New shot on the block?

A potential new COVID-19 vaccine that uses familiar science could help boost the number of people getting inoculated.

Under development by European-based pharmaceutical companies Sanofi and GlaxoSmithKline (GSK), the new vaccine relies on older, more conventional technology to stimulate an immune response against the novel coronavirus.

“As the pandemic enters its third year and this virus continues to mutate, it’s important we keep up with how well our vaccines are protecting us against new strains,” said Shalika Katugaha, MD, system director of infectious diseases at Baptist Health. “This is very exciting news because the Sanofi-GSK vaccine gives us the possibility to expand our vaccine options and provide another form of protection against COVID-19. It’s also currently the only vaccine that has undergone a global late-stage efficacy study during a period with so many variants of concern.”

How does the Sanofi-GSK vaccine work?

Rather than using genetic information to make a virus protein and alert the immune system of an infection, like an mRNA (Pfizer-BioNTech or Moderna) vaccine, the Sanofi-GSK shot uses a slightly modified version of the protein to stimulate an immune response. This protein-based technology is a well-established approach that has been widely applied in vaccinations to prevent infection from other viruses, such as influenza. The vaccine can be used as a two-dose series or a booster.

Why is this new vaccine promising?

“We’ve had decades of experience using and vaccinating people with protein-based technology, including for the seasonal flu, human papillomavirus (HPV) and shingles,” said Dr. Katugaha. “Using this more familiar technology may prompt people who are hesitant to adopt the newer mRNA technology to get the shot.”

Dr. Katugaha added, “Protein-based vaccines are also relatively inexpensive to manufacture. These types of vaccines don’t have to be stored in ultra-cold temperatures like mRNA vaccines do. They can be refrigerated instead, making them more easily accessible and better candidates for use in underdeveloped areas that might really need it.”

Is the vaccine effective?

Late-stage clinical trials found that two doses of the vaccine were 100% effective at preventing severe disease and hospitalization and 75% effective against moderate to severe disease. The vaccine showed 58% efficacy against symptomatic disease, which is lower than initial Pfizer-BioNTech and Moderna trials, but in line with what's expected based on new variants of concern.

“Another clinical study by Sanofi and GSK looked at the vaccine’s effectiveness as a booster,” said Dr. Katugaha. “They found the shot produced a robust antibody response when used as an extra dose after one of the other available coronavirus vaccines, like Pfizer-BioNTech or Moderna. This is great because many individuals in the U.S. and Europe have already gotten their primary series.”

When will the Sanofi-GSK vaccine be approved?

In February 2022, Sanofi and GSK announced they completed Phase III clinical trials and are submitting the vaccine for authorization in the U.S. and Europe.

“There are several stages to vaccine development, including exploratory, pre-clinical, clinical development, review and approval, manufacturing and quality control,” explained Dr. Katugaha. “The clinical development stage includes three phases involving human participation in the trials. We most recently saw the Sanofi-GSK vaccine complete this stage, in which it was tested in around 10,000 individuals from the U.S., Asia, Africa and Latin America. One of the most significant benefits of this vaccine is that it was actually tested against a variety of variants, including omicron.”

What’s next?

Sanofi and GSK will likely soon submit the vaccine to the U.S. Food & Drug Administration (FDA) for Emergency Use Authorization (EUA).

“We’ll see vaccines against COVID-19 continue to evolve since the epidemiology of the virus is continually evolving,” said Dr. Katugaha. “Anyone who is still holding out or waiting to get vaccinated should go ahead and get whichever vaccine is accessible to him or her.”

Dr. Katugaha concluded, “I believe we are heading in the right direction, toward a calmer time and more of a sense of normalcy. COVID-19 cases are dropping drastically, and our numbers are looking quite favorable and promising. If there is a silver lining of this pandemic, it's what COVID-19 has done to the vaccine industry. I believe we’ll see a lot of new frontiers explored with vaccines in the next several years.”

At Baptist Health, we want to help keep our community informed about COVID-19. For more information about COVID-19 vaccines, visit baptistjax.com/covid19vaccine. Click here to find a vaccination location near you.