Johnson & Johnson JNJ and AstraZeneca AZN are likely to resume paused clinical studies evaluating their respective coronavirus vaccine candidates as early as this week.
Coronavirus vaccine/therapy development field hit a few roadblocks in the recent past with some major pharma players pausing their late-stage studies. The compressed timeline for coronavirus clinical studies has raised concerns about vaccine safety. However, the head of Operation Warp Speed (“OWS”), Moncef Slaoui, provided some relief by stating that he expects clinical studies of J&J and AstraZeneca to resume as early as this week, as reported in a Bloomberg article.
Last week, J&J announced that it has paused dosing in all clinical studies on its adenovirus-based vaccine candidate, JNJ-78436735, including the large pivotal phase III study, ENSEMBLE. The halt in study was the result of an unexplained illness observed in a study participant that is now being probed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) and J&J’s own internal physicians.
Last month, AstraZeneca/Oxford University had temporarily paused all its global late-stage studies on their adenovirus-based vaccine candidate, AZD1222, as a patient in U.K. suffered an unspecified illness. However, while studies have resumed in the UK, Brazil, South Africa, India and Japan, the study in the United States remains on hold and the company is in discussion with the FDA to provide the necessary information to re-start it. Meanwhile, Brazilian health authority reported on Wednesday that a volunteer in AstraZeneca’s coronavirus vaccine study in Brazil has died. However, it is being reported that the deceased person was presumably part of the control arm and the study will continue unaffected.
Notably, Moncef also stated that the final decision on resumption of the studies will be made by the FDA based on data and independent DSMB review.
While shares of J&J have declined 1.3% so far this year, AstraZeneca’s shares have gained 3.4% in the same time frame. The industry has witnessed a decline of 2.6% in the said time frame.
We remind investors that almost $10 billion Operation Warp Speed program is a partnership among components of U.S. federal government’s Department of Health and Human Services (HHS) — Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) — and the Department of Defense (DoD). As part of this program, the federal government is engaging with other public and private entities to rapidly develop a vaccine or treatment for COVID-19. The program has a goal to produce and deliver 300 million doses of safe and effective vaccines with initial doses to be available by January 2021.
The vaccine-makers included in this program have received extra federal funds to support their clinical studies and for manufacturing assistance. The program includes 14 promising vaccine candidates from several pharma/biotech companies including J&J, AstraZeneca, Moderna MRNA, Pfizer PFE and Merck. Partners in OWS program are also developing a plan for delivering a safe and effective product to Americans as quickly and reliably as possible.
Moncef stated that inclusion of several vaccine candidate in OWS program provides an advantage as some of these vaccines will have different performances. Some may be effective in elderly people while others may work better in another patient group. Multiple candidates also diversify the risk of program failure.
Meanwhile, the FDA is also looking to expedite the development of a vaccine, However, it has made it quite clear that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approval. Moreover, nine pharma/biotech companies signed a pledge in September to develop their vaccines by observing the highest ethical standards and making the safety and well-being of the vaccinated individuals their top-most priority.
With involvement of several federal agencies, the FDA’s guidance for vaccine authorization/approval and commitment of companies to ethical standards, we can expect a safe vaccine to be made available for the public. Moreover, Pfizer and BioNtech’s mRNA-based coronavirus vaccine candidate is leading the race to get an emergency use authorization, anticipated as early as next month, followed by Moderna.
J&J and AstraZeneca both carry a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Click to get this free report Johnson Johnson (JNJ) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research