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Health & Fit Moderna's coronavirus vaccine just started its phase 3 trial — the first in the US. Here's how it'll work.

01:12  28 july  2020
01:12  28 july  2020 Source:   businessinsider.com

Doctors Break Down the Long Road Ahead to Getting a Viable COVID-19 Vaccine

  Doctors Break Down the Long Road Ahead to Getting a Viable COVID-19 Vaccine Be prepared for a long wait.

Biotech company Moderna said on Monday that it has started dosing participants in the Phase III clinical trial for its coronavirus vaccine “This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection

Here in the United States , the government has put its money behind several different vaccine candidates through Operation Warp Speed. This phase of the trial is expected to involve 30,000 volunteers and will test whether the vaccine protects people against the coronavirus .

A researcher works on a vaccine for the new coronavirus at the Copenhagen University research lab in Copenhagen, Denmark, on March 23, 2020. THIBAULT SAVARY/AFP via Getty Images © THIBAULT SAVARY/AFP via Getty Images A researcher works on a vaccine for the new coronavirus at the Copenhagen University research lab in Copenhagen, Denmark, on March 23, 2020. THIBAULT SAVARY/AFP via Getty Images
  • Moderna's coronavirus vaccine candidate entered its next phase of human trials on Monday.
  • The company hopes to have results by Thanksgiving.
  • The candidate is an mRNA vaccine that can be manufactured more quickly than most traditional vaccines.
  • However, some researchers caution that mRNA vaccines are new and could come with side effects.
  • For more stories like this, sign up here for our healthcare newsletter Dispensed.

Moderna's coronavirus vaccine entered a new and crucial phase of testing on Monday: Its phase 3 clinical trial, which involves 30,000 volunteers at 87 sites across the US.

A Vaccine Reality Check

  A Vaccine Reality Check So much hope is riding on a breakthrough, but a vaccine is only the beginning of the end.Nearly five months into the pandemic, all hopes of extinguishing COVID-19 are riding on a still-hypothetical vaccine. And so a refrain has caught on: We might have to stay home—until we have a vaccine. Close schools—until we have a vaccine. Wear masks—but only until we have a vaccine. During these months of misery, this mantra has offered a small glimmer of hope. Normal life is on the other side, and we just have to wait—until we have a vaccine.

Moderna has started a phase 3 trial for its coronavirus vaccine , as it races with AstraZeneca Moderna , Pfizer and AstraZeneca have the lead in the race to develop a coronavirus vaccine . Earlier this year, Moderna set a record in by creating an experimental coronavirus vaccine just 42

No vaccines have started their large Phase 3 trials in the United States . On Thursday, an investigator working on the Moderna vaccine candidate said the US vaccine maker Inovio said on Tuesday that its coronavirus vaccine already has shown some positive early data in a Phase 1 trial .

It's the first late-stage trial of a potential coronavirus vaccine to begin in the US. Moderna's CEO has said the company is likely to deliver results by Thanksgiving. If those findings are good, the FDA might then quickly approve the vaccine for emergency use among high-risk people, as it considers full approval.

Moderna, which is headquartered in Massachusetts, partnered with the National Institute of Allergy and Infectious Diseases to come up with the vaccine. Its candidate is one of several funded by the US government as part of Operation Warp Speed, an initiative that aims to deliver 300 million doses of a safe and effective vaccine by January 2021.

The global risk of “vaccine nationalism”

  The global risk of “vaccine nationalism” A Covid-19 outbreak in one country is a threat to all. What happens if the vaccine race is every nation for itself?The United Kingdom, along with its American and Canadian counterparts, said it was “95 percent sure” that hackers tied to Russian intelligence tried to probe their drug companies and research groups. US officials told the New York Times that Russia didn’t seem to be sabotaging efforts to find a vaccine. Instead, the Russians wanted to pilfer the research, to help themselves speed up their vaccine development.

Massachusetts biotech company Moderna launched Phase 3 of its coronavirus vaccine trial on Monday. Moderna is working with the NIH and BARDA to develop its vaccine as part of Operation Warp Speed, the In the meantime, we welcome your feedback to help us enhance the experience.

(Reuters) - Moderna Inc (O:MRNA) said on Monday it had started a late-stage trial to test the effectiveness of its COVID-19 vaccine candidate, the first such study under the Trump administration' s program to speed development of measures against the novel coronavirus .

Other vaccines backed by Warp Speed include shots from a collaboration between Pfizer and BioNTech and from a partnership between the University of Oxford and AstraZeneca. The Oxford vaccine has already started its phase 3 trials, with participants in the UK, Brazil, and South Africa. The researchers plan on starting to test it in the US in August.

What phase 3 means

A phase 3 trial is usually a drug or vaccine's final test before it can be sold to the public. Phases 1 and 2, which typically involve giving the drug to smaller groups of volunteers, aim to show that a vaccine candidate generates an antibody response and is generally safe.

Phase 3 trials test a vaccine's safety and efficacy on a larger number of people across multiple locations.

For Moderna's trial, volunteers will receive two injections about 28 days apart. Half the participants will receive the vaccine candidate, and the other half will get a placebo. It's a double-blind trial, which means neither the researchers nor the volunteers will know who got which doses.

How anti-vaxxers are thinking about a Covid-19 vaccine

  How anti-vaxxers are thinking about a Covid-19 vaccine Vaccine refusal was growing before the pandemic. Then came Covid-19.These words were offered by Barbara Loe Fisher, founder of the largest national organization in the US opposed to vaccine requirements in 2019, long before Americans had imagined the Covid-19 outbreak. Speaking at an event organized by “Crazy Mothers,” a group whose stated goals include bringing attention to injuries caused by childhood vaccines and empowering mothers to make informed health care decisions, Fisher’s comments were meant to condemn state laws that require childhood vaccinations for school attendance and recent state efforts to tighten enforcement of those requirements.

Vietnam will evacuate tourists after its first cases in months. One of the first large studies of safety and effectiveness of a coronavirus vaccine in the United States began on Monday Moderna said on Sunday that it would receive up to 2 million in additional funding from the federal government

In its first -quarter update on Thursday, Moderna appeared to be speeding up its timeline for a coronavirus vaccine , stating that the next phase would begin “shortly.” The company is also gearing up for a Phase 3 trial in the summer, and hopes to have the final vaccine approved “as soon as 2021.”

a person wearing a hat and sunglasses: Nurse Kath Olmstead gives volunteer Melissa Harting, of Harpersville, New York, an injection as the phase 3 trial of Moderna's vaccine candidate gets underway, July 27, 2020, in Binghamton, New York. AP Photo/Hans Pennink © AP Photo/Hans Pennink Nurse Kath Olmstead gives volunteer Melissa Harting, of Harpersville, New York, an injection as the phase 3 trial of Moderna's vaccine candidate gets underway, July 27, 2020, in Binghamton, New York. AP Photo/Hans Pennink

Moderna's phase 2 testing is still ongoing, but the results of its phase 1 tests, published earlier this month, showed the vaccine was safe overall and triggered immune responses in volunteers.

Betting on an mRNA vaccine

Moderna's vaccine, called mRNA-1273, is different from other existing vaccines. It uses a technology called messenger RNA to create vaccine doses using only a virus' genetic code. As a result, mRNA vaccine development can take less time.

But no mRNA vaccines exist yet on the market, largely because the science behind them is new. If approved, Moderna's vaccine would be the first mRNA vaccine. Pfizer's coronavirus vaccine candidates are also mRNA-based.

Traditional vaccines rely on several other methods, such as using live samples of a weakened virus, or a virus that's been killed.

Covid-19 Vaccine Push Lacks a Key Ingredient: Trust

  Covid-19 Vaccine Push Lacks a Key Ingredient: Trust Operation Warp Speed is pursuing a worthy goal, but it still operates in the shadows.Operation Warp Speed, launched in April, is administered by the Department of Health and Human Services, the Biomedical Advance Research and Development Authority, and the Department of Defense, along with several other federal agencies. A handful of pharmaceutical companies, including AstraZeneca Plc, GlaxoSmithKline Plc, Johnson & Johnson, Moderna Inc., Novavax Inc., Pfizer Inc. and Sanofi SA, have received the lion’s share of the federal funding.

Moderna Inc said on Monday it has started a U . S . government-backed late-stage trial for its COVID-19 vaccine candidate, the first to The federal government is supporting Moderna ' s vaccine project with nearly a billion dollars and has chosen it as one of the first to enter large-scale human trials .

Volunteers who received Moderna ' s Covid-19 vaccine had positive early results, according to the biotech While the vaccine had promising results in the lab, it ' s not known if it will protect people in the The US Food and Drug Administration has cleared the company to begin Phase 2 trials , which

Experimental mRNA vaccines have successfully provoked immune responses in cancer patients, however. And some research even suggests that mRNA vaccines could trigger a stronger immune response than ordinary vaccines by stimulating our innate immune system: the parts of our immune system we're born with, like skin and mucous membranes. Most vaccines stimulate the parts of our immune system that get activated when we come into contact with pathogens, like T cells.

If Moderna's bet pays off, it could revolutionize vaccine development. But there are still a lot of unknowns: Researchers don't yet know whether mRNA vaccines will generate long-term immunity, prompt adequate immune responses, or come without harmful side effects.

The potential cost of the vaccine is also still to be determined. Moderna's CEO Stephane Bancel recently told Business Insider that the company is considering setting two prices, with a lower cost during the pandemic. However, the startup lost a legal dispute over a patent last week, which means Moderna might have to pay for the use of foundational mRNA technology. That could force it to set a higher vaccine price point.

Moderna has never gotten a vaccine approved

Moderna raised over $600 million in its initial public offering in December 2018, the biggest biotech IPO in history.

Why it’s unlikely we’ll have a Covid-19 vaccine before Election Day

  Why it’s unlikely we’ll have a Covid-19 vaccine before Election Day Even the appearance of political pressure could hurt public confidence in a coronavirus vaccine.The Food and Drug Administration approving a vaccine by then would certainly be a monumental October surprise, one that could help speed the pandemic’s end and may give Trump a much-needed boost.

The company was started in 2010, and its sole focus since then has been using synthetic mRNA to reprogram living cells to develop immune responses. Other big pharmaceutical companies see that bet as risky because mRNA delivery systems have the potential to generate adverse side effects.

Vials of an mRNA type vaccine candidate being developed for COVID-19 are pictured at Chulalongkorn University in Bangkok, Thailand, May 25, 2020. Athit Perawongmetha/Reuters © Athit Perawongmetha/Reuters Vials of an mRNA type vaccine candidate being developed for COVID-19 are pictured at Chulalongkorn University in Bangkok, Thailand, May 25, 2020. Athit Perawongmetha/Reuters

In 2016, an editorial in the journal Nature even compared Moderna to the failed biotech startup Theranos, accusing the company of choosing "stealth over disclosure of data" since Moderna hadn't yet described its methods in a peer-reviewed journal. It has since published findings related to its coronavirus vaccine in the New England Journal of Medicine, however.

Moderna's board of directors includes prominent and respected scientists like Robert Langer, an award-winning professor of chemical engineering at MIT, and Betsy Nabel, president of the Harvard-affiliated Brigham Health network.

"Having spoken with a lot of Moderna employees, even those who are skeptical of the future of the company, they almost all say, 'This isn't Theranos. There is some real science here,'" STAT News' Damian Garde told WBUR.

The vaccine has plenty of hurdles ahead

Even if Moderna's vaccine succeeds in its phase 3 trial by this fall, getting it approved could take longer, and getting any coronavirus vaccine approved by January 2021 would be an unprecedented feat.

We Will Not Have a Vaccine by November

  We Will Not Have a Vaccine by November No matter what the president says, the timeline is not possible.This is, in Trump Land, what passes for a conservative estimate. “We think we can probably have it sometime during the month of October,” the president told reporters earlier this month. Trump went as far as to call Redfield’s timeline “incorrect information, because a vaccine would really be ready sooner: “We’re ready to go immediately as the vaccine is announced, and it could be announced in October. It could be announced a little bit after October.

Even then, other factors could undermine its ability to end the pandemic: Antibody protection could fade quickly, making booster shots necessary; there could be logistical and supply challenges in the vaccine's mass production and distribution; and some people might choose not to get the shots in the first place.

Then, of course, there's a chance the vaccine candidate won't succeed at all. A 2016 study of 640 phase 3 trials found that 344 failed — around 54%. Another study found that of 302 new drug applications submitted to the FDA following phase 3 trials, 50% of those drugs were initially rejected. Nearly half of the rejected drugs were ultimately approved, however.

Who Moderna is racing against

Including Moderna's, four vaccine candidates have advanced to phase 3 trials so far. The other three are being developed by Sinovac, Sinopharm, and the University of Oxford in collaboration with AstraZeneca.

Sinovac's Brazil-based trial and Sinopharm's trial in the United Arab Emirates are both expected to take three to six months. The Oxford trial has not specified the length of its phase 3 trial, but the researchers have said they hope to have a vaccine available by Christmas.

Overall, there are 24 potential coronavirus vaccines now in human testing, and at least 18 more that could be ready to start clinical trials this year.

Read the original article on Business Insider

Video: Dr. Ramin Oskoui on hopes for potential COVID-19 vaccine (FOX News)

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