The US Food and Drug Administration plans to release guidance on Tuesday outlining its conditions for approving a vaccine for the coronavirus, the Wall Street Journal reported, citing a summary of the guidance.
The agency would require drugmakers to show "clearly demonstrated" proof of a vaccine's safety and effectiveness through a clinical study, and at least 50 percent more effectiveness than a placebo, the report said.
There is currently no US-approved treatment or vaccine for the respiratory illness that has claimed over 126,100 lives in the country, according to a Reuters tally.
More than 100 vaccines are being tested worldwide against the virus, with only a handful in the human testing phase, including candidates from AstraZeneca Plc and Moderna Inc.
Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a safe and effective vaccine through clinical trials.
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.
The guidance is expected to be discussed by FDA Commissioner Stephen Hahn in an appearance before a Senate committee on Tuesday, the report said.Follow our full coverage of the coronavirus pandemic here.