The vehicles entered the campus of Merck’s headquarters in Whitehouse Station, New Jersey, USA, on Thursday, December 13, 2007. Merck & Co.’s Cholesterol Pill. Cordaptive did not get approval from U.S. regulators, less than a week after it was recommended for marketing in the European Union.
Photographer: Emile Wamsteker / Bloomberg
Photographer: Emile Wamsteker / Bloomberg
Merck & Co. is failing to develop its two experimental Covid-19 vaccines after initial trial data showed that they failed to generate comparable immune responses to a natural infection or to existing vaccines.
The American drug giant, which has a long history of successful vaccine development, had adopted a different strategy from its rivals. Pfizer Inc., Moderna Inc. i Johnson & Johnson, using a more traditional approach of focusing on weakened virus-based shots. One, called V590, borrowed Merck’s Ebola inoculation technology, while the other, V591, is based on a measles vaccine used in Europe.
Both V590 and V591 were retarded in the vaccine development race. Merck finished recruiting the first participants for safety studies in the early stages towards the end of 2020, when front runners Pfizer and Moderna were preparing to report final phase data on the effectiveness of their shots. Merck received provisional results from its trials this month.
The results were “disappointing and somewhat surprising,” said Nick Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck Research Laboratories. Both shots generated fewer neutralizing antibodies to stop the infection than other Covid-19 vaccines and produced lower immune responses compared to people who had naturally contracted the coronavirus.
“We didn’t have what we needed to be able to move forward,” Kartsonis said in an interview Sunday. After evaluating the data, Merck’s senior leadership decided to disrupt the programs and divert resources to the company’s efforts to develop Covid-19 treatments.
Shares fell 0.8% in trading before US markets opened on Monday. They have lost 9.7% in the last twelve months to the close on Friday.
Vaccine anxiety
While Merck vaccines were not expected to be part of the initial push for vaccination in the United States, development occurs amid increased anxiety over the supply of vaccines and a slow pace of injections. The emergence of new variants of the coronavirus has also raised questions about whether vaccines that have been eliminated lose effectiveness as the pathogen mutates.
The failure of Merck’s candidates will also leave it locked in a market that could eventually be dominated by two of its historic American rivals. Pfizer was the first drug maker to obtain a permit for a Covid vaccine in the United States, followed closely by Moderna, and in the coming weeks Johnson & Johnson is expected to release data on the effectiveness of the vaccine and apply for an emergency use permit.
None of Merck’s candidates were part of the top six vaccines in the U.S. government’s Warp Speed operations portfolio, although his leadership watched them closely. The drug manufacturer and its partner, the International AIDS Vaccine Initiative (IAVI), received funding from the government. Both candidates would have been taken in a single dose.
Merck, based in Kenilworth, New Jersey, will record a pre-tax charge for the fourth quarter of 2020 for costs related to stopping programs. He did not disclose the amount of the charge Monday. The results of the initial phase trial will be presented in a peer-reviewed medical journal.
Two coronavirus vaccines have been phased out for use in the U.S., but a continuing increase in infections has highlighted the need for more treatment options. Merck will focus resources on two drugs it has in the development of the final phase to fight the disease, according to Kartsonis.
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“In the world of pharmaceutical development, a quick death is not bad, as it allows you to reposition and reuse your assets,” he said.
Several Merck vaccine manufacturing facilities are being reused to produce one of its Covid-19 drug candidates, MK-7110, which is complex and difficult to manufacture on a large scale. In a provisional study, intravenous therapy significantly improved the likelihood and speed of recovery in severe and critically ill Covid-19 patients in need of oxygen, reducing the risks of respiratory failure and death by more than 50%. Full results of the study are expected during the first trimester.
Merck executives expect U.S. regulators to grant emergency use authorization for the drug after those results, and Kartsonis said it could reach sick patients by mid-year. The United States has already agreed to pay $ 365 million for 60,000 to 100,000 doses.
Antiviral pill
Merck is also working on a pill for patients with Covid-19 in earlier stages of the disease. Known as molnupiravir, antiviral therapy was discovered by scientists at Emory University and is being studied in end-stage trials in both inpatient and outpatient settings. Merck and its partner Ridgeback Biotherapeutics LP expect to have initial data on the drug’s effectiveness during the first quarter and finish studies in May, the company said in a statement.
Chief Marketing Officer Michael Nally said in December that Merck is awaiting regulatory clearance shortly after the company reports data, should it be successful.
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It is intended to take the antiviral twice a day for five days, for a total of ten capsules. Merck predicts it will be able to produce more than 20 million treatment runs, or 200 million capsules, by 2021, Nally said.
The slow deployment of vaccines shows that the need for therapeutic treatments will persist, Kartsonis said, and that the drugs could work against future viruses.
(Pre-market trade updates in the sixth paragraph)