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As Delta Surges, FDA Pressured to Fully Approve COVID Vaccines

July 9, 2021 – More and more experts are urging the FDA to grant full approval to the Pfizer and Moderna COVID-19 vaccines, as this could revive the stalled national vaccination program and slow the outbreak of the infection with Delta variant.

The FDA granted emergency use authorization in December for these two vaccines, which are based on mRNA technology. Both companies have requested full approval, but it is not known when the FDA will act.

Eric Topol, professor of molecular medicine at Scripps Research and editor of WebMD’s sister site, Medscape, is a scientist seeking full approval soon.

In an essay invited in The New York Times, he wrote that people who take a wait-and-see attitude to the vaccine could get vaccinated if the FDA grants full approval. In addition, people could take the plunge if their employer requires it.

“Some people who understand that the ‘E’ in ‘EUA’ means ’emergency’ wait for full FDA approval before they get an injection,” Topol wrote. “Others may not get the vaccine unless their employers require it, and many organizations – including, it seems, the military – wait for vaccines to be fully approved before instituting such warrants. “

Topol said the rapid spread of the Delta variant was one of the reasons the FDA was acting faster.

“The agency should make full approval its number one priority, and its management should communicate its plans to the public,” he wrote.

The CDC says that 183 million doses of the Pfizer vaccine and 135 million doses of the Modern vaccine have been administered in the United States since December. Infections, hospitalizations and deaths have fallen sharply since then.

“It’s as good as it gets when it comes to having data on safety and efficacy,” said Celine Gounder, MD, an epidemiologist at Bellevue Hospital in New York City, according to Politico. request?”

But vaccine hesitation remains. The CDC says that only 55.2% of the total United States population has received at least one dose and 47.7% is fully vaccinated. The Delta variant has been recognized as the dominant strain in the United States.

In a comment to Politico, FDA spokeswoman Abby Capobianco declined to offer a timeline for when the agency could grant full approval for the Pfizer and Moderna vaccines.

“Although an authorization is not an FDA approval, the FDA has conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and the medical community that the vaccines meet the stringent FDA standards. safety, efficiency and build quality, ”she said. .

Politico said Pfizer and Moderna have requested a priority review, which means the agency’s goal would be to make a decision within 6 months of receiving the request.

Some scientists want the FDA to slow down. A group of them have filed a “citizens’ petition” with the FDA asking the agency to delay full approval, according to a blog post on the FDA’s website. BMJ, formerly known as British medical journal.

“The message of our petition is, ‘Slow down and get the science right – there is no legitimate reason to rush to license a coronavirus vaccine.” We believe the existing evidence base – at both before and after authorization – is simply not mature enough at this stage to adequately judge whether the clinical benefits outweigh the risks in all populations ”, the BMJ reported.

Johnson & Johnson’s single-injection vaccine received emergency clearance in February, but the company has yet to seek full approval. This vaccine does not use mRNA technology.

Delta variant grows rapidly inside people, study finds

Meanwhile, two studies have shown the dangers of the Delta variant.

Researchers at the Guangdong Provincial Center for Disease Control and Prevention in China say the Delta variant is not only highly transmissible. It also grows faster inside an infected person than other strains, according to NPR.

Scientists have determined that “people infected with the Delta variant have about 1,000 times more copies of the virus in their airways than those infected with the original strain of the coronavirus,” NPR said.

The Delta variant also makes a person sicker faster, taking about 4 days to reach detectable levels inside a person, compared to 6 days with the original COVID-19 strain, NPR said.

A second study, outside of France, highlighted the importance of getting two injections of two-dose vaccines like Moderna and Pfizer.

The study indicated that one dose “barely inhibited” the Delta variant infection, while two doses provided a 95% neutralizing response. The study, published in Nature, echoes previous research on the protection offered by vaccines against the Delta variant.

LA County COVID cases jump 165% in one week

COVID-19 is making a comeback in Los Angeles County, also because of the Delta variant.

Los Angeles County Public Health said in a press release that there were 839 new cases of COVID-19 this week, a 165% increase from last week.

The average daily rate of cases is now 3.5 cases per 100,000 people, up from 1.74 cases a week ago. The positivity rate for daily tests Thursday was 2.5%, down from 1.2% last week.

“The overall trends in COVID-19 are heading in the wrong direction for everyone, and are of particular concern given the proliferation of the Delta variant,” said Barbara Ferrer, director of public health.

The department said the Delta variant was the most commonly sequenced variant in LA County since early June and “now represents the majority of variants of concern identified by the labs.”

WebMD Health News

Sources

The New York Times: “It’s time for the FDA to fully approve mRNA vaccines. “

Politico: “Calls for the FDA to formally approve Covid vaccines as Delta rises.”

BMJ. “Why we have asked the FDA to refrain from fully approving any vaccine against covid-19 this year.”

Virological: “Viral infection and transmission in a large, well-traced epidemic caused by the Delta SARS-CoV-2 variant.”

NPR: “The Delta variant is not only hyper-contagious. It is also growing faster inside you.

Nature: “Reduced sensitivity of the Delta variant of SARS-CoV-2 to neutralization of antibodies”

LA County Department of Public Health: “LA County sees increased spread of COVID-19 and Delta variant cases; Fully vaccinated people remain well protected – 11 new deaths and 839 new confirmed cases of COVID-19 in Los Angeles County. “


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