One of the most promising signs in the battle against COVID-19 came this week with the announcement of the U.S. government’s decision to buy 100 million doses of a vaccine jointly developed by Pfizer and BioNTech. 

Under the terms of the $1.95 billion deal, the government will make the vaccine available for free and has an option to buy an additional 500 million doses. 

Pfizer/BioNTech intend to have the 100 million doses manufactured by the end of 2020 and 1.3 billion doses by the end of 2021.

“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 chair and CEO Dr. Albert Bourla said.

“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.”

Mobilization

The degree to which the biopharma industry has mobilized to fight the COVID-19 pandemic is unprecedented.

Collaboration among biopharma companies and research institutions, and with industry and the government, is at a high water mark. Industry and public investment in COVID-19 research and development is unparalleled.

There are over 165 vaccines in development, 27 of which are in human trials. There are an even greater number of treatments being studied (vaccines prevent disease, whereas treatments manage or cure disease after infection).

The federal government’s decision to purchase the Pfizer and BioNTech vaccine comes in the wake of very positive clinical trial results.

In order for a medicine to be approved by the U.S. Food and Drug Administration, a manufacturer must demonstrate safety and efficacy in three stages of clinical trials.

Phase I is conducted among a very small group of volunteers to begin to assess safety and appropriate dosage.

Phase II, typically conducted among a slightly larger group of volunteers, assesses safety and side effects, but also begins to gauge whether a drug works.

Phase III involves a large number of volunteers, often on the order of 30,000, to more fully assess safety and efficacy.  

Clinical Data

Phase I and II clinical data for the Pfizer/BioNTech COVID-19 vaccine indicated a robust antibody/immune response, elevated T-cell levels and only minor, if any, safety concerns/side effects.

Sufficient antibody levels are necessary to alert the immune system to fight off a pathogen like the novel coronavirus.

T-cells also help fight pathogens as well as being important in helping the immune system “remember” or recognize a pathogen over time.

Clinical data for the Pfizer/BioNTech COVID-19 vaccine indicated a robust antibody/immune response.

Like another COVID -19 vaccine candidate under development by Moderna, the Pfizer/BioNTech vaccine is a messenger RNA (mRNA) vaccine.

Such vaccines are a significant innovation over traditional vaccines.

Unlike older vaccines, which use fragments of weakened or dead viruses, mRNA vaccines cause the body’s own cells to make enough viral fragments to provoke an immune response.

This translates into a significantly faster manufacturing process for mRNA vaccines.

Immune Response

In addition, mRNA vaccines work on both the innate and acquired immune systems (what we are born with and what we develop over time). 

Another distinguishing attribute of the Pfizer/BioNTech vaccine is the small amount of active ingredient it involves.

The Pfizer/BioNTech vaccine triggers an immune response using something on the order of two micrograms of active ingredient versus, for example, 100 micrograms for Moderna’s mRNA vaccine. 

If Phase III trials show safety and efficacy equivalent to Phase II, we can expect FDA approval this fall.

Needing a less active ingredient means the vaccine goes a lot farther, making more doses available sooner.

If Phase III clinical trials show safety and efficacy equivalent to what was seen in Phase II trials, we can expect FDA approval of the Pfizer/BioNTEch vaccine this fall, availability in small quantities for essential workers late this year, and wider availability in 2021.


For more information, contact the Connecticut Bioscience Growth Council's Paul Pescatello (860.244.1938) | @CTBio