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About 100 research groups around the world are pursuing vaccines against the coronavirus, with nearly a dozen in early stages of human trials or poised to start. Finding out for sure if any of the vaccines work in the real world comes next. (May 4)<\/p>\n

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An unprecedented, all-out global race to develop a safe vaccine\u00a0against the new coronavirus is underway. The stakes couldn’t be higher, as public health officials and world leaders say an effective vaccine or treatment against the virus that causes the disease COVID-19 is necessary to fully restart economies and resume civic life.<\/p>\n

As the pace\u00a0accelerates,\u00a0USA TODAY is rounding up some of the week’s most notable vaccine developments.\u00a0\u00a0<\/p>\n

First US\u00a0vaccine candidate cleared by FDA for Phase 2 of testing<\/h2>\n

The first U.S. SARS-CoV-2 trial vaccine\u00a0has been cleared to go into Phase 2 testing by the Food and Drug Administration, Massachusetts-based Moderna announced Thursday<\/a>. The vaccine candidate (a potential vaccine that could be used if found safe and effective)<\/strong>is\u00a0called mRNA-1273 and\u00a0was first given to volunteers in Seattle on March 16 as Phase 1 testing began.<\/p>\n

FDA has completed its review of Moderna’s Investigational New Drug application for mRNA-1273, which allows it to now proceed to Phase 2 study. Moderna expects such tests to begin \u201cshortly,\u201d it said in a news release.<\/p>\n

Phase 2 testing is done with several hundred volunteers and looks to see how their immune systems respond to the vaccine and whether it makes them immune to the disease. Safety and side effects are also studied.\u00a0<\/p>\n

Moderna said it is finalizing the protocol for Phase 3 study of mRNA-1273. Those tests are expected to begin in early summer.<\/p>\n

Phase 3 trials involve giving a vaccine to large numbers of people to see whether it works, whether it is safe and whether it has unknown or rare side effects. These can range from the thousands to the tens of thousands of volunteers.<\/p>\n

WHO is tracking 8 vaccines in clinical evaluation<\/h2>\n

As\u00a0of Wednesday, the World Health Organization was tracking eight potential\u00a0vaccines <\/a>for COVID-19 (called candidate vaccines)\u00a0in clinical evaluation. These included four from China, one from England, two from the United States and one from the European Union.<\/p>\n

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The list also includes 100 candidate vaccines in preclinical evaluation, meaning they are still being tested in test tubes or in animals. The previous version of the list, published on April 20, included 5 candidate vaccines in clinical evaluation and 71 in preclinical evaluation.<\/p>\n

Pfizer begins vaccine tests in humans<\/h2>\n

New York-based pharmaceutical giant Pfizer on Monday began testing a vaccine candidate\u00a0for SARS-CoV-2, the virus that causes COVID-19. In its announcement, the company said it went\u00a0from pre-clinical studies in test tubes and animals to injecting humans with a possible vaccine in less than four months.<\/p>\n

The trials, which are taking place in the United States,\u00a0are still Phase 1. These test\u00a0whether a potential vaccine is safe, has side effects and produces the desired response from the body\u2019s immune system. Vaccines must go through Phase 1, 2\u00a0and 3\u00a0testing before they can be licensed. Each phase involves larger numbers of volunteers.<\/p>\n

Pfizer is working with German pharmaceutical company BioNTech on the candidate vaccine, dubbed BNT162. The company first tested it in Germany last month on 12 healthy adults. The companies say they\u00a0plan to test the candidate vaccine on 360 healthy volunteers<\/a> in the United States<\/p>\n

BNT162 is a messenger RNA vaccine that instructs cells to make a specific piece of protein to match what\u2019s on SARS-CoV-2\u2019s spike protein. The hope is the protein pieces will cause the body to\u00a0create\u00a0antibodies that will stop the virus from being able to attach to and invade cells.<\/p>\n

Oxford University scientists\u00a0to start testing<\/h2>\n

Scientists at Oxford University\u2019s Jenner Institute plan to test a candidate vaccine on more than 6,000 people by the end of May.<\/a> If it is effective and safe, they could have millions of doses ready in the fall.<\/p>\n

The work is being done at the university\u2019s Jenner Institute, named for Edward Jenner, the 18th-century British physician who pioneered the smallpox vaccination. Tests done in six rhesus macaque monkeys seemed to show the candidate vaccine was protective. Now Phase 1\u00a0human tests are beginning.<\/p>\n

The university is partnering with the British pharmaceutical company AstraZeneca to move forward with manufacturing\u00a0should the candidate vaccine prove effective.<\/p>\n

Both have agreed to operate on a not-for-profit basis for the duration of the coronavirus pandemic, with only the costs of production and distribution being covered. Oxford University and its spin-out company Vaccitech, which jointly hold the rights to the technology used to develop the candidate vaccine, will receive no royalties during the pandemic, the university said.<\/p>\n

World leaders pledge $8B for\u00a0vaccine<\/h2>\n

In a video meeting on Monday hosted by the European Union, world leaders, nonprofits and celebrities pledged $8 million to fund laboratories working to develop and produce a vaccine<\/a>.<\/p>\n

The money was for the Access to COVID-19 Tools Accelerator, or the ACT\u00a0Accelerator, a collaboration between the World Health organization and governments, nonprofits and industry worldwide. It was launched April 24. They all pledged to work with and support the effort.<\/p>\n

The collaboration\u2019s mission statement said in part, \u201cWe know that as long as anyone is at risk from this virus, the entire world is at risk \u2013 every single person on the planet needs to be protected from this disease.\u2019<\/p>\n

China and the United States are among the few countries not taking part in the effort.<\/p>\n

The three-hour event fundraising effort on Monday was something like an old-fashioned telethon, with a leader from each country taking a few minutes on the video call to pledge money for the ACTS Accelerator.<\/p>\n

To submit a\u00a0development for the weekly roundup, or\u00a0share other vaccine news, please email Elizabeth Weise at eweise@usatoday.com<\/em><\/span><\/p>\n

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