A committee set up by US Food and Drug Administration (FDA) on Tuesday recommended Merck and Co's antiviral COVID-19 pill Molnupiravir for high-risk individuals. This is the first such recommendation for an antiviral pill by the US, the pill has received approvals in the UK.
This comes in light of the new Omicron variant being reported from across the world.
The recommendation comes despite the company having declared a revised efficacy for the pill. The pharma major had announced on Friday that the experimental COVID-19 pill was less effective in cutting hospitalisations and deaths than earlier anticipated.
Earlier in October, the data had shown that Merck's experimental pill, Molnupiravir had an efficacy of about 50%. The latest data suggests that it is 30% effective against hospitalisations and deaths.
On the other hand, Pfizer Inc's experimental pill, Paxlovid shows an efficacy of about 89% against hospitalisations and deaths. The analysis was derived, based on data from 1,200 patients. Pfizer has sought emergency approval for their pill from the FDA.
Why is there such interest in pushing for antiviral COVID pills?
The reason why there is a stress on introducing COVID-19 pills is that they can help to fight the virus more effectively. While we have vaccines and booster doses, pills like Molnupiravir and Paxlovid opens up more treatment options.
The pills will help in fighting the virus in patients at an early stage and at home. The pills work as a 5-day course.
How does the pill work?
Molnupiravir is designed to introduce errors into the genetic code of the virus that causes COVID-19. It is taken twice a day for five days as a pill rather than injected or given intravenously.
To be most effective, it needs to be given within five days of developing symptoms.
The pill was initially developed to treat flu.
Is Molnupiravir effective against variants?
Early viral sequencing done so far has shown molnupiravir is effective against all variants of Covid, Merck has said, including the highly infectious Delta variant. This was before Omicron emerged.
What are its advantages?
Merck's antiviral COVID-19 pill could be a game changer, experts believe.
Apart from its effectiveness in preventing severe illness and death, the Merck treatment also has the advantage of being extremely convenient and easy to use at home.
These pills are easier to use at home unlike monoclonal antibody treatments that are expensive and given intravenously at hospitals.
What is Merck's production target?
Merck said it was expecting to produce 10 million courses of the treatment by the end of 2021, with at least 20 million set to be manufactured in 2022, Reuters reported.
Reports suggest that a five day course of Molnupiravir can be taken at home. The US has invested $700 per course of the drug, reported Bloomberg.
The UK has agreed to purchase 480,000 courses with the first deliveries expected in November, BBC reported.
Australia, Singapore and South Korea have also made purchase agreements.
How does Merck's COVID pill differ from Pfizer's?
The two pills have different mechanisms. While Merck's will introduce errors in the genetic code of the virus, Paxlovid will block an enzyme that Coronavirus needs to multiply.
Are these pills approved in India?
Not yet, but there are reports Molnupiravir will get emergency approval in a few weeks in India. Six Indian pharma companies are working to manufacture Molnupiravir. Earlier in June, five pharma companies had come together to conduct clinical trials of the drug to treat mild COVID-19.
According to Business Standard, Hetero Pharma also has a non-exclusive licensing agreement with Merck for manufacturing and supplying the drug in India and 100 low and middle income countries.
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