The federal government is spending nearly $2 billion for the first 100 million doses of a vaccine under development for Covid-19 and will have the option to acquire an additional 500 million, assuming it wins Food and Drug Administration emergency use authorization or approval.
New York-based Pfizer and Mainz, Germany-based BioNTech said the government had placed an order for the first 100 million doses of the vaccine, BNT162, for $1.95 billion, which would enable Americans to receive it for free. The companies have been developing the messenger RNA-based vaccine under a partnership.
Following the news, shares of Pfizer were up 4.2% on the New York Stock Exchange in early afternoon trading Wednesday, while shares of BioNTech were up 10.4% on the Nasdaq.
The deal is part of Operation Warp Speed, the program under the Department of Health and Human Services that aims to deliver 300 million doses of a vaccine against Covid-19 in 2021. Pfizer and BioNTech aim to manufacture up to 100 million doses by the end of this year and potentially up to 1.3 billion by the end of next year. However, the two companies, which are investigating four vaccine candidates under the BNT162 umbrella, did not seek government funding for their development. A Phase IIb/III clinical trial is planned to begin later this month.
“We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” Pfizer CEO Albert Bourla said in a statement. “We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an emergency use authorization is granted.”
The companies released preliminary data on one of the vaccine candidates, BNT162b1, at the beginning of the month on a pre-print server, meaning it had not undergone peer review. The data, on 24 subjects, showed that the vaccine produced neutralizing antibodies against SARS-CoV-2, the virus that causes Covid-19. However, while encouraging, neutralizing antibody data do not indicate whether a vaccine will be effective at preventing Covid-19, or for how long.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Of the numerous companies developing vaccines for Covid-19, the nearest competitor is Cambridge, Massachusetts-based Moderna, whose vaccine mRNA-1273 also works through mRNA. Moderna published early data on the vaccine last week and plans to launch its Phase III trial of 30,000 healthy volunteers on Saturday.
Photo: Teka77, Getty Images
