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An Entirely New Vaccine Against the Most Severe Strain of the Covid-19 Virus Is Fighting for FDA Approval!

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Sanofi and GSK reported Wednesday that a new COVID-19 vaccine has achieved 100 percent effectiveness against severe illness and hospitalisation. The businesses are now preparing to submit applications to regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval to market the vaccine as a two-dose vaccination and booster injection.

In contrast to mRNA-based vaccinations, the new Sanofi-GSK product is a protein-based vaccine – a “well-established technique that has been widely used to prevent infection with other viruses, including pandemic flu,” according to GSK President Roger Connor in a statement today.

“We are certain that this vaccine will be critical in addressing the pandemic and preparing for the post-pandemic phase,” he added.

As with previous COVID-19 vaccinations, the new dosage is aimed against the spike protein of the SARS-CoV-2 virus that causes the sickness. While mRNA vaccines function by providing our cells with the information necessary to create their own spikes to train against, the Sanofi-GSK vaccination imparts protection by including a modified version of the spike.

While the vaccine alone is reported to have an efficacy rate of just 57.8 percent against any symptoms of the disease – significantly less than the efficacy rates reported for mRNA vaccines produced by companies such as Pfizer and Moderna – the company claims an unmatched 100 percent efficacy against severe disease and hospitalizations, as well as 75 percent efficacy against moderate-to-severe disease.

“We are delighted with these results, which validate our excellent science and the efficacy of our COVID-19 vaccine,” Sanofi Executive Vice President Thomas Triomphe stated. “The Sanofi-GSK vaccination exhibits an unmatched capacity to increase immunity across all platforms and age groups.”

Covid-19 Virus

If the Sanofi-GSK proposal is approved by regulators, there are a number of possible benefits. Because it is not dependent on mRNA, it can be made cheaply and stored at refrigerator temperatures rather than requiring ultra-cold storage — excellent news for those living in low-income nations where vaccine implementation has been alarmingly slow.

It may also persuade some vaccine-averse individuals to receive the shot, as it is based on older, more generally accepted technologies.

And, while the overall effectiveness rate against any symptoms may not meet mRNA-vaccine criteria, neutralising antibody levels grew more than twice as much following the Sanofi-GSK vaccination as they did following the mRNA competitors.

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This impact was magnified when the Sanofi-GSK vaccination was administered as a booster: among trial participants who had previously received another vaccine, a Sanofi-GSK booster injection enhanced neutralising antibody levels 18- to 30-fold across vaccine platforms and age groups, according to the statement.

This rise was an astounding 84- to 153-fold for research participants whose initial immunisation regimen was Sanofi-GSK.

“We… saw the vaccine’s remarkable effectiveness in a main series in today’s tough epidemiological setting,” Triomphe said. “No other worldwide Phase 3 effectiveness research with this many variations of concern, including Omicron, has been conducted during this time span, and these efficacy statistics are comparable to current clinical data from licenced vaccines.”

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