The United States Food and Drug Administration (FDA) on April 18 authorized a second dose of the so-called bivalent COVID-19 vaccines for people 65 years of age and older, at least four months after their first injection. The measure is part of a package communicated to simplify the use of messenger RNA vaccines.
The FDA also withdrew its emergency use authorization for the older messenger RNA vaccines, from Moderna Inc and Pfizer-BioNTech, as it seeks to shift toward a simpler vaccination schedule with the use of the new omicron-targeted shots. In August, it had authorized the so-called bivalent COVID boosters, aimed at the BA.4 and BA.5 ómicron subvariants, and the original strain of the coronavirus.
Here is the full statement:
The US Food and Drug Administration modified the emergency use authorizations (EUAs) for the bivalent mRNA COVID-19 vaccines from Moderna and Pfizer-BioNTech to simplify the vaccination schedule for most people. This action includes authorizing the use of the current bivalent vaccines (parent and omicron BA.4/BA.5 strains) for all doses administered to persons 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
What you need to know:
• M ost people, based on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine can receive a single dose of a bivalent vaccine.
• Most people who have already received a single dose of the bivalent vaccine are currently not eligible to receive another dose. The FDA intends to make decisions about future vaccinations after receiving recommendations on the composition of the fall strain at an FDA advisory committee in June.
• People over 65 years of age who have received a single dose of a bivalent vaccine can receive an additional dose at least four months after the initial bivalent dose.
• Most people with certain types of immunocompromise who have received a bivalent COVID-19 vaccine can receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months after one dose of a bivalent COVID-19 vaccine. COVID-19, and additional doses may be administered at the discretion and at intervals determined by your healthcare provider. However, for immunocompromised individuals ages 6 months to 4 years, eligibility for additional doses will depend on the vaccine previously received.
• Most unvaccinated people can receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
• Unvaccinated children 6 months to 5 years of age can receive a two-dose series of the bivalent Moderna vaccine (6 months to 5 years of age) OR a three-dose series of the bivalent Pfizer-BioNTech vaccine ( 6 months to 4 years of age). Children 5 years old can receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
• Children ages 6 months to 5 years who have received one, two, or three doses of a monovalent COVID-19 vaccine can receive a bivalent vaccine, but the number of doses they receive will depend on the vaccine and their vaccination history.
"At this stage of the pandemic, the data supports streamlining the use of the authorized bivalent mRNA COVID-19 vaccines and the agency believes this approach will help encourage vaccination in the future," said Dr. Peter Marks , director from the FDA’s Center for Biologics Evaluation and Research. “There is now available evidence that the majority of the US population ages 5 and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either through vaccination or infection that can serve as a basis for the protection provided by bivalent vaccines. COVID-19 remains a very real risk for many people, and we encourage individuals to consider staying up to date with vaccination, even with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization and death,” he continued.
Available data show that almost the entire US population aged 5 years and older now has antibodies as a result of vaccination or infection against SARS-CoV-2. The use of bivalent COVID-19 vaccines for all doses administered to persons 6 months of age and older is supported by the data described below, as well as post-marketing data, including real-world data , with the monovalent and bivalent mRNA vaccines against COVID-19, which have been administered to millions of people, including young children. A second bivalent dose for people aged 65 years and older is supported by data showing waning immunity in this population over time and its restoration with an additional dose. Additionally, based on evidence from previously conducted studies, immunocompromised individuals may require additional doses.
Moderna COVID-19 bivalent vaccine
The safety and effectiveness of the bivalent Moderna COVID-19 Vaccine is based on FDA’s prior analysis of clinical trial data of the monovalent Moderna COVID-19 Vaccine in persons 6 months of age and older and a Moderna COVID-19 Vaccine. 19 bivalent under investigation (original and omicron BA.1) in people over 18 years of age.
Additionally, the effectiveness of a single dose is supported by the FDA’s analysis of immune response data from clinical studies involving 145 people ages 6 years and older who had evidence of prior SARS-CoV-2 infection. and 1,376 people 6 years of age and older without evidence of prior SARS-CoV-2 infection who had received two doses of the monovalent Moderna COVID-19 vaccine. The immune response after one dose of vaccine among participants with evidence of prior infection was comparable to the immune response after two doses among participants without evidence of prior infection.
The data accumulated with the investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 vaccine are relevant to the bivalent Moderna COVID-19 vaccine, because these vaccines are manufactured using the same process .
Pfizer-BioNTech COVID-19 Bivalent Vaccine
The safety and effectiveness of the Pfizer-BioNTech bivalent COVID-19 vaccine is based on FDA’s prior analysis of clinical trial data of the Pfizer-BioNTech monovalent COVID-19 vaccine for use in people aged 6 months and older, an investigational bivalent vaccine from Pfizer-BioNTech against COVID-19. BioNTech COVID-19 Vaccine (original and omicron BA.1) in people over 55 years of age, as well as safety data with Pfizer-BioNTech COVID-19 Vaccine, Bivalent (original and omicron BA.4/BA.5) in individuals 6 months of age and older and immune response data in individuals 6 months to 4 years of age.
Additionally, the efficacy of a single dose is supported by observational data from England on the efficacy of a single dose of the monovalent Pfizer-BioNTech COVID-19 vaccine. Among individuals ages 12 to 17 who had received only one dose of the Pfizer-BioNTech COVID-19 vaccine, those who had evidence of prior infection with alpha, delta, or omicron variants had greater protection against symptomatic omicron infection. compared to those without evidence. of previous infection.
The data accumulated with the investigational bivalent Pfizer-BioNTech COVID-19 Vaccine (original and omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine are relevant to the bivalent Pfizer-BioNTech COVID-19 Vaccine because these vaccines They are manufactured with the same process.
With today’s authorizations, the technical sheets for the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent have been updated and consolidated. Each vaccine now has one fact sheet for healthcare providers and one fact sheet for recipients and caregivers, rather than different fact sheets for the different authorized age groups.
Vaccines and Related Biological Products Advisory Committee
The new authorizations arose following meetings that took place during a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on January 26. At that time, by unanimous vote, the committee recommended harmonizing the strain composition of the COVID-19 vaccines used in the U.S. There was also support for simplifying the vaccine dosing schedule.
In June, the FDA will hold a meeting of its VRBPAC to discuss the strain composition of COVID-19 vaccines for fall 2023. As the FDA does annually with influenza vaccines, the agency will look to the opinion of the committee in which SARS is analyzed. CoV-2 variants and lineages are more likely to circulate next year. Once specific strains are selected for COVID-19 vaccines, the FDA expects manufacturers to update vaccine formulations to make them available this fall.
The EUA amendments were issued to ModernaTX Inc. and Pfizer Inc.
