AstraZeneca Share Price Topples as FDA Widens its Inquiry on COVID-19 Vaccine

Summary

• The US FDA is yet to provide a go-ahead to AstraZeneca for recommencing the late-stage clinical trial of its COVID-19 vaccine candidate in the U.S.
• The FDA stated that it had broadened its investigation of a serious illness in AstraZeneca’s COVID-19 vaccine trial and would require some time for examining the clinical trial as mentioned by Reuters.
• On 9 September 2020, AstraZeneca updated the market that it had suspended the late-stage trial of its COVID-19 vaccine candidate after a volunteer developed some unexplained illness.

Share price of British-Swedish multinational pharma and biotech company AstraZeneca Plc (LON:AZN) tumbled by 0.56% to close the market at US$54.80 on 30 September 2020.

The U.S. Food and Drug Administration (FDA) is still to give approval to AstraZeneca plc for recommencing the late-stage clinical trial of its COVID-19 vaccine candidate, AZD1222, in the United States.

Meantime, the US FDA stated that it had broadened its investigation of a serious illness in AstraZeneca’s COVID-19 vaccine trial. The agency shall examine the data from earlier clinical trials of similar vaccines developed by the same scientists the Reuters stated.

As mentioned by Reuters, the FDA said that it would require some time for examining the clinical trial of AstraZeneca’s COVID-19 vaccine. The review to be conducted is intended to scrutinise other side effects.

MUST READ: COVID-19 vaccine race: AstraZeneca yet to resume US trials

About AstraZeneca Plc

British-Swedish healthcare major AstraZeneca Plc is a global biopharmaceutical player that is engaged in the discovery, development and commercialisation of prescription medicines. Primarily, the Company provides treatment for diseases in therapeutic areas of oncology, respiratory, cardiovascular, and renal & metabolism.

What Happened with AstraZeneca’s late-stage COVID-19 trial?

AstraZeneca and Oxford are developing COVID-19 vaccine candidate AZD1222 which is currently under Phase 3 clinical trial.

Early September 2020, AstraZeneca updated the market that it had suspended late-stage trial of its COVID-19 vaccine candidate. The Company stated that the trials was put on hold when a volunteer developed some unexplained illness.

AstraZeneca also added that it voluntarily paused trials to review the safety data of a single incident that happened in the UK Phase 3 clinical trial.

DID YOU KNOW: Why has AstraZeneca paused its Phase 3 COVID-19 vaccine study?

After three days of announcing pause, AstraZeneca made another announcement stating that clinical trials of AZD1222 resumed in the United Kingdom subsequent to confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to perform trials. Whereas regulators of other countries such as India, South Africa, and Brazil have also permitted AstraZeneca to recommence trails.

However, the FDA is still to give approval for commencing its trial in the United States.

Another reason for the delay is the date presentation to FDA. The data required by the U.S. regulator is in different format then what is requested by FDA.

ALSO READ: How are developing world economies preparing for COVID-19 vaccine deployment and testing?

Market Participants Eyeing AstraZeneca's vaccine development

The COVID-19 pandemic has shaken the world; it has also impacted share markets across the world. Now the hopes of the markets are on a potent vaccine for this life-threatening ongoing infection. So far, COVID-19 has affected approximately 33.5 million individuals and taken more than 1 million lives as reported by the World Health Organization (WHO) as of 30 September 2020 (4:28 pm CEST).

Market participants are closely watching the companies who are engaged in the development of vaccine or a treatment for COVID-19. This time the fate of vaccine developers totally depends on the outcomes of the clinical trial of their COVID-19 vaccine candidate.

The COVID-19 vaccine candidate of Oxford/AstraZeneca has attained significant success in the preliminary trials and in one of the main vaccine contenders in the race as against Moderna Inc MRNA.O, Pfizer PFE.N, and Johnson & Johnson JNJ.N.

AstraZeneca has signed deals in advance with governments of many nations and healthcare companies across the world to supply its COVID-19 vaccine if proven to be safe.

Recently, the Australian government had reached an agreement for ASX-200 listed giant CSL Limited (ASX:CSL) to make nearly 30 million doses of Oxford/AstraZeneca’s COVID-19 vaccine in Melbourne, Australia, if it demonstrates positive results.

READ MORE: ASX 200 Biotech Major CSL Inks Two Deals to Manufacture COVID-19 Vaccines in Australia