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Monday, June 29, 2020

Coronavirus vaccine: Will it be ready by fall? Here's what's happening now - CNET

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Experts are hopeful that a vaccine against the SARS-CoV-2 virus will become available sooner rather than later.

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For the most up-to-date news and information about the coronavirus pandemic, visit the WHO website.

Coronaviruscases are surging in over half of US states, three of which -- California, Texas and Florida -- are reporting record numbers of new cases day by day, raising concern that a second wave of the virus could be building momentum. For people in the US who've grown weary of lockdowns, social distancing and the polarizing issue of face masks, a vaccine can't arrive soon enough.

In the meantime, some or all of the measures meant to curb the spread of COVID-19 could return, even as schools begin to open and sports tentatively resume. (Although large-scale events such as music festivals, tech conferences and the Olympics are still on indeterminate hold.) What will it take to get a coronavirus vaccine?

The answer, unfortunately, is time. Vaccines typically take years -- sometimes even decades -- to develop, approve, manufacture and distribute globally. That said, there have never been so many doctors and scientists working this hard and fast at it. Just half a year since SARS-CoV-2 was first discovered, at least six vaccine development projects are already reporting encouraging progress, with many more underway. 

Thanks to the federal "Operation Warp Speed" vaccine acceleration program (keep reading for more on how it works), director of the National Institute of Allergy and Infectious Disease Dr. Anthony Fauci said he expects the US will have "hundreds of millions of doses" of the vaccine ready to deploy by early 2021.

This article updates frequently and is intended to be a general overview, not a source of medical advice. If you're seeking more information about coronavirus testing, here's how to find a testing site near you. Here's how to know if you qualify for a test and how to get an at-home coronavirus test.

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Latest COVID-19 vaccine news 

Read moreWhat it will take for life to return to normal after lockdown ends

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An effective coronavirus vaccine might be the only way to bring a stop to preventative measures, like social distancing and face masks.

James Martin/CNET

The presumed frontrunners: Moderna and Oxford University

Moderna has been making headlines for its coronavirus vaccine development -- both positive and negative. Early reports that Moderna's first trials showed promise for immunity caused its stock to soar. Soon after, however, scientists cast doubt on the company's data, causing the same stocks to falter.

Moderna is a beneficiary of the US Food and Drug Administration's program to fast-track vaccines. The fast-track process expedites approval by allowing select labs to submit their review process by phases, rather than submitting all sections of the application at once, which is the usual way. The company ran Phase 1 clinical trials and reported preliminary data that it says supports the move to a larger Phase 2 trial, which is currently ongoing. Phase 3 is reportedly slated for July. You can learn more about Moderna's vaccine candidate, mRNA-1273

Another vaccine is under development at Oxford University in the UK. Scientists there say that vaccine could be ready by the fall of 2020. Oxford is working with pharmaceutical giant AstraZeneca. Its vaccine candidate was slated to begin simultaneous Phase 2 and Phase 3 trials in June.

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Experts say recent surges in coronavirus cases aren't merely the result of the US doing more testing, as a higher percentage of those tested are coming up positive compared to earlier stages of the pandemic.

James Martin/CNET

Scientists say in a paper that the results from Oxford's trials on mice and rhesus monkeys are mixed, however, speculating that humans who eventually take the vaccine might still be able to spread the virus. You can read more about this effort, called ChAdOx1 nCoV-19, at AstraZeneca's website.

What is Operation Warp Speed?

This April, the White House began organizing Operation Warp Speed, according to Bloomberg, a sort of coronavirus vaccine task force that has identified 14 vaccine projects that it will focus on fast-tracking. The "Warp Speed" project itself, which the White House acknowledged during an April press briefing, has a stated goal of readying 300 million doses of vaccine to be available by January 2021, which coincides with Fauci's estimation.

Talking to JAMA editor in chief Howard Bauchner in June, Fauci said Operation Warp Speed is financially backing efforts to start manufacturing doses while clinical trials are still ongoing. That means, if and when those vaccines do get approved, there will already be a store of doses ready to distribute nationally.

Will there be just one vaccine for everyone?

We won't know for a long time, but Fauci co-authored a paper about vaccines published May 11 in the journal Science that suggests it might take several different vaccines made and distributed by different labs in order to effectively eradicate COVID-19 from the planet. 

Vaccines: How long it usually takes to make them

A vaccine is a medical treatment that protects you against a disease like the coronavirus or smallpox. For a deeper dive into how vaccines work, check out this in-depth coronavirus treatment explainer by CNET's Science Editor Jackson Ryan. The short and sweet of it is that a vaccine tricks your body into thinking it's already had the disease, so your body's natural defense -- the immune system -- builds antibodies against it. Then, if you were to become infected, your body would call upon the antibodies to fight the virus before you feel sick.

Vaccines typically take about 10 to 15 years to develop. That's in part because any new medical treatment needs to be thoroughly tested for safety before it can be distributed to millions or billions of people. The mumps vaccine took four years, which is widely considered the fastest vaccine approval in the history of infectious disease. Even if one or more of the vaccines now in the works turns out to be effective, the FDA approval process typically takes a year or longer. 

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Why a vaccine may be key to ending the pandemic

Most health experts predict that the virus won't stop spreading until 60% to 70% of the world's population is immune, and they say the only way to reach that level of immunity without a monumental death toll is through vaccines. Such is the opinion of Carl T. Bergstrom, a biology professor at the University of Washington and Natalie Dean, an assistant professor of biostatistics at the University of Florida, in a joint editorial published in the New York Times.

How good are the odds for finding a vaccine?

Statistically, only about 6% of vaccine candidates ever make it through to market, according to a Reuters special report, and not just because they don't work. There's a whole litany of problems that could cancel even a promising candidate. 

Take, for example, what happened when scientists tried to develop a vaccine for SARS -- it backfired and actually made people more susceptible to the disease. The same thing happened with a vaccine for Dengue fever. To make matters worse, coronaviruses are a large class of viruses and so far there are no vaccines for any of them.

However, this particular coronavirus, SARS-CoV-2, has some unique traits that may help researchers working on a vaccine. For example, some viruses, like the flu, mutate quickly and often, which is why there's a new flu vaccine every year. Early evidence suggests that the coronavirus doesn't appear to do that. Although some researchers have hypothesized that a more contagious strain has developed, others aren't so sure

Either way, it's thought that the virus has not yet mutated significantly enough to disrupt vaccine development, nor is it expected to, though it's too soon to say for certain, and there are still many unknowns about the virus' behavior.

What steps do vaccines have to go through to get approved?

Rules and regulations vary by country, but, generally speaking, most industrialized nations have similar protocols for approving a vaccine. The following path is how vaccines are approved in the US under the FDA:

  • Before clinical trials can begin: Once a laboratory has researched and developed a potential vaccine, which includes testing it in animal models and working out manufacturing and quality control processes, it can apply to the FDA to start clinical trials.
  • Phase 1 clinical trials: The vaccine is tested for safety and effectiveness in a small number (dozens) of closely monitored subjects. 
  • Phase 2 clinical trials: Various dosages of the vaccine are tested on hundreds of human subjects. 
  • Phase 3 clinical trials: Thousands of subjects are enrolled to measure the overall effectiveness of the vaccine. 
  • If a vaccine passes all three phases: The lab must then apply to the FDA for a license to produce and distribute the vaccine. That application is reviewed by both FDA and non-FDA scientists.
  • If approved: The lab begins producing the vaccine while the FDA closely monitors production. 
  • Phase 4: Although at this point the vaccine may be released to the market, many vaccines continue with what's called Phase 4 studies, during which the FDA continues to review the safety and efficacy of the vaccine.
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Until there's a vaccine, expect safety precautions like face masks and social distancing to be a part of everyday life.

Robert Rodriguez/CNET

What happens if we never find a coronavirus vaccine?

The longer we go without a vaccine, the more likely focus will shift toward treatments, such as the experimental antiviral drug remdesivir, which has reportedly shown promising results. With effective therapeutic treatments, many viruses that used to be fatal are no longer death sentences. Patients with HIV, for example, can now expect to enjoy the same life expectancy as non-HIV-positive individuals, thanks to tremendous advances in treatment.

Without a coronavirus vaccine, the road back to "normal life" may be harder and longer, but not necessarily impossible. Coronavirus testing, including antibody testing, and contact-tracing efforts would need to intensify, experts say. 

Lockdown measures are already lifting throughout the world, although with a potential second wave of coronavirus infections, cities could bring back certain quarantine measures, including requiring face masks and social distancing. Eventually, the global population may reach the 60% to 70% rate required for herd immunity to protect those who aren't immune.

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Coronavirus vaccine: Will it be ready by fall? Here's what's happening now - CNET
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