AstraZeneca’s Covid-19 Vaccine Put On Fast Track By EU Regulator

AstraZeneca’s Covid-19 candidate AZD1222 has been put under a rolling review by the European Medicines Agency (EMA), which could potentially speed up assessment for future approval of the experimental vaccine.

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The start of the rolling review means that the EMA has started evaluating the first batch of data on AstraZeneca’s (AZN) Covid-19 vaccine candidate, which come from laboratory studies (non-clinical data). A rolling review is one of the regulatory tools that the EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.

“This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted,” the EMA said.

The EMA said that the start the rolling review of the vaccine candidate developed by AstraZeneca and Oxford University is based on preliminary results from non-clinical and early clinical studies suggesting that it triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the Covid-19 virus. The rolling review will continue until enough evidence from ongoing studies is collected for a formal marketing authorization application, the agency said.

AZN shares have gained 10% this year as the drugmaker joined the list of companies engaged in the development of a potential coronavirus vaccine. The Phase 2/3 study of the AstraZeneca/Oxford vaccine candidate was last month put on hold after an adverse event in a single participant from the UK. The trial has now been restarted in the UK but is still on hold in the US. (See AstraZeneca stock analysis on TipRanks)

SVB Leerink analyst Andrew Berens recently reiterated a Buy rating on the stock with a $65 price target (19% 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 41% in the coming 12 months.