- With the U.S. FDA saying that COVID-19 booster vaccines need to include protection against Omicron variant subvariants , Ocugen ( NASDAQ: OCGN ) could see its fortunes improved.
- In January, Ocugen and partner Bharat Biotech reported data on a booster dose of its Covaxin vaccine that showed it neutralized both the Omicron and Delta variants .
- Covaxin is authorized in 14 countries and by the World Health Organization, but the U.S. is not one of them. The U.S. FDA put a clinical hold on a phase 2/3 trial of the shot in April, but removed it in May .
- One of the key benefits of Covaxin is that unlike mRNA vaccines, it does not require freezing cold storage.
- However, given that Pfizer ( PFE )/BioNTech ( BNTX ), Moderna ( MRNA ), and Novavax ( NVAX ) are all developing Omicron-targeted vaccines, even if Covaxin is authorized, it would face stiff competition.
- In June, interim data from the phase 2/3 trial found that the efficacy of Covaxin was better in children than in adults .
For further details see:
Ocugen in renewed focus as FDA wants COVID boosters to fight Omicron variant