FDA-approved or authorized vaccines and therapeutics for Covid-19

Since the beginning of the covid 19 pandemic, a few covid 19 vaccines and therapeutics have been approved or granted the Emergency Use Authorization by the FDA.

Currently, the first and only COVID-19 vaccine approved by the FDA is the Pfizer-BioNTech COVID-19 Vaccine which is marketed as Comirnaty. It is indicated for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccines under EUA are The Janssen and Moderna COVID‐19 Vaccines.
Both of these vaccines are For the prevention of 2019 COVID-19 Disease for individuals 18 years of age and older
The Pfizer-BioNTech COVID-19 Vaccine indicated for individuals 12 through 15 years of age and for the administration of a third dose is also under the emergency use authorization (EUA)

The first drug for the treatment of COVID-19 is Veklury (remdesivir). It is an antiviral drug indicated for individuals 12 years of age and older who require hospitalization. Veklury should only be administered in an inpatient setting.

There are 3 Monoclonal antibody treatments under EUA in the US: Regen-cov, sotrovimab and the combination of Bamlanivimab and etesevimab.

The other 2 medications under EUA are Actemra and Olumiant. Actemra is a recombinant humanized monoclonal antibody that selectively binds to human IL-6 receptors. Olumiant is a Janus kinase inhibitor. It should be used in combination with Veklury.
Both medications are indicated to treat selected hospitalized patients due to covid 19 infection.

COVID-19 convalescent plasma is human plasma collected from individuals who have recovered from COVID-19 infections. The plasma contains anti-SARS-CoV-2 antibodies. Convalescent plasma therapy may be given to hospitalized patients with COVID-19 who are either at the early stage of the disease or who have weakened immune systems.
Convalescent plasma therapy may lessen the severity or shorten the length of covid 19.

Some of the treatment can be very effective in preventing the progression of COVID-19 disease. However, none of the treatments should be considered replacement for COVID-19 vaccination. COVID-19 vaccine continues to play a critical role in the containment of the covid 19 pandemic.

What is an Emergency Use Authorization or EUA?
According to the FDA, An Emergency Use Authorization or EUA is a mechanism to facilitate the availability and use of medical countermeasures like therapeutics, vaccines etc during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.