HQ Team
September 12, 2023: The US drug and medicine regulator, the FDA, approved COVID-19 vaccines made by Moderna Inc., Pfizer Inc., and BioNTech Manufacturing GmbH to target new mutants of the deadly virus.
“Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5,” according to a Food and Drug Administration statement.
Individuals aged between six months and four years, who’ve been previously vaccinated against the COVID-19 virus are eligible to receive one or two doses of an updated messenger RNA COVID-19 vaccine in the US.
Regardless of previous vaccination US residents between five years and older are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least two months after the last dose of any COVID-19 vaccine.
Unvaccinated individuals in the range of six months and four years are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 vaccine, according to the statement.
Seasonal flu season
The vaccine shots will be available alongside a seasonal flu vaccine to protect infants and older adults from RSV, a potentially lethal respiratory virus. The Centers for Disease Control and Prevention is soon expected to announce the candidates for the new jabs.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
“The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.”
The variants include EG.5 and BA.2.86.
Ready by fall
Manufacturers have announced that the updated vaccines will be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future, according to the FDA.
As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Pfizer and BioNTech have been manufacturing the 2023-2024 COVID-19 vaccine at risk to ensure supply readiness ahead of the fall and winter season, when demand for COVID-19 vaccination is expected to increase in line with the seasonality period also seen with other respiratory viruses.
“This decision comes at a time when COVID-19 cases are once again climbing. Now, most people 6 months or older in the U.S. are eligible to receive this season’s COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,” said Albert Bourla, Chairman and Chief Executive Officer at Pfizer.
“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak.”
Monovalent composition
In June the USFDA advised manufacturers, who were updating their COVID-19 vaccines, that they should develop vaccines with a monovalent XBB 1.5 composition.
Pfizer Inc. and BioNTech SE submitted regulatory applications to the FDA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older, for the 2023-2024 fall and winter season.
The Omicron XBB sublineages currently account for nearly all COVID-19 cases in the US and are further antigenically distant from prior circulating SARS-CoV-2 variants, including Omicron BA.4/BA.5 and the original SARS-CoV-2 strain.
“COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season,” said Stéphane Bancel, CEO of Moderna.
“We appreciate the FDA’s timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time.”
