The Race for a Coronavirus (COVID-19) Vaccine

The Race for a Coronavirus (COVID-19) Vaccine

The coronavirus, or COVID-19 , continues its relentless spread around the world. Researchers have begun to develop vaccines that could save lives by preventing people from acquiring the disease. But how close are we to a vaccine? And is it reasonable to expect one anytime soon?

Here’s a look at how vaccines are made and which ones are currently in development for the coronavirus. We’ll update this page as vaccines move forward in the research process, so check back regularly.

What is a vaccine?

A vaccine helps prevent a disease or reduce the risk of infection. It works with your body’s natural defense system to build immunity.
According to the Centers for Disease Control and Prevention, a vaccine contains ingredients that imitate an infection in your body. It could be a weakened or dead virus or bacteria, or parts of a virus or bacteria. Though vaccines can cause side effects, they do not make you sick with the illness you’re vaccinating against. But they do cause your body to produce immune cells called macrophages, T-lymphocytes, and B-lymphocytes to fight off the disease.
After getting a vaccine, it takes your body time to build up protection. If you are exposed to the actual virus or bacteria in the future, your body remembers how to fight it. Some vaccines are good for life while others may require a booster shot after some time.

How long does it take to develop a vaccine?

It usually takes about 10 to 15 years — and sometimes longer — to develop a vaccine. Why so long?
Vaccines go through a multistage research process that includes several rounds of testing. The stages are meant to ensure that the vaccine works and is safe.

Exploratory stage

Researchers identify substances related to the virus or bacteria in question, also known as antigens, that might produce an immune response in your body. These can potentially be used in the vaccine to help prevent or fight a disease.

Preclinical stage

The potential vaccine is tested in cells and then in animals. These tests help them determine if the vaccine creates an immune response. Researchers may even vaccinate animals and then try to infect them with the disease. Many vaccines don’t make it past this stage because they don’t prompt an immune response.

Approval and licensing

If the phase III trial is successful, the manufacturer will submit a Biologics License Application (BLA) to the FDA. The FDA evaluates the clinical trial data for the vaccine to see if it is safe and effective in preventing infection. They also inspect the facility where the vaccine is made and then decide whether to approve it.

Post-licensure monitoring

The FDA continues to monitor the manufacturer’s facilities and reviews the vaccines for safety and purity. The FDA also has several programs that allow healthcare providers, manufacturers, and patients to submit problems they encounter with the vaccine after it is on the market.

What coronavirus vaccines are currently in development?

Ten vaccines are currently being tested in human clinical trials. While some trials are in phase II, it could still be many months before we know whether any of these vaccines will protect people against COVID-19.

Vaccines in Phase I and II clinical trials in the U.S.

There are three vaccines for COVID-19 that were developed by U.S. companies and are currently in clinical trials. One is called mRNA-1273. It is in phase I testing, and it was recently approved for phase II testing, to occur simultaneously. Volunteers are currently being enrolled in Seattle; Decatur, Georgia; and Bethesda, Maryland.

This vaccine was developed by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with a biotechnology company called Moderna, Inc. Instead of using a dead or weakened virus, researchers used genetic material copied from the virus to make the vaccine. They hope that the vaccine will mimic the natural infection of the coronavirus and cause a person’s immune system to mount a response. Early results show that eight phase I participants developed antibodies to COVID-19 similar to those seen in people who have recovered from infection.
Another vaccine in phase I testing in the U.S. is called INO-4800. It was developed by Inovio Pharmaceuticals with funding from the Bill and Melinda Gates Foundation, the U.S. Department of Defense, and the Coalition for Epidemic Preparedness Innovations. It aims to enroll 40 healthy volunteers in Philadelphia and Kansas City, Missouri. Similar to mRNA-1273, Inovio made the vaccine using genetic material from the virus.
The third vaccine in clinical trials in the U.S., dubbed NVX-CoV2373, is being developed by Novavax with support from the Coalition for Epidemic Preparedness. The company has already begun to recruit volunteers in Australia for the phase I trial. The vaccine contains coronavirus proteins that are directly injected into the body, which should produce an immune response. Researchers call this a “subunit” vaccine, and vaccines of this type are already being used against the human papillomavirus infection (HPV), hepatitis B, and shingles.
Finally, Pfizer is working on multiple vaccines with BioNTech, a German biotechnology company, and Fosun Pharma, a biotechnology company in China. Pfizer and BioNTech recently began phase I human clinical trials in Germany and the U.S. The companies will test four different variations of an RNA vaccine, which contains genetic material copied from the virus.
The phase I trial in Germany will involve 200 healthy volunteers ages 18 to 55. The second phase will involve volunteers who have a higher risk of becoming infected with the coronavirus or developing a serious infection. The phase I trial in the U.S. will enroll up to 360 healthy subjects in two age groups (18 to 55 and 65 to 85).

 

When will we have a vaccine?

Moderna’s chief medical officer has said that the company’s vaccine could be available to the general public as early as January if future studies are successful. The company has also said it could distribute a limited number of vaccines to healthcare workers this fall. 

However, Dr. Anthony Fauci, the director of NIAID, has said that even if initial trials of vaccines go well, it could be a year to a year and a half before a vaccine is ready for use by the public. Since it typically takes 10 to 15 years to develop a vaccine, this would be an incredibly accelerated timeline.

Once the vaccine is approved, it will still need to be mass produced. Early on, supplies would probably be limited and go to higher priority groups such as healthcare workers and the elderly.

Does the flu vaccine work against COVID-19?

There are vaccines for many different types of viruses and bacteria. However, a vaccine that works against one type of virus, such as influenza A (which can cause the seasonal flu), won’t work against another type, like SARS-CoV-2 (the coronavirus that causes COVID-19). The flu vaccine is designed to target strains of influenza, and won’t protect against the coronavirus, which is an entirely different virus.