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Coronavirus | Vaccines

What does FDA approval for the Pfizer covid-19 vaccine mean?

The Pfizer vaccine has become the first vaccine to be fully-approved by the FDA and there are hopes that it will mean an increase in vaccination rates.

The US Food and Drug Administration on August 23, fully approved the Pfizer-BioNTech Covid shot, triggering a new wave of vaccine mandates as the Delta variant batters the country.
Robyn BeckAFP

The Pfizer vaccine was fully approved by the FDA on Monday, marking the first of the three emergency covid-19 vaccines to receive the nod. Officials are hoping that the full approval will convince a vaccine-hesitant population to finally get the jab. Currently, 52% of Americans are fully vaccinated, but the rate has slowed to a crawl in recent months.

Renewed fears of the Delta variant means the Biden administration is looking for anyway to force people to get the vaccine to avoid a repeat of last winter, with thousands of deaths and business closures. The full approval comes as booster vaccines are also to be permitted for use in the fall.

What is the difference to an emergency approval?

The Moderna and Johnson & Johnson vaccines in use in the US are classified for 'emergency use.' While still undergoing rigorous testing, they are allowed for public use sooner due to a specific public need and the view that the positives far outweigh the negatives. Moderna has also applied to have their vaccine given full approval.

While the FDA took steps to increase staff and resources, it had previously said it would take six months to get the required data. The approval ultimately came less than four months after Pfizer filed for licensing in early May making it the fastest vaccine approval in FDA history.

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Will it affect vaccination rates?

There has been some recent polling which could indicate that one of the primary reasons people are hesitant to take up the vaccine is because they are not fully approved.

Even though it is a step toward boosting rates, for many Americans full approval is not the deciding factor when deciding whether to get a vaccine or not. For minority groups, traditional mistrust of central government is a big reason.

"The FDA approval is not their main concern or the reason why they are not taking the vaccine," said Jonathan Bulter, executive director of African American Faith Coalition. "They are concerned with the mistrust in government, and there is also a lot of misinformation on social media that they are overwhelmed by."

Fully approved vaccines give the authorities more leeway when demanding federal organizations to have vaccine mandates. Service members are the latest group which will be required to take the vaccine or risk losing their job. Other state controlled mandates are likely to be a factor when younger Americans decide whether to take a vaccine.

"Rules and regulations like college's vaccination requirements or requirements to dine indoors or go to clubs or gyms will also sway a significant number of young adults," Dr. Jason Nagata, MD, assistant professor of pediatrics at UCSF, said

What has President Biden said?

“If you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened,” the president said on Monday. “The moment you’ve been waiting for is here.”

“So please, get your shot today,” he said. “There is no time to waste.”


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