Covid-19 vaccine race: AstraZeneca yet to resume US trials, Novavax starts phase 3 study

Summary

• The USFDA is yet to provide its approval to AstraZeneca for resuming the trials of its vaccine in the US. The study was stopped in the first week of September 2020 due to unexplained illness in a volunteer from Britain.
• AstraZeneca would ensure that both the volunteers and the general public do not infer any wrong conclusions, which may impact trial enrollment.
• Joining the Covid-19 vaccine race, Novavax from the US announced that it has started stage three study of its vaccine candidate.
• Novavax would enroll volunteers over the next four to six weeks.

The United States Food and Drug Administration (USFDA) is yet to give a go-ahead to AstraZeneca plc (LON: AZN) for restarting the clinical trial of its Covid-19 vaccine candidate, AZD1222, in the US. It is to be recalled that the pharmaceutical major had to stop the trails in the first week of September 2020 due to an unexplained illness in a volunteer from Britain. It is likely that the share price of AstraZeneca would see a downward movement as it is almost three weeks that the company is waiting for the trials to begin. On 25 September 2020, at 10.22 AM, the company’s stock was trading at £8,512.00 down 0.55 per cent from its previous day’s close of £ 8,559.00.

At the same time, other companies are quickly entering their phase three trials in the race to launch a safe and successful vaccine for the infectious disease that is driving a severe economic crisis around the world. On 24 September 2020, Novavax Inc, a biotechnology company from the US announced that it has begun a stage three study of its vaccine candidate, NVX-CoV2373. The examination would assess the efficacy, of its potential COVID-19 vaccine.

We present the details around the two announcements and also track the stock performance.

AstraZeneca’s US trial on hold as regulators probe illness in UK volunteer

The trial of AstraZeneca’s Covid-19 vaccine candidate developed in association with the University of Oxford is still on hold as the regulators are examining the illness that a UK volunteer had developed. It is to be noted that the company has resumed its trials outside the US, including Britain. The US Department of Health and Human Services (HHS) commented on 23 September 2020 that the ongoing pause indicated that the FDA is serious regarding the safety of the vaccine. The HHS works towards improving the health and well-being of the US citizens. During mid-September 2020, the Oxford University had mentioned that the unexplained illness in the UK volunteer which resulted in the pause of the trials might not have been linked with the vaccine.

AstraZeneca said that being the sponsor of the trails in the US, it submitted relevant details to the FDA and was looking forward to its decision. Regarding the illness suffered by the UK participant, the vaccine maker stated that the regulators of the clinical trials along with the independent supervisors were protecting the volunteer’s privacy.

AstraZeneca would focus on increasing transparency without hurting the rights of the individual. It would ensure that both the volunteers and the general public do not infer any wrong conclusion, endangering any trial enrollment. AstraZeneca has initiated talks with other companies in this regard. It is important to note that the company is yet to begin the tests of its potential vaccine on children.

AstraZeneca started its last-stage trials in late-August 2020. Pfizer and Moderna began trials for their vaccine candidates in late-July 2020. In end-May 2020, the US government said that it would pay up to $1.2 billion to AstraZeneca for its experimental vaccine and receive around 300 million doses.

AstraZeneca’s vaccine candidate, AZD1222, is known to have used genetic material from the coronavirus with a modified adenovirus. The company has implemented the same technologies that were used to manufacture an experimental Ebola vaccine. In July 2020, AstraZeneca released data presenting a promising immune response in an early-stage trial. There were no adverse effects with only fatigue, pain at the injection site, chills, fever, and muscle aches reported by volunteers.

Share performance of AstraZeneca: On 25 September 2020, at 10.22 AM, the company’s stock (LON: AZN) was trading at £8,512.00 down 0.55 per cent from its previous day’s close of £ 8,559.00. With a market capitalisation (Mcap) of £112,318.71 million, the stock provided a positive return on price, which was plus 11.74 per cent on a year to date (YTD) basis. The total volume of shares traded at the time of reporting was recorded at 294,904.

Novavax begins last-stage trial of its potential vaccine in the UK

Novavax has planned to enroll up to 10,000 volunteers aged 18-84 with or without relevant co-morbidities to give its Covid-19 vaccine shots over the next four to six weeks. The biotechnology company is constantly expanding its manufacturing capabilities and produce up to 2 billion doses on an annual basis, once all capacity would be brought online by mid-2021.

The potential vaccine candidate, NVX-CoV2373, from Novavax is a stable and prefusion protein that has been made using the company’s recombinant protein nanoparticle technology that comprises of the proprietary MatrixM™ adjuvant from Novavax. The vaccine has an encouraging product profile that would facilitate handling in an unfrozen, liquid formulation that could be stored at 2 to 8 degrees Celsius. This would potentially help in distribution using standard vaccine channels.

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Novavax, Inc. is a late-stage biotechnology company that works on improving health globally by discovering, developing, and commercialising innovative vaccines in order to prevent infectious diseases. The company has been one of the leading innovators of recombinant vaccines. The proprietary recombinant technology platform includes the power and speed of genetic engineering to manufacture highly immunogenic nanoparticles for addressing global health needs.

Finally, there is still an uncertainty on how long it would take AstraZeneca to restart the US trials. It is important to note that around two thirds of the participants said in a recent US poll that they would not consider taking a vaccine shot as soon as it gets launched. So, it is very important that the drug makers focus on the safety of their potential candidate rather than just win the vaccine race. As many countries have ramped up their Covid-19 testing, the number of infections is also rising. Given the fear of a second wave of infections, a successful vaccine remains a possible hope both regarding public health and speed of economic recovery.