The head of the US Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on August 30.
Dr. Stephen Hahn, the FDA Commissioner, said his agency was prepared to authorize a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks, the newspaper reported.
Without providing evidence, US President Donald Trump last Saturday accused members of a so-called "deep state" working within the FDA of complicating efforts to test COVID-19 vaccines in order to delay results until after the November 3 presidential election.
A day later, the FDA gave "emergency use authorization" of a coronavirus treatment that uses blood plasma from recovered patients.
"Our emergency use authorization is not the same as a full approval," Hahn told the FT, adding that his decisions will not be made because of political pressure.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"This is going to be a science, medicine, data decision. This is not going to be a political decision," Hahn said, according to the report.
He said the safest way for the vaccine to be available for use before the end of Phase Three trials, which involve thousands of patients and can take years, would be by issuing an emergency authorization for use by certain groups rather than a blanket approval, the FT reported.Follow our full coverage of the coronavirus pandemic here.