Companies researching Coronavirus vaccine should be sure by the end of the year, say federal regulators, if they will shield people from the virus.
Officials with the Project High Speed Coronavirus vaccine initiative told reporters Friday that the public-private collaboration is not cutting corners, but it does not take long to tell them whether one or more of the vaccines work.
During a telephone briefing, Paul Mango, deputy chief of strategy at the Department of Health Human Services, said Operation Warp Speed was “completely on target … if not a little faster” in the race to produce a Covid-19 vaccine by 2021.
“Science does not have any promises. But what Operation Warp Speed does is increase the chance of receiving at least one vaccine”. Mango said.
Coronavirus vaccine trials are on
Mango said the Food and Drug Administration had asked each trial to recruit 30,000 participants. “And we’re over the halfway mark”. With development for three vaccines already underway.
But he said the approval process for any future coronavirus vaccine will be the same as for any vaccine.
Mango said Operation Warp Speed is likely to proceed if President Donald Trump loses the November presidential election, as the “vast majority” of people working on it are not political candidates.
Meanwhile, the FDA has extended its permission for emergency use of remdesivir to all patients treated with coronavirus. Regardless of the seriousness of their illness.
An EUA helps the FDA to expand the use of a coronavirus drug, which has not yet been officially approved.
Originally, in May, the FDA only approved remdesivir for emergency use in patients with extreme coronavirus that needed extra oxygen or mechanical ventilation to help breathe. For certain patients with coronavirus the treatment has been shown to shorten the healing time.
The FDA said Friday that a five-day course of the medication could shorten treatment time. This is in critically ill patients with Covid-19 pneumonia, clinical trials of ramdev sivir, including phase three trials, showed.
“Data show that this therapy also has the ability to benefit many more sick patients. Suffering from the symptoms of this debilitating infection,” Dr. Stephen Hahn, FDA Commissioner said in a statement.