Pfizer becomes first Covid vaccine to gain full FDA approval

Pfizer becomes first Covid vaccine to gain full FDA approval
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Daily US Times: The US Food and Drug Administration (FDA) fully approved two-dose Covid-19 vaccine made by Pfizer – the first jab to be licensed in the nation.

Pfizer’s Covid-19 vaccine had initially been given emergency use authorisation. Its two jabs, which have to be taken three weeks apart, are now fully approved for those aged 16 and older.

The approval is expected to set off more vaccine mandates by organisations and employers across the country.

The FDA approval comes amid lingering vaccine hesitancy among many Americans.

The FDA said in a statement that its review for approval of the vaccine included data from approximately 44,000 people. The vaccine was found to be 91% effective in preventing Covid disease.

Janet Woodcock, acting FDA commissioner, said that the public “can be very confident” the vaccine meets high effectiveness, safety and manufacturing quality standards.

Pfizer vaccine still has emergency use authorisation for children aged 12 to 15.

Following the announcement, the US military said they would officially require all 1.3 million active duty US soldiers to get vaccinated.

The vaccines are being provided at no cost to Americans.

The FDA initially gave temporary authorisation to Pfizer vaccine – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.

This full approval of the vaccine is essentially permanent. The licensing process requires companies to provide information to FDA on where and how the product is made, as well as other clinical testing data.

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