Pfizer Inc’s antiviral Covid-19 tablet, the first oral as well as at-home treatment of the disease, was approved by the medical regulator of the United States. This is being seen as the possible new tool to fight against the very infectious and fast spreading Omicron variant of the coronavirus. The approval was awarded for persons aged 12 years and older who are at risk of serious illness.
According to results from Pfizer’s clinical study, Paxlovid, an antiviral medication, was almost 90 per cent effective in reducing hospitalizations and deaths in individuals at high risk of severe illness for Covid-19. According to Pfizer, latest lab data indicates that the medication is still efficacious against Omicron.
Pfizer increased its manufacturing predictions for 2022 to 120 million treatment courses, up from 80 million, and said it was ready to begin delivery in the United States immediately. A new medicine plus an older antiviral called ritonavir make up the treatment’s two-drug combination.
According to White House Covid-19 response coordinator Jeff Zients, the US government will have 265,000 treatment courses accessible by January, with supply ramping up in the months after that. Within six months, the government anticipated to get access to the 10 million courses it has requested.
“Paxlovid’s approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection,” said Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security.
“There are two key issues, however, that remain: It will be scarce in the coming weeks and its optimal use requires prompt diagnosis, which can be difficult with the continual testing problems that plague us,” Adalja added.
This year, Pfizer claims to have 180,000 treatment courses ready to be shipped. The government of the United States has placed an order for 10 million courses of the medicine at a cost of $530 each course.
The FDA’s decision to provide emergency approval for the medication comes as the United States battles an outbreak of Covid-19 infections caused by the Omicron form, with President Joe Biden announcing preparations for new federal vaccine and testing locations.
According to William Schaffner, a leading infectious disease expert at Vanderbilt University School of Medicine, the medicines can fill a therapy gap left by the Omicron variety. The most extensively used monoclonal antibody treatments for Covid-19 have proven ineffective in combating the variation, and the one remaining medication that works is in short supply, he said.
Monoclonal antibodies are usually administered intravenously in hospitals and are not generally available, and cost more than twice as much as a Pfizer pill.
According to the US Centers for Disease Control and Prevention, the Omicron variety, which was initially identified in southern Africa and Hong Kong in November, has spread throughout the world and currently accounts for more than 70% of new coronavirus infections in the United States. Studies have revealed that prior infection and immunizations only partially prevent infection from the variation, while a booster injection does improve protection.
Paxlovid has been approved by the FDA for the treatment of mild-to-moderate disease in adults and adolescents aged 12 and above who are at high risk of developing severe Covid-19.
(Adapted from CGTN.com)