AstraZeneca Rekindles the Hope of Vaccine After A Voluntary Halt in Late-Stage Trial

  • Sep 12, 2020 BST
  • Team Kalkine
AstraZeneca Rekindles the Hope of Vaccine After A Voluntary Halt in Late-Stage Trial

Summary

  • AstraZeneca Plc after a voluntary halt in the phase 3 trial of its coronavirus vaccine has said that the Covid-19 vaccine could still be available the end of the year
  • The UK-based pharmaceutical company is involved in the Covid-19 vaccine development with the University of Oxford
  • The Covid-19 has triggered a global race to develop a vaccine at lightning speed using multiple platforms.

More than 100 vaccines are being developed and tested around the world to conquer the war against the deadly disease, which has killed hundreds of thousands and ravaged the global economy. The experimental vaccine of AstraZeneca has been one of the world's leading candidate and the most advanced in terms of development. The company has signed agreements with governments around the globe to supply the vaccine once it gets the approval that it can be brought to use.

However, AstraZeneca Plc (LON: AZN), the UK-based pharmaceutical company, involved in the Covid-19 vaccine development with the University of Oxford, has been in the news recently regarding the halt in the late-stage trial of the Covid-19 vaccine candidate.

To know more, do read: AstraZeneca Suspends COVID-19 Vaccine Trial on Safety Concern

The British drugmaker had voluntarily halted the phase 3 trial of its coronavirus vaccine developed by the University of Oxford after a woman participant developed an adverse reaction on 8 September 2020. But amidst the talks of the impact of AstraZeneca pausing the vaccine development programme, the chief executive of the company, Pascal Soriot said on 10 September 2020 that despite a randomised clinical trial being paused, the Covid-19 vaccine could still be available by the end of the year.

The vaccine in development, called AZD1222, uses a weakened version of a common cold-causing adenovirus which spikes the protein level that the novel coronavirus uses to invade cells. After vaccination, this protein is produced inside the human body, which safeguards the immune system to attack the coronavirus if the person is later infected.

There has been a sudden surge in stocks of AstraZeneca PLC with the announcement of Pascal Soriot, the stock last traded at GBX 8,429.00 on 11 September 2020, up by 1.13 per cent from its previous close of 8,335.00. The 52-week low/high price range of the stock was GBX 6,221.00/9,320.00. The market cap of the company was reported at £109,379.18 million, while it has given a positive return of 10.04 per cent on a year to date basis.

Also read: AstraZeneca Starts U.S. Final-Stage Trial

The pause in the trail highlights the gap between the expectation and reality

While the whole world is waiting for the early development of a safe vaccine against Covid-19, it needs to be kept in mind that developing a novel vaccine is a long, complex process that generally takes 10-15 years. But the Covid-19 has triggered a global race to develop a vaccine at lightning speed using multiple platforms. However, the Oxford-AstraZeneca’s vaccine trial pause has brought to our notice that vaccine development poses challenges, even with novel platforms. The incident also highlights the need to wait for results of large, properly designed trials to assess safety and efficiency before a vaccine is being approved for widespread use. According to Hatchett, head of the Coalition for Epidemic Preparedness Innovations, the importance of rigorous final-stage trials to pick up on potential side effects or rare events is highlighted by the pause. It also emphasises the need to have a diversified portfolio of Covid-19 vaccines under development.

What is the Procedure for Vaccine Development?

Though the medical experts from all over the world estimate that a vaccine to cure coronavirus could be developed in one or one and half years, past experiences are a proof that the much-awaited vaccine could take years to develop.

The development cycle of a vaccine consists of the following five stages:

Exploratory Phase- This is the first stage of vaccine development which involves basic laboratory research. Since research is an extensive process, this could last up to 2 to 4 years. Given the current scenario, the entire world is looking forward to the vaccine as soon as possible. More than 100 vaccines are under the process, hoping that some or the other company would succeed.

Pre-clinical Stage- The second stage of the vaccine development involves the research process, which is generally carried out in animals in order to know whether it produces an immune response. This stage extends up to 1 to 2 years. Determination of safe dosage and ways to administer the vaccine is included in this stage.

Clinical Development- The third phase of vaccine development consists of three sub-phases and refers to human trials.

Phase 1- The trial is executed on a limited number of healthy volunteers such as 20-100 candidates to determine whether the vaccine can treat the humans and the type and extent of immunity repose. It extends to a period of over 2 months.

Phase 2- This phase involves the trial taking place on hundreds or thousands of humans, segregated as their age. This is done to determine the effect of the vaccine on different age groups. The researchers also try finding out the immunogenicity, proposed doses, schedule of immunisation, and method of delivery. It extends to a period of over 4 months to 1 year.

Phase 3- The volunteers are vaccinated in this stage to see whether there are any side-effects or not. This phase involves the final step towards the approval for public use.

Approval Stage- This stage involves the approval the vaccine gets for public usage after it has passed the human trials.

Manufacturing Process- This stage refers to the manufacturing of the vaccine, which requires massive capacity and stringent quality control measures.

Other vaccine candidates in the advanced stages of their trial

Various candidates have moved or will be moving into the final or phase 3 clinical trials, increasing hopes of having a coronavirus vaccine by the end of this year or early next year.

The global pharma majors, GlaxoSmithKline PLC and Sanofi had started the first and second phases of human clinical trials in the US on 3 September 2020 for the joint development of their vaccine candidate. Around 400 healthy adults having being enrolled in the trial across various investigational sites in the United States, will be under the study of the vaccine candidate by the partner drug makers, evaluating the safety, immune response, and tolerability of the shot of their vaccine candidate. The first results would be coming out in the month of December 2020 so as to support the initiation of a third phase trial in the same month. On the basis of these results, the firms will apply for the necessary approvals during the first half of 2021. 

To know more, do read: GSK and Sanofi Proceed With Human Trials of Potential Covid-19 Vaccine

GSK stocks last traded at GBX 1,523.80 on 11 September 2020, up by 0.45 per cent from its previous close of GBX 1,517.00. The 52-week low/high price range of the stock was GBX 1,374.60/1,846.00. The market cap of the company was reported at £76,113.41 million, while it has given a negative return of 14.26 per cent on a year to date basis.

Conclusion

Covid-19 vaccine development is all over the news, but the process is not that easy, and success is not guaranteed. Covid-19 is a critical disease, and clinical trials are very challenging for the pharma companies. With so many companies into the development, there hope that a vaccine would be available in the near future, and people suffering from the deadly disease can be cured easily.

 

 


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