Pfizer's Antiviral COVID-19 Pill Gets US FDA Approval: What Is It?
Pfizer COVID-19 antiviral pill: Paxlovid is meant for high risk individuals over the age of 12.
US health regulators, on Thursday, 23 December, approved the use of Pfizer Inc.'s experimental antiviral COVID-19 pill, Paxlovid, making it the first at-home oral medication to be authorised for COVID-19 in the US.
The COVID-19 pill has been authorised for people over the age of 12 who are at a high risk of developing severe illness.
The oral antiviral COVID-19 treatment reduces the risk of hospitalisation and death by 89 percent, said the company earlier this month.
In November, the UK became the first country in the world to approve the use of an oral antiviral treatment for COVID-19. Incidentally, the pill– molnupiravir–is jointly developed by US-based companies, Merck and Ridgeback Biotherapeutics.
Merck's COVID-19 pill is currently under review by the US FDA as well.
What Do We Know About Pfizer’s COVID Pill?
The Pfizer antiviral drug comes in the form of oral pills which makes it much more accessible, easy to transport, and administer than the existing intravenous treatments.
According to Pfizer, it is an 'investigational SARS-CoV-2 protease inhibitor antiviral therapy'.
Essentially, the pill works by inhibiting or curbing the release of an enzyme required by the COVID virus to replicate, similar to the Merck oral treatment.
The pill is intended to be prescribed to those who have tested positive, have symptomatic illness, or have been exposed to the virus in order to nip it in the bud and keep the infection from escalating to severe illness.
Because the pill is durable, easy to mass produce, transport and store, it can be a game changer in a populous country like India, as far as COVID-19 treatments are concerned.
The Study and What it Found
Back in March, Pfizer had announced that they were testing out an oral antiviral drug, which was then in the 1st stage of clinical trials, after preclinical trials showed the drug's therapeutic use in inhibiting the multiplication of the SARS-CoV2 virus in the body.
On Friday, 5 November, the company released the interim results of its 2/3 Clinical trials.
The study involved a total of 1881 participants, 19 percent of whom were administered the antiviral treatment, and 21 percent were given placebo.
The study found that the antiviral pill reduced the risk of hospitalisation and death in patients by 89 percent.
Less than 1 percent of the participants in the treatment wing required hospitalisation, and no deaths were reported.
In May Pfizer had announced that if all goes well, the pill could be available in the market by the end of this year.
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