A bull’s-eye from 24 feet? COVID-19 vaccine timelines are overly hopeful, analyst says – FiercePharma

Americans have been tolddaily that researchers are urgently working on COVID-19 vaccines, and that one might be available in 12 to 18 months. That timeline hasmade its way to high levels of government and throughnational mediacoverage.

Butone influentialbiopharmaanalyst doesn't buy itand he has plenty of reasons why.

In a 25-page note titled Sober Up! 25 Reasons Not to Count on COVID Vaccine for Herd Immunity in 1-2years, SVB Leerinkanalyst GeoffreyPorgessays itll takeseveralyearsnot monthsto developa safe and effectivevaccine and administer it to enough people for widespread protection.

We view the current expectations for a vaccine in this timeframe as the equivalent of standing 24 feet (the usual distance is 8 feet) from a dartboard, with one dart in hand, and counting on a bullseye from one throw, the analyst wrote. It is theoretically possible, but highly unlikely, that such expectations are correct.

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As the title of his note suggests, Porges doesnt have one or two concerns about the 12-to 18-month vaccine development timeline. Hislist of worries spans more than two dozen about the target itselfanovel coronavirus thats highly communicableplus concerns aboutunleashing a vaccine with limited testing.

Just consider the history of vaccines, Porges and his team point out. For more than 10 key vaccines now widely used, the time betweenpathogen discovery to vaccine approvalranged from10 years to more than 100 years. Many pivotal trialsfor recently approved shots have takenmore than 3.5 years alone, he wrote.

Add on the time it would take to manufacture and deploya quickly developed shot to the masses, and the hoped-for herd immunity looks even farther away.

Even witha highly accelerated timeline" that includes demonstratingsafety and efficacy in humans and then designing, developing and implementinga mass immunization program,getting to a herd immunity of 70% to 80%would take until2023 or 2024, Porges figures.

That's still an optimistic view, Porges wrote. Itwould require robust first pass immunization results, lenient regulation, rapid development of manufacturing and highly cooperative behavior by the American people (or coercive behavior by government) during the immunization phase.Each one of those requirements couldbring its own challenges.

The analyst isnt alonein believingcurrently discussedtimelines are optimistic. A recent AI analysisof the two most advanced programs in the U.S.Moderna andInovio, which recently entered human testingfound it couldtake 5 years to complete development for full approval. That might well change, the firm noted, for a variety of reasons; for instance, if the companies are able to hit their ambitious goals for launching later-stage trials.

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One difference this time, as Clarivate noted?Industry and others are coming together in an unprecedented fashionto advancedrugs and vaccines against the novel coronavirus. Johnson & Johnson, Sanofi, GlaxoSmithKline, Pfizer and many others are all working on programs, with more than 70 programs underway worldwide.

Meanwhile, Bill Gates has saidhis foundation iswilling to lose billions of dollars funding factories for sevenpromising vaccineseven ahead of the programs demonstrating efficacy. Only oneor twowill succeed, but Gates said the early investment in factories would advance manufacturing and distribution timelinesa worthwhile ventureto get vaccines to people faster.

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A bull's-eye from 24 feet? COVID-19 vaccine timelines are overly hopeful, analyst says - FiercePharma