On Friday 19th November, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for both the Moderna and Pfizer Covid-19 vaccines, meaning that everyone 18 years and older can get the boosters.
The Advisory Committee on Immunisation Practices voted unanimously in favour of the boosters in the afternoon.
Committee member Dr Camille Kotton said following the vote: “As a clinician deep in the clinical trenches, I am really glad that we have clarity and streamlining of the recommendation so that all Americans can understand the vaccines that are recommended for them at this time.”
It is expected that the Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky is set to approve the shots very soon.
The approval means that any adult who received a second dose of the vaccine at least six months prior is now eligible for a booster. Before the boosters were approved, some states were encouraging individuals to go seek a third shot out, which has led to more than 30 million people submitting to another injection.
Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research said: “The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech Covid-19 vaccines to individuals 18 years of age and older.”
In the United States, the Covid-19 vaccine boosters have been authorised for people 65 years and older who were vaccinated with Pfizer or Moderna jabs at least six months ago, and also for adults who are vulnerable, such as those with compromised immune systems.
Last week, Pfizer requested authorisation of its booster shot and submitted results of a Phase 3 trial that had more than 10,000 participants. According to the results, the trial found the booster shot to be “safe” and “95% effective.” Additionally, Moderna sought approval of their booster jab on Wednesday.
However, the Pfizer and Moderna jabs have been linked to an increase in health conditions such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the sac surrounding the heart). These conditions have been highly reported amongst younger males who have received either a single or both doses of the vaccine, and it is disturbing to see that the boosters are set to be approved for this age group.
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