Top in ID: FDA OKs COVID-19 antiviral, long-acting injectable for HIV prevention
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Leading the top stories in infectious disease last week are two announcements from the FDA: the emergency use authorization of the first oral antiviral for COVID-19 and the approval of the first long-acting injectable for HIV prevention.
The FDA authorized Pfizer’s Paxlovid for people aged 12 years or older who test positive for SARS-CoV-2 infection and are at high risk for severe disease. The pill is available by prescription only and should be taken as soon as possible after diagnosis, the FDA said. (Last week, the agency also issued an emergency use authorization for Merck’s COVID-19 antiviral molnupiravir.)
In addition, the FDA approved ViiV Healthcare’s cabotegravir as the first long-acting injectable for HIV preexposure prophylaxis (PrEP). The medication is administered every 2 months after two initial injections that are given 1 month apart.
Read these and more top stories in infectious disease below:
‘A major step forward’: FDA issues EUA for Pfizer’s COVID-19 antiviral pill
The FDA issued an emergency use authorization for Pfizer’s Paxlovid, making it the first available oral antiviral treatment for COVID-19. Read more.
FDA approves first long-acting injectable for HIV prevention
The FDA approved ViiV Healthcare’s cabotegravir as the first long-acting injectable for HIV PrEP. Read more.
Moderna says booster increases protection against omicron
Moderna said that a booster dose of its messenger RNA COVID-19 vaccine, given at the authorized dose of 50 µg, offered a 37-fold increase in protection against the omicron variant, compared with pre-boost levels. Read more.
Biden’s omicron plan promises 500 million free at-home tests
The Biden administration announced new actions to fight the omicron variant, including a promise to purchase 500 million at-home tests and distribute them for free to Americans beginning next month. Read more.
Novavax’s COVID-19 vaccine gets nod from WHO as FDA submission looms
WHO has issued two emergency use listings for Novavax’s COVID-19 vaccine following the publication of positive results from a phase 3 trial, and the company said it expects to begin submitting data to the FDA by the end of the year. Read more.