Matching articles for "Spikevax"
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.
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).