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I'm a Doctor and Here's When We Will Get the COVID-19 Vaccine

A preventative shot is on the way. It's just a matter of how long.

July in America is off to a tough start, as the novel coronavirus continues to spread around the United States, reaching 250,000 new cases in less than a week. In efforts to solve the problem through global scale vaccination, multiple companies and research institutions are racing to develop COVID-19 vaccines. As the shelter at home orders are lifted and states try to reopen the economy, doctors and scientists alike agree that having at least one functional vaccine would accelerate society to go back to normal. But how close are we to getting a COVID-19 vaccine?

A Few Things Have to Happen First

Today, masks are being treated like homemade vaccines. In fact, you could think of them as place holders for the real jab. Although staying away from friends and family wasn't on your plans for this year, not sharing your air with other people is the smart thing to do until we get a vaccine for the novel coronavirus. Dr. Anthony Fauci, the country's leading expert in infectious diseases, rightfully noted that no vaccine would be effective in the U.S., if too many people refused to get it. For a vaccination to work, we must all agree to get it once available, and I am hopeful that good options are underway—it seems like that when humanity puts its focus into something good, we get it done. 

There are many challenges with solving the problem with this virus, including its rapid spread and our failure to contain the coronavirus, for that vaccine researchers are trying new ways to recruit the thousands of healthy volunteers needed to finish testing coronavirus drugs in late stages of development. While testing new drugs on healthy volunteers, researchers must make sure they are testing on a wide variety of people, including gender, age groups, underlying health conditions and ethnicity.  Let's not forget that BIPOC communities in the U.S. are 3 times as likely to contract the coronavirus than their white neighbors—and nearly twice as likely to die, according to new data published by The New York Times. So, a big part of the job that vaccine scientists work on is to make sure to test the vaccines on every community. 

The first human study of one of the vaccine candidates, focused largely on whether it is safe, began enrolling subjects in May, but they are not alone—in fact, there are about 17 vaccines in human testing, and more than 130 are in development by researchers and different companies.

Who Gets it First?

To cover the United States population, we will need at least 330 million doses, if the approved vaccine requires only one dose. Then, we need to understand and come to an agreement on who gets it first. Once a vaccine is approved, the U.S. Centers for Disease Control and Prevention will have to decide who should get it first. Given the mortality data that we have available so far, it is safe to assume that people who are most likely to die if infected with COVID-19 may receive it first —like elderly populations living in nursing homes. Essential workers and healthcare providers will likely be considered to receive it first. However, the ultimate decision on who gets vaccinated first, should a COVID vaccine become available, will be made at state and local level.

How Much Will it Cost?

Because drug pricing isn't done in a straightforward manner, a bipartisan coalition in the House recently proposed two new bills to ensure affordable COVID-19 vaccine pricing. Drug pricing has been a challenge for many years, and it's troublesome for other diseases such as cancer and diabetes. For those familiar with the struggle to get medications that are overpriced, are also familiar with the term "financial toxicity"—which in fact reflects another hurdle that patients need to overcome when they get sick. Another layer to this is that Medicare is not allowed to participate in price negotiations for drugs that are covered by its part D drug plan. Until the vaccine candidate is tested and tried, we will not know how much it will cost. 

The Vaccine Candidates

Several coronavirus vaccine candidates are set to enter large clinical trials in the United States this summer, along with at least another hundred that are still developing and have not started human testing.

Preclinical vaccine development seeks to collect data to support feasibility and safety of the candidate, entering the Phase I of clinical trials that evaluates the safety and immune response, on Phase II they may test efficacy on a medium-sized group of individuals and lastly the Phase III clinical trial that will evaluate on thousands of individuals the safety and efficacy of the drug. After that, Government agencies will review the trial's clinical data and issue approvals as warranted. 

The University of Oxford/AstraZeneca Phase III trial is planned to start in the United States in August 2020, whereas the Pfizer vaccine candidate is set to begin Phase III studies later this month in the U.S. as well as Moderna/NIAID drug candidate mRNA-1273. Johnson&Johnson's viral vector vaccine candidate is promised to launch Phase III studies in the U.S. in September. 

Regardless of which vaccine candidate will be released first and made available for all, one thing we should be aware of is that it might take several different vaccines made and distributed by different labs in order to effectively eradicate COVID-19 from the planet, as Dr. Fauci first said in June 2020. 

And meanwhile, "the federal government will pay the vaccine maker Novavax $1.6 billion to expedite the development of 100 million doses of a coronavirus vaccine by the beginning of next year, the company said Tuesday," reports the New York Times. "The deal is the largest that the Trump administration has made so far with a company as part of Operation Warp Speed, the sprawling federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible. In doing so, the government has placed a significant bet on Novavax," and signed a $450 million contract with Regeneron for the development of a COVID-19 therapy.

When Can We Expect It?

Vaccine development usually takes many years and, in some cases, the vaccine never comes to fruition. An example of that is that we have not developed successfully a HIV vaccine, and researchers have been working on it for over 30 years. Thankfully, patients living with HIV have the same life expectancy as non-HIV-positive people, due to advances in prevention and treatment.

The challenge is not only to develop and approve a new vaccine but also to manufacture and distribute globally. The Federal Agency that regulates new medications, The Food and Drug Administration, will have to approve the new vaccine for use and label it as "safe and effective," and the minimum standards set by the FDA for approval, includes the requirement that a vaccine must be at least 50% better than a placebo at preventing COVID-19. 

So when can we expect one? Moderna is promising a vaccine by Q4 2020, and Oxford University's shot will likely be ready Q1 2021.

The Doctor's Final Thoughts

In humanity's history, there have never been so many doctors and scientists working this hard and fast at solving a health problem. It has been just half a year since SARS-CoV-2 was first discovered, and we already have 17 vaccine candidates in human trials, with dozens more still being developed. 

From the data that companies and researchers have shared, it is unlikely that we never find a coronavirus vaccine. There is reason to be confident that we will find novel ways of preventing infection, disease severity and attenuating the viral replication, one way or another. 

In case such vaccines do not turn out to be safe or effective, the focus will likely be shifted towards finding effective treatments, in the same fashion it was done for HIV. Regardless of the vaccine outcomes, to successfully eradicate COVID-19, the country needs a Federal Task Force dedicated to COVID testing, antibody surveillance, and contact-tracing, if we are to return to what we remember as normal life to be. 

Until we have a COVID-19 vaccine, make sure to wear a mask and don't share your air—facial coverings and social distancing helps to contain the spread of the virus. And to get through this pandemic at your healthiest, don't miss these Things You Should Never Do During the Coronavirus Pandemic.

Leo Nissola, MD
Leo Nissola, M.D. is an award-winning immunologist and scientist. Follow him on Instagram @DoctorLeo and on Twitter @LeoNissolaMD. Read more about Leo
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