The giant pharmaceutical company “Pfizer” announced that it started injecting the first doses on Americans with experimental coronavirus vaccines for its clinical trial in cooperation with the German company BioNTech SE.
According to the Daily Mail report, if the vaccine proves to be safe and effective in trials, it is likely that it will be ready for widespread distribution in the United States by the end of the year, blocking several years from the usual schedule for vaccine development.
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The vaccine, which uses RNA technology (mRNA), is probably among the first vaccines against the virus that infected more than a million people in the United States and killed about 68,000.
There are currently no approved treatments or vaccines for the new coronavirus, although some drugs are used for patients under an emergency use license.
Pfizer said last week it hoped to obtain emergency permission from the U.S. Food and Drug Administration (FDA) early in October, and could distribute up to 20 million doses by the end of 2020, focusing on producing hundreds of millions of next doses a year.
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“Until the transition from a few million to 20 million will allow the virus to be protected, then the virus will be expelled from our community as we rise to hundreds of millions of doses,” Michael Dolstein, director of Pfizer Research, told Reuters in an interview. .
The companies said the use of synthetic mRNA technology could enable the vaccine to be developed and manufactured faster than conventional vaccines, and Pfizer said last week it expected safety data on the vaccine to be available by late May.
Initially, the experiment will aim to test different dose regimens for four prospective vaccine candidates for approximately 360 health volunteers divided into a younger group and a group of older adults.
Kirsten Lake, director of the Center for Vaccine Development and Global Health at the University of Maryland, who is participating in the experiment, said the experiment will expand to include more topics after researchers identify the most effective compounds and dosage regimens, and doses have already been given to some volunteers at NYU School of Medicine and the College of Medicine. University of Maryland.
A spokeswoman for the company said that Pfizer plans to extend the experience to sites across the United States in early July, and may eventually register more than 8,000 participants.
If successful, the American clinical trial would be one of the fastest-ever vaccine developments from early-stage studies to regulatory approval, putting pressure on the development process that often takes up to a little over nine months.
“This is equivalent to carrying out the first, second and third stage of a typical clinical trial but all of them are compressed in the May-October timeframe,” Pfizer invests in developing its vaccine manufacturing capacity and is setting up sites in Massachusetts, Michigan, Missouri and Belgium to start production.
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