Demystifying the COVID-19 Vaccine Process

A COVID-19 vaccine could be just weeks away for the most vulnerable among us. Here’s what we know so far.

COVID-19 vaccine

Black folks don’t need much help distrusting the health care system. No need to recount our history and current dealings with the racially biased structure – we’re all familiar. So, when talk of a COVID-19 vaccine inevitably comes up in conversation, our reaction is typically a half-shoulder shrug and a skeptical, “Y’all go first.” It doesn’t help that the development process has been hastened. Still, wariness respected, it’s important that we center science and facts over fears and speculation.

Black Americans are almost five times more likely than white Americans to be hospitalized due to complications from COVID, according to the Centers for Disease Control and Prevention – and more than twice as likely to die. The possible availability of a vaccine in the coming weeks is something to which we need to lend particular attention. So, what’s the real deal? 

What is Operation Warp Speed?

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In May, an initiative was adopted with the goal to fast-track the production and distribution of 300 million doses of a COVID-19 vaccine, with initial doses to be available by January 2021. Operation Warp Speed is a collaboration between several government agencies including the Department of Health and Human Services, the CDC, the National Institutes of Health and others to accelerate the development of vaccines, therapeutics and diagnostics.

The name of the program, it seems, was meant to instill confidence, to make us feel like these entities are moving with urgency. It may have had the opposite effect, helping to spur fears that corners were being cut and safety sacrificed to rush a vaccine to market. 

It can take years to develop a vaccine, and so the process is being hurried – but that’s because operations that are typically carried out sequentially are being completed simultaneously. Under normal circumstances, clinical trials are concluded and, once a concoction is approved by the FDA, manufacturing is figured out – and then distribution, supplies and other particulars. But everything’s being handled all at once. Clinical trials are happening while a plan for distribution has already been crafted. 

Dr. Francis Collins, director of the National Institutes of Health, told NPR in late October, “Before anybody starts to worry, I also want to reassure everybody (that) we are not doing this by cutting corners. These will be vaccines that are tested with the most rigorous standards for safety and efficacy.”

Collins also said that he was “guardedly optimistic” that a vaccine could be approved by the end of the year, late November at the earliest. Under Operation Warp Speed, the companies looking to be the first to develop a COVID vaccine also have a significant amount of government support, to the tune of $12 billion dollars. The federal government started with 14 candidates, and then whittled that down to the most promising to back during early-stage clinical trials, before moving on to large-scale randomized trials.

What the Clinical Trial Process?

Sponsors – the federal government, in this instance – select methodology and developing candidates through lab research and animal trials. With FDA approval, human trials begin, which happen in three phases.

PHASE 1 assesses safety in a small number of volunteers.

PHASE 2 assesses safety and efficacy in slightly larger study groups.

PHASE 3 assesses efficacy in a large population against control groups. Larger than usual groups are being used in COVID-19 trials. 

Who Are the Front-Runners – & are the Key Dates?

Johnson & Johnson (Janssen)

MARCH 30: The Department of Health and Human Services announces $456 million to fund the company’s candidate vaccine.

JULY 27: Phase 1 clinical trials begin in the United States.

AUG. 5: HHS announces about $1 billion to support the large-scale manufacturing and delivery of their investigational vaccine candidate. 

SEPT. 22: Large-scale, Phase 3 clinical trials begin in the U.S., with 60,000 participants to be recruited.

OCT. 12: The company temporarily pauses its trial after a study participant’s “unexplained illness.”

OCT. 23: Johnson & Johnson announces that it will resume Phase 3 of its randomized, double-blind trial after the mystery illness – a stroke – was deemed unrelated to the vaccine.  

OCT. 30: The company announces that it will begin testing its experimental vaccine on youth ages 12 to 18 “as soon as possible.” 

AstraZeneca and Oxford University 

MAY 21: HHS announces up to $1.2 billion to support AstraZeneca’s candidate vaccine, being developed with Oxford University. 

EARLY SEPTEMBER: Phase 3 trials are put on hold after a participant in the U.K. developed a spinal cord injury. 

OCT. 9: HHS announces a partnership with the company for late-stage development and large-scale manufacturing of its cocktail of two monoclonal antibodies that may prevent or treat COVID-19. 

OCT. 23: The FDA gives the OK for trials to continue in the U.S. 

Moderna 

MARCH 16: Phase 1 clinical trials begin, with a fast-track designation from the FDA.

APRIL 16: HHS makes up to $483 million available to support Moderna’s candidate vaccine.

JULY 26: An additional $472 million is given to fund late-stage clinical development.

JULY 27: Phase 3 clinical trials begin, the first government-funded trial to enter this phase.

AUG. 11: HHS announces $1.5 billion to support the large-scale manufacturing and delivery of Moderna’s investigational vaccine candidate. 

OCT. 29: The company announces that it’s “actively preparing” for the launch of 20 million doses by the end of the year. 

Pfizer

JULY 22: HHS announces up to $1.95 billion to support the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. 

JULY 27: Phase 3 clinical trials begin. 

OCT. 27: Pfizer and its partner BioNTech announce its Phase 3 44,000-person clinical trial is just 2,000 enrollees away from being full.

How Do Vaccines Work?

Coronaviruses have a spike-like structure on their surfaces called an S protein. This protein attaches to human cells allowing the virus to penetrate the cell and then reproduce. A vaccine that targets this S protein may prevent the virus from binding to human cells and reproducing, according to the Mayo Clinic. However, different approaches are in the works. 

Live vaccines use a weakened – or attenuated – form of the germ that causes a disease, prompting an immune response without causing disease. These vaccines are used to protect against measles, mumps, smallpox and chickenpox. The problem with live vaccines is that extensive safety testing is required, and they could pose a concern for people with weak or compromised immune systems.

Inactivated vaccines use a killed version of the germ that causes disease, triggering an immune response without causing infection. They’re used to prevent rabies, Hepatitis A and the flu. The downside with inactivated vaccines is that they may not provide protection as strong as when a live virus is used. Multiple doses followed by booster doses are often required to provide long-term protection.

Genetically engineered vaccines use genetically engineered RNA or DNA that has instructions for making copies of the S protein. With this vaccine, an immune response is triggered with no need to actually handle any infectious virus. While genetically engineered vaccines are in the works, none have been approved for human use. 

What’s the Distribution Plan?

If all continues according to plan, initial doses of the COVID-19 vaccine could be available in a matter of weeks, but don’t count on automatically being able to walk into your local drugstore and get a shot just quite yet.

Because available doses will be limited to start, American most at risk will likely be first in line. If supplies are limited, the Advisory Committee on Immunization Practices – a federal advisory committee made up of medical and public health experts – will recommend priority for:

• Health care personnel

• Essential workers

• People at risk for serious complications due to underlying medical conditions

• People 65 and over

Also, those with weakened immune systems or allergies to components of the vaccine may not be able to be vaccinated. And, of course, some people will choose not to get the injection. Vaccinating enough of the population may help with herd immunity, offering some protection to those who aren’t vaccinated. 

The World Health Organization recommends that if you can get vaccinated, do. You’d be protecting not just yourself, but members of your community who aren’t able to be vaccinated. In mid-September, the Trump administration released its COVID-19 distribution plan, developed by HHS, the Department of Defense and the CDC. Once the FDA approves a vaccine, the strategy outlines four key tasks to get it out, which are to:

  1. Engage with state, local and tribal partners, and the public, to communicate public health information before and after distribution starts to promote vaccine confidence and reception.
  2. Distribute vaccines immediately under the FDA’s Emergency Use Authorization, using a transparently developed, phased allocation methodology. 
  3. Ensure safe administration of the vaccine and availability of necessary supplies.
  4. Monitor necessary tracking, distribution and administration data.

In October, under an Operation Warp Speed program, agreements were made with CVS and Walgreens to administer COVID-19 vaccines to residents and staff of long-term care facilities at no cost. The pharmacies will work directly with the facilities to coordinate on-site clinics when a vaccine is approved and available.

It’s expected that three visits over about two months will be necessary to effectively administer the required doses. John Standley, Walgreens president said in a statement, “Ensuring access to COVID-19 vaccines, particularly among our most vulnerable populations, will be critical to saving lives and helping our nation recover from the pandemic.” 

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