FDA Grants Full Approval for Pfizer Vaccine

FDA+Grants+Full+Approval+for+Pfizer+Vaccine

Samantha Epner, staff writer

After almost two years of masks, social distancing, and experimental vaccines to fight the Covid-19 disease, people can finally be reassured. On August 23, 2021, the FDA granted full approval for the Pfizer BioNTech Covid-19 vaccine for ages 16 and older.

On December 11, 2020, the FDA issued a EUA for the vaccine, A EUA is an Emergency Use Authorization that the FDA grants for medical products, drugs, and vaccines in times of crisis. The FDA can only issue a EUA after the head of the HHS (The Department of Health and Human Services) declare a medical emergency. A EUA is granted to a medical product that has not gone through all the stages of testing. When granting a EUA there are three requirements; a reason to believe that the product will be effective, meaning it has been tested on multiple subjects, the benefits of the product outweighs the short term or long term side effects, and finally only if there are no other approved adequate or available options or alternatives to this product. Although the Pfizer vaccine has full FDA approval for ages 16 and up, it is still under a EUA for ages 12-15. The Johnson and Johnson vaccine and the Moderna vaccine are still under a EUA for ages 18 and older in the US and other countries. Also under a EUA is a third dose of the Pfizer vaccine for certain immune-compromised individuals. 

Although the FDA approval of the Pfizer vaccine is a big milestone in the battle against the Coronavirus, some people don’t think that it is a good thing. The FDA granting the Pfizer vaccine approval means it can now be mandated in school districts, corporate businesses, federal workplaces, the military, etc. Already in many states across the US, the vaccine is becoming mandatory for healthcare and federal employees. Many community colleges and universities across the state of California have given a mandate for all staff to get the vaccine or get tested weekly. 

As of Tuesday, September 7, 2021, 53.2 % of the US population is fully vaccinated and 62.5 % has had one dose of the vaccine. This means that the larger part of the US population has been vaccinated. Companies and businesses are starting to become looser with their Covid-19 restrictions because cases are dropping. They feel better about Covid-19 because the US is starting to win the fight against this global epidemic. 

The KKF (Kaiser Family Foundation) has an ongoing research project to track the public’s attitude toward the vaccine. 14% of the people that they interviewed said that they would not get the vaccine even if it is required. They’ve found that an overwhelming number of the people that said they will not get the vaccine are white adults. The New York Times also interviewed different people across the US who have not been vaccinated. The majority of the people they interviewed believe that they don’t need the vaccine because they’re young and healthy. Others are waiting to see if it is safe because they believe the vaccine was developed and approved too quickly. 

Although Covid cases are dropping and some restrictions are being lifted, vaccinated people are getting angrier and angrier at unvaccinated people. They are blaming them because they are still spreading the virus leading to businesses, stores, and establishments requiring fully vaccinated people to wear masks and social distance. This is making vaccinated people angry because they are often the people who did their part before the vaccine came out. They wore their masks outdoors, were socially distanced, and tried to stay in as much as possible. The fact that so many people are not getting vaccinated is frustrating because the unvaccinated are most of the time the people who also refuse to wear masks and social distance.

Now that the Pfizer Covid vaccine has been fully approved vaccination rates are going up and new Covid cases are dropping. 

 

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