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JPM: 'Very soon,' says Johnson & Johnson CEO as world waits for its COVID-19 vaccine data
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J&J's late-stage trial
https://www.cnbc.com/2021/01/11/johnson-johnson-covid-vaccine-analysts-are-cautiously-optimistic.html
Johnson & Johnson is expected to deliver preliminary late-stage trial results for its one-dose Covid vaccine candidate by the end of January. If its jab is proven to be safe and effective, the company aims to deliver at least 1 billion doses by the end of the year.
J&J completed enrolment of its 45,000-participant phase three clinical trial for its single-dose vaccine candidate on December 17. Preliminary data from the trial is expected to be available by the end of the month.
If the data indicates the vaccine is safe and effective, the company expects to submit an Emergency Use Authorization application to the U.S. Food and Drug Administration in February. Other health regulatory applications around the world are expected to be made in parallel.
The J&J vaccine was developed by the company's Belgian unit, Janssen Pharmaceutica, and is based on viral adenovirus vector technology, the same approach used to create the University of Oxford-AstraZeneca vaccine. This type of shot is easier to scale up than those developed by Pfizer-BioNTech and Moderna which are based on messenger RNA technology.
Health care analyst Adam Barker at Shore Capital said in an email to CNBC last week: "The J&J vaccine is more like the AstraZeneca vaccine, but it uses only one dose. So we know this approach works (viral-vector) and it targets the spike protein. We know that target works too. But, we'll have to see what one dose does."
A report by the Tony Blair Institute for Global Change, which is founded by the former British prime minister, calls the AstraZeneca and Johnson & Johnson jabs "the two workhorse vaccines" because these should be deliverable at scale and are easier to administer than the mRNA shots.
Supply agreements
The company has committed to selling the vaccine on a not-for-profit basis for emergency pandemic use.
J&J entered into an agreement with the U.S. in August 2020 to deliver 100 million doses of the vaccine following approval or emergency use authorization by the FDA, and the option to purchase up to 200 million additional doses under a subsequent agreement.
The U.K. negotiated a deal in August to initially purchase 30 million doses of the J&J vaccine with an option to purchase up to 22 million additional doses. The EU signed a deal with J&J in October for the supply of up to 400 million doses.
J&J has also agreed to provide up to 500 million doses of its vaccine as part of an agreement in principle with The Vaccine Alliance (Gavi), which is responsible for equitable access to vaccines, including to lower-income countries via COVAX. These doses will be distributed through 2022 if the vaccine candidate is approved for use.
"If J&J's Ad26 platform is able to confer 80%+ efficacy via a single-dose regimen, given the vaccine's favourable handling requirements and significant manufacturing scale, we would view this as a compelling outcome," said Morgan Stanley.
As for what governments should do in the meantime, Jonathan Reiner, professor of medicine and surgery at the George Washington University School of Medicine & Health Sciences argues: "The J&J vaccine is why we should not abandon the two-dose strategy for Pfizer-BioNTech and Moderna. We're likely to have all the vaccine we need. We need to focus on getting the vaccines into arms."
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Johnson & Johnson's Covid-19 Vaccine Could Alter the Course of the Pandemic. Investors Will Soon Know if It Works.
Jan. 12, 2021
https://www.barrons.com/articles/johnson-johnsons-covid-19-vaccine-could-alter-the-course-of-the-pandemic-investors-will-soon-know-if-it-works-51610459381
Johnson & Johnson says it can make enough doses of its Covid-19 vaccine this year to inoculate almost a billion people against the virus.
That would be a massive shot in the arm to the effort to end the pandemic—as long as the vaccine works. Its efficacy should become clear in just a few days.
Unlike the vaccines from Pfizer (PFE) and Moderna (MRNA), which require a two-dose regimen, the Johnson & Johnson vaccine is being tested in a single-dose formulation. The vaccine also is not subject to the same cumbersome storage requirements as the two authorized vaccines.
"The JNJ data could be the most influential event of the month given its potential impact on the market and on [Moderna] and [Pfizer] as first-to-market players," wrote Jefferies health-care trading-desk analyst Jared Holz in an email to investors on Monday. "JNJ, as a single injection that has a less cumbersome supply chain around it, could be very important."
∼85%+ efficacy" for the Johnson & Johnson vaccine…...Less than "85% would be materially weaker,"
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JPM: 'Very soon,' says Johnson & Johnson CEO as world waits for its COVID-19 vaccine data
by Eric Sagonowsky
Jan 12, 2021
https://www.fiercepharma.com/pharma/jpm-j-j-hopes-to-share-phase-3-coronavirus-vaccine-data-very-soon-ceo-says
Johnson & Johnson's one-dose COVID-19 vaccine regimen could jump-start an immunization push that's faltering in spite of the millions of doses Pfizer, BioNTech, AstraZeneca and Moderna are rolling out around the world.
And the J&J shot is on the verge of its next big step forward.
The pharma giant is in the "final stages" of data analysis for its phase 3 trial, CEO Alex Gorsky said Monday at the annual J.P. Morgan healthcare conference. The company hopes "to have that information very soon," he added.
J&J initially set out to test its adenovirus-based vaccine candidate in a 60,000-patient phase 3 trial, but it halted enrollment at around 45,000 patients last month. Now, it's nearly ready to deliver its first efficacy numbers—and find out how they stack up against the other vaccines in the mix.
The Pfizer-BioNTech and Moderna vaccines posted efficacy numbers better than 90%. AstraZeneca's vaccine was 70% effective on average, but a half-dose regimen was 90% effective, the company reported in November.
Gorsky's JPM remarks come after Operation Warp Speed official Moncef Slaoui recently predicted J&J efficacy data in January and a potential FDA emergency authorization in February. Importantly, J&J's vaccine works with just one dose, which Slaoui said could be a "game-changer," as quoted by the New York Post. The drugmaker is also testing its shot as a two-dose regimen.
While J&J's candidate didn't beat the mRNA shots from Pfizer and Moderna to the market, the company's program could still play a crucial role in expanding vaccine access in the U.S. and beyond. As of Monday, about 7 million vaccine doses were administered in the U.S., and the nationwide rollout has gotten off to a slower-than-expected start.
But it's not just about developing a vaccine, Gorsky said Monday. The company is also focused on production and is "on track" to deliver hundreds of millions of doses in the first half of 2021. In all of 2021, the drugmaker intends to produce nearly 1 billion doses.
Aside from J&J, other vaccine developers—including late-stage players Novavax and AstraZeneca—will be aiming to score U.S. authorizations in 2021. Novavax plans to report interim phase 3 data in the first quarter and is already stockpiling doses in the event the program wins regulatory green lights, CEO Stan Erck said at the virtual JPM conference Monday.
Since the start of last year, Novavax has established a worldwide manufacturing network that will be able to produce 2 billion vaccine doses per year, Erck added.
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