BioNTech May Have Covid-Vaccine Ready This Year

13.07.2020 - Germany’s BioNTech is confident it will be ready to seek regulatory approval for its mRNA-based Covid-19 vaccine by the end of this year, its co-founder and chief executive Ugur Sahin said in an interview with the Wall Street Journal (WSJ).

Pending regulatory approval, BioNTech expects to begin Phase 3 trials at the end of this month. Some 30,000 people have signed up to participate in a randomized study expected to be completed by the end of the year. Following a successful final phase that will test the vaccine’s efficacy of a vaccine, the company plans to file for marketing authorization globally.

Ahead of approvals, the biotech, which is working with US pharma giant Pfizer, said several hundred million doses could be produced, and more than 1 billion by the end of 2021. Production of a first batch is expected to take nine to 11 days.

Early trial data showed better than expected results the company said in early July.  Volunteers showed higher levels of antibodies than convalescing Covid-19 patients four weeks after being vaccinated and seven days after getting a second dose. The vaccine candidate produced some side effects that were judged not to be serious.

BioNTech’s candidate is in line to be the first or one of the first mRNA vaccines approved for commercial use. This type of vaccine that leverages a genetic mechanism to induce the body to produce certain proteins that generate antibodies and cellular immunity. This approach is seen as easier and cheaper than producing traditional vaccines based on inactivated or partial virus cells.

According to reports, 17 vaccines to prevent Covid-19 are currently being developed globally. Some are being trialed by biotechs and conventional pharmaceutical producers working together, some by partnerships between universities and research think-tanks. A number are receiving financial aid from national governments.

In addition to its link with Pfizer, BioNTech also has collaborates with China’s Shanghai Fosun Pharmaceutical Co. Ltd. The US drugmaker holds 1% of BioNTech but all rights to the vaccine belong to the Mainz-based company  majority-owned by two German investors. The Bill and Melinda Gates Foundation, Sanofi and Genentech also own shares.

Despite the increasingly encouraging news about vaccines of late, the novel coronavirus has become so widespread that it would take about 10 years before humanity achieved sufficient immunity to the disease, even if several companies launch a vaccine at the same time, Sahin told WSJ.