Vehicles will enter the campus of Merck’s corporate headquarters in Whitehouse Station, New Jersey, USA on Thursday, December 13, 2007. The Cordaptive cholesterol pill from Merck & Co. received no approval from US 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. will stop developing its two experimental Covid-19 vaccines after early research data showed that they could not generate immune responses comparable to a natural infection or existing vaccines.
The US drug giant, which has a long history of successfully developing vaccines, had followed a different strategy from its rivals Pfizer Inc., Moderna Inc. and Johnson & Johnson, which takes a more traditional approach to focusing on attenuated virus shots. One, called V590, derived technology from Merck’s Ebola vaccination, while the other, V591, is based on a measles vaccine used in Europe.
Both V590 and V591 were laggards in the race for vaccine development. Merck completed recruiting the first participants for early safety studies by the end of 2020, as frontrunners Pfizer and Moderna prepared to report late-stage data on the effectiveness of their shots. Merck received interim results from its trials this month.
The results were “disappointing and a bit of a surprise,” said Nick Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck Research Laboratories. Both shots produced fewer neutralizing antibodies to stop infection than other Covid-19 vaccines, and produced an inferior immune response compared to humans who naturally contracted the coronavirus.
“We didn’t have what we needed to move forward,” Kartsonis said in an interview on Sunday. After reviewing the data, Merck’s senior management decided to discontinue the programs and devote resources to the company’s efforts to develop Covid-19 treatments.
Shares fell 0.8% in trading before US markets opened Monday. They have lost 9.7% in the last 12 months through Friday’s close.
Vaccine anxiety
While Merck’s vaccines were not expected to be part of the first immunization push in the US, the development comes amid heightened concerns about vaccine stocks and a slow injection rate. The emergence of new variants of the coronavirus has also raised questions about whether the cleared shots will lose effectiveness if the pathogen mutates.
The failure of Merck’s candidates also locks it out of a market that could eventually be dominated by two of its historic US rivals. Pfizer was the first drug manufacturer to receive approval for a Covid vaccine in the US, closely followed by Moderna, and Johnson & Johnson is expected to publish data on the vaccine’s efficacy and apply for a license in the coming weeks for emergency use.
None of Merck’s candidates were ultimately among the six primary vaccines in the US government’s Operation Warp Speed portfolio, although the leaders kept a close eye on them. The drugmaker and his partner, the International AIDS Vaccine Initiative (IAVI), did receive some research funding from the government. Both candidates would have been single-dose shots.
Merck, based in Kenilworth, will record a pre-tax charge for the fourth quarter of 2020 for costs related to the discontinuation of the programs. It did not disclose the amount of the charge on Monday. The results of the early stage study will be submitted to a peer-reviewed medical journal.
Two coronavirus vaccines have been approved for use in the US, but a sustained increase in infections has highlighted the need for more treatment options. According to Kartsonis, Merck will send resources to two drugs it has at a late stage of development to fight the disease.
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“In the world of pharmaceutical development, a quick kill isn’t a bad thing because it allows you to reposition and reuse your resources,” he said.
Several of Merck’s vaccine manufacturing facilities are being adapted to produce one of the Covid-19 drug candidates, MK-7110, which is complex and difficult to manufacture on a large scale. In an interim study, intravenous therapy significantly improved the likelihood and speed of recovery for severe and critical Covid-19 patients requiring oxygen, reducing the risk of respiratory failure and death by more than 50%. Full study results are expected in the first quarter.
Merck executives expect US regulators to grant emergency use permits following these results, and Kartsonis said it could reach sick patients by mid-year. The US has already agreed to pay $ 365 million for 60,000 to 100,000 doses.
Antiviral pill
Merck is also working on a pill for Covid-19 patients in earlier stages of the disease. Known as molnupiravir, the antiviral therapy was discovered by scientists at Emory University and is being studied at a late stage in both hospital and outpatient settings. Merck and partner Ridgeback Biotherapeutics LP expect to have the first data on the drug’s effectiveness in the first quarter and to complete the studies in May, the company said in a statement.
Chief Marketing Officer Michael Nally said in December that Merck expects regulatory approval soon after the company reports data should it prove successful.
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The antiviral is intended to be taken twice a day for five days, for a total of ten capsules. Merck expects to be able to produce more than 20 million courses of the treatment, or 200 million capsules, by 2021, Nally said.
The slow rollout of vaccines shows that the need for therapeutics will continue, Kartsonis said, and the drugs could work against future viruses.
(Updates with sixth paragraph premarket trading)