Johnson & Johnson’s investigational COVID-19 vaccine entered Phase 3 clinical trials in the week , making it the fourth vaccine candidate within the U.S. to try to to so and providing additional details which will help investors differentiate the pool of late-stage coronavirus vaccines.
Shares of J&J JNJ, +0.68% were up 0.3% in trading on Friday, two days after the health care giant announced it had dosed the primary of an estimated 60,000 participants within the Phase 3 trial for Ad26.COV2.S, which is additionally mentioned as JNJ-78436735.
J&J’s vaccine candidate joins a gaggle of late-stage vaccines being developed by AstraZeneca AZN, +2.47% AZN, +0.19% and therefore the University of Oxford, BioNTech BNTX, +6.14% and Pfizer Inc. PFE, +0.81%, and Moderna Inc. MRNA, +6.59% a minimum of three other vaccines developed by Inovio Pharmaceuticals Inc. INO, +10.21%, Novavax Inc. NVAX, +10.85%, and Sanofi SNY, -0.02% SAN, -0.60% also are being tested in early- and mid-stage clinical trials within the U.S.
One of the unique characteristics of this race to develop a vaccine is how different the candidates are, right down to the sort of vaccine.
“We have three categories of vaccines that are moving forward: there’s protein vaccines, which are coming with an adjuvant, to form them [stronger], we’ve the macromolecule vaccines, and that we have the viral vectors,” said Dr. Corey Casper, president and CEO of the communicable disease Research Institute, a not-for-profit biotechnology organization. “There’s pluses and minuses of all of them. None of them are perfect.”
Here’s what we all know so far:
Vaccine type: The AstraZeneca and J&J vaccines are viral-vector vaccines, while Moderna and Pfizer’s candidates are messenger RNA vaccines. An mRNA vaccine has never been approved by the Food and Drug Administration, while there’s just one approved viral-vector vaccine, Merck & Co. Inc.’s MRK, -0.26% Ebola vaccine, which received FDA approval in December of last year. The Novavax vaccine, which is predicted to soon enter Phase 3 trials, may be a protein-based vaccine, almost like the common flu shot. The challenge with this sort of vaccine, despite its proven safety profile, is that it often requires an adjuvant to spice up its effectiveness. Dr. Michael Farzan, a professor of immunology and microbiology at the Scripps Research Institute, in the week told Mizuho Securities analysts that it’s easier to quickly build up production of an mRNA vaccine, but it’s going to be harder to scale this type of vaccine.
Trial size: J&J is that the leader in terms of trial size, with plans to enroll 60,000 participants. AstraZeneca, BioNTech/Pfizer, and Moderna each committed to enrolling 30,000 participants, though BioNTech and Pfizer recently expanded their target group to 44,000 people.
Dosing: J&J’s vaccine is that the only single-dose vaccine to enter late-stage studies within the U.S., though separate clinical trials in Northern Ireland and therefore the U.K. will test a two-dose regimen. the opposite three candidates require two doses, spaced between roughly three to four weeks apart, counting on the vaccine. “The single dose might be a source of economic differentiation, and also means [J&J’s] pivotal trial could read out more quickly (since it only takes one dose to immunize an individual , not two doses spaced a month apart),” Bernstein’s Vincent Chen wrote on Sept. 17.
Adherence to medication within the U.S. may be a well-documented issue — one study estimates that 1 of 8 Americans prescription drugs for atherosclerotic disorder don’t take them, citing cost, while other research found that up to 30% of prescriptions are never filled. However, GlaxoSmithKline GSK, +1.12%, which markets the Shingrix shingles vaccine, has data through March showing that 80% of individuals return for the second and final dose of the vaccine, consistent with a corporation spokesperson.
Refrigeration requirements: BioNTech and Pfizer’s vaccine, BNT162b2, and Moderna’s mRNA-1273 are both mRNA vaccines that need freezing levels of storage, within the range of negative 94 degrees Fahrenheit for BNT162b2 to negative 4 degrees Fahrenheit for mRNA-1273. AstraZeneca’s vaccine will likely require refrigeration but not freezing, consistent with a corporation spokesperson. “Our current expectation is that the ultimate packaged multi-dose vials would require refrigeration to make sure product quality,” he wrote in an email. It’s unclear at this point whether J&J’s vaccine would require refrigeration or freezing.
The need to refrigerate vaccines generally (and not just the COVID-19 ones) has long been a problem for vaccination programs, consistent with Casper. ”Even in highly industrialized countries…it is extremely challenging to stay vaccines refrigerated, just at refrigeration temperatures,” he said.
Effectiveness goal: The FDA in June issued guidance that involved COVID-19 vaccines to be a minimum of 50% effective at preventing infections with COVID-19 or by reducing severity of disease. AstraZeneca’s candidate is targeting an effectiveness rate of 50%; however, the effectiveness goals for BNT162b2, Ad26. COV2, and mRNA-1273 are 60%, consistent with the individual trial protocols.
Dr. Stanley Plotkin, a vaccine expert and a former pharmaceutical executive, in the week told SVB Leerink analysts that achieving between 60% and 70% protection should aid “long-term containment of the pandemic,” though he doesn’t expect the primary generation of COVID-19 vaccines to realize those efficacy levels.
Timeline: Despite the prevalance of vaccine timeline talk among administration officials, companies are cautious sharing dates for once they expect to publish the primary batches of Phase 3 data. Here’s a tally created by Mizuho’s Difei Yang: Though AstraZeneca’s trial within the U.S. remains on hold thanks to an adverse event, the corporate previously said it expected to urge late-stage data by the top of the year, Moderna expects a Phase 3 readout in “November or December,” and BioNTech and Pfizer expect Phase 3 efficacy data by the top of October. J&J said in the week it expects to file for an emergency use authorization in early 2021.
The race so far: Analysts have mixed views on which vaccine is that the front-runner. SVB Leerink analysts told investors during a Sept. 18 note that the trial protocols seem to favor BioNTech and Pfizer, in comparison with Moderna. J.P. Morgan said Sept. 22 that the Phase 1 data provided thus far by AstraZeneca, BioNTech/Pfizer, and Moderna didn’t have a “real standout in terms of the security profile. That said, mRNA-1273 tends to possess slightly higher rates of fever, chills, headache than competitors.”