Sanofi and GSK Say COVID-19 Vaccine Did Well in Trial, Will Seek US Clearance

A COVID-19 vaccine created by Sanofi and GlaxoSmithKline (GSK) performed well in a clinical trial, the companies said on Feb. 23. The vaccine was 100 percent effective against hospitalization, 75 percent effective against moderate to severe disease, and 58 percent effective against any symptoms, the companies said in a joint statement. The phase 3 trial, which is still ongoing, is analyzing a primary vaccination series, which consists of two doses spaced several weeks apart. The trial includes more than 10,000 participants 18 or older at sides in the United States, Asia, Africa, and Latin America. “We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” Thomas Triomphe, Sanofi’s executive vice president, said in a statement. The companies didn’t release data from the trial or another study that is looking at how well a booster dose of the same vaccine does. “In transparency and for scientific exchange we are sharing the topline data publicly upon receiving it. We will complete the analysis and publish the full data for both the primary and booster studies in the coming months,” a GSK spokesperson told The Epoch Times in an email. The companies weren’t able to say whether the vaccine is effective against the Omicron virus variant, which is currently dominant in many countries around the world. They expect to have more participants with Omicron in the next stage of the study. The three COVID-19 vaccines authorized for use in the United States have all performed worse against Omicron than previous variants of the CCP (Chinese Communist Party) virus, which causes COVID-19. Two of the vaccines are built on messenger RNA technology; they were the first of their kind to receive U.S. regulatory clearance. The third, Johnson & Johnson’s, uses a viral vector. The Sanofi and GSK shot is a protein-based vaccine. The companies plan to complete a request for authorization from the Food and Drug Administration in the coming weeks, the spokesman said. “SARS-CoV2 remains a new virus, and the emergence of variants like Omicron will mean the need for boosters will likely continue for some time. Additional boosters are to be expected at a minimum for at-risk segments of the population, with timing and frequency determined by epidemiology,” he said, adding that the trial data suggested the vaccine could work as a booster in people who receive other vaccines. Novovax in late January asked the administration for emergency use authorization for its protein-based vaccine, but regulators haven’t yet authorized or rejected the application. “I do think it would be beneficial to have one, at least one protein subunit vaccine out there,” Paul Mango, a former Department of Health and Human Services official, told The Epoch Times. Mango said the type of vaccine may be more robust against new variants. Under the Trump administration, the U.S. government reached a deal with Sanofi and GSK to pay up to $2.1 billion for up to 100 million doses of the vaccine candidate. The vaccine was on track to be ready in 2021 but results from a clinical trial showed an “insufficient response,” the drugmakers said in late 2020.

Sanofi and GSK Say COVID-19 Vaccine Did Well in Trial, Will Seek US Clearance

A COVID-19 vaccine created by Sanofi and GlaxoSmithKline (GSK) performed well in a clinical trial, the companies said on Feb. 23.

The vaccine was 100 percent effective against hospitalization, 75 percent effective against moderate to severe disease, and 58 percent effective against any symptoms, the companies said in a joint statement.

The phase 3 trial, which is still ongoing, is analyzing a primary vaccination series, which consists of two doses spaced several weeks apart. The trial includes more than 10,000 participants 18 or older at sides in the United States, Asia, Africa, and Latin America.

“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” Thomas Triomphe, Sanofi’s executive vice president, said in a statement.

The companies didn’t release data from the trial or another study that is looking at how well a booster dose of the same vaccine does.

“In transparency and for scientific exchange we are sharing the topline data publicly upon receiving it. We will complete the analysis and publish the full data for both the primary and booster studies in the coming months,” a GSK spokesperson told The Epoch Times in an email.

The companies weren’t able to say whether the vaccine is effective against the Omicron virus variant, which is currently dominant in many countries around the world. They expect to have more participants with Omicron in the next stage of the study.

The three COVID-19 vaccines authorized for use in the United States have all performed worse against Omicron than previous variants of the CCP (Chinese Communist Party) virus, which causes COVID-19.

Two of the vaccines are built on messenger RNA technology; they were the first of their kind to receive U.S. regulatory clearance. The third, Johnson & Johnson’s, uses a viral vector. The Sanofi and GSK shot is a protein-based vaccine.

The companies plan to complete a request for authorization from the Food and Drug Administration in the coming weeks, the spokesman said.

“SARS-CoV2 remains a new virus, and the emergence of variants like Omicron will mean the need for boosters will likely continue for some time. Additional boosters are to be expected at a minimum for at-risk segments of the population, with timing and frequency determined by epidemiology,” he said, adding that the trial data suggested the vaccine could work as a booster in people who receive other vaccines.

Novovax in late January asked the administration for emergency use authorization for its protein-based vaccine, but regulators haven’t yet authorized or rejected the application.

“I do think it would be beneficial to have one, at least one protein subunit vaccine out there,” Paul Mango, a former Department of Health and Human Services official, told The Epoch Times.

Mango said the type of vaccine may be more robust against new variants.

Under the Trump administration, the U.S. government reached a deal with Sanofi and GSK to pay up to $2.1 billion for up to 100 million doses of the vaccine candidate.

The vaccine was on track to be ready in 2021 but results from a clinical trial showed an “insufficient response,” the drugmakers said in late 2020.