Some of the Vaccines Undergoing Pre-clinical Trial Phase Photo: Getty Images

We can’t get ahead of ourselves over COVID-19 vaccines, says FDA

*Agency declares 25 of over 140 vaccines for cure still in preclinical trial phase

*Finding absolute best cure will take time, thousands of trials

*Don’t bet on Coronavirus vaccine by end of 2020 ─Healthcare analyst

Web Editor | ConsumerConnect

As expected, many impatiently hope for the production, release and distribution of vaccines for the treatment of the novel Coronavirus pandemic by the end of year 2020.

An analyst has questioned if we’ll see anything at all by the end of the year, saying, we’d all like to have a COVID-19 vaccine… by like yesterday! While the United States Food and Drug Administration’s (FDA) latest guidance doesn’t spell out the ‘ifs’ and ‘whens’.

In the new guidance, “Development and Licensure of Vaccines to Prevent COVID-19”, Dr. Stephen M. Hahn, FDA Commissioner, made it black and white that it’s not going to cut any corners in its decision-making on it, agency report said.

Mahn said: “This is particularly important, as we know that some people are skeptical of vaccine development efforts.

“We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data.

“This is a commitment that the American public can have confidence in and one that I will continue to uphold.”

According to the FDA Commissioner, “while we all would like the vaccine process to move at warp speed, the simple fact is that it’s not likely.

Out of the 140+ vaccines that have jumped on the bandwagon for a cure, only about 25 have gotten out of the preclinical trial phase.”

Only two medications have received emergency use authorisation from the FDA: the Antiviral Remdesivir and a drug used to sedate people on a ventilator, says Healthline.

“The FDA seems to suggest that thousands of subjects of safety, and at least six months duration of observation, and clinical efficacy, are all required before any vaccine approval,” wrote analyst Geoffrey Porges of healthcare and life sciences investment firm SVB Leerink, in a note seen by Barrons.

Porges noted: “This is not consistent with the many developers who have suggested that they could be on the market by the end of this year.

“With pivotal trials only getting underway in Q3 or later, it is hard to see how those studies could enroll thousands of patients, vaccinate them, and then observe them for safety for six months or more, and then be approved by December 2020.”

“I think we’ll have to have one more cycle of this virus in the fall, heading into the winter, before we get to a vaccine,” Gottlieb said on CNBC’s “Squawk Box.” “I really think a vaccine is probably a 2021 event, in terms of having wide availability of a vaccine for the general population.”

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