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 because it might jump-start the stalled national vaccination program and slow down the surge of the Delta variant infection.
The FDA granted emergency use authorization in December to those two vaccines, which are based on mRNA technology. Both companies have applied for full approval but it’s unclear when the FDA will act.
Eric Topol, a professor of molecular medicine at Scripps Research, and editor-in-chief of WebMD’s sister site, Medscape, is one scientist urging full approval soon.
In a guest essay in The New York Times, he wrote that people taking a wait-and-see attitude toward the vaccine might get a shot if the FDA granted full approval. Also, people might take the step if required by their employers.
“Some people who understand that the ‘E’ in ‘EUA’ stands for ‘emergency’ are waiting for full FDA approval before they receive a shot,” Topol wrote. “Others may not get immunized unless their employers require it, and many organizations — including, reportedly, the military — are waiting for the vaccines to be fully approved before instituting such mandates.”
Topol said the rapid spread of the Delta variant is one reason for the FDA to move more quickly.
The FDA says all three vaccines have been “thoroughly evaluated” and “meet the FDA’s rigorous standards,” but also says the data still needs to be “reviewed and evaluated.” Square that circle. https://t.co/bY4XcUUgJN
— James Surowiecki (@JamesSurowiecki) July 9, 2021
“The agency should make full approval its number one priority, and its leadership should communicate its plans to the public,” he wrote.
The CDC says 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 dropped sharply since.
“That’s as good as it gets when it comes to having data on safety and efficacy,” said Céline Gounder, MD, an epidemiologist at New York’s Bellevue Hospital, according to Politico. “We have it in real life — what more can people ask for?”
But vaccine hesitancy remains. The CDC says only 55.2% of the total U.S. population has gotten 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 spokesperson Abby Capobianco declined to offer a timeline for when the agency might grant full approval of the Pfizer and Moderna vaccines.
“Although an authorization is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and medical community that the vaccines meet FDA’s rigorous standards for safety, effectiveness, and manufacturing quality,” she said.
Politico said Pfizer and Moderna requested priority review, meaning the agency’s goal would be to make a decision within 6 months of receiving the application.
Some scientists want the FDA to go slow. A group of them lodged a “Citizen Petition” with the FDA asking the agency to delay full approval, according to a blog on the website of the BMJ, formerly known as the British Medical Journal.
“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations,” the BMJ reported.
The one-shot Johnson & Johnson vaccine received emergency authorization in February, but the company has not applied for full approval yet. That vaccine does not use mRNA technology.
Delta Variant Grows Quickly Inside People, Study Says
Meanwhile, two studies showed the dangers the Delta variant poses.
Researchers at the Guangdong Provincial Center for Disease Control and Prevention in China say the Delta variant is not just highly transmissible. It also grows faster inside an infected person than other strains, according to NPR.
The scientists determined that “people infected with the Delta variant had about 1,000 times more copies of the virus in their respiratory tracts than those infected with the original strain of the coronavirus,” NPR said.
The Delta variant also makes a person sicker faster, taking around 4 days to reach detectable levels inside a person, compared to 6 days with the original COVID-19 strain, NPR said.
A second study, out of France, highlighted the importance of getting two shots of two-dose vaccines like Moderna and Pfizer.
The study said one dose “barely inhibited” infection by the Delta variant, whereas two doses provided a 95% neutralizing response. The study, published in Nature, echoes previous research about how much protection vaccines offer against the Delta variant.
L.A. County COVID Cases Jump 165% in a 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 news release that there were 839 new COVID-19 cases this week, a 165% increase over last week.
L.A. 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. https://t.co/a1aPgDLrCX for more pic.twitter.com/l2eIHCk5OH
— LA Public Health (@lapublichealth) July 8, 2021
The daily average case rate is now 3.5 cases per 100,000 people, compared to 1.74 cases a week ago. The daily test positivity rate on Thursday was 2.5%, up from 1.2% last week.
“Overall COVID-19 trends are going in the wrong direction for everyone, and are particularly concerning 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 L.A. County since the beginning of June and “now accounts for the majority of variants of concern identified by labs.”
WebMD Health News
The New York Times: “It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines.”
Politico: “Calls mount on FDA to formally endorse Covid vaccines as Delta surges.”
BMJ. “Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year.”
Virological: “Viral infection and transmission in a large well-traced outbreak caused by the Delta SARS-CoV-2 variant.”
NPR: “The Delta Variant Isn’t Just Hyper-Contagious. It Also Grows More Rapidly Inside You.”
Nature: “Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization”
L.A. County Department of Public Health: “L.A. 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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