On Friday, the Food and Drug Administration panel– responsible to investigate the effectiveness of COVID-19 vaccine— has given its Emergency Use Authorization (EUA) to pharmaceutical companies, Pfizer and BioNTech.
This means, the said vaccine of the companies will be the first official COVID-19 vaccine in the United States. However, here’s bad news. Not everything may be good news on this vaccine approval. Here’s why.
Pfizer/BioNTech vaccine gets approved!
In the last couple of weeks, Pfizer company has stirred the nation over its claims of 94% effective vaccine against the virus.
Though it’s a good news for all countries, taking medicine inside the body isn’t an easy job to do. The FDA needs to be strict, in order to understand the vaccine component and whether it is really safe to use for humans.
Since the panel already approved Pfizer’s request for EUA, there’ll be less chances now to remove the vaccine on the market.
Here’s why it’s approved
How does FDA panel come up with the decision to released approval to Pfizer company?
According to the official FDA EUA letter sent to Pfizer, there were a lot of reasons why the FDA found the vaccine effective to treat COVID-19.
The immediate need
As said on the letter, one of FDA’s criteria to choose Pfizer for EUA is the country’s immediate need for a vaccine amid pandemic.
The number of victims of COVID-19 in the country is still rising, as of today. Over 15 million Americans were affected with the virus. Meanwhile, at least 300,000 people already died from the virus, in US alone.
It was also written that SARS-CoV-2 can “cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus.” Thus, people needs the vaccine now.
No other vaccines are proved effective
Pfizer is currently the number one US-candidate for effective COVID-19 vaccine. Therefore, there are no other choices to pick, instead of the drug.
Vaccine outweighs its potential risks
Six people did die during the 44,000 person Pfizer vaccine trial in the United Kingdom– wherein it was first tested.
After this news, a lot of people were hesitant to try the vaccine. However, the FDA approval letter states that:
“It is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks.”
The FDA has surely given enough time to investigate about the Pfizer vaccine. However, some Americans still think that this approval is too early and rushed.
Pfizer company still have to wait for another approval from the government before the public dissemination of the drug.
Still, other experts in the field, thought that Pfizer has done a great job to present its vaccine for the FDA. Thus, they deserved the approval.
For now, let’s see where this will be heading in the future.