New analysis reveals Merck's Covid-19 pill, Molnupiravir, has lower efficacy
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The report strictly cautions pregnant women from using the drug. Also, no pregnant women were included in the clinical trials
US Food and Drug Administration approved molnupiravir, an anti-Covid pill developed by Merck, as effective against the deadly virus. However, the recent analysis shows a lower efficacy rate than a previous estimate. The preliminary report will be used to guide a panel of FDA experts to consider whether to authorise emergency use of the pill.
The report strictly cautions pregnant women from using the drug. Also, no pregnant women were included in the clinical trials. However, tests involving pregnant rats and rabbits found higher rates of developing underweight and malformed fetuses.
"Both known and possibly unknown risks ... in pregnant or lactating individuals and pediatric patients," the report stated.
After the clinical trial, it was revealed that the drug could help in reducing the rate of hospitalisations and deaths due to Covid by half. The finding, which included a 48 per cent reduction rate, was significant.
It was considered persuasive enough that an independent data review committee decided, in consultation with the FDA, to halt the drug trial ahead of schedule.
Full results were concluded after a clinical trial of over 1,400 patients. These resulted in a more modest reduction rate of hospitalisation and death. It found out that the hospitalisation rate among patients who received the drug was 6.8 per cent.
The FDA attempted to look into Merck's data on safety against the virus before taking a decision.
Merck's CEO Robert Davis had earlier said that the data was submitted to the FDA within 10 days after getting the analysis to move with "unprecedented urgency".
(With inputs from agencies)