After the Food and Drug Administration presented dubious knowledge to justify its approval of blood plasma to treat COVID-19, some scientists are concerned that the company is trying to approve a coronavirus vaccine before it is fully tested.
On Sunday, President Donald Trump announced that the FDA had issued an emergency use authorization for blood plasma. The president, the secretary of health and human services and the head of the FDA said the remedy had reduced the number of deaths among COVID-19 patients by 35%.
This is not the case and scientists promptly questioned the FDA’s claims about the data.
“You saw the FDA being bullied by the president of the United States to approve anything it didn’t need to pass before, because he was looking for it,” said Dr. Paul Offit, director of the Children’s Hospital’s Vaccine Education Center. in Philadelphia, in an online interview Monday with the editor of the Journal of the American Medical Association.
Knowledge showed a decrease in mortality rate by only a small fraction of those who gained blood plasma, an antibody-rich fluid derived from the blood of COVID-19 survivors. Specifically, it helped others under the age of 80 who had no fan and who obtained plasma within 3 days of diagnosis.
Without a control organization of patients who didn’t get blood plasma, it’s highly unlikely to know if plasma stores lives.
The American Society of Infectious Diseases was sufficiently involved to factor out a saying that if there were “positive signs” that plasma was helping, it deserved to not be allowed wider use until randomized and controlled studies were conducted.
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According to the unreleased study, approximately 9% of patients in this organization, those who were younger, received early plasma and obtained the best doses of antibodies, died after receiving treatment, and 12% of those who earned it later and in smaller amounts. .
This is about 35% difference for this group, but that means that treatment has reduced the same number of coVID-19 deaths overall.
The FDA’s exaggeration and approval of the emergency use of the cOVID-19 remedy based on an incorrect application of an existing cure are a source of fear for scientists and vaccine-focused researchers.
They are concerned that the FDA will bend to pressure from the White House to consider an emergency use authorization, or the U.S., for a coronavirus vaccine to increase the president’s chances of re-election.
Trump said he expects a “very soon” vaccine. He raised the option that an alleged “deep-state” conspiracy at the FDA could delay it until the November 3 presidential election.
Last week, Dr Peter Marks, who heads the FDA’s vaccination group, told Reuters that he had not faced political strain on a vaccine without sufficient protection and efficacy data. He said he’d quit if that happened.
But several scientists said the plasma permit renewed their considerations. “You can bet he considers me, ” said Offit.
“It is now seeking to intimidate the FDA into approving, through an emergency use authorization, a vaccine or vaccines before they have been well tested,” he said. “This is a major mistake.”
While the remedy is given to people in poor health, vaccines are given to healthy people, so there is much more at stake.
“Vaccines can be given to millions of others, many millions of others around the world, or even billions,” said Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California.
“How are we going to accept as true with this guy and our FDA in the coming months in connection with an emergency vaccine authorization?” He said. “We’re in the middle of a pandemic, what’s at stake is really high. It couldn’t be higher.”
It would possibly be sensible to grant emergency use for a COVID-19 vaccine if the comprehensive knowledge of a Phase 3 clinical trial has demonstrated fair protection and transparent evidence to eliminate the disease, and only certain “disruptions or technical or administrative steps” remain. said Dr. Jesse Goodman, Director of georgetown University’s Center for Safety and Management at Medical Product Access.
If the company made this decision, the vaccine would only be used for others at increased risk of exposure to COVID-19 or disease, he said. It would be “essential for recipients to obviously perceive that the product is not FDA approved and why, and what is known and not known about the protection and efficacy of the product.”
More people could end up being whether the FDA is following the procedure of fully authorizing a coronavirus vaccine rather than approving it urgently, said Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. .
“It would take longer, but it could have more impact, because if other people perceive the procedure to be the general procedure and shown, it hasn’t accelerated, more people are likely to get out of it,” he said. Said.
Since a significant number of Americans are already involved in vaccine safety, approving it without rigorous scrutiny can only public confidence in vaccines in the coming years, said Dr. William Schaffner, a professor in the Division of Preventive Medicine and Infectious Diseases at Vanderbilt University in Nashville. Tennessee.
“I can hear skeptical vaccine teams standing up and lashing out at the entire vaccine evaluation system,” he said. “That would be a profoundly bad thing for public health.”
This can also be a recruitment into long-term vaccine studies to protect themselves from SARS-CoV-2, the virus that causes COVID-19, as the public would possibly lose confidence in the process.
“One of the potential risks if a vaccine is released is that it would be difficult, if not impossible, for other vaccines to recruit others in their trials,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Reuters said monday.
“What you wouldn’t need to see with a vaccine is getting an A.S.A. before you get a sign of efficacy,” he said.
Barry Bloom, immunologist and vaccine expert who is a professor of public aptitude at Harvard T.H. Chan School of Public Health said he had great confidence in FDA technical staff. But this is the third time in the pandemic that the FDA has made decisions more policy-based than data, he said.
The first was the issuance of an emergency authorization for hydroxychloroquine as a remedy against COVID-19 and its elimination. The timing was the FDA’s ruling to allow corporations to market antibody tests without prior approval. And now emergency approval of the blood plasma remedy in a fragile clinical field.
Plasma from others who have recovered from the disease contains antibodies that can help others who are recently fighting the disease. The remedy has been used for more than a century against various diseases, from diphtheria in the 1890s to Ebola in 2014 and 2015.
But each and every disease is another and plasma can do more harm than good. That’s why careful studies are needed, Bloom said.
“I hope FDA leaders will stand firm on a clinical basis,” he said Tuesday. “Otherwise, accepting it as true across the clinical business is compromised.”
The FDA authorizes all vaccines used in the United States. At the last level of testing, called a phase 3 clinical trial, the vaccine is given to thousands of people to make sure it is effective.
When completed, knowledge is collected in an application that is reviewed through an FDA team that includes doctors, microbiologists, chemists, biostatisticians and others.
“It’s a round-trip process” between the FDA and the well-connected company, Norman Baylor, ceo of Biologics Consulting and former director of the FDA’s Office of Vaccine Research and Review.
“The reviews are very thorough. They will have to be; are the gold standard,” he said.
But officials have hinted that they can speed up the COVID-19 vaccine procedure to make it public faster and save lives.
Brands and DR. Stephen Hahn, FDA commissioner, said no corners would be cut. Schaffner is involved in “having left room for manoeuvre.”
For example, he said, the FDA may simply review knowledge of a giant Phase 3 clinical trial before its final touch and that, based on the effects at this stage, a vaccine gave the impression of being safe and effective enough to be marketed.
Phase 3 trials for the SARS-CoV-2 vaccine come with 30,000 people, of whom 15,000 get the vaccine and 15,000 get a placebo.
“It wouldn’t be great to start with the vaccine in the audience if we stopped in half, if we only had another 7,500 people who won the vaccine,” Schaffner said.
It takes time to see if there are protection problems among thousands of volunteers and judge whether they are due to an infection, Topol said.
Despite Trump’s repeated statements that a vaccine will soon arrive, there has been no time for this knowledge to become available.
“There is no meaningful knowledge this year. Point,” Topol said. All that happens so temporarily is “a hoax.”