AstraZeneca’s US Covid-19 vaccine trial is poised to resume as early as this week after the US Food and Drug Administration completed its review of a serious illness in a study participant, Reuters reported.
AstraZeneca’s (AZN) large, late-stage US trial was put on hold since Sept. 6, after an adverse event. One of the participants in the drugmaker’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.
According to the Reuters report, the the trial could resume later this week, while it remained unclear how the FDA would characterize the illness.
The US regulator has demanded from researchers conducting the trial to provide more information about the incident to consent forms signed by study participants.
UK regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine. It permitted the trial to resume in the UK, according to a draft of the updated consent form shared with Reuters.
“In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare products Regulatory Agency) recommended that vaccinations should continue,” the draft consent form stated. “Close monitoring of the affected individual and other participants will be continued.”
Responding to a request about the AstraZeneca trial, British regulators shared with Reuters a draft of a form letter to UK vaccine trial participants, dated Oct. 14, which says that the FDA had “completed their analysis” and said vaccination under the study in the US would resume shortly.
FDA “has come to the same conclusion as the other drug regulators including the MHRA,” the letter states.
AZN shares have lost almost 7% over the past month as the Phase 2/3 study of its AstraZeneca/Oxford vaccine candidate was paused. (See AstraZeneca stock analysis on TipRanks)
SVB Leerink analyst Andrew Berens recently reiterated a Buy rating on the stock with a $65 price target (25% upside potential) suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca’s shares as well as in the stock of other companies with Covid vaccine programs until the exact nature of the event is clear.
As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.
Overall, AZN scores a Strong Buy consensus from the analyst community with 4 unanimous Buy ratings. Looking ahead, the $77.38 average analyst price target puts the upside potential at a promising 48% in the coming 12 months.
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