Astrazeneca, all the numbers of the experimentation in the USA
Astrazeneca is ready to ask the American FDA for the authorization of the anti Covid vaccine
80% efficacy against symptomatic Covid-19. 100% effectiveness against serious illnesses and the need for hospitalization. And most importantly, no serious side effects. These are, in a nutshell, the results obtained by the Astrazeneca vaccine in a broad spectrum study conducted in the USA.
The company is ready to ask the FDA for emergency use, trying to overcome the fears arising from an obstacle trial. All the details.
THE EFFECTIVENESS OF THE ASTRAZENECA VACCINE
The Astrazeneca vaccine, AZD1222, developed by the University of Oxford and its spin-out company, Vaccitech, in collaboration with the Italian Irbm, which uses a chimpanzee viral vector, containing the genetic material of the virus spike protein Sars-Cov-2, has "demonstrated a statistically significant vaccine efficacy of 79% in preventing symptomatic COVID-19 and 100% in preventing serious illness and hospitalization", reads the Astrazeneca website .
THE AMERICAN STUDIO
The phase III study involved 32,449 participants, who accrued 141 symptomatic cases of COVID-19. The study had a 2: 1 randomization of the vaccine to placebo. About 20% of the participants were 65 years of age and older, and about 60% had comorbidities associated with an increased risk of severe Covid-19 progression, such as diabetes, severe obesity, or heart disease.
NO SERIOUS SIDE EFFECTS
Not just good effectiveness. "The vaccine – explains Astrazeneca – was well tolerated and the independent data safety monitoring committee (DSMB) did not identify any safety problems related to the vaccine". The committee “conducted a specific review of thrombotic events and cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or thrombotic events among the 21,583 participants who received at least one dose of the vaccine. CVST-specific search found no events in this study ”.
ASTRAZENECA READY TO SEEK FDA AUTHORIZATION
The pharmaceutical company will continue to analyze the data obtained in the new trial and will prepare to apply "in the coming weeks" for emergency clearance from the Food and Drug Administration, explains The New York Times.
A FREE ROUTE THAT WOULD STRENGTHEN REPUTATION
Yes, because Astrazeneca, despite having already been approved in more than 70 countries, has not yet obtained the authorization of the American regulatory authorities . And now a green light from the FDA would certainly strengthen the vaccine's reputation globally.
AN EXPERIMENTATION WITH OBSTACLES
Reputation that in the USA has already been undermined by obstacle testing. Last autumn, all phase 3 global clinical trials of the vaccine were abruptly stopped after a patient in the UK presented with symptoms of transverse myelitis. The experimentation resumed after several days (45 in America). In the UK, the wrong amounts of the active ingredient were administered to some patients during the phase III clinical trial, leading to different efficacy data.
In recent days, the Astrazeneca vaccine has been withdrawn in several European countries due to some thrombotic events concomitant with the inoculation of the vaccine. The drug was then rehabilitated for use with the approval of EMA, the European Medicines Agency.
ASTRAZENECA BEHIND PFIZER, MODERN AND J&J
“All of these setbacks have affected the company's progress in the vaccine race, putting it behind Pfizer, Moderna and Johnson & Johnson,” writes Forbes.
THE COMMENT OF ASTRAZENECA
These findings add to the growing body of evidence showing that this vaccine is well tolerated and highly effective against all severities of Covid-19 and across all age groups. We are confident that this vaccine can play an important role in protecting millions of people around the world from this deadly virus. We are preparing to present these findings to the US Food and Drug Administration and to launch millions of doses across America in the event the vaccine gains authorization for emergency use in the US, "he commented. Mene Pangalos, Executive Vice President, Biopharmaceutical Research and Development.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/astrazeneca-tutti-i-numeri-della-sperimentazione-negli-usa/ on Mon, 22 Mar 2021 14:05:05 +0000.