Pharmaceutical companies try to quickly create a vaccine in coming months
written By: Josephine Pyles, guest writer
The Centers for Disease Control and Prevention (CDC) announced last week that it should be ready to launch COVID-19 vaccination campaigns by early November.
Vaccines can often take up to 10 years to develop according to a 2013 study conducted by Esther S. Pronker and others, “Risk in Vaccine Research and Development Quantified.”
However, researchers and pharmaceutical companies aim to bring their potential coronavirus vaccines to market in 12-18 months.
Some hope to get government-issued emergency-use authorizations before the end of 2020.
Scientists say that previous knowledge of similar viruses combined with recent improvements in viral genome sequencing technologies have contributed a great deal to the ability to expedite the production of a COVID-19 vaccine.
These sequencing devices have enabled researchers to identify the “spike protein” of the pathogen, which the virus uses to enter human cells, as the vaccine’s primary target.
Approved altered-testing timelines have also contributed to the ability to speed up the production process.
Normally, vaccine development occurs in six general stages, moving progressively from trials on animals to trials on humans. However, as companies and countries rush to stop the spread of COVID-19, several vaccine developers, including Johnson & Johnson, Moderna Inc. and Pfizer Inc., are running these testing stages in parallel.
“We’re not skipping steps, but we are doing things at the same time,” Vice President and Chief Scientific Officer of Viral Vaccines at Pfizer Inc. Philip Dormitzer said in a recent interview. “(This) of course costs a lot more and is a lot more work than if we did it one after the other. But that’s really the key to this.”
The newspaper also reported that pharmaceutical companies are working to address concerns about a rush to mass vaccination. To ease these concerns, they plan to issue a joint, public pledge in the coming weeks.
The pledge will allegedly uphold the companies’ initiative to not seek government approval for the vaccine until it can be shown to be “safe and effective.” The pledge will also reportedly assure the companies’ adherence to high scientific and ethical standards in the conduct of clinical studies and in manufacturing.
The draft statement claims that drug makers will submit applications for a government emergency-use authorization of vaccines based on “substantial evidence of safety and efficacy” from Phase III clinical trials conducted under Food and Drug Administration guidance.
Phase III studies are the final stages of testing and are designed to prove whether the vaccine can significantly reduce rates of COVID-19 symptomatic infection compared to people without vaccination. Pfizer Inc. and Moderna Inc. currently have vaccines in late-stage Phase III clinical trials in the United States, with Johnson & Johnson preparing to enter Phase 3 as well. Collaboratively, the companies are testing four main types of vaccines, including weakened viruses, proteins, viral vectors and genetic code vaccines.
Pfizer, Moderna and Inovio Pharmaceuticals have reportedly been optimistic about the efficacy of these vaccines.
This type of vaccine injects pieces of the virus’s genetic code into skin cells, which instructs the cells to make many copies of the COVID-19 “spike protein.” Once these proteins are produced, the immune system fights against them, which builds immunity against a patient’s encounter with the true, live virus.
Pfizer Chief Executive Albert Bourla said that the company expects to have enough data on its genetic code vaccine to file for an emergency authorization that will enable them to begin vaccination campaigns with the CDC.
Bourla said the company would never submit any vaccine for approval before Pfizer feels that it is safe and effective.
Bourla also said Pfizer hasn’t felt any political pressure to rush a vaccine out. Bourla said, “We will not cut corners.”