Matching articles for "Comirnaty"
Addendum: Effectiveness of mRNA COVID-19 Vaccines (online only)
The Medical Letter on Drugs and Therapeutics • October 14, 2024; (Issue 1713)
A reader of our article on the 2024-2025 formulations of
the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) asked us
to provide more information on the data that...
A reader of our article on the 2024-2025 formulations of
the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) asked us
to provide more information on the data that supported
their licensure.
COVID-19 Update: New Pfizer and Moderna Vaccine Formulations for 2024-2025
The Medical Letter on Drugs and Therapeutics • September 16, 2024; (Issue 1711)
New 2024-2025 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) that more closely target
currently circulating variants have been licensed by
the...
New 2024-2025 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) that more closely target
currently circulating variants have been licensed by
the FDA for persons ≥12 years old and made available
under FDA Emergency Use Authorizations (EUAs) for
use in persons 6 months to 11 years old.1-3 A 2024-2025
formulation of the adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax is expected to
become available soon for persons ≥12 years old.
COVID-19 Update: New Novavax Vaccine Formulation for 2023-2024
The Medical Letter on Drugs and Therapeutics • November 13, 2023; (Issue 1689)
A new 2023-2024 formulation of the adjuvanted
protein subunit COVID-19 vaccine manufactured by
Novavax that was developed to more closely target
currently circulating SARS-CoV-2 variants has been
made...
A new 2023-2024 formulation of the adjuvanted
protein subunit COVID-19 vaccine manufactured by
Novavax that was developed to more closely target
currently circulating SARS-CoV-2 variants has been
made available in the US under an FDA Emergency Use Authorization (EUA) for use in persons ≥12
years old. The original formulation of the Novavax
vaccine is no longer authorized for use in the US.
In September, updated formulations of the mRNA
COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were
licensed by the FDA for use in persons ≥12 years old
and made available under EUAs for use in persons
6 months to 11 years old.
COVID-19 Update: New Pfizer and Moderna Vaccine Formulations for 2023-2024
The Medical Letter on Drugs and Therapeutics • October 16, 2023; (Issue 1687)
New 2023-2024 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech
(Comirnaty) and...
New 2023-2024 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech
(Comirnaty) and that more
closely target currently circulating variants have
been licensed by the FDA for use in persons ≥12 years
old and made available under FDA Emergency Use
Authorizations (EUAs) for use in persons 6 months
to 11 years old. The bivalent (original and Omicron
BA.4/5) formulations of the Pfizer and Moderna
vaccines are no longer authorized for use in the US.
Vaccination Recommendations for Updated 2023-2024 COVID-19 Vaccines (online only)
The Medical Letter on Drugs and Therapeutics • October 16, 2023; (Issue 1687)
...
View the Vaccination Recommendations for Updated 2023-2024 COVID-19 Vaccines
Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines (online only)
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
...
View the Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines
COVID-19 Update: Pfizer Bivalent Vaccine Booster Dose for Children 6 Months to 4 Years Old
The Medical Letter on Drugs and Therapeutics • April 17, 2023; (Issue 1674)
The FDA has expanded its Emergency Use
Authorization (EUA) for the COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) to
permit use of the bivalent formulation (containing
mRNA from the original...
The FDA has expanded its Emergency Use
Authorization (EUA) for the COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) to
permit use of the bivalent formulation (containing
mRNA from the original and BA.4/5 Omicron strains of
SARS-CoV-2) as a booster dose in children 6 months
to 4 years old who completed the primary series with
3 doses of the monovalent formulation ≥2 months
previously. The Pfizer bivalent vaccine had previously
been authorized for use as a booster dose in persons
≥5 years old and as a third primary dose in children 6
months to 4 years old. Booster doses of the Moderna bivalent COVID-19 vaccine (Spikevax) for children
6 months to 5 years old were authorized earlier.
COVID-19 Update: Bivalent Pfizer and Moderna Vaccines Authorized for Children ≥6 Months Old (Online Only)
The Medical Letter on Drugs and Therapeutics • December 12, 2022; (Issue 1665)
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these...
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these products (containing mRNA
from the original and BA.4/5 Omicron strains of
SARS-CoV-2) in children as young as 6 months.
The bivalent Pfizer vaccine is authorized for use as
the final dose of a 3-dose primary series in children
6 months to 4 years old. The bivalent Moderna
vaccine is authorized for use as a booster dose in
children 6 months to 5 years old who completed
a primary series with the monovalent Moderna
vaccine.1 Bivalent vaccines had previously been
authorized for use as a booster dose in persons
≥5 years old (Pfizer) or ≥6 years old (Moderna).
COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only)
The Medical Letter on Drugs and Therapeutics • October 31, 2022; (Issue 1662)
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary series with any COVID-19
vaccine ≥6 months previously and are unable or
unwilling to receive a booster dose of a bivalent mRNA
vaccine. The Novavax vaccine is not authorized for
use in persons who have received a booster dose of
any other COVID-19 vaccine.
COVID Update: Bivalent Vaccine Booster Doses Authorized for Children ≥5 Years Old (online only)
The Medical Letter on Drugs and Therapeutics • October 17, 2022; (Issue 1661)
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these...
The FDA has expanded its Emergency Use
Authorizations (EUAs) for the COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to permit use of the bivalent
formulations of these products (containing mRNA
from the original and BA.4/5 Omicron strains of
SARS-CoV-2) as a booster dose in children as young
as 5 years old (Pfizer) or 6 years old (Moderna).
The bivalent Pfizer vaccine had previously been
authorized for use in persons ≥12 years old and the
bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for primary
immunization against COVID-19. The monovalent
Pfizer and Moderna COVID-19 vaccines are no longer
authorized for use as booster doses in any age group.
COVID-19 Update: Bivalent Pfizer and Moderna COVID-19 Vaccines for Booster Immunization
The Medical Letter on Drugs and Therapeutics • October 3, 2022; (Issue 1660)
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the...
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the products as a single booster dose
in persons ≥12 years old (Pfizer) or ≥18 years old
(Moderna) whose most recent COVID-19 vaccine dose
was a monovalent product given ≥2 months previously
as a booster or for completion of a primary series. The
bivalent formulations are not authorized for primary
immunization. Monovalent Pfizer and Moderna
COVID-19 vaccines are no longer authorized for use as
booster doses in persons ≥12 years old.
COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • August 8, 2022; (Issue 1656)
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent...
The FDA has issued an Emergency Use Authorization
(EUA) for an adjuvanted protein subunit COVID-19
vaccine manufactured by Novavax. The vaccine
is indicated for use as a two-dose primary series
to prevent COVID-19 in adults; it is not authorized
for use in children or as a booster dose. Three
other COVID-19 vaccines are available in the US for
primary immunization of adults; the mRNA vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) are FDA-licensed for this indication,
and the adenovirus-based vaccine manufactured
by Johnson & Johnson (Janssen) is available under an
EUA for use in adults who are unable or unwilling to
receive another COVID-19 vaccine.
COVID-19 Update: Pfizer/BioNTech and Moderna Vaccines Authorized for Children ≥6 Months Old
The Medical Letter on Drugs and Therapeutics • July 11, 2022; (Issue 1654)
The FDA has expanded its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use in children
as young as...
The FDA has expanded its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use in children
as young as 6 months old. The Pfizer vaccine was
previously authorized for use in persons ≥5 years old,
and the Moderna vaccine was authorized for use in
adults ≥18 years old.
COVID-19 Update: Booster Dose of the Pfizer Vaccine for Children 5-11 Years Old
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who...
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.
COVID-19 Update: FDA Narrows EUA for the Johnson & Johnson Vaccine
The Medical Letter on Drugs and Therapeutics • June 13, 2022; (Issue 1652)
The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19...
The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19 vaccine. The mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are preferred for all persons without a contraindication.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • April 18, 2022; (Issue 1648)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use as a second
booster dose...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer-BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use as a second
booster dose ≥4 months after a first booster dose in
adults ≥50 years old and in persons aged ≥12 years
(Pfizer) or ≥18 years (Moderna) who have undergone
solid organ transplantation or have a condition that
compromises the immune system to a similar extent.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • March 21, 2022; (Issue 1646)
The CDC has issued new guidance allowing for
an interval of up to 8 weeks between the first and
second primary doses of an mRNA COVID-19 vaccine
in certain patients 12-64 years old.1 Product...
The CDC has issued new guidance allowing for
an interval of up to 8 weeks between the first and
second primary doses of an mRNA COVID-19 vaccine
in certain patients 12-64 years old.1 Product labeling
currently recommends a 3-week interval between the
first two doses of the Pfizer/BioNTech mRNA vaccine
(Comirnaty) and a 4-week interval between the first
two doses of the Moderna mRNA vaccine (Spikevax).
The new guidance is based on data suggesting that
a longer interval can decrease the risk of myocarditis
and may improve vaccine efficacy.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • February 21, 2022; (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead)
has been available for treatment of COVID-19 in
hospitalized patients since 2020. Now, the FDA has
approved remdesivir for treatment of mild to moderate
COVID-19 in outpatients ≥12 years old who weigh
≥40 kg and are at high risk for progression to severe
disease, including hospitalization or death; they
also issued an Emergency Use Authorization (EUA)
allowing its use in any other high-risk outpatient who
weighs ≥3.5 kg.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • January 24, 2022; (Issue 1642)
On January 3, the FDA amended its Emergency
Use Authorization (EUA) for the Pfizer-BioNTech
COVID-19 vaccine (Comirnaty) to incorporate the
following changes. The anti-SARS-CoV-2 antibody...
On January 3, the FDA amended its Emergency
Use Authorization (EUA) for the Pfizer-BioNTech
COVID-19 vaccine (Comirnaty) to incorporate the
following changes. The anti-SARS-CoV-2 antibody combinations
casirivimab plus imdevimab (REGEN-COV) and
bamlanivimab plus etesevimab are not active
against the Omicron variant of SARS-CoV-2.
In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults
The Medical Letter on Drugs and Therapeutics • December 27, 2021; (Issue 1640)
On November 19, the FDA expanded the Emergency Use
Authorizations (EUAs) for the mRNA-based COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to include administration
of...
On November 19, the FDA expanded the Emergency Use
Authorizations (EUAs) for the mRNA-based COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to include administration
of a booster dose for all adults ≥18 years old after
primary immunization with either the same COVID-19
vaccine or a different one. Booster doses of these
vaccines were previously authorized only for select
populations (age ≥65 years or persons at high risk for
severe COVID-19). The EUA for the adenovirus-based
vaccine manufactured by Johnson & Johnson was
amended in October 2021 to include administration of
a booster dose for all adults ≥18 years old after primary
immunization with the Johnson & Johnson vaccine.
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Children 5-11 Years Old
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) for use
in children...
The FDA has issued an Emergency Use Authorization
(EUA) for a lower-strength (10 mcg/0.2 mL) formulation
of the mRNA-based COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) for use
in children 5-11 years old. The original formulation
of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for
use in persons ≥16 years old and available under an
EUA for use in adolescents 12-15 years old.
Booster Doses of COVID-19 Vaccines
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) and the adenovirus-based...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) and the adenovirus-based vaccine
manufactured by Johnson & Johnson/Janssen to
include administration of a booster dose in select
populations after primary immunization with either the
same COVID-19 vaccine or a different one.
Drugs for Rheumatoid Arthritis
The Medical Letter on Drugs and Therapeutics • November 15, 2021; (Issue 1637)
Rheumatoid arthritis (RA) is prevalent in 0.5% of
adults in the US; it is about 2.5 times more common
in women than in men. Guidelines for treatment
of RA from the American College of Rheumatology
were...
Rheumatoid arthritis (RA) is prevalent in 0.5% of
adults in the US; it is about 2.5 times more common
in women than in men. Guidelines for treatment
of RA from the American College of Rheumatology
were recently updated. The goal of treatment is to
minimize disease activity and prevent irreversible
joint damage.
Booster Dose of the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty)
The Medical Letter on Drugs and Therapeutics • October 18, 2021; (Issue 1635)
On September 22, on the advice of its Vaccines and
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine...
On September 22, on the advice of its Vaccines and
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine (Comirnaty) to include administration of a
booster dose ≥6 months after a 2-dose primary series
in adults who are ≥65 years old or at high risk for severe
COVID-19 because of an underlying medical condition
or frequent institutional or occupational exposure
to SARS-CoV-2 (see Table 1). The FDA Advisory
Committee recommended against authorization of a
booster dose of Comirnaty for all persons ≥16 years
old, citing a lack of adequate data.
In Brief: Third Dose of mRNA-based COVID-19 Vaccines for Immunocompromised Persons
The Medical Letter on Drugs and Therapeutics • September 20, 2021; (Issue 1633)
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to include administration of a third
dose...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to include administration of a third
dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18
years old (Moderna) who have undergone solid organ
transplantation or have a condition that compromises
the immune system to a similar extent (see Table 1).