- Pfizer and BioNTech SE have started working on the new version of the COVID vaccine.
- Pfizer & BioNTech’s vaccine has proven 90% effective against hospitalization due to COVID-19.
- EMA (European Medicines Agency) has stated that clinical studies are required before the approval of a new vaccine.
Pfizer and BioNTech are starting a clinical trial for a new version of the COVID vaccine, which will be targeted specifically on the Omicron variant.
Now, the companies aim to test the Omicron-based vaccine as a three-shot vaccine for unvaccinated people and as a booster shot for the people who have earlier received the two-dose vaccine.
Vaccine not effective against Omicron
The two-dose vaccine is not sufficient to protect against the new variant. A study in Israel has also hinted that the fourth dose of mRNA vaccine might boost antibodies but the level is not enough to prevent Omicron.
Kathrin Jansen, the Head of Vaccine R&D stated, “While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future.”
BioNTech and Pfizer need proven clinical results
Previously, Ugur Sahin, Chief Executive of BioNTech, had stated that their vaccine will require no clinical trials on humans.
EMA offered a debate and stated that international regulators will require clinical studies before the approval of the new vaccine. It highlighted two specific results from the studies,
- The study should demonstrate that neutralizing antibodies in the blood of participants is superior to those produced by the current vaccine Booster Shot.
- The new vaccine should protect against other COVID variants of concern
Pfizer & BioNTech will be testing the safety and tolerability of the vaccine in more than 1,400 people who have enrolled for the trial.
Pfizer and BioNTech should work on a vaccine that renders effective for the Omicron variant and its different subforms such as BA2 which is proving to be a bigger concern.