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Pfizer COVID-19 vaccine gets full approval in USA, first to be licensed

Tuesday, 24th August 2021

Pfizer COVID-19 vaccine gets full approval in USA, first to be licensed
Pfizer's two-dose Covid-19 vaccine has received full approval from the US Food and Drug Administration (FDA) - the first vaccine to be licensed in the nation.

The two jab coronavirus vaccine was initially authorized for emergency uses, and the second dose required to be taken within three weeks of the first. Pfizer COVID-19 vaccine still has emergency use authorization for children from aged 12 to 15 years.

The Jabs are being administrated free of charge to the Americans.

The US Food and Drug Administration (FDA) stated that the Pfizer vaccine had been licensed after the examination of data from over 44,000 people. The vaccine, now marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.

The recent approval by FDA is more likely to make vaccination mandates from employers and organizations across the country.

Acting FDA Commissioner Janet Woodcock said the public "can be very confident" the vaccine meets high safety, efficacy and production quality standards.

Following the announcement, the US military said it would officially require all 1.3m active duty US troops to be vaccinated against the coronavirus.

The FDA initially gave Pfizer a temporary authorization - a permit if the agency determines the benefits of a product outweigh the potential risks during a public health emergency. The full approval is permanent. The licensing process requires companies to provide FDA information on how and where the product is made, as well as other clinical test data.

Critics have called on the FDA to speed up the approval process as the nation struggles to increase vaccination rates. The proliferation of the contagious Delta variant has already given some hard-hit regions a bump in vaccination rates in recent weeks.

While the agency took steps to increase staff and resources, it had previously said it would take six months to obtain the required data.

The approval finally came less than four months after Pfizer -BioNTech submitted the license in early May - the fastest vaccine approval in the FDA in more than 100 years of history.

Polling data released by the Kaiser Family Foundation in late June found that about 30% of unvaccinated US patients said they were more likely to get a vaccine if they got full FDA approval. The number is rising to nearly 50% among Americans who take a "wait and see" approach to vaccinations.

In a televised address Monday, President Biden spoke directly to the "millions" of Americans he said were awaiting full and final FDA approval.

"The moment you were waiting for is here,"It's time for you to get your vaccination. Get it today." President Joe Biden

In addition, Mr. Biden called on private sector companies and nonprofits to require employees to be vaccinated or "set strict requirements".

Businesses, healthcare systems, universities and other organizations are now expected to report vaccine claims as the country returns to normalcy. The US military has also said vaccination will be mandatory for 1.3 million active troops after FDA approval.

To date, more than 92 million vaccinated Americans - more than half of the total - have received the Pfizer vaccine.