After nearly a year of struggle against the virus, a year that has not only been pockmarked by a tremendous sense of loss and grief but has also been a time that has led us to radically alter our lives, to such an extent that it has shredded our social fabric to an irreparable degree. But as this horrible year draws to a painful end, news of having successfully created a vaccine against the Coronavirus has been welcomed with jubilation. Unfortunately, this year and the bad omen that it carries with it has once again succeeded in wiping the smiles off our faces. Tabloids in the last few weeks were filled with the news that AstraZeneca and Oxford University have created a vaccine that is in effect cheaper than a cup of coffee. However, these celebrations and the sense of triumph were short-lived as both institutes soon acknowledged that there had been a ‘dosage error’ in the administration of the vaccine, calling into question the effectiveness and the validity of the said vaccine.
AstraZeneca was the third company worldwide aiming to successfully create a vaccine. The vaccines initially appeared to be 90% or 62% effective, depending on the dose that had been administered. The large difference in the number and the methods used to arrive at the conclusions had already been scrutinized and challenged, even before AstraZeneca and Oxford University acknowledged the grave error on their part. In light of the recent announcement, however many have voiced serious concerns about why there was such a big variation in the effectiveness of the vaccine at different stages and why the smaller dose appears to produce much better results.
The press release suddenly brought the entire vaccine testing process under the scanner, as it raised more uncomfortable questions for AstraZeneca which did not receive satisfactory answers. Given the stark difference in the effectiveness of the vaccine, based on the dosage, several eyebrows had already touched hair lines, but the accusations have increased manifold in recent times, with many blaming the company for poor transparency and rigor. To make matters worse, AstraZenneca pooled results from two differently designed clinical trials In Britain and Brazil, which happens to be a pretty serious break from standard practice in reporting the results of drug and vaccine trials. In a further break from tradition, the company after recording a fall in their share prices decided to release further information that was not included in the initial statement. This again did not play out the way the company would have wanted it to, as it led the public to raise a series of questions.
The recent statement by AstraZeneca and the criticism hurled at the company, has led to a 5% fall in the shares this week, and investors seem to be highly disappointed by the ‘suspicious’ results, keeping in mind the success achieved by AstraZenneca’s rivals, Pfizer and Moderna. Both Pizer and Moderna in the last months have been able to successfully engineer a vaccine against the virus using the ‘Messenger RNA’ technology, which has resulted in an effective measure of 90% and 95% respectively. The AstraZeneca vaccine on the other hand used an approach that involved using a chimpanzee virus to provoke an immune response to the coronavirus. The vaccine in its early stages was said to have had all the signs of being the next blockbuster- it was easy to make, it was considerably cheaper than all its competitors, it could be stored in normal refrigerators for months at end, whereas the Moderna and Pfizer vaccines need to be sorted in special refrigerators.
However, even before AstraZeneca released or published any of the results, international health professionals and leading medical bodies and organizations believed the company to be inexperienced in the realms of vaccine production and scrutinized it minutely for its handling of the testing process. This is not the first time that the country has found itself under the spotlight for malpractice and failure. In September, global clinical trials had to be paused after a participant fell ill, and the company chose not to disclose information of the same to the public, choosing rather to discuss the nature of the illness on a private conference call with investors. This was seen as a case of major clinical and ethical malpractice.
The perceived benefits of the vaccine before the recent announcement led several governments to endorse it and order millions of doses. A case in point is the United Kingdom where Prime Minister Boris Johnson claimed the vaccine to have the ‘Makings of a wonderful British scientific achievement’ and hailed it to be the country’s most important effort towards fighting the pandemic. In light of the recent problem of the results and the methods of testing, the future of vaccines in the United States remains unclear. The company, however, has said that it would seek guidance from the US Food and Drug Administration on whether it should formally submit its findings to apply for emergency authorization. Dr. Pangalos, who leads AstraZeneca's small molecules research and early development activities, said that the company is planning to initiate global trials to compare the two dosing regimens. These trials will include thousands of participants, as the company is of the strong belief that the only way they’re going to find out the validity of their results is by specifically and deliberately testing these observations.
References:
1. https://www.bbc.co.uk/news/health-55086927
2. https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html 3. https://www.euronews.com/2020/11/26/astrazeneca-reveals-dosing-mistake-in-coronavirus vaccine-trials
4. https://www.walesonline.co.uk/news/uk-news/chris-whitty-oxford-vaccine-error-19354045 5. https://www.independent.co.uk/news/astrazeneca-manufacturing-error-clouds-vaccine-study results-questions-volunteers-vaccine-astrazeneca-results-b1762045.html
By-
Ratnadityasinh Chavda