US FDA releases guidance for approval of COVID-19 vaccines

The US Food and Drug Administration has released guidance to approve a coronavirus vaccine. It highlights that the vaccine has to prevent or decrease disease severity in at least 50 per cent of people who are inoculated.

More than 100 vaccines are being tested worldwide against the virus, which has claimed over 126,100 lives in the US, according to a Reuters tally.

In May, the Trump administration announced ‘Operation Warp Speed’, a programme to speed up the development of COVID-19 therapeutics and vaccines, as the country has none approved for treating COVID-19.

Several companies such as Moderna, Pfizer and AstraZeneca 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,” the FDA said.

Experts have said it could take 12 to 18 months for a vaccine to be developed.

Vaccine developers have also been asked for data to support use during pregnancy and to show safety and effectiveness in children, the health regulator said.

“The guidelines are pretty standard, they look pretty much like influenza vaccine guidelines,” Gregory Poland, Director of Mayo Vaccine Research Group said.

“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.”