The FDA has Approved the Pfizer-BioNTech Covid Vaccine

by Wall Street Rebel | Michael London | 08/23/2021 10:16 AM
The FDA has Approved the Pfizer-BioNTech Covid Vaccine

Individuals aged 16 and older have been given full approval by the Food and Drug Administration for the Pfizer-coronavirus BioNTech vaccine, making it the first immunization in the United States to be authorized for regular use rather than just for emergency use.

 

On Monday, the Food and Drug Administration gave full clearance to Pfizer-coronavirus BioNTech's vaccine for individuals aged 16 and older, making it the first vaccination in the United States to be approved for routine use rather than just for emergency usage.

In the United States, the vaccine has been approved for emergency use since December, and according to statistics released on Sunday, it has been administered to more than 204 million individuals.

However, none of the three COVID-19 vaccines that have been approved had previously obtained full FDA clearance. All three COVID-19 vaccines had already received FDA clearance.

Public health authorities believe that it will persuade more unvaccinated Americans that Pfizer's vaccine is safe and effective due to this campaign.

Some Americans' apprehension has hampered the United States' reaction to the new coronavirus about being vaccinated.

So far, about 51 percent of Americans have received a complete vaccine, despite a recent outbreak of illnesses triggered by the virulent Delta variety wreaking havoc in areas of the country with poor vaccination rates.

It is expected that hospitals, universities, businesses, and other organizations would implement vaccination mandates due to the ruling.

According to a recent announcement, United Airlines workers would be required to produce evidence of immunization within five weeks of receiving regulatory clearance for the vaccine.

The same mandate for all state employees has been enacted by Oregon, as have a slew of colleges in states ranging from Louisiana to Minnesota.

Once Pfizer's clearance is received, the Pentagon has said that it would require the injections for the country's 1.3 million active-duty soldiers.

While the nation's battle against the pandemic has escalated anew, the highly contagious Delta variety has reversed most of the progress achieved during the first half of the year, prompting the approval.

As a result of this discovery, the Biden administration believes that at least some of the approximately 85 million unvaccinated Americans eligible for vaccinations will be motivated to receive them.

Pfizer said that it provided the Food and Drug Administration with data from 44,000 clinical trial participants throughout the United States, the European Union, Turkey, South Africa, and South America, among other places.

When the vaccine was approved for emergency use earlier this year, the company reported that the vaccine was 91% effective in preventing infection. This represents a slight decrease from the 95% efficacy rate reported when the Food and Drug Administration decided to approve the vaccine for emergency use in December.

According to Pfizer, the reduction was because researchers had more time to detect individuals who had been infected due to the increased time.

According to a recent poll conducted by the Kaiser Family Foundation, which has been tracking public attitudes throughout the pandemic, three out of every ten unvaccinated people said they would be more likely to get vaccinated if the Food and Drug Administration had fully approved the vaccine.

Meanwhile, the Pfizer-BioNTech vaccine will continue to be approved for emergency use in children aged 12 to 15 while Pfizer gathers the necessary evidence for full approval.

It is possible that a decision on whether to approve the vaccination for children younger than 12 will not be made for many months.

Pfizer vaccines have been administered to more than 92 million Americans so far, accounting for 54 percent of those who have been completely immunized.

Moderna's vaccine was administered to the vast majority of the remaining participants.

The Food and Drug Administration is in the middle of a decision-making marathon involving coronavirus vaccinations.

The decision on whether or not to approve booster injections is the next big one on the horizon for regulators.

Last week, the Biden administration said that, pending approval from the Food and Drug Administration, it would begin offering third doses to individuals who had the Pfizer and Moderna vaccinations eight months after their second injection on September 20.

Federal health authorities have said that the potency of Pfizer-BioNTech and Moderna's vaccines, which are based on the same technology, diminishes with time.

According to the researchers, those who finished their vaccines at the beginning of the year are becoming more susceptible to infection. This trend is converging with the development of the especially deadly Delta strain.

Several health professionals have questioned the decision to suggest booster doses as premature, claiming that the evidence indicates that the vaccinations are effective against severe illness and hospitalization, even the Delta version.

In other cases, boosters would only be necessary if the vaccinations were failing to prevent hospitalizations due to Covid-19, according to researchers who have studied the disease.

Regulatory authorities are still reviewing Moderna's application for complete approval of their vaccine.

It may take many weeks for a decision to be made.

Johnson & Johnson is likely to submit a formal application for full clearance in the near future.

 

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