As Delta Surges, FDA Pressured to Fully Approve COVID Vaccines

photo of covid 19 virus

July 9, 2021 – More and more experts are urging the FDA to fully approve the Pfizer and Moderna COVID-19 Vaccines This is because it can initiate a stalled national vaccination program and slow the rate of delta mutation infection.

The FDA authorized emergency use for those two in December Vaccines, Which is based on mRNA technology. Both companies have applied for full approval but it is not clear when the FDA will act.

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

In a guest essay The New York Times, He wrote, that people have the attitude of waiting and watching Vaccine The shot can be obtained if approved by the FDA in its entirety. Also, people can step in if needed by their employer.

“Some people who understand the ‘E’ in the EuAA as ‘Emergency’ are waiting for full FDA approval before they receive the shot,” wrote Topol.

Topol said the rapid spread of the Delta variant is one reason the FDA moves more quickly.

“The agency must give full approval to its first priority and its leadership should make its plans known to the public,” he wrote.

The CDC says 183 million doses of Pfizer and 135 million doses of modern vaccine have been issued in the United States since December. Infections, hospitalizations and deaths have dropped sharply since then.

According to Politico, MD Celine Gounder, an epidemiologist at Bellevue Hospital in New York, “is as good as it gets when it comes to data on safety and effectiveness.” “We have it in real life – what do people ask for?”

But vaccine hesitation remains. The CDC said that only 55.2% of the total US population had received at least one dose and 47.7% were completely vaccinated. The delta mutation has been identified as the dominant strain in the United States.

In a comment to Politico, FDA spokeswoman Abby Capobianco declined to give Pfizer and Moderna vaccines any time the agency can fully approve.

“Although not authorized by the FDA, the FDA conducted a thorough scientific evaluation of each of the official vaccines and can assure the public and the medical community that vaccines meet the FDA’s stringent standards for safety, efficacy and product quality,” he said. .

Politico has requested Pfizer and Moderna’s priority review, meaning the agency’s goal is to make a decision within 6 months of receiving the application.

Some scientists want the FDA to go slow. Their group has filed a “Citizen Petition” with the FDA and asked the agency to delay full approval, according to a blog on its website BMJ, Formerly it was called British Medical Journal.

“The message of our application is ‘Slow down and get the science right – there is no legitimate reason to rush to license a coronavirus vaccine.’ We believe that the basis of existing evidence – both pre- and post-empowerment – is insufficient at this time to adequately assess whether clinical benefits outweigh risks in all populations. ” BMJ Reported.

The One-Shot Johnson and Johnson vaccine received emergency approval in February, but the company has not yet applied for full approval. The vaccine does not use mRNA technology.

Delta transformation grows rapidly within people, the study says

Meanwhile, two studies have shown the risks that delta mutation can cause.

Researchers at Guangdong Provincial Disease Control and Prevention in China say the delta mutation is not as prevalent. According to NPR, it grows faster than other strains within an infected person.

Scientists say “people infected with the Delta mutation have about 1,000 times more virus copies in their respiratory tract in their respiratory tract” Coronavirus, ”Said NPR.

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

A second study outside of France showed the importance of getting two shots of two-dose vaccines, such as Moderna and Pfizer.

The study said that a single dose of the delta mutation “only inhibited” the infection, but the two doses yielded a 95% neutralizing reaction. Studied, published Nature, Echoing previous research on how many vaccines offer protection against delta mutation.

LA County COVID cases increased by 165% in one week

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

The Los Angeles County Public Health Newsletter reported 839 new COPID-19 cases this week, up 165% from last week.

The daily average case rate is now 3.5 cases per 100,000 people, compared to 1.74 cases a week ago. Thursday’s daily test positive rate was 2.5%, up from 1.2% last week.

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

The Department said the Delta variant has been the most commonly sequenced variant in LA County since early June and is “now responsible for most of the care variants identified by laboratories.”

WebMD Health News


The New York Times: “Time to FDA Approve MDRA Vaccines Fully.”

Politico: “As DeVita Increases Calls for FDA to Endorse Covid Vaccines Ly Increased.”

BMJ. “This is why we applied to the FDA not to fully approve any Kovid-19 vaccine this year.”

VIronically: “Viral Infection and Spread of Large-Detected Outbreaks Caused by Delta SARS-CoV-2 Mutations.”

NPR: “Delta transformation is not just a hyper-epidemic. It grows faster inside you. ”

Nature: “Low sensitivity of SARS-CoV-2 mutation delta to antibody neutralization”

LA County Department of Public Health: “LA County has increased the prevalence of COVID-19 and Delta mutation cases; Completely vaccinated people are better protected – 11 new deaths in Los Angeles County and 839 new cases of COVID-19. ”

© 2021 WebMD, LLC. All rights reserved.

Source link