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Compliance In Focus
Posted by John Lehmann on Tue, Oct 27, 2020

The Coronavirus Vaccine Trials: Which Companies Are in the Lead?

The coronavirus vaccine trials are well underway, with 11 vaccines now in Phase 3 testing globally, according to the World Health Organization’s vaccine tracker.

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Dr. Jay Butler, deputy director of the US coronavirus vaccine initiative, Operation Warp Speed, said in a press conference Friday he believes it’s “reasonable to expect that we will have at least one, possibly two products available before the end of the calendar year.”

However, he noted widespread distribution will take several months.

Here’s an update on the coronavirus vaccine trials, which companies are in the lead and what we know so far about the distribution plan.

What’s the Status of Coronavirus Vaccine Trials Globally?

Less than nine months since the WHO declared COVID-19 a global pandemic, the number of coronavirus vaccines in the works is unprecedented in history.

On Friday, the WHO reported the following updates on vaccine development worldwide:

  • 170 vaccines at the pre-clinical phase, being tested in the laboratory and on animals
  • 36 vaccines in Phase 1, being tested for safety in small cohorts of healthy young people
  • 16 vaccines in Phase 2 expanded safety trials
  • 11 vaccines in Phase 3, widespread testing to determine effectiveness and safety

Coronavirus vaccines that have entered Phase 3 clinical trials are undergoing large-scale tests, involving thousands of subjects, to demonstrate the efficacy of the vaccine and its comparative safety. The goal of Phase 3 is to demonstrate that the benefits of the vaccine outweigh any potential side effects.

The fact that nearly a dozen vaccines have reached this milestone so quickly when it would normally take years underscores what is at stake.

There is intense pressure to put an end to the virus, which has infected over 43 million people and killed 1.2 million worldwide, including over 225,000 in the United States alone.

The global pharmaceutical industry has directed overwhelming firepower toward fighting this threat, including the US government’s investment of nearly $11 billion so far.

Which coronavirus vaccines are in Phase 3 clinical trials?

As October comes to an end, there are several coronavirus vaccine frontrunners in the United States. Here’s a closer look at each of them.

Pfizer and BioNTech

Pfizer and German company BioNTech have been developing a coronavirus vaccine that uses messenger RNA (mRNA). Messenger RNA delivers a type of blueprint to the body’s immune system to create an antigen against the virus without actually infecting a person with it. This eliminates the risk of contracting the virus from a vaccine.

However, one downside of this technology is that it has never been used in previously approved vaccines. If it is approved, it will likely require multiple doses.

So far, Pfizer and BioNTech have tested their coronavirus vaccine on nearly 40,000 participants in five countries, including 39 of the 50 states. They are now expanding Phase 3 trials to collect additional safety and efficacy data by increasing the size and diversity of the study's participants, including testing it on children.

Assuming the vaccine is approved, Pfizer and BioNTech have stated plans to manufacture up to 100 million doses by the end of 2020 and 1.3 billion doses by the end of next year.

Johnson & Johnson and Janssen

Johnson & Johnson recently resumed recruitment of a Phase 3 clinical trial for a coronavirus vaccine developed by its Belgium-based company, Janssen, after one of its study participants experienced unexplained illness.

After consulting with its independent Data Safety Monitoring Board (DSMB) and the FDA, the company found no evidence the vaccine caused the adverse event.

The Janssen vaccine is a one-dose coronavirus vaccine, the first of its kind to be tested in the United States. This recombinant vector vaccine uses a human adenovirus (the virus that causes the common cold) to trigger an immune response. However, the virus has been modified so it can’t reproduce within the body.

The fact that it requires a single dose (unlike other leading contenders) could make a big difference in a national rollout of a vaccine. The trial is enrolling more than 60,000 participants worldwide, making this the largest Phase 3 trial of the four in Operation Warp Speed.

AstraZeneca

AstraZeneca and the University of Oxford are developing another frontrunner in the coronavirus vaccine trials. Regulators concluded it was safe to resume testing last week in the US after the company voluntarily paused its Phase 3 study when a participant developed neurological symptoms. While there was no evidence it was related to the vaccine, the FDA is still investigating whether it could cause serious side effects.

Earlier results showed the viral vector vaccine triggered an immune response to the coronavirus in older adults. However, it would likely require a second booster shot instead of a single dose.

Moderna

Moderna was one of the first companies off the starting block. It completed its first experimental vaccine just 25 days after Chinese researchers shared the genetic sequence of COVID-19. After a successful Phase 2, Moderna’s Phase 3 trial involves 30,000 volunteers who will receive either an injection of the mRNA vaccine or a placebo.

Moderna’s CEO said its vaccine would not be ready for full approval and general distribution until next spring, although it could apply for emergency use authorization as soon as late November.

Some Phase 3 trials are underway in other countries as well. Novavax recently moved its experimental vaccine into final-stage testing in the UK and aims to test up to 10,000 volunteers, at least a quarter of them over age 65.

The standards that these companies met to begin Phase 3 trials do not apply worldwide. Russia, for example, decided it would begin using the vaccine in those at highest risk last month before even beginning the Phase 3 trial. The first use will be in military personnel.

History of Clinical Research VIDEO

The race to the finish line

If a vaccine is ready in 2021, it will be the fastest development in history. The search for a vaccine for HIV continues into its 36th year. To date, the speed champion in vaccine development has been for the mumps, which went from concept to approval in just four years, ending in 1967.

Although there is no official, widely accepted date for bringing forth an effective and safe vaccine and distributing it in sufficient doses to halt the pandemic, there are plenty of reasons to be hopeful.

The WHO stipulates many conditions of declaring the success of a vaccine--for example, that all nations and populations worldwide have access to a proven vaccine at the same time. On September 21, it unveiled plans for distributing a coronavirus vaccine globally.

"The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification,” the WHO stated. “These vaccines will be offered equally to all participating countries, proportional to their populations, initially prioritizing healthcare workers.”

In the US, the CDC has begun making recommendations for coronavirus vaccine distribution based on input from the Advisory Committee on Immunization Practices.

If supplies are limited, as they are expected to be in the first part of next year, the CDC will likely recommend the first vaccines go to healthcare personnel, people in essential industries, those at higher risk for serious illness due to underlying medical conditions and people who are 65 or older.

IMARC’s perspective on the coronavirus vaccine trials

At IMARC Research, our mission is to help companies win the approval of innovative medical devices. Although we are not on the front lines of the coronavirus vaccine trials, we are closely monitoring recent developments and eagerly awaiting news.

We hope to see a vaccine approved soon, but the history of clinical research has taught us that the risks of any medical advancement should never outweigh the benefits.

For more updates on the coronavirus vaccine trials and the changing global medical device landscape, take a moment to subscribe to our blog.

 

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