merck scraps covid-19 vaccine candidates
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Merck Scraps Covid-19 VaccineCandidatesThe two shots generated comparatively weakimmune responses in early-stage studies
Appeared in the January 26, 2021, print edition as 'MerckScraps Two Experimental Covid-19 Vaccines.'
Merck said it would now focus on advancing twoexperimental Covid-19 drugs.
PHOTO: SETH WENIG/ASSCIATED PRESS
By Updated Jan. 25, 2021 1:12 pm ET
Jared S. Hopkins
Merck & Co. said Monday that it ishalting development of its two experimentalCovid-19 vaccines, after early clinical-trial datashowed the shots generated disappointing immuneresponses against the virus.
Early-stage studies of the vaccines indicated theyproduced inferior immune responses in subjectsgiven the shots compared with people whosurvived Covid-19 or took authorized Covid-19vaccines, the company said.
The exit removes a major vaccine player from theconstellation of companies seeking shots to curbthe spread of the virus, as the few that have beenable to bring shots to market struggle to meetheavy demand.
Kenilworth, N.J.-based Merck, one of the world’sleading vaccine makers, said it would now focus onadvancing two experimental Covid-19 drugs.
Merck said it expects test results for the pair ofdrugs in the coming weeks, and the company couldask regulators to authorize use if the results arepositive.
“We’re quickly informing society so that obviouslywe can refocus on therapeutics, but also so thatsome of the knowledge is shared with the broadercommunity,” Nick Kartsonis, who oversees Merck’svaccine clinical research, said in an interview.
Dr. Kartsonis said it was unclear why the shotsweren’t very effective, though they were safe.Merck didn’t provide the study results, saying itwould submit the findings for publication in a peer-reviewed medical journal.
Due to the discontinuation, the company said itwould record an unspecified tax charge in thefourth quarter of 2020.
Merck’s decision Monday underscores thedifficulty in developing a vaccine, which normallytakes years to bring to market. Development of aCovid-19 vaccine by Sanofi SA andGlaxoSmithKline PLC was set back lastyear after a laboratory mistake, delaying apotential authorization by several months.
Some 60 Covid-19 vaccines are in human testing,according to the World Health Organization, butregulators have only authorized a handful forgeneral use, leaving limited supplies.
Many scientists and public-health experts placedhigh hopes on Merck, which pioneered vaccinesthat have become staples around the world,including the first to prevent mumps, chickenpox,rubella and shingles.
Yet Merck was slower than rivals to pursue Covid-19 vaccines. Chief Executive Ken Frazier and then-R&D chief Roger Perlmutter expressed concernabout the years vaccine research usually takes, andthat it would divert resources from thriving areas,such as cancer drugs, The Wall Street Journalreported in October.
Merck executives have also said they wanted to usevaccine technologies that have worked againstother viruses, and that could be fashioned into asingle-dose regimen.
The drugmaker discussed collaborating with theUniversity of Oxford on its experimental vaccine,but university scientists and the U.K. governmentresisted a proposed deal, the Journal reported.Oxford ended up joining with AstraZeneca
PLC.
In late May, Merck said it was pursuing two Covid-19 vaccines, one as a result of the company’sacquisition of Themis Bioscience and the other inpartnership with the scientific-researchorganization IAVI.
The Themis vaccine uses a weakened version of thevirus that causes measles to deliver coronavirus’sspike protein to the immune system, helpingtrigger an immune response. Merck conducted a260-person early-stage study to evaluate whetherit worked safely against Covid-19.
Merck’s second vaccine, developed with IAVI,employs the technology that is the basis for thedrugmaker’s Ebola virus vaccine, using a modifiedand weakened virus to carry the geneticinstructions to teach cells to make a protein fromthe coronavirus. The vaccine was tested in a 252-person trial.
In reviewing the results from the early-stagestudies for both vaccines, Merck wasn’tencouraged when it looked at data for antibodyproduction, including the neutralizing antibodiesthat play a key role preventing the virus fromentering cells and replicating, Dr. Kartsonis said.
“It doesn’t appear that our responses arenumerically on par with what you would see eitherfollowing natural infection or what we’ve beenseeing” with vaccines from Pfizer Inc., Moderna Inc. or AstraZeneca, he said.
The vaccines from Pfizer, and its partner BioNTechSE, and Moderna are authorized foruse in the U.S. AstraZeneca’s shot has been clearedfor use in the U.K. and certain other countries,though not the U.S.
The Pfizer-BioNTech and Moderna vaccines weremore than 94% effective in late-stage trials, whilethe AstraZeneca-Oxford shot was at least 62%effective in some final-stage studies. All are givenin two doses.
Merck’s vaccines were so much further behind indevelopment that health authorities didn’tanticipate them to be part of the initial vaccinerollout under way globally. But they may haveserved as crucial backstops to countries that don’thave access to the first wave of vaccines or havebeen another tool to use against the emergingvariants.
Some scientists had hoped Merck’s vaccines mighthave meant the longest protection due to theirproven platforms.
Merck and vaccine experts also said the proventechnologies and single-does potential made thevaccines easier to manufacture and distribute topoorer countries that lack the infrastructureneeded to handle some of the vaccines alreadycleared by regulators.
One of the experimental drugs Merck is working onwould treat severe and critical Covid-19 patients.Merck acquired the drug via a $425 millionacquisition of a company named OncoImmune.Merck expects results from a late-stage study bythe end of March.
Merck signed a $356 million agreement with theU.S. government to supply the drug, shouldregulators give the treatment a green light.
The company’s second Covid-19 therapy, an oralantiviral called molnupiravir and developed withprivately held Ridgeback Biotherapeutics LP, isunder evaluation in hospitalized and outpatientCovid-19 patients. The companies expect late-stagetrial data by the end of March, Merck said.
Having effective Covid-19 treatments remainsimportant, especially as new variants emerge thatmay be able to thwart vaccines, Dr. Kartsonis said.
Despite Merck’s storied history in vaccines, thecompany in recent years grew to become themarket leader in the emerging field of cancerimmunotherapy, thanks to its top-selling product,Keytruda. The drug generated more than $11 billionin sales in 2019.
Meanwhile, Merck’s research and developmentunderwent a change at the top, with Dean Li, whojoined the company in 2017 after holding positionsin medical research at the University of Utah,taking over this month as Dr. Perlmutter retired atthe end of last year.
IAVI and Merck are still studying in preclinicalanimal testing whether the vaccine could be moreeffective if given orally or intranasally, as well aswhether the vaccine itself could be adjusted, saidIAVI President Mark Feinberg. No decision hasbeen made whether to advance toward humantesting.
Write to Jared S. Hopkins [email protected]
Corrections & Amplifications Merck & Co. said it would record an unspecified taxcharge in the fourth quarter of 2020. An earlierversion of this article incorrectly said the companywould record an unspecified pretax charge. (Jan.25)
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