Michael Erman, Manas Mahra

(Reuters) -Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.

Based on 1,433 patient data, the drugmaker claimed that its pill led to a 30% decrease in deaths and hospitalizations. According to data from 775 patients, its October data nL1N2QX0QJ indicated a nearly 50% efficacy. Ridgeback Biotherapeutics developed the drug, Molnupiravir.

Merck’s pill could be less effective than it was, which may have major implications for countries that continue to use the medicine. Data from 1200 people in interim Pfizer Inc’s Paxlovid trial, an experimental pill that Inc has been trading under the NYSE:, saw a 89% decrease in hopsitalizations, and even more deaths.

Merck shares plunged 3.5% to $79.39 morning trading.

Merck provided the data just before the U.S Food and Drug Administration (FDA) published documents Friday. These were intended to provide information to a panel outside experts, who will be meeting on Tuesday to determine whether they recommend the authorization of the pill.

It was not the staff of the agency that made their recommendation on whether or not to authorize the use of this pill.

FDA personnel asked the panel for feedback on whether there are benefits to the drug that outweigh risks, and whether it should be restricted in the number of people who should have the drug approved.

A committee member was asked by them to discuss concerns that the drug may encourage virus mutation, as well as how they could mitigate these concerns.

Paxlovid, molnupiravir, and Paxlovid are potential new tools for the fight against pandemic. These meds can be administered at home as an early treatment to reduce COVID-19 hospitalizations. These pills could be useful in areas and countries with low vaccination rates or limited vaccine access.

EASIER TREATMENT

Merck’s and Pfizer’s pills are more affordable to make and are easier to administer that existing treatments options like Eli Lilly (NYSE 🙂 or Regeneron (NASDAQ :). These are usually administered intravenous.

They have distinct mechanisms of action. Merck’s drug is intended to cause errors in the virus’ genetic code. Pfizer’s protease inhibitors are designed to stop the virus from multiplying.

Merck applied for U.S. approval of Molnupiravir Oct. 11 after receiving interim data and has submitted updated data to FDA this week.

According to updated data, the hospitalization rate and death rate for the molnupiravir group of the study was 6.8%. In contrast, the hospitalization rate and death rates for placebo were 9.7%.

One of the patients in the molnupiravir-treated group died while nine were in the placebo.

Molnupiravir was approved by the United Kingdom earlier in this month.

Merck anticipates producing 10 million treatment courses by the end this year. At least 20 million are expected to be produced in 2022. The U.S. government has granted Merck a contract to provide up to 5 million course at $700 each. Many countries around the world have secured thousands of pill courses.

Merck stated that data showed that molnupiravir was not capable of inducing any genetic changes in humans cells. Men who were enrolled in Merck’s trials, however, had to choose to have contraception or abstain form heterosexual relations. Also, women who are pregnant had to be on birth control.

The FDA stated in the briefing that the drug could cause birth defects and asked for the panel’s opinion on whether it should be made available to pregnant women.