Pfizer vaccine becomes fully F.D.A. approved

pfizer-vaccine-approval-fda.html

Lafraniere, Sharon, and Noah Weiland. “F.D.A. Fully Approves PFIZER-BIOTECH’S VACCINE, a First for A Covid-19 Shot.” The New York Times, The New York Times, 24 Aug. 2021, www.nytimes.com/2021/08/24/health/pfizer-vaccine-approval-fda.html . 

In the article, "F.D.A. Fully Approves Pfizer-BioNTech's Vaccine, a First for a Covid-19 shot," Sharon LaFraniere and Noah Weiland break down the United States' latest hope for curtailing the Covid-19 virus: the F.D.A.'s approval of the Pfizer-BioNTech's vaccine for people 16 and older. It is the first and hopefully not the last of the vaccines to become approved by the Food and Drug Administration (F.D.A.). According to the authors, the F.D.A.'s decision comes just 97 days after the company submitted the last of what regulators said were hundreds of thousands of documents. Opposed to what the impatient public may think, 97 days is less than half the time it usually takes officials to make such a decision. Though regulators did not skip any steps to reach a conclusion, instead were working around the clock, nights and weekends. To earn the approval of its vaccine from the F.D.A., Pfizer had to submit data from 44,000 clinical trial participants. Half of the 44,000 participants received the vaccine; the other half received a placebo. According to the F.D.A., the data showed the vaccine was 91% effective in preventing disease. This was a 4% efficacy drop from the rate in December when the vaccine was cleared for emergency use. Though, the decrease demonstrated the fact that researchers had more time to catch people who became sick. LaFraniere and Weiland, throughout the article, described what the decision means for the United States, shedding light on both the positive and negative impacts of the Pfizer-BioNTech's vaccine becoming F.D.A. fully approved. The positive: F.D.A. will likely encourage civilians to get vaccinated and allow for vaccine mandates, as the approval proves there is no scientific evidence against the vaccine. The article says, "A recent poll by the Kaiser Family Foundation...found that three of every 10 unvaccinated people said they would be more likely to get vaccinated with a shot that had been fully approved," (LaFraniere and Weiland). On the contrary, the negative impact of the approval, which is outweighed by the positives, is that it may release a wave of demands from vaccine recipients who want their doctors to prescribe booster doses. Though, the impact of a third dose is still unknown by health experts. More than one million Americans have been able to land themselves an extra shot; with F.D.A. approval, the demand for a booster shot could become uncontrollable. 

The full vaccine approval could not have come at a better time. The United States effort to flatten the curve has been crushed by the Delta variant. As of Sunday, August 29th, 2021, the seven-day average was 1,008 daily deaths, per the New York Times database. However, these numbers are set to improve with an increase in vaccination likely to occur, as all fears of the vaccine should be limited by the F.D.A’s decision. For example, Dr. Janet Woodcock, the current F.D.A. commissioner, announced to reporters, "The public can be confident that this vaccine meets the F.D.A.'s gold standard for safety, effectiveness, and manufacturing quality that we require for an approved product," (LaFraniere and Weiland). The faster the rate of vaccination rises, the sooner normalcy will occur. The sooner the entire country can be in school, go to the office, out to dinner, travel without having to worry about Covid-19 constantly. The idea that you won't have to debate whether or not your sore throat is a covid symptom or the seasonal cold is so taunting yet so possible with this vaccine. The approval of Pfizer-BioNTech's vaccine is even causing happiness on Wall Street. Shares of Pfizer climbed 2.5 percent; higher vaccination rates in the United States would not only be good for health but also would be an economic positive going forward. 

LaFraniere and Weiland's article was well written, the overall message of the article was crystal clear. It was very informative right from the start; by the 4th line, the approval effects were beginning to be discussed. The piece was well researched, featuring both statistics and quotes from experts. Experts such as Dr. Jesse L. Goodman, a medical professor at Georgetown University who was once chief scientist at the F.D.A. The article was unbiased and neutral, displaying both the pros and cons of the vaccine becoming fully F.D.A. approved for ages 16 and older. The authors explain in some detail the F.D.A.'s process to approve this vaccine; however, more information would have enhanced the article and readers' understanding. The process is quite interesting and complex, and as a reader, I am left with some questions. Questions such as: what is the difference between emergency use authorization vs. approval? Does this affect whether or not someone should receive a booster shot? If the writers were to rewrite this article, these questions and answers should be included throughout the piece. It would also be favorable for the reader's knowledge to have a timeline of the F.D.A.'s approval process.