The FDA has published documents outlining the first analysis of Pfizer’s COVID-19 booster shots.
Last week, the US Food and Drug Administration (FDA) released the first analysis of Pfizer’s COVID-19 booster shots. The documents provide the first look at the company’s application of a booster shot. Furthermore, it reviews the safety and efficacy of the third dose in a group of 300 adults, a part of Pfizer’s clinical trial.
In April of this year, Pfizer’s CEO Albert Bourla had predicted the need for annual booster shots of COVID-19. He stated that the constantly mutating coronavirus will lead to people receiving booster shots every 6 or 12 months. The prediction might be coming true as multiple countries across the world approve the third dose in the wake of the spreading delta variant.
The analysis looked at Pfizer’s data on 300 adults who had received a booster shot six months after their second dose. According to the vaccine manufacturer, the study participants had an increased immune response after the booster shot. Moreover, they did not report any adverse effects among the recipients. Pfizer further cited multiple other studies that showed the immune response wanes overtime after the second dose. However, FDA argues that the decrease in immunity could be a result of the rising delta variant infections.
This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.
Dr. Janet Woodcock, Acting FDA Commissioner
Booster Shots for 65 and Above
The talk of booster shots has stirred some controversy among the healthcare industry. Many scientists believe that a third dose is unnecessary. Additionally, there is a lack of evidence on the shot’s safety and efficacy. The World Health Organization (WHO) has also called for a temporary suspension of booster shots. The decision was made in an effort to reduce the worldwide vaccine disparity.
Last month, the CDC approved COVID-19 booster shots in immunocompromised individuals. Now, the FDA has further amended its emergency use authorization for Pfizer’s booster shot. As per the new statement, individuals aged 65 years and above, those at high risk of severe COVID-19, and individuals working in high-risk settings are eligible for a booster shot.
Although Moderna and Johnson & Johnson have also submitted their data to the FDA, the regulatory committee has so far only approved Pfizer’s booster shots.
Source: US Food and Drug Administration
