AstraZeneca plc (AZN - Free Report) resumed its late-stage clinical studies on its COVID-19 vaccine candidate, AZD1222, in the United Kingdom, which it had halted last week.
Last week, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, which it is developing in partnership with Oxford University, as a patient in U.K. suffered an unspecified illness. The British drug giant voluntarily paused the studies to allow independent committees and international regulators to review the safety data. AstraZeneca said the review by the independent data committee was a standard procedure when there is an unexplained illness observed in a study.
However, it has now resumed the studies in the United Kingdom after the Medicines Health Regulatory Authority (MHRA) confirmed that it was safe to do so. The U.K. Committee has completed its investigations.
However, AstraZeneca refrained from disclosing any medical information about the kind and seriousness of the disease and whether the adverse event was related to the vaccine shot. The adverse reaction in the patient in United Kingdom was probably transient enough to allow the studies to resume. The company said it is working with other health authorities as to when they can resume the other studies on AZD1222.
So far this year, AstraZeneca’s stock is up 7.8% in contrast to the 0.2% decline of the industry.
Late-stage studies on AZD1222 were ongoing in the United States UK, Brazil and South Africa with studies due to start in Japan and Russia shortly. The pause in vaccinations covered the studies in the United States as well as other countries. The trials aim to enroll up to 50,000 participants globally.
Several drugmakers are working relentlessly to develop a vaccine for the deadly coronavirus disease, which has infected 29.2 million people globally and killed almost 0.9 million.
AstraZeneca’s COVID-19 vaccine candidate is probably the most advanced in terms of development and is being viewed as one of the first candidates to reach the market. The voluntary suspension could have delayed the timeline of the studies and subsequently the vaccine’s approval. However, the pause did not last long and the resumption of AstraZeneca’s U.K. study has rekindled hopes for a coronavirus vaccine. Other than AstraZeneca /Oxford University, COVID-19 vaccine candidates of Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech are also in late-stage development. J&J (JNJ - Free Report) is expected to initiate a pivotal phase III study this month. Pfizer/BioNTech, on Sep 12, announced that they are proposing to expand the size of the late-stage studies on their potential coronavirus vaccine, from 30,000 subjects to approximately 44,000 subjects.
There have been rising public concerns about a rushed approval of a potential COVID-19 vaccine to boost the chances of President Trump’s re-election.
Though the FDA is looking to expedite the development of a vaccine, it made it clear that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approval.
Last week, chief executive officers of nine leading drug companies making a vaccine for COVID-19 signed a pledge to develop their vaccines by observing the highest ethical standards. The companies vowed not to look out for approval or emergency use authorization (EUA) for their vaccine candidates from the FDA and other regulatory agencies until their respective vaccines are proven to be safe and effective.
The White House Press Secretary Kayleigh McEnany said that there is no political pressure on U.S. regulatory agencies to quickly approve a vaccine. Meanwhile, FDA’s head Stephen Hahn, last month, said that the regulatory agency may consider granting Emergency Use Authorization (EUA) to a COVID-19 vaccine as long as its benefits outweigh the risks, which is the regulatory agency’s criteria for EUA before advanced phase III studies are completed. However, he clarified that it will not do so to please President Trump.
AstraZeneca currently carries 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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