GSK announces COVID-19 vaccine candidate effective in preventing Omicron infection –

Another COVID-19 vaccine could hit the market in the United States soon after European pharmaceutical giants Sanofi and GlaxoSmithKline (GSK) announced on Friday that vaccine candidates are more than 70% effective at preventing infection by the highly contagious Omicron strain. .

The companies have yet to apply for authorization in the United States, but are expected to make a proposal to add their injections to the Pfizer-BioNTech, Moderna, and Novavax vaccines in the injection arsenal available in the United States and around the world.

That’s because the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been criticized for approving Pfizer and Moderna injections for children six months to four years old.

The news comes as the Covid situation in America remains steady at 99,984 cases per day, but the death toll rose 20% last week to 385 per day.

The so-called bivalent vaccine targets both the beta variant first identified in South Africa and the original Wuhan virus strain.

In a study of 13,000 adults, the vaccine showed 64.7% efficacy against symptomatic Covid and 72% against infections specifically caused by the Omicron variant.

Results were stronger when used in people who had previously had Covid. The companies said the vaccine had an efficacy rate of 75.1 percent against symptomatic COVID and 93.2 percent in Omicron-confirmed symptomatic cases.

GSK and Sanofi collaborate on candidate COVID-19 vaccine that is over 70% effective in preventing Omicron variant infection (archive photo)

“The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled study in an environment with high circulation of Omicron variants,” Sanofi said in a statement. Said.

Sanofi shares traded in Paris and GSK shares traded in London rose more than 1% in morning trading.

Earlier this month, the bivalent vaccine demonstrated potential in two studies to protect against worrisome major variants of the virus (Omicron BA.1 and BA.2 strains) when used as a booster injection.

Sanofi and GSK, two of the world’s largest vaccine manufacturers, hope to gain a foothold in the Covid vaccine market, which is focused on next-generation variants after the original crashed into the pandemic race.

The companies said Friday that new data supporting the bivalent vaccine will be made available to regulators in hopes of making the injection available later this year.

Sanofi and GSK’s original Covid vaccine is currently under review by the European Medicines Agency.

The companies have bet that this bivalent vaccine, formulated on the now-modified beta variant, will offer broad protection against future viral strains based on the fact that the beta expresses similar mutations in many related variants, including Omicron.

Health officials recently targeted approving Covid vaccines for children aged six months to five years, another move that has been criticized for not providing much value.

Dr. Vinay Prasad, an associate professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco, criticized officials and others in a YouTube video he uploaded Wednesday morning, saying there was little evidence of the need for injections. being “honest” about the shot.

“All your lies and exaggerations will be the same. [of parents] it’s going to happen [vaccinate their children] and you will not turn down the oaths,” he said.

“You can’t convince anyone. You put it in a little thicker and then you discredited it”

He also fiercely criticized the data used by the mainstream media to promote the vaccine, such as the New York Times.

Prasad claims that the Moderna vaccine is 38% effective against the virus. He says that when the data is adjusted by the company to account for in-home testing, in some cases when not properly recorded, effectiveness drops by as much as 27%.

He also said there is little data to support the claim that the Pfizer vaccine is 80% effective at preventing infections.

“We have to be honest about it,” he said.

Dr. Marty Makary, a public health expert at Johns Hopkins University, shared similar thoughts in an email to DailyMail.com and said:

The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe Covid-19 infection. As a result, the FDA allowed both companies to estimate efficacy by measuring antibody levels, referring to data from older children and adults.

“They had enough reliability stats to guide us through an aircraft carrier. (They reported the largest confidence interval I’ve seen in my 20-year career as a researcher.)