the FDA. That accelerated procedure, which is reserved for only health emergencies, lets medical products enter the market on lower scale in contrast to the traditionally FDA approved medicines.

However, the FDA now has made it clear that only the vaccines which are shown effective and safe will be allowed for treating coronavirus.

Meanwhile, President Donald Trump has insisted repeatedly that a vaccine might be authorized by 3 November, in a video that was recorded upon his return to White House.

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