Moderna Seeks FDA Emergency Authorization for 4th COVID-19 Vaccine Shot

A vial of Moderna's COVID-19 vaccine in Los Angeles, Calif., on Dec. 15, 2021. Frederic J. Brown/AFP via Getty Images

Moderna has requested the U.S. Food and Drug Administration (FDA) for emergency use authorization of a fourth COVID-19 vaccine dose for all adults aged 18 and above.

The request is broader than that of rival pharmaceutical company Pfizer, which requested earlier this week for the regulator to approve a booster shot for all adults aged 65 and above.

In a release on Thursday, Moderna said that it asked the FDA to include all adults “to provide flexibility for the U.S. Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose ... including for those at higher risk of COVID-19 due to age or comorbidities.”

The request was “based in part on recently published data generated in the United States and Israel following the emergence of Omicron,” the drugmaker said, without further elaborating. It also has not commented on the effectiveness of a fourth shot.

The Epoch Times has reached out to Moderna for comment.

For the Moderna COVID-19 vaccine, the U.S. Centers for Disease Control and Prevention (CDC) currently recommends a primary series of two doses spaced 4–8 weeks apart, followed by a booster dose at least 5 months after the last dose.

Moderna and Pfizer-BioNTech have both been testing a booster shot specific toward the Omicron COVID-19 variant.

Moderna President Stephen Hoge said on March 14 that certain groups are likely to benefit from a fourth dose.

“For those who are immune-compromised, those who are older adults, over the age of 50 or at least 65, we want to strongly recommend and encourage [a fourth shot], the same way we do with flu vaccines,” Hoge told Business Insider.

He said the rest of the public will find a “benefit” if they get the shot. “Is it necessary? I think that’s a strong word. I think it will provide a benefit to anyone who gets it,” he said.

The White House has said that Congress needs to approve more funding to enable the government to provide Americans with “lifesaving tools: vaccines, booster shots, treatments, tests, and high-quality masks.” The Biden administration told Congress it needs $22.5 billion in immediate emergency funding for COVID-19 testing, vaccine, and treatment efforts.

COVID-19 vaccines from both Moderna and Pfizer/BioNTech COVID-19 have been linked to rare cases of heart inflammation, particularly in young men. Several studies have suggested that Moderna’s vaccine is likely to cause heart inflammation of the heart muscle at a higher rate than Pfizer’s, Reuters reported.

Vaccine providers are required to report any serious adverse effects or vaccination administration errors to VAERS, hosted by the U.S. Department of Health and Human Services.

The federal government has a countermeasures program that can compensate eligible persons who suffer serious injury from approved vaccines. But the burden of proof has proven a challenging process.

Vaccine manufacturers are immune from liability for any adverse reactions unless there’s “willful misconduct” involved.

Isabel van Brugen contributed to this report.