Information That the FDA Has Not Approved Pfizer’s Vaccine is False

Reading Time: 3 minutes

Reading Time: 3 minutes

35
VIEWS

A Facebook user Nina Marji published a video on February 25. In the video, an answering machine of Pfizer’s anti-coronavirus vaccine info hotline says that the vaccine has not been approved by the FDA. The description of the video mentions that Pfizer’s anti-coronavirus vaccine has not been approved because it has not gone through test periods and, therefore, is being tested directly on humans during the widescale vaccination.

 

;

Nina Marji’s claim that FDA has not approved Pfizer’s vaccine, and that the latter is being directly tested on humans is false. Pfizer’s vaccine completed all three stages of clinical trials, with up to 44,000 participants. Due to an urgent need for the vaccine, it received an Emergency Use Authorization (EUA) on December 11. 

  • What does an Emergency Use Authorization mean?

The United States Food and Drug Administration (FDA) granted the Pfizer/BioNTech vaccine an EUA on December 11, 2020, allowing the company to distribute the vaccine in the United States. The statement reads that the FDA considered medical evidence collected at the clinical trials stage, as well as the information received from the manufacturing company and independent experts while making the decision to grant the authorization. The EUA means that the Pfizer/BioNTech vaccine meets the FDA requirements and provides scientific evidence of its efficiency against COVID-19, and that the known and potential benefits outweigh the known and potential risks.

Commissioner of the FDA, Stephen Hahn, stated that such authorization has been granted due to multiple analysis of transparent research results and that this event would totally alter the efficiency of the fight against the coronavirus in the US. The FDA defined the necessity to grant the EUA to a potential substance against COVID-19 as early as on February 4, 2020, when the United States Department of Health and Human Services issued a notice on this issue. According to the notice, the spread of the coronavirus was a threat to public health and national security. Therefore, the FDA was granted the right to issue the EUA to an anti-coronavirus substance before issuing an official license.

The EUA does not mean that the product has not undergone respective trials and that the FDA has not verified its efficiency. The necessity to issue EUA stems from the emergency situation and indicates the urgent need for a medicament/vaccine.

  • The Pfizer/BioNTech vaccine is not being tested directly on people

Nina Marji also claimed that the Pfizer vaccine is being tested directly on humans. In fact, the Pfizer/BioNTech vaccine completed the three main stages necessary for the approval of a vaccine, meaning that it has been tested both on a small group of people, as well on thousands of people. A total of 43,500 people from six countries have participated in clinical trials of this vaccine.

The company published the information about the completion of the third stage of the clinical trials in November 2020. According to the published data, the vaccine showed 95% efficacy 28 days after the initial dose. It was after this that Pfizer/BioNTech applied for the EUA to the FDA.

Myth Detector has verified disinformation on anti-coronavirus vaccines on several occasions:


The article has been written in the framework of Facebook’s fact-checking program. You can read more about the restrictions that Facebook may impose based on this article via this link. You can find information about appealing or editing our assessment via this link.

Read detailed instructions for editing the article.
Read detailed appeal instructions.

Violation: Disinformation
Country: USA
Source

Last News

Welcome Back!

Login to your account below

Retrieve your password

Please enter your username or email address to reset your password.

Add New Playlist