Two Coronavirus Vaccines Entering Critical Human Clinical Trials

( Two coronavirus vaccines are entering a critical stage of clinical trials.

Moderna, who is working with the National Institutes of Health, began the first series of clinical trials in the U.S. Monday. This stage will include 30,000 participants, with half receiving the vaccine and half getting a placebo.

At the same time, Pfizer is beginning its vaccine trials on 30,000 volunteers. These trials will be held at 120 sites around the world.

At a news conference, Dr. Anthony Fauci, the leading infectious disease expert in the United States, said:

“We are participating today in the launching of a truly historic event in the history of vaccinology.”

Fauci said the U.S. has never moved this quickly in vaccination development, from the beginning of science research to Phase 3 of clinical trials, which are designed to test both the effectiveness and safety of the drug.

While Fauci said Moderna researchers would most likely have answers on whether the vaccine was effective in November or December of this year, there was also a “distinct possibility” they could have an answer before then. Despite this record speed, safety has not been compromised.

“There is no compromise at all, with regard to safety, nor of scientific integrity,” Fauci said.

Pfizer officials have said they are expecting to be able to progress to the regulatory authorization approval stage by October of this year.

Both the Moderna and Pfizer vaccine require people to take two doses, which are spaced weeks apart from each other. Once the doses are given, researchers then have to simply wait to see whether participants get infected or sock from the coronavirus.

The hope, of course, is that the vaccines result in fewer people contracting coronavirus, or at the very least having less severe infections of COVID-19. The challenge to knowing this is figuring out whether enough people in the clinical trial get infected.

Fauci said that in order for Moderna’s vaccine to be proven 60% effective, there would have to be roughly 150 infections for the 30,000 participants.

If either the Moderna or Pfizer vaccine ends up getting approved for use, it would make history. That’s because they are both in a new class of medicines.

The vaccine helps to deliver genetic material into the body, carrying with it a “blueprint” for the protein that attaches to the surface of the coronavirus. The vaccine will give instructions to the person’s cells on how to build these proteins. Their immune systems will also learn how to recognize and defend against the virus before an actual infection ever occurs.

As Stephane Bancel, the chief executive of Moderna, said:

“I believe it is a historic day: the first Phase 3 COVID-19 vaccine being run in the U.S. It’s a historic day for science, as well. This is the first Phase 3 of a messenger RNA medicine in the world.”

Some people are worried that because of this genetic material, the vaccine poses a risk to people getting infected with coronavirus. The vaccine itself poses no infection risk at all, though. The genetic material simply includes a code for a part of the virus.