Matching articles for "Vaxzevria"
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 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.
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.
Two New Pneumococcal Vaccines - Prevnar 20 and Vaxneuvance
The Medical Letter on Drugs and Therapeutics • November 29, 2021; (Issue 1638)
The FDA has licensed two new pneumococcal
conjugate vaccines (PCVs) for prevention of invasive
pneumococcal disease in adults: Prevnar 20 (PCV20;
Pfizer), which contains antigens from 20 serotypes...
The FDA has licensed two new pneumococcal
conjugate vaccines (PCVs) for prevention of invasive
pneumococcal disease in adults: Prevnar 20 (PCV20;
Pfizer), which contains antigens from 20 serotypes of
pneumococcus, and Vaxneuvance (PCV15; Merck),
which contains antigens from 15 serotypes. Two
other pneumococcal vaccines are available in the
US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate
vaccine licensed for use in persons ≥6 weeks old,
and Pneumovax 23 (PPSV23; Merck), a 23-valent
pneumococcal polysaccharide vaccine licensed for
use in persons ≥2 years old.