The latest on global search for coronavirus vaccine: First US candidate set for Phase 2; WHO tracking 8 efforts; Pfizer tests in humans

The latest on global search for coronavirus vaccine: First US candidate set for Phase 2; WHO tracking 8 efforts; Pfizer tests in humans

An unprecedented, all-out global race to develop a safe vaccine against 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.

As the pace accelerates, USA TODAY is rounding up some of the week's most notable vaccine developments.

First US vaccine candidate cleared by FDA for Phase 2 of testing

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

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 “shortly,” it said in a news release.

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.

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

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.

WHO is tracking 8 vaccines in clinical evaluation

As of Wednesday, the World Health Organization was tracking eight potential vaccines for COVID-19 (called candidate vaccines) in clinical evaluation. These included four from China, one from England, two from the United States and one from the European Union.

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.

Pfizer begins vaccine tests in humans

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

The trials, which are taking place in the United States, are still Phase 1. These test whether a potential vaccine is safe, has side effects and produces the desired response from the body’s immune system. Vaccines must go through Phase 1, 2 and 3 testing before they can be licensed. Each phase involves larger numbers of volunteers.

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 plan to test the candidate vaccine on 360 healthy volunteers in the United States

BNT162 is a messenger RNA vaccine that instructs cells to make a specific piece of protein to match what’s on SARS-CoV-2’s spike protein. The hope is the protein pieces will cause the body to create antibodies that will stop the virus from being able to attach to and invade cells.

Oxford University scientists to start testing

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

The work is being done at the university’s 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 human tests are beginning.

The university is partnering with the British pharmaceutical company AstraZeneca to move forward with manufacturing should the candidate vaccine prove effective.

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.

World leaders pledge $8B for vaccine

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.

The money was for the Access to COVID-19 Tools Accelerator, or the ACT Accelerator, 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.

The collaboration’s mission statement said in part, “We know that as long as anyone is at risk from this virus, the entire world is at risk – every single person on the planet needs to be protected from this disease.’

China and the United States are among the few countries not taking part in the effort.

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.

To submit a development for the weekly roundup, or share other vaccine news, please email Elizabeth Weise at eweise@usatoday.com

Source: https://www.usatoday.com/story/news/health/2020/05/09/coronavirus-vaccine-race-us-testing/5179665002/

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