COVID-19 clinical trials and the promise of a vaccine

The genome sequence of the SARS-Cov-2 virus was deposited on a National Institutes of Health (NIH) server on Jan. 10, 2020. Within days, scientists all over the world started to use the sequence to make vaccines. Two vaccines are now approved for limited use; eight vaccines are in large-scale phase 3 clinical trials; 13 are in expanded phase 2 safety trials; 21 are moving through phase 1 safety testing. 

More than 135 vaccines are at earlier stages of development. These numbers are being curated by the New York Times and are updated frequently. Search for their Coronavirus Vaccine Tracker; The Times will not fail to keep you updated. 

How the vaccines work

All of the vaccines are designed to present a SARS-CoV-2 spike protein to the human immune system and provoke the production of circulating antibodies and T-cells that kill lung or other cells infected with the virus. After a vaccination or illness, the immune response subsides, but many antibody-producing B cells and cell-killing T cells are banked. When infection occurs, thousands or millions of lymphocytes leap into action and block or minimize the infection. 

With some vaccines the banked cells last a long time; with others, only a few months

The spike protein is a string of about 400 amino acids in a unique order. During its synthesis, the protein folds into a spike shape and is assembled into the SARS-CoV-2. The tip of the spike protein grasps a protruding protein on the surface of human cells and the attached virus is pulled inside, where it unfolds and starts the production of much more virus. 

mRNA as one option

The vaccines in phase 3 testing are all products of genetic manipulation. In one approach, scientists inserted the gene that carries the information for the spike protein into an attenuated animal virus. The Oxford-AstraZeneca group uses a weakened chimpanzee adenovirus with an inserted spike protein gene. They have a Phase III trial in Arizona and lots of other places. The Chinese have four vaccines completing phase 3 and starting general use. 

The method that is most intriguing to me is purely chemical. Recipients get no live or dead virus, which is reassuring for some people. The new method makes the mRNA that provides instructions for the synthesis of the spike protein, but all in a test tube. The scientists wrap the coding mRNA in lipid and inject it into macaques or humans, where it enters cells and uses their protein synthesis capacity to make spike protein. 

In macaques, the mRNA-1273 vaccine successfully defends the host from the coronavirus. This novel vaccine is the product of Tony Fauci’s National Institute of Allergy and Infectious Diseases and a company called Moderna that specializes in RNA-based defenses against infectious disease. The vaccine is in phase 3 trials on 30,000 people. 

Seeking trial volunteers 

The study is recruiting volunteers. 

All clinical trials must register with an organization at the National Library of Medicine at the NIH. Anyone can find the list of clinical trials for a disease or condition at www.ClinicalTrials.gov. If you are interested in joining a SARS-Cov-2 clinical trial, you will also find medical centers involved in the trials at that website  (enter code identifier NCT04470427).

Being a participant requires commitment, because the people running a trial want to know if you produce antibody and new T-cells in response to a vaccination and how long it lasts — which means occasional blood tests. 

They want to know about side effects of inoculation. They are eager to have and are required to have participants of all ages and ethnicities. 

In the Northeast, there are few sites because there is a relatively low level of disease. If we want to test a vaccine, we have to go where disease rates are high—in the United States that means Texas, Alabama, Georgia, Arizona, Missouri and California.

The new techniques now being tested are effective and fast but we have to know about new viruses that will surely appear. New techniques will not do us much good if we ignore pandemic preparedness plans, eliminate virus surveillance programs, leave the World Health Organization, disparage the CDC and denigrate scientists and physicians who are trying to keep us alive. 

 

Richard Kessin Ph.D is Professor Emeritus of Pathology and Cell Biology at Columbia University’s Irving Medical Center. He can be reached at Richard.kessin@gmail.com.

Latest News

McCarron wins silver at state meet

Indoor track BL champs

Provided

Housatonic Valley Regional High School senior Kyle McCarron’s 1600-meter time of 4:30.31 earned him second place in this year’s indoor state meet. He was within two seconds of first-place finisher Matthew Kraszewski from Nathan Hale-Ray High School.

McCarron was one of eight runners to represent HVRHS in the 2025 Connecticut Interscholastic Athletic Conference Class S indoor track meet at Floyd Little Athletic Center in New Haven Feb. 15. In addition to his 1600-meter silver medal, McCarron placed sixth in the 3200-meter run.

Keep ReadingShow less
Joy Brown’s retrospective celebrates 50 years of women at Hotchkiss

Joy Brown installing work for her show at the Tremaine Art Gallery at Hotchkiss.

Natalia Zukerman

This year, The Hotchkiss School is marking 50 years of co-education with a series of special events, including an exhibition by renowned sculptor Joy Brown. “The Art of Joy Brown,” opening Saturday, Feb. 22, in the Tremaine Art Gallery, offers a rare retrospective of Brown’s work, spanning five decades from her early pottery to her large-scale bronze sculptures.

“It’s an honor to show my work in celebration of fifty years of women at Hotchkiss,” Brown shared. “This exhibition traces my journey—from my roots in pottery to the figures and murals that have evolved over time.”

Keep ReadingShow less
Special screening of ‘The Brutalist’ at the Triplex Cinema
Yale professor Elihu Rubin led discussions before and after “The Brutalist” screening at Triplex Cinema on Feb. 2. He highlighted how the film brings architecture into focus, inviting the audience to explore Brutalism as both a style and a theme.
L. Tomaino

A special screening of “The Brutalist” was held on Feb. 2 at the Triplex Cinema in Great Barrington. Elihu Rubin, a Henry Hart Rice Associate Professor of Architecture and Urban Studies at Yale, led discussions both before and after the film.

“The Brutalist” stars Adrien Brody as fictional character, architect Laszlo Toth, a Hungarian-born Jewish architect. Toth trained at the Bauhaus and was interred at the concentration camp Buchenwald during World War II. The film tells of his struggle as an immigrant to gain back his standing and respect as an architect. Brody was winner of the Best Actor Golden Globe, while Bradley Corbet, director of the film, won best director and the film took home the Golden Globe for Best Film Drama. They have been nominated again for Academy Awards.

Keep ReadingShow less