Pfizer COVID Shot Gets Priority Review
Posted on 07/16/2021
Pharma giant Pfizer Inc. disclosed that its COVID-19 mRNA shot was granted priority review by the U.S. Food and Drug Administration (FDA). According to data from the Centers for Disease Control and Prevention (CD), some 85 million people have been fully vaccinated with the two-dose shot regimen. Pfizer and its German partner BioNTech SE said in a statement Friday that the FDA plans to decide whether to approve the shot for use in people 16 and older by January 2022. The Pfizer–BioNTech COVID-19 vaccine (INN: tozinameran) is sold under the brand name Comirnaty and it is an mRNA-based COVID-19 vaccine.
A significant portion of the U.S. population are reluctant to take the COVID shot due to the experimental nature and possible side effects (short-term and long-term). There have been no long-term studies to analyze the impact of the COVID shots in the long-run. In addition, there is widespread controversy over U.S. government, social media, and corporate collusion on the proper messaging of COVID shots.
Blanket Immunity
On March 10, 2020, Secretary Azar invoked the PREP Act and determined that COVID-19 constitutes a public health emergency.
Emergency use authorization (EUA) in the U.S. has been issued as a result of the severity of the COVID pandemic. When the pandemic is over, the EUA will cease and vaccine manufacturers will need to apply for full U.S. FDA approval. The U.S. federal government has granted companies like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with the COVID shots.
Johnson & Johnson COVID Shot
Recently, the FDA warned that the Johnson & Johnson COVID vaccine could cause a rare and potentially dangerous neurological reaction. Some J&J recipients have developed Guillain-Barré syndrome as a result of taking the J&J shot. The FDA announced the new warning as flagging reports of Guillain-Barre syndrome grew. Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells.
