Moderna Requests FDA Approval for Fourth COVID-19 Dose

Moderna Inc asked the US FDA to approve a second booster dose of its coronavirus jab for all American adults.

Moderna Requests FDA Approval for Fourth COVID-19 Dose

On Thursday, Cambridge, Massachusetts-based pharmaceutical firm Moderna Inc, asked the U.S. federal health agency to approve a second booster dose of its coronavirus jab for all American adults, as a surge in infections in some parts across the globe fuels worries of another pandemic wave. The request is more wide-ranging than competitor drug firm Pfizer’s appeal on March 14 for the US FDA to authorize the 4th dose for all US seniors.

The drug and the biotechnology firm said in a news release that its request for Fourth Dose authorization for all adults was made to offer flexibility to U.S. CDC and health providers to determine the appropriateness of a 2nd booster shot of messenger-RNA jab, including for those at increased risk of fatal coronavirus disease amid comorbidities or age.

Moreover, American officials have been laying the laying the groundwork to offer additional boosters to bolster the protection of jabs against severe disease and fatality from coronavirus disease. The White House has been alerting that it needs U.S. Congress to immediately authorize more funding for the U.S. government to secure additional COVID-19 vaccines shots, either for extra booster doses or variant-targeted inoculations.

Currently, American health officials recommend an initial series of 2 shots of the Moderna-made vaccine and an additional shot months later. The Drug-maker said that its EUA request for the second booster was based on freshly declared data generated in America and the State of Israel following the emergence of a more virulent Omicron version.

Fourth COVID Vaccine Dose is Necessary

Albert Bourla, Pfizer’s chairman and CEO, said the pharmaceutical firm is submitting to U.S. FDA on the necessity of a second booster or fourth dose of its vaccine. While the COVID-19 vaccine dose Pfizer and its German partner BioNTech is presently manufacturing still proves effective against the fatal disease, Pfizer-BioNTech now believes an additional dose is required to fend off severe infections.

In an interview with ‘Face The Nation’ on Sunday, Pfizer CEO said currently, the way they’ve seen, it’s essential, the 4th Dose right away. The defense that we’re receiving from the 3rd shot, it’s adequately good, really good against hospital admissions and fatalities. But it isn’t decent against virus infections.

A spokesperson for Pfizer Inc said that Mr. Bourla was mentioning preliminary data and pointed to research declared in January 2022 examining both Omicron-specific dose and a 4th shot of the currently-approved dose. Steven Danehy said they’d continue to gather and assess all available information and remain in open discussion with health regulators and officials to help inform a coronavirus jab strategy as the lethal virus evolves.

A spokesperson for the White House referred inquiries regarding the submission to the Food and Drug Administration. However, the FDA spokesperson declined to give any comment.

Furthermore, previously, in an interview with CNBC, Pfizer CEO ha designated the firm’s submission as a significant package for data about the necessity of the 2nd booster. His deductions echo trends observed by health authorities worldwide, who have worked on the effectiveness of the COVID-19 vaccine during the highly infectious Omicron-wave earlier in 2022.

Moderna Requests FDA Approval for Fourth COVID-19 Dose
Moderna Requests FDA Approval for Fourth COVID-19 Dose
Source: Web

COVID-19 In the United States

While coronavirus infections are falling in America and much of the globe, cases are increasing in the People’s Republic of China. In Europe and the United Kingdom, there has been a reversal in the decreasing trend of coronavirus infections as economies have opened up, and a 2nd Omicron variant circulates.

According to the JHU CSSE, over 970K Americans have died from fatal disease caused by SARS-CoV-2. When US President Mr. Joseph Robinette Biden Jr. took office from the ex-US President Trump, approximately 400K people in the US had perished.


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