Two Drug Manufacturers Seek Approval of New COVID-19 Vaccine

February 24, 2022:

Drugmakers Sanofi and GlaxoSmithKline said Wednesday that they will seek authorization for a new COVID-19 vaccine after clinical trials showed a high level of protection, according to The Associated Press.

Late-stage trials found that two doses of the vaccine were about 58% effective at preventing infection, 75% effective at preventing moderate to severe disease, and 100% effective at preventing severe disease and hospitalization, the companies said.

In addition, a separate study that used the vaccine as a booster shot showed that it “induced a significant increase in neutralizing antibodies” among people who had previously received a Pfizer or Moderna vaccine, they said.

“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” Roger Connor, president of GSK Vaccines, said in a statement.

The Sanofi-GSK vaccine “uses a well-established approach that has been applied widely to prevent infection with other viruses, including pandemic flu,” he said. “We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period.”

The companies said they plan to seek regulatory approval from both the FDA and European Medicines Agency for the adjuvanted protein-based vaccine, which can be stored at refrigerator temperatures. The vaccine could be used as an initial two-dose series or a booster shot.

Sanofi and GSK had planned for the vaccine to be ready last year, the AP reported., However, early clinical trials showed that the shot didn’t produce a robust immune response in ages 60 and older because it didn’t contain enough of the material that prompts the body to create antibodies.

With an updated vaccine, late-stage clinical trials included 10,000 adults in the U.S., Asia, Africa, and Latin America. The companies didn’t provide a breakdown of vaccine effectiveness for different age groups, the AP reported. Full results will be published later this year.

If authorized, the shot could bolster pandemic efforts around the world, the AP reported. Sanofi and GSK have signed agreements to supply millions of doses to the U.S., Canada, European Union and developing countries. WebMD