Green light from Aifa to Sanofi and Gsk’s anti-Covid vaccine (also good against Omicron)
After the mRNA vaccine project stalled, Sanofi and GSK chose to focus on a more traditional scientific approach and finally succeeded. All the details on the latest AIFA-approved anti-Covid vaccine
Following the approval by the European Medicines Agency (Ema), the Italian Medicines Agency (Aifa) also authorized the Sanofi and Gsk anti-Covid vaccine as a booster for people aged 18 and over.
WHAT AIFA SAID
“We approved the Sanofi booster after the EMA's approval and it will be available soon. Official communications with the Ministry of Health are underway in parallel with the delivery times ”, said the director general of Aifa, Nicola Magrini.
Pharmaceutical companies have announced that shipments are ready to be distributed to European countries as per advance purchase agreements.
“Sanofi's protein vaccine can be used as a booster,” Magrini added, saying it is “another option that may be useful to have available”.
WHAT VACCINE IS IT
After the mRna vaccine project stalled, Sanofi and Gsk chose to focus on a more traditional scientific approach, achieving excellent results. The same recombinant protein technology is used in Sanofi-approved seasonal flu vaccines.
VidPrevtyn Beta is in fact a monovalentprotein-type vaccine that is based on the Beta variant antigen and includes the Gsk pandemic adjuvant, a substance that helps strengthen the immune response to the vaccine.
Unlike mRNA vaccines, which contain the genetic instructions for making the spike protein, this one uses a slightly modified version of the protein itself to stimulate an immune response.
TO WHOM IT IS RECOMMENDED
The vaccine from Sanofi and GSK is indicated as a booster for adults aged 18 and over who have already completed their vaccination course.
WHAT THE STUDIES SAY
From Sanofi they report that in studies conducted in periods in which Omicron strains were predominantly in circulation, the vaccine "induced a strong immune response against multiple variants".
The main studies conducted with VidPrevtyn Beta, on which the EMA opinion was based, are two immunobridging studies that compare the immune response induced by the new vaccine with that of another already authorized one – Pfizer's Comirnaty was chosen for these studies /BioNTech, i.e. the one based only on the original strain of the virus and not the updated version.
The first trial involved 162 people aged 18 and older who were given a booster dose of either the Sanofi/Gsk or Pfizer/BioNTech vaccine. The study showed that that of Sanofi / Gsk triggers a greater production of antibodies against the subvariant Omicron 1 compared to Comirnaty.
In the second trial, however, it was observed that the Sanofi/Gsk vaccine, always administered as a booster in 627 people aged 18 or over who had previously completed a primary vaccination course with any of the already authorized vaccines, restored immunity against several variants.
The most common side effects, which disappeared within a couple of days after vaccination, were pain at the injection site, headache, muscle or joint pain, feeling generally unwell and chills.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/luce-verde-dallaifa-al-vaccino-anti-covid-di-sanofi-e-gsk-buono-anche-contro-omicron/ on Fri, 18 Nov 2022 13:48:59 +0000.