Is the purchase of Ocugen stock advisable at present?
In the ever-evolving landscape of the COVID-19 vaccine market, Ocugen, a biotech company trading under the symbol OCGN, faces regulatory challenges in its attempt to enter the North American market with Covaxin, a vaccine developed by India-based Bharat Biotech.
The primary regulatory hurdle for Covaxin in the U.S. is the Food and Drug Administration's (FDA) suggestion, as of June 2021, that Ocugen pursue the longer route to full FDA approval rather than Emergency Use Authorization (EUA). Ocugen submitted its master file for Covaxin, an inactivated vaccine, to the FDA on March 26, 2021, but the FDA recommended that instead of seeking EUA, Covaxin should go through the complete approval process, which is more time-consuming and demanding.
In Europe, there is no clear publicly available update on Covaxin’s regulatory progress with the European Medicines Agency (EMA) or the European Commission (EC) as of mid-2025. Ocugen's regulatory focus in Europe seems directed toward other products.
In the U.S., the main hurdle for Covaxin is that the FDA expects Ocugen to pursue full approval rather than EUA, which delays availability. This delay, coupled with the fact that more than 230 million people in the U.S. and Canada have been inoculated with Pfizer, Moderna, and Johnson & Johnson's COVID-19 vaccines, makes Ocugen's near-term financial outlook somewhat dim given Covaxin's dim prospects in North America.
However, Ocugen recently reported data from a clinical trial on a booster dose of Covaxin, which has shown effectiveness in neutralizing the delta and omicron variants of the coronavirus. More than 90% of the study participants showed neutralizing antibodies, according to Ocugen.
Yet, it is unclear whether Covaxin will be authorized as a booster, as mix-and-match booster doses have been authorized for Pfizer, Moderna, and Johnson & Johnson's vaccines in the U.S., but it is unclear whether Covaxin will follow suit.
The question for potential new investors is where Ocugen will go from here. Ocugen's other drug candidates are too early in their development stages to meaningfully impact the company's near-term financial outlook.
For investors considering Ocugen, it's important to note that Ocugen will only keep 45% of any profits Covaxin generates in the U.S. and Canada. Additionally, there are far more attractive biotech stocks to consider.
Despite the regulatory challenges, Covaxin has received EUA from the World Health Organization and approvals from regulators in 13 countries, including India and Mexico.
As Ocugen navigates the complexities of the vaccine market, it remains to be seen whether Covaxin will find its place in North America.
Technology plays a crucial role in the development and testing of the Covaxin vaccine, as the booster dose data from a clinical trial was recently shared using advanced digital platforms. In the realm of finance and investing, Ocugen's near-term financial outlook remains challenging given the regulatory hurdles in North America, and potential investors might find more attractive biotech stocks on the market.
