Largest COVID-19 vaccine study under way in US

The world's biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government -- one of several candidates in the final stretch of the global vaccine race.

There's still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc., will really protect.

The needed proof: Volunteers won't know if they're getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.

Melissa Harting is participating in Phase 3 of the trial in Binghamton, New York.  She says she wants to do her part to help.

"You know, we've never really seen anything like this. And to be able to be part of, you know, hopefully finding a vaccine for it is huge. You know, there's any anybody in your family can be affected by it. There's you know, everyone in my family is medical. My husband is a police officer. So we're all on the front lines and can be easily affected by it.  So doing our part to eradicate it is very important to me," shares Harting.

Moderna said Savannah, Georgia was the first site to get underway among more than seven dozen trial sites scattered around the country.

Dr. Frank Eder is the principal investigator at Meridian Clinical Research in Binghamton, New York.  He says there are 38 participants scheduled for today and they plan to have about 500 to 1000 participants from the area.

"Once we introduce this into a large group of people, we can truly see the efficacy of the vaccine as well as the safety of the vaccine.  And once we get past this trial, we can move into the general public and actually mass producing and having this given to the population."

Several other vaccines made by China and by Britain's Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.

But the U.S. requires its own tests of any vaccine that might be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate -- each one with 30,000 newly recruited volunteers.

The massive studies aren't just to test if the shots work — they're needed to check each potential vaccine's safety. And following the same study rules will let scientists eventually compare all the shots.

Next up in August, the final study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October -- if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer.

It normally takes years to create a new vaccine from scratch, but scientists are setting speed record this time around, spurred by knowledge that vaccination is the world's best hope against the pandemic. The coronavirus wasn't even known to exist before late December, and vaccine makers sprang into action Jan. 10 when China shared the virus' genetic sequence.

Just 65 days later in March, the NIH-made vaccine was tested in people. The first recipient is encouraging others to volunteer now.

"There's very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that I'm doing something," Jennifer Haller of Seattle told the AP.

That first-stage study that included Haller and 44 others showed the shots revved up volunteers' immune systems in ways scientists expect will be protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results.