COVID-19 Vaccine Update

NIH panel refutes FDA’s claims of the benefits of coronavirus plasma treatment – CNBC

Convalescent plasma from a recovered coronavirus disease (COVID-19) patient is seen at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington, April 17, 2020.
Lindsey Wasson | Reuters

A panel of experts convened by the National Institutes of Health said Tuesday there is “insufficient data” to show convalescent plasma works against the coronavirus, refuting claims made by President Donald Trump and the head of the Food and Drug Administration.
The panel said it reviewed available data on the treatment and found nothing from “well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma” for the treatment of Covid-19. It also said “there was no difference in 7-day survival” for patients, contradicting FDA Commissioner Dr. Stephen Hahn, who said the treatment resulted in a 35% improvement in survival. 

“There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19,” the panel said in a statement. “Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19.”

There are no formally approved drugs or vaccines for the coronavirus. The plasma is taken from patients who have recovered from Covid-19 and developed antibodies against the virus and then infused in sick patients. It is one of several therapies being tested as a potential treatment.
The FDA granted the treatment emergency authorization on Aug. 23, allowing U.S. health-care providers to use the plasma to treat suspected or confirmed infections in hospitalized patients.
Results of a study by the Mayo Clinic that the FDA cited in its authorization of the plasma treatment indicates that patients below age 80 who were not on a respirator and received plasma with a high level of antibodies within three days of diagnosis fared better than patients who received plasma with a low level of antibodies. A weakness of the Mayo study was that it did not include a controlled group of patients receiving a placebo.
The FDA’s decision to authorize emergency use came a day after Trump accused the FDA of delaying enrollment in clinical trials for Covid-19 vaccines or therapeutics. The criticism from Trump and action from the FDA led some scientists to say the emergency use was politically motivated, especially since it was announced on the eve of the Republican National Convention.

Hahn, under intense criticism, later walked back comments he made on the benefits of convalescent plasma, saying he could have done a better job of explaining the data on its effectiveness.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn tweeted Aug. 24. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”
He also said he wasn’t bowing to pressure from Trump. “The decision was made by FDA career scientists based on data submitted a few weeks ago,” Hahn tweeted.
“We looked at the Mayo Clinic data,” he said during a CBS interview on Aug 25. “The Mayo Clinic identified a group of patients, certain patients that it looked like this benefited the most, that the antibodies benefited them the most. We asked for additional validation data that came in, which supported that, meaning that comparing those patients who got high concentrations of antibodies versus those that got low concentrations of antibodies.”
The FDA has issued emergency use authorization for several coronavirus tests and some drugs. In May, the agency granted antiviral remdesivir the authorization, allowing hospitals and doctors to use the drug on hospitalized Covid-19 patients. Hydroxychloroquine was also granted emergency authorization, but the FDA later removed the designation once the agency found the malaria drug was unlikely to be effective.
The NIH panel said Tuesday it will continue to evaluate emerging clinical data on the use of convalescent plasma of Covid-19. It said “well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe.”

FDA willing to fast-track coronavirus vaccine, agency chief says

The head of the U.S. Food and Drug Administration (FDA) said on Sunday that he is willing to fast-track a coronavirus vaccine in an effort to make it available as soon as possible.

Speaking to the Financial Times, Commissioner Stephen Hahn said the FDA is willing to authorize a vaccine before the end of Phase Three clinical trials – “as long as officials believed the benefits outweighed the risks,” the newspaper reported. He said the possibility was not linked to any pressure from the Trump administration.
“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the newspaper. “If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

In this scenario, Hahn said the FDA may grant emergency approval for specific groups “rather than a blanket approval,” per the outlet.

“Our emergency use authorization is not the same as a full approval,” Hahn said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”
The news comes after President Trump on Aug. 22 accused the “deep state” at the FDA of making it hard for drug companies to test coronavirus treatments – and suggested the agency is trying to delay them until after Election Day.

A day later, the FDA granted an emergency use authorization, or EUA, for convalescent plasma, a coronavirus treatment that uses the blood plasma from recovered patients to help those who are still battling the disease.

But Hahn was criticized after he grossly misstated, then corrected, claims about the lifesaving power of a plasma therapy for COVID-19 authorized by his agency. Per the Financial Times, Hahn claimed the treatment could save the lives of 35 out of 100 patients, but data reportedly shows those estimates are closer to 5 out of 100 patients.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction,” Hahn said on Twitter after facing criticism.

Hahn told the Financial Times that he regrets “contributing to any misperception.”
“I could have done a much better job last Sunday explaining relative risks,” he continued.

“We have a convergence of the COVID-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles. This is going to be a science, medicine, data decision. This is not going to be a political decision,” he added.
Fox News’s Adam Shaw and the Associated Press contributed to this report. 

Dr. Deborah Birx ‘hopeful’ for coronavirus vaccine, but says, ‘wear a mask’

White House coronavirus task force coordinator Dr. Deborah Birx on Sunday said that while she’s “hopeful” for a  vaccine, she’s also convinced that the spread of COVID-19 can be stopped through mask-wearing and social distancing.

Speaking at an event in Minnesota, Birx urged Americans to “do the right thing” now, so there are fewer cases of the virus in the fall, CNN reported.
“Yes, I’m hopeful for a vaccine,” Birx said, “but I’m also very convinced right now that we can stop community spread by wearing masks, socially distancing and avoiding crowds.”

The physician pointed out that crowds aren’t limited to events such as concerts, but also backyard barbecues with 25 people who aren’t wearing masks.

Scientists and health experts have voiced concerns that President Trump might apply pressure on the Food and Drug Administration to approve a vaccine before November to increase his chances of winning another term.

Large-scale clinical trials of the leading vaccine candidates from Moderna, Pfizer, and AstraZeneca were launched in recent weeks. Earlier this month, Johnson & Johnson said it hoped to include 60,000 subjects in its Phase 3 trial, according to Reuters.

Dr. Anthony Fauci, another White House coronavirus expert, has warned against fast-tracking a vaccine through an emergency-use authorization before it is proven safe in large trials.

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci told Reuters last week.