All the hitches of the Astrazeneca-Irbm anti Covid vaccine
Astrazeneca launches additional studies for the Covid vaccine. The odds that the FDA will authorize emergency use are removed.
Headaches in the Astrazaneca household. The company that produces and develops the vaccine developed by the University of Oxford, in collaboration with the Italian Irbm, could start an additional study to verify whether the fortuitous dose administration error, which led to an efficacy of 90 % , will repeat the performance on a large scale.
Meanwhile, experts' confidence in what could be the cheapest and easiest vaccine to confirm is faltering and even the FDA may not give the green light to emergency use.
Let's go step by step.
THE ASTRAZENECA VACCINE
Let's start with the vaccine. AZD1222 is a drug for the prevention of Covid-19 developed by the University of Oxford and its spin-out company, Vaccitech, in collaboration with the Italian Irbm. It harnesses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus containing the genetic material of the Sars-Cov-2 virus spike protein . After vaccination, the surface spike protein is produced, which prepares the immune system to attack Covid-19 in case of infection.
A LUCKY MISTAKE
The vaccine, according to the first results that emerged from the phase 3 trial in Great Britain and Brazil, is effective. How much? This is yet to be established precisely. Thanks to an error, in fact, the Astrazeneca vaccine has been shown to have an efficacy of 90% in subjects in which, by mistake, half a dose was administered, instead of the full dose.
AN ADDITIONAL STUDY
Is it a scientific discovery born of chance? Astrazeneca will do further studies. We need "an additional study, as we have identified what appear to be the best conditions for the dosage to be effective, but we need to validate them," Pascal Soriot, number one of the pharmaceutical company, told Bloomberg .
THE INTOPPI OF THE ASTRAZENECA VACCINE
Indeed, it is not easy for this performance to be repeated on a large scale. The half dose that turned out to be the winning choice was administered, in fact, only to less than 2,800 volunteers out of 23,000 participants in the study (discovered the error, in fact, the researchers then administered the full dose). And again: the positive results refer to a trial conducted only on a small group of patients under 55 years, that is the least risk group. Will the Astrazeneca vaccine also be effective in the elderly?
CONFIDENCE IN DISCUSSION
While waiting for new supplementary results to arrive, despite the validity not being questioned, the confidence of the experts falters: is the dosage mistake the only one? With this mistake, "I think they have really jeopardized confidence in their entire development program," Geoffrey Porges , an analyst at investment bank SVB Leerink told the New York Times.
ASTREAZENECA: WE HAVE USED HIGH STANDARDS
Astrazeneca tries to recover. Michele Meixell, a spokesman for the pharmaceutical company, said the trials "were conducted to the highest standards". Menelas Pangalos, the executive responsible for much of the company's R&D, also defended the company's management of the tests and its public disclosures, arguing that the dosing mistake was made by a contractor and that, once discovered, Astrazeneca immediately notified regulators and signed the plan to continue testing the vaccine in different doses.
VACCINE ASTRAZENECA: EMERGENCY USE IN DISCUSSION
But will the correctness of the processes be enough to get the green light for emergency use? Hard. According to reports from the New York Times, in fact, the need for new additional tests removes "the likelihood that regulators in the United States and elsewhere will quickly authorize the emergency use of the Astrazeneca vaccine".
VERIFICATIONS START IN GREAT BRITAIN
In reality, not all authorities question the vaccine. The UK Drug Regulatory Authority (MHRA) scrutiny of Astrazeneca's vaccine candidate began today. This is the first step in getting the green light for mass distribution.
THE COLLAPSE IN THE STOCK
Meanwhile, the company is also dealing with the markets. The shares of Astrazeneca, Corriere della Sera stressed, fell by more than 6 percent, causing the pharmaceutical multinational to lose 8 billion in capitalization.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/tutti-gli-intoppi-del-vaccino-astrazeneca-irbm-anti-covid/ on Fri, 27 Nov 2020 10:36:25 +0000.