How is the Medicago and Gsk plant-based vaccine made
Will the world's first plant-based vaccine for human use by Medicago and Gsk be enough to convince the No Vax? All the details on composition and effectiveness
Of course, perhaps, it will not be enough to convince those who believe that Covid does not exist but the new vaccine produced by the Canadian Medicago and the English GlaxoSmithKline (Gsk) could have excellent effects on the most suspicious . Because?
The two pharmaceutical companies have created the world's first plant-based vaccine for human use, which has successfully passed the phase 3 trial demonstrating an overall effectiveness of 71%.
HOW IT'S DONE
The Medicago and Gsk vaccine has nothing to do with the methodologies used by AstraZeneca and Johnson & Johnson – a viral vector – nor with Pfizer / BioNTech and Moderna mRna technologies. This innovative drug works with pseudoviral particles generated from specially infected plants.
This means that it contains a reproduction of the external structure of the virus, without the genetic material responsible for its replication and infection.
HOW LONG IT TAKES TO PRODUCE IT
In an interview with CTV News , Medicago's executive vice president of innovation development and medical affairs, Marc-Andre D'Aoust, said Medicago only takes a few "days" to produce the vaccine from the moment the sequence of the virus is hands of researchers.
WHAT THE WHO SAYS ABOUT PLANT-BASED VACCINES
Speaking of plant-based vaccines, the World Health Organization (WHO) says they have several advantages : they can be produced at low cost and in very high quantities, they are easily accepted by patients, and plant-derived antigens are stable and can be stored for long periods of time. However, some technical and regulatory challenges remain to be resolved before they can be deployed on a large scale, but the emergency imposed by the pandemic could speed up times.
TESTS, RESULTS AND SIDE EFFECTS
Medicago and Gsk, on their respective sites , announced that their vaccine showed an overall effectiveness of 71% and 75.6% in people who had never tested positive. This is what emerged in tests conducted on over 24,000 adults aged 18 and over in 6 countries.
In the study there were no severe cases of the disease in vaccinated people and no serious side effects. The frequency of mild fever was low, even after the second dose.
HOW EFFECTIVE IS IT AGAINST VARIATIONS
The results, unlike most of the published Phase 3 efficacy studies for currently available Covid vaccines, were obtained in an environment dominated by variants of SARS-CoV-2, while the others were conducted when only the original strain of the virus.
The efficacy against the Delta variant – still considered globally dominant – was 75.3% and 88.6% against the Gamma. Omicron was not around during the study.
HOW IT IS STORED
The Medicago and Gsk product does not require extreme temperatures: in fact it is stored between 2 ° C and 8 ° C, allowing the use of traditional supply channels.
HOW IT IS ADMINISTERED
The first plant-based vaccine involves two doses (3.75 micrograms of antigen in combination with the Gsk pandemic adjuvant) administered intramuscularly 21 days apart.
THE NEXT STEPS
The vaccine candidate is not yet approved by any regulatory authority, but based on these results, the companies have announced that they will submit the application for approval to health authorities, starting in Canada, as soon as possible.
Medicago, the press release reads, has begun the regulatory filing process with the Food and Drug Administration (Fda) and the British Medicines Regulatory Agency (Mhra).
Preliminary discussions are also underway with the WHO for the preparation of the presentation. In Japan, however, the application for approval is expected to be submitted next spring.
THE COMMENT OF THE CEO OF MEDICAGO
“This is an incredible time for Medicago and for the innovative vaccine platforms. The results of our clinical studies show the power of plant-based vaccine manufacturing technology, "said Takashi Nagao, CEO and president of the company:" If approved, we will contribute to the global fight against the pandemic with the first plant-based vaccine for human use ".
THE COMMENT OF THE CEO OF GSK
"The pandemic continues to show new facets with the current dominance of the Delta variant, the arrival of Omicron and other variants likely to follow," added Thomas Breuer, GSK's Chief Global Health Officer. "Combining the Gsk pandemic adjuvant with Medicago's plant-based vaccine technology has the potential to be an effective option to help protect against SARS-CoV-2."
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/come-fatto-il-vaccino-a-base-vegetale-di-medicago-e-gsk/ on Thu, 09 Dec 2021 09:02:58 +0000.