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AstraZeneca (AZN) COVID-19 Vaccine Data May Be Outdated Per NIH

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It seems AstraZeneca’s AZN troubles related to its COVID-19 vaccine are unending. The stock declined 2.5% in pre-market trading on Tuesday after National Institutes of Health’s (NIH) Data Safety Monitoring Board (DSMB) doubted that the late-stage data released by AstraZeneca from a large-scale U.S. study on its COVID-19 vaccine may have included “outdated” information. The outdated information, as a result, may have provided an incomplete picture of the efficacy data, the statement released by the DSMB said. The DSMB has urged the company to work with it to review the efficacy data.

The DSMB’s statement was released just hours after AstraZeneca announced interim data from a U.S. late-stage study on its vaccine candidate, AZD1222, which showed that the candidate was, on average, about 79% effective in preventing COVID-19.

The study also demonstrated 100% efficacy against severe or critical disease and hospitalization.In participants aged 65 years and over, vaccine efficacy was 80%. The efficacy analysis was based on 32,449 participants. There were 141 cases of symptomatic COVID-19 among the participants. In the press release, the company also mentioned that a specific review of thrombotic events was conducted by the study’s independent DSMB. The DSMB concluded that there was no increased risk of thrombosis or events characterized by thrombosis in the 21,583 participants who had received at least one dose of the vaccine.

AstraZeneca plans to submit the data from the U.S. study to the FDA to seek Emergency Use Authorization (EUA) for its vaccine. Its vaccine is approved for temporary/conditional use in more than 50 countries including the European Union. However, it has not yet received authorization from the FDA. On the other hand, vaccines of Pfizer PFE/BioNTech, Moderna MRNA and J&J JNJ have already been approved (emergency approval) in the United States and vaccinations are in full swing.

The DSMB’s statement could mean a delay in approval from the FDA for its COVID-19 vaccine. As it is,AstraZeneca is lagging in terms of launch ofits vaccine shot in the United States.

This year so far, the company’s shares have risen 2.4% against a decrease of 1.1% for the industry.

AstraZeneca’s vaccine has been surrounded by controversies and negative reports for some time now.

AstraZeneca’s stock recently took a hit as many European countries, including Germany, France and Italy, temporarily paused vaccinations with AstraZeneca’s jab following some reports of blood clots in people who had received the shot. However, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded there was no increase in the overall risk of blood clots with the use of AstraZeneca’s vaccine. Germany, France, Italy and some other European nations have now resumed using AstraZeneca's COVID-19 vaccine after EMA’s report.

Reportedly, AstraZeneca is also facing supply shortages of the vaccine to different member countries of the European Union due to difficulties with international supply chains.

Meanwhile, we remind investors that last year, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, as a patient in U.K. suffered an unspecified illness.

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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