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US regulator endorses Moderna’s COVID-19 vaccine as safe, effective

*The Food and Drug Administration (FDA) officials will decide whether to issue formal emergency use authorisation following a meeting this Thursday

Isola Moses | ConsumerConnect

The United States (US) Food and Drug Administration (FDA) officials have endorsed Moderna’s COVID-19 vaccine as safe and effective.

ConsumerConnect reports the regulatory agency’s endorsement, contained in documents released Tuesday, December 15, 2020, now places the Coronavirus vaccine closer to receiving the official greenlight, so it can begin going out to the public soonest.

The FDA staff in the report on the endorsement stated the agency had determined that clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorisation for Vaccines to Prevent COVID-19.

“FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorisation of the product under an EUA.”

Meanwhile, the FDA is set to decide whether to issue formal emergency use authorization for Moderna’s vaccine Thursday, December 17 after a meeting with a panel of outside advisers.

The FDA “typically follows the advice of the panel, but is not required to do so,” reports Reuters.

It was learnt if the vaccine wins authorisation, vaccines could be administered to the American public as early as next week.

Recall Pfizer’s COVID-19 vaccine has already been authorised by the country’s regulators.

Subsequently, hospitals in the US began giving the company’s shots to patients Monday.

The vaccine was cleared for use in people aged 16 and older, while Moderna is asking the FDA to approve its vaccine for use in people 18 and older.

The vaccine producer stated that its clinical trials found that the vaccine was more than 94 percent effective in preventing COVID-19, according to report.

The US Government, last week, announced its intent to purchase an 100 million additional doses of Moderna’s vaccine.

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