The Food and Drug Administration has once again granted “emergency use authorization” to Pfizer-BioNTech and Moderna for their Covid-19 vaccine “booster” shots. The FDA announced the EUAs on Wednesday:
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.
The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.
The FDA then provided basic information on the booster shots themselves:
- The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
- The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the U.S. and are predicted to circulate this fall and winter. In June, the agency’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an omicron component in COVID-19 booster vaccines.
The FDA also made a revision to the EUA for the “monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older.”
With today’s authorization, the FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. At this time, the Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.
The health agency did not provide a reason for the revision in this particular announcement. It did, however, continue to tout the vaccines.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert M. Califf claimed. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations. The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”
Despite the nation being nearly three years into the Covid pandemic, the FDA continues to shield the vaccine manufacturers from liability by issuing them EUAs.
Meanwhile, in the United Kingdom, hundreds of British citizens have received payments of up to $140,000 each for successfully claimed vaccine injuries. No such payments have yet been recorded in the United States.
“More than 5,000 of those [vaccine injury claims] are directly related to the Covid-19 vaccines, with injuries ranging from a sore shoulder to death, according to the Health Resources and Services Administration,” Politico reported in June. “An additional 3,000 complaints related to everything from drugs and devices to the failure of hospital staff to limit infection spread have also been filed.”
“Yet the pandemic fund has paid zero claims, in part because officials are waiting for people to submit detailed medical records and documentation to back up their allegations,” the report added.
“Compensation determinations are made based on individual case reviews, and the statute sets a very high standard that a claimant must meet to be eligible for compensation,” HRSA spokesperson David Bowman said.
The FDA’s issuance of the EUAs is another sign that the U.S. government believes the Covid pandemic is still a national health emergency. According to seroprevalence data taken in December, at least 99% of Americans have antibodies to the coronavirus.
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