Several drugmakers are working relentlessly to develop a vaccine for the deadly coronavirus disease, which has infected 27.7 million people globally and killed almost 0.9 million. There has been rising pressure from President Trump administration to get a vaccine approved before the elections in November. 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.
To address public concerns about a rushed approval of a potential vaccine, on Tuesday, 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 and making the safety and well-being of the vaccinated individuals their top-most priority. 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 signatories include AstraZeneca (AZN - Free Report) , Pfizer (PFE - Free Report) and its German partner BioNTech, Glaxo (GSK - Free Report) , J&J (JNJ - Free Report) , Merck (MRK - Free Report) , Moderna (MRNA - Free Report) , Novavax (NVAX - Free Report) , and Sanofi.
Just as optimism on timely approval of a safe vaccine was increasing, the vaccine development efforts of AstraZeneca hit a roadblock. AstraZeneca is temporarily pausing its late-stage studies on its COVID-19 vaccine candidate, AZD1222, which it was developing in partnership with Oxford University as a patient in U.K. suffered an unspecified illness. The health news site STAT first reported the pause in studies.
The British drug giant voluntarily paused the studies to allow an independent data committee to review the safety data. There is no update on the kind and seriousness of the disease. It is also not clear whether theadverse event was related to the vaccine shot.
The pipeline setback hit AstraZeneca’s shares hard, which were down 8% in after-hours trading on Tuesday. However, so far this year, AstraZeneca’s stock is up 9.7% in contrast to the 0.5% decline of the industry.
AstraZeneca said the review by the independent data committee is a standard procedure when there is an unexplained illness observed in a study.
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 covers the studies in the United States as well as other countries. The trials aim to enroll up to 50,000 participants globally.
Other than AstraZeneca (AZN - Free Report) /Oxford University, COVID-19 vaccine candidates of Moderna and Pfizer/BioNTech are also in late-stage development. J&J is expected to initiate a pivotal phase III study this month.
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 may delay the timeline of the studies and subsequently the vaccine’s approval. It may also have an impact on clinical studies of other COVID-19 vaccine manufacturers. Meanwhile, proving that the adverse reaction was unrelated to the vaccine shot may prove to be difficult for AstraZeneca.
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