The U.S. Food and Drug Administration announced Wednesday it sanctioned updated booster shots for Moderna and Pfizer/BioNTech that target the omicron variant of the coronavirus.
The pharmaceutical companies developed bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The authorized bivalent COVID-19 vaccines, also known as updated boosters, include an mRNA component of the SARS-CoV-2 virus to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variants BA.4 and BA.5 to protect against the omicron variant.
According to the Center For Disease Control and Prevention, the BA.4 and BA.5 lineages of the omicron variant are causing most cases of COVID-19 in the U.S. The FDA said these variants are predicted to circulate this fall and winter.
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single 50- booster dose authorized for individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is approved for use as a single 30-microgram booster dose for individuals 12 years of age and older.
“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, M.D. said in a statement. “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.”
Authorization from federal regulators comes nearly a week after Moderna filed a patent infringement against Pfizer and BioNTech "for infringing patents central to (its) mRNA technology platform," the company announced.
"We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic," wrote Moderna Chief Executive Officer Stéphane Bancel in a statement.
Pfizer/BioNTech did not publicly address the lawsuit but wrote a statement to a news outlet, saying “we are surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech's proprietary mRNA technology and developed by both BioNTech and Pfizer”.
“We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit,” the company wrote in a statement.
