Category: Regulations

Fauci Criticizes Russia for Allowing Citizens to Take Covid-19 Vaccine After Passing Phase 2 Safety Trials

Milton Friedman thought that, at the very least, the FDA should allow Americans the freedom to choose to take drugs or vaccines after their safety has been established (basically meaning after passing the Phase 2 safety trials). Isn’t it strange that in the FDA’s United States, citizens may not do so, but in Putin’s authoritarian Russia, citizens are allowed that choice?

(p. A4) In a panel discussion, Dr. Anthony S. Fauci, the nation’s top infections disease expert, criticized Russia’s rushed clearance of a coronavirus vaccine. The vaccine, called Sputnik V, was approved without evidence that Phase 3 clinical trials had been completed, an essential part of the development pipeline to prove a product is safe and effective in people.

. . .

Dr. Fauci called attention to the many other coronavirus vaccines vying for eventual clearance, including several that are in Phase 3 trials in the United States. The process for testing vaccines can last months and usually involves thousands of people.

“So if we wanted to take the chance of hurting a lot of people or giving them something that doesn’t work, we could start doing this, you know, next week if we wanted to,” Dr. Fauci said. “But that’s not the way this works.”

For the full story, see:

Barron, James. “Coronavirus Update.” The New York Times (Thursday, August 11, 2020): A4.

(Note: ellipsis added.)

(Note: the online version of the story was updated August 14, 2020, and has the title “U.S. Coronavirus Death Toll Reflects Sun Belt Outbreaks.” Where there are slight differences in wording between the versions in the passages quoted, the online version appears above. The online version does not list an author. I cite James Barron, who is listed as the author in the print version.)

Viruses Mutate More Nimbly Than Therapies Hobbled by FDA Regulations

(p. A7) In a laboratory in New York City, researchers coaxed a key piece of the coronavirus — its infamous outer “spike” — to mutate so that it became invisible to disease-fighting antibodies, according to a new study that has not yet been published in a scientific journal.

The provocative finding should not set off alarm bells, experts said. The altered spikes were not attached to the real coronavirus, which mutates at a much slower pace than most laboratory viruses. But the study does underscore the need for treatments and vaccines that attack the virus in different ways, so that if the pathogen manages to evade one approach, another will be waiting in the wings.

“It’s an old story for virology,” said Dr. Sallie Permar, a virologist and pediatrician at Duke University who was not involved in the study. “If you only target one little region, that virus is going to find a way to get away from it. It’s why viruses are so successful in this world.”

. . .

Several types of monoclonal antibodies are now in clinical trials. If all goes well, such concoctions might not only treat coronavirus infections but also prevent them. That could help millions of people, especially as the world awaits a vaccine, said Akiko Iwasaki, an immunologist at Yale University who was not involved in the study.

But the new findings also hint that single-antibody formulations “may not be as successful,” Dr. Taylor said, at least in the long term. Developing a cocktail containing a diverse blend of antibodies could be a safer bet.

Such mixtures would also more accurately mimic the body’s natural response to the coronavirus. In the study, viruses flushed with samples of convalescent plasma — fractions of blood donated by people who have recovered from Covid-19 — struggled to infect cells.

Some scientists, including those at American biotechnology company Regeneron, are already attempting this combo approach, mixing two potent types of monoclonal antibodies into a single treatment.

But Dr. Iwasaki pointed out that antibody cocktails might be tougher to bring to market. “Every time you make a drug, you get approval for each component separately,” she said. . . .

The lesson of diversity might be even more powerful for vaccines, which can marshal a multifaceted immune response. Some immune cells and molecules will be tailored to home in on the spike, whereas others might prefer other parts of the virus. Vaccines that present the body with many pieces of the coronavirus, rather than the spike alone, could have a better shot at triggering a suite of these defenses, said Dr. Taia Wang, an immunologist at Stanford University who was not involved in the study.

For the full story, see:

Katherine J. Wu. “Experiment on Spike Protein Shows Obstacles of Mutation.” The New York Times (Wednesday, July 29, 2020): A7.

(Note: ellipsis added.)

(Note: the online version of the story has the date July 28, 2020, and has the title “The Coronavirus Could Dodge Some Treatments, Study Suggests.” The online version has an extra paragraph that does not appear in the print version. In my quotations above, I stick to the print version.)

Masks “Absolutely Essential” to “Get Control of the Virus”

(p. 6A) Adm. Brett Giroir, a member of the White House coronavirus task force, called mask-wearing in public, which has been met with resistance in some U.S. states, “absolutely essential.”

Giroir, the assistant secretary at the Health and Human Services Department, told ABC’s “This Week” on Sunday [July 12, 2020] that “if we don’t have that, we will not get control of the virus.”

For the full story, see:

AP. “As U.S Wrestles With Virus Florida Sets Daily Record.” Omaha World Herald (Monday, July 13, 2020): A6.

(Note: bracketed date added.)

Jim Pethokoukis Asks Art Diamond How to Increase Innovative Dynamism

Jim Pethokoukis recently posted an abbreviated transcript of our conversation on his Political Economy podcast about my Openness to Creative Destruction: Sustaining Innovative Dynamism book.

Posted by Arthur Diamond on Thursday, August 6, 2020

China Allows Some Volunteers to Receive Covid-19 Vaccines After Only Phase 2 Trials

(p. B1) The offer to employees at the state-owned oil giant was compelling: Be among the first in China to take a coronavirus vaccine.

The employees at PetroChina could use one of two vaccines “for emergency use” to protect themselves when working overseas as part of China’s ambitious infrastructure program, according to a copy of the notice, which was reviewed by The New York Times.

. . .

(p. B6) Such “emergency use” is rare, and the taking of unapproved vaccines is typically reserved for health care professionals. Although the government has stressed that taking the vaccine is voluntary, the state-owned workers and soldiers could feel pressure to participate.

. . .

Along with the testing at the oil company, Sinopharm, which has completed Phase 2 trials for two products, has injected the vaccine into its chairman and other senior officials, according to the State-owned Assets Supervision and Administration Commission, or SASAC, the government agency managing all employees at state-backed companies. The Chinese government has allowed the CanSino-military vaccine to be given to its armed forces, a first for the military of any country.

. . .

“If you are a regulatory body, if you play by the rules, if you are hard-nosed about it, you say this is very wrong,” said Ray Yip, the former head of the Gates Foundation in China.

Dr. Yip added that it would be useful for company executives to know that they had given the dose to “a couple of thousand people, but no one has dropped dead, so that’s pretty good.”

Dr. Yip said the people taking the vaccines should read up on reports of the safety data and make an informed decision. He said he would be willing to take it.

“If you offer that to me saying it’s safe and there’s an 85 percent chance that it works, would I take it today?” he said. “You know what, I probably will. Because then I don’t have to worry.”

In a post on its official WeChat account, a government agency reported that the “vaccine pretest” on Sinopharm employees showed that antibody levels were high enough in subjects to combat the coronavirus, indicating that it was safe and effective.

. . .

In June [2020], Sinopharm began the third phase of clinical trials in Beijing, Wuhan and Abu Dhabi, becoming the first company to enter the final regulatory stage. China’s Sinovac Biotech is teaming up with Instituto Butantan in Brazil, which has the world’s second-highest case count after the United States.

. . .

Dimas Tadeu Covas, the director of Butantan, said that he was impressed with Sinovac’s preliminary results and that the vaccine “has the greatest potential for success.” He cited results from Sinovac’s Phase 1 trials that showed no adverse effects and Phase 2 trials that showed 90 percent protection against Sars-Cov2.

“I know vaccines, and I am betting a lot on this one,” Dr. Covas said.

For the full story, see:

Sui-Lee Wee and Mariana Simões. “China Skirts Convention For Vaccines.” The New York Times (Friday, July 17, 2020): B1 & B6.

(Note: ellipses added.)

(Note: the online version of the story was updated June 17, 2020, and has the title “In Coronavirus Vaccine Race, China Strays From the Official Paths.”)

“Quite Good” Moderna Vaccine Starts Phase 3 Trial on July 27, 2020

(p. A6) New details about the first human study of Moderna Inc.’s experimental coronavirus vaccine emerged Tuesday, which researchers said reinforced their decision to take the shot into a large, decisive clinical trial scheduled to start in late July [2020].

The new results, published online by the New England Journal of Medicine, showed that the vaccine induced the desired immune response for all 45 people evaluated—a larger group than in the preliminary data Moderna released in May—and was generally safe and well-tolerated.

“This is really quite good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview Tuesday. NIAID co-developed the Moderna vaccine and led the study.

“The gold standard of protection against a viral infection is neutralizing antibodies,” he added. “And the data from the study, small numbers as it may be, are pretty clear that this vaccine is capable of inducing quite good [levels] of neutralizing antibodies.”

Researchers said they found no serious safety risks, though some participants had injection-site pain and symptoms such as fatigue, headache and chills.

Dr. Fauci said it is possible that the coming large study would yield an answer by year-end about whether the vaccine induced immune responses sufficient to protect people safely from Covid-19. A positive answer would clear the way for wider use and potentially help curb the deadly pandemic.

The new “Cove” study, scheduled to start July 27, will aim to enroll about 30,000 adults at nearly 90 different U.S. locations.

For the full story, see:

Loftus, Peter. “Data Show Vaccine Is Ready for Big Trial.” The Wall Street Journal (Weds., July 15, 2020): A6.

(Note: bracketed year added.)

(Note: the online version of the story was updated June 14, 2020, and has the title “Moderna’s Covid-19 Vaccine Moves to Bigger Study.”)

Citron Research Alleged That DNA Vaccine Firm Inovio Is “the COVID-19 Version of Theranos”

(p. A10) Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14.

Together, the sisters make up about 5 percent of the first ever clinical trial of a DNA vaccine for the novel coronavirus. How they respond to it will help determine the future of the vaccine. If it proves safe in this trial and effective in future trials, it could become not only one of the first coronavirus vaccines, but also the first DNA vaccine ever approved for commercial use against a human disease.

. . .

In many of these studies, the vaccine recipe isn’t the only thing on trial. Gene-based vaccines — and at least 20 coronavirus vaccines in development fall into this category — have yet to make it to market. Should one end up in doctors’ offices amid the rush to shield billions from Covid-19, it would represent a new chapter for vaccine development.

And though vaccine research has never moved this quickly — potentially meaning enhanced risks for volunteers — it has never been easier to recruit subjects, according to Dr. John E. Ervin, who is overseeing the DNA vaccine trial at the Center for Pharmaceutical Research in Kansas City, Mo., in which the sisters are involved. For the Phase 1 trial of the vaccine, which was developed by Inovio Pharmaceuticals, 90 people applied for the 20 slots in Kansas City.

“We probably could charge people to let them in and still fill it up,” he said. (In fact, the participants were paid per visit.)

. . .

Inovio researchers engineered the vaccine in just three hours, according to Kate Broderick, the company’s senior vice president for research and development. Or, rather, their computer algorithm did: On Jan. 10 [2020], when Chinese researchers released the genetic code of the novel coronavirus, the team ran the sequence through its software, which popped out a formula.

This timeline struck some in the financial sector as too good to be true. Citron Research, which advises investors on companies to bet on, called Inovio “the Covid-19 version of Theranos,” referring to the blood-testing device company that imploded as its supposedly revolutionary product was revealed to be a hoax.

“Much like Theranos, Inovio claims to have a ‘secret sauce’ that, miraculously, no pharma giant has been able to figure out,” Citron Research wrote. “This is the same ‘secret sauce’ that supposedly developed a vaccine for Covid-19 in just three hours.”

For the full story, see:

Heather Murphy. “Fight Against Coronavirus Could Produce a First: A DNA Vaccine.” The New York Times (Friday, June 19, 2020): A10.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story was updated June 22 [sic], 2020, and has the title “Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers.”)

Art Diamond Interviewed on Using Masks and Speeding Vaccines to Stop Covid-19

I was interviewed early on Mon., July 20, 2020 on Jim Blasingame’s Small Business Advocate radio program on using masks and speeding vaccines to stop Covid-19.