In a significant development, the U.S. Food and Drug Administration (FDA) has released guidance for approving a coronavirus vaccine stating that the vaccine has to prevent or decrease the severity of the COVID-19 disease in at least 50% of people who have been inoculated.
Worldwide more than 100 vaccines are being tested against the coronavirus which emerged from Wuhan, China and which has so far claimed 126,100 lives in the United States alone.
In May 2020, the Trump administration announced “Operation Warp Speed”, a program to speed up the development of COVID-19 therapeutics and vaccines. No country has any prescribed treatment for the COVID-19 disease, although several pharmaceutical companies including Pfizer Inc, Moderna Inc, and AstraZeneca Plc are in the race to develop a vaccine.
“While the FDA is committed to expediting this work, we will not cut corners in our decisions,” said the FDA.
According to experts, it could take 12 to 18 months to develop a vaccine.
The FDA statement also says, vaccine developers have to also show data to support the use of the vaccine by pregnant women as well as demonstrate its safety and effectiveness in children.
“The guidelines are pretty standard, they look pretty much like influenza vaccine guidelines,” said Gregory Poland, director of Mayo Vaccine Research Group. “I don’t think that’s a high bar. I think that’s a low to maybe an appropriate bar for a first-generation COVID-19 vaccine.”
According to Michael Yee, an analyst at Jefferies, flu vaccines are effective only by 30%-70% in any given year. In comparison, these guidelines for the COVID-19 vaccine is seen as setting a relatively high bar given the urgency to accelerate availability of a vaccine, said Yee.
According to Dr. Anthony Fauci, the top infectious diseases expert in the United States, there is no guarantee of a safe and effective vaccine.