Woman wearing a mask

Since the novel coronavirus was declared a pandemic by the World Health Organization in March, many questions have been on the tops of people’s minds. Perhaps among the more important ones are when will a vaccine be ready to be distributed and how will it proceed in human trials? With the flu season near, vaccine developers and other manufacturers and researchers are aiming to expedite development of a COVID-19 vaccine by the end of 2020.

Where does the science stand?

While there is currently no vaccine to prevent the coronavirus disease, clinical trials, vaccine prices and various investors have emerged in the news, as the Trump administration is attempting to deliver 300 million doses of an effective COVID-19 vaccine by January 2021, introduced through the Operation Warp Speed initiative in June.

Some health experts, and even one adviser from the U.S. Food and Drug Administration, which regulates vaccines, has said it is not realistic to expect a vaccine for COVID-19 in 2020. But other experts are more optimistic.

“It is vitally important to have a vaccine for the COVID-19 virus because of the way it is rapidly spread and the toll it takes on the human body,” says Dr. LaTasha Perkins, a family physician in Washington, D.C., who specializes in immune health. “It’s unclear and a little early to know for sure at this stage in the vaccine’s development. My optimistic opinion is we may have an approved vaccine by spring 2021.”

Dean L. Fanelli, who has over 20 years of experience in pharmaceutical and chemical-related technologies, including diagnostics, biologics and medical devices, and is a partner at Seyfarth Shaw in Washington, D.C., also thinks a vaccine could be available for the general public by early 2021.

“The SARS-CoV-2 virus is a contagious and deadly virus. Until a vaccine is approved, our only means of protection against transmitting and acquiring the virus is to wear face coverings and social distance,” Fanelli says.

Dr. Soren Christiansen, president and CEO of Sharps Technology in New York City and a former top executive at pharmaceutical company Merck overseeing vaccines, thinks at least one vaccine will be approved by the FDA before the end of the year.

“Today, there are limited options to treat a severely ill patient with COVID-19. The best way of dealing with a virus like this is prevention, which means vaccinating people,” Christiansen says.

Availability and safety

According to Christiansen, for a vaccine to be successful, it has to show an acceptable balance between safety and potential side effects and efficacy.

“Several of the vaccine candidates in development are two-dose regimens,” he says. “This creates some logistical challenges, since you have to make sure the individual comes back for the second shot. If they do not, the efficacy of the vaccine is compromised. It will be highly preferable to have a one-dose vaccine.”

Perkins says side effects won’t be known until the vaccine is developed and ready for distribution.

“My main concern is the transparency around the process of the vaccine’s development and ensuring that information is readily available to the community, especially in light of its record-setting development,” she says.

For a vaccine to be effective and truly establish herd immunity, it is important for the organizations creating it to be transparent about the process and science behind its development, Perkins says.

“We need to start having conversations within our communities to establish trust in the vaccine, so people will be willing to get the vaccine to protect not only themselves but others, as well,” she says. “Getting a vaccine is a selfless act, but people have to understand it in order to trust it and feel safe getting it.”

In human vaccine trials, the most advanced vaccine candidates are in the third phase — the last hurdle before being approved by regulatory agencies like the FDA, Christiansen says.

“When you get a vaccine candidate to that stage, the likelihood of success is 80%, so my expectation is that several of the current candidates will show good efficacy and protection with an acceptable safety profile,” Christiansen says.

In Phase 3 trials, scientists will be looking for protection against the virus, presence of viral load in nasal cavities and lungs, and the presence of an immune response, Fanelli adds.

“The vaccine development is an extraordinary work of science,” he says. “Delivering the vaccine once approved throughout the world is logistically also very challenging.”

Christiansen says capacity will also be of major concern — not only with respect to the vaccine but also syringes.

“Remember, this vaccine will be in addition to the ‘normal’ vaccine programs, like MMR, HPV, Shingles and others, so this will be a huge challenge all around,” Christiansen says. “A concern could be that some of the current vaccine programs will be deprioritized due to the focus on COVID-19, and that could lead to whole new challenges and debates.”