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The British health regulators will monitor clinical data in real-time while having an active dialogue with the drugmaker to accelerate the approval process.
AstraZeneca Plc (NASDAQ: AZN), one of the leading pharmaceutical companies in the COVID-19 vaccine trial received a major push from Britain’s health regulators. On Sunday, November 1, the regulators announced starting an accelerated review of AstraZeneca’s potential coronavirus vaccine.
The latest announcement comes as the COVID-19 cases have spiked in the UK and other parts of Europe in the last few weeks. As reported by Reuters, the AstraZeneca spokesperson said:
“We confirm the MHRA’s (Medicines and Healthcare Products Regulatory Agency) rolling review of our potential COVID-19 vaccine”.
With rolling reviews, the health regulators can see the clinical data in real-time. Besides, they can also have an active dialogue with the drugmakers which, in turn, will help to accelerate the drug approval process. In the long term, this approach will also help to speed up the evaluations of vaccines in case of a public health emergency.
For its COVID-19 vaccine, AstraZeneca is working in partnership with the University of Oxford. The British pharma giant is competing with other players like Pfizer Inc (NYSE: PFE), Johnson & Johnson (NYSE: JNJ), and Moderna Inc (NASDAQ: MRNA). AstraZeneca’s vaccine trials are in the late-stage and we can expect interim data in the coming weeks.
Rocky Ride of AstraZeneca with Its COVID-19 Vaccine Trial
It has been a roller-coaster ride for the British pharma giant during the entire testing phase of its COVID-19 vaccine. Back in September, AstraZeneca had to pause its vaccine trials on reports of one of the participants showing inflation on the spinal cord.
The company has been conducting trials for its AZD1222 or ChAdOx1 nCoV-19, the viral vector vaccine, all across the globe. However, it has now restarted its trials in the U.K, South Africa, and Brazil. However, the USFDA suspended AstraZeneca’s trial for six weeks following an investigation. Last week, the regulator gave a go-ahead after it discovered that the illness wasn’t related to the vaccine.
Investors of AstraZeneca have been observing the developments and waiting on the sidelines. However, the recent go-ahead from the regulator is likely to instill confidence back again in the market. As of last Friday’s closing, AstraZeneca stock is trading at a price of $50.16 with a market cap of $131 billion.
If its COVID-19 vaccine shows successful results, the British pharma giant will supply 300 million doses to the U.S, 400 million doses to the EU, and 84 million doses to New Zealand. Among other COVID-19 vaccine producers, AstraZeneca has one of the largest production capacities. The company expects to produce nearly 2 billion doses per year on trial success.