Health Highlights: Aug. 11, 2020

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Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Russia Approves COVID-19 Vaccine Before Trials Completed

Before completing clinical trials to ensure the vaccine is safe and effective, the Russian government has gone ahead and approved a vaccine against the new coronavirus, the New York Times reported Tuesday.

According to Russian President Vladimir Putin, the vaccine works “effectively enough.”

The premature approval of a vaccine confirms concerns from other nations that Russia is more interested in making political and propaganda hay in the race to acquire a working vaccine, the Times reported.

Putin’s announcement comes despite a lack of published data on any testing for the vaccine.

Last week the World Health Organization urged Russia not to bypass the usual methods of testing to ensure safety and effectiveness.

“It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” Putin told a Cabinet meeting on Tuesday. He also said one of his daughters been given the vaccine, the Times said.

The Russian vaccine was rushed through monkey and early human trials and was most likely successful. But it hasn’t been widely tested in large phase 3 trials — the only way of ensuring it’s safe and effective in broad populations.

Mikhail Murashko, Russia’s minister of health, has said mass vaccination will start in October, beginning with teachers and medical workers.

The Russia approval comes far ahead of when Western countries are expected to have a working vaccine, which isn’t expected before the end of the year.

The United States, Canada and Britain have accused Russian hackers of trying to steal vaccine research, spurring doubt that Russia has achieved any medical breakthrough on its own.

The Russians have said say their vaccine is based on an Ebola vaccine they developed years ago, the Times reported.

The Russian vaccine uses two strains of adenovirus — viruses that typically cause mild colds in humans. Similar vaccines are being tested in other countries. It’s the approach being used by Oxford University and drug maker AstraZeneca.

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FDA Head Says Any Approved COVID-19 Vaccine Will Be Safe

Dr. Stephen Hahn, the head of the U.S. Food and Drug Administration, said Monday that the agency will not compromise safety when approving COVID-19 vaccines, CNN reported.

That assurance was given during a video briefing with the American Medical Association.

Because of how fast the FDA is working, some have questioned if the agency will weaken its usual rigor when it reviews data from clinical trials.

“Let me assure you that we will not cut corners,” Hahn said. “All of our decisions will continue to be based on good science and the same careful deliberative processes we have always used when reviewing medical products.”

Many Americans are wary of a vaccine. Hahn said he has seen surveys that show that many people will be reluctant to get vaccinated.

In May, a CNN poll found one-third of Americans wouldn’t get a COVID-19 vaccine even if it is widely available and inexpensive.

Hahn urged doctors to get their patients to take the vaccine when it’s approved.

“We hope that you will urge your patients to take an approved vaccine so that we can seek to establish widespread immunity,” he said.

More than 200 trials are underway, Hahn said, but no one knows when the results of those trials will be ready.

“I can promise you that when the data are available, FDA will review them, using its established rigorous and deliberative scientific process. We all understand that only by engaging in an open review process and relying on good science and sound data can the public, and you as providers, have confidence in the integrity of our decisions,” he said.

Despite claims by President Donald Trump that a vaccine will be ready in November, experts say that’s not possible.

“I don’t see how that would be possible,” Dr. Paul Offit, a vaccinologist at Children’s Hospital of Philadelphia, told CNN.

Before a trial can start, Moderna, a company that’s ahead of most in developing a vaccine, needs to finish enrolling patients in late-stage trials. That might happen by the end of September. Then the volunteers have to have their first shots, wait 28 days, and then give a second shot. After that, researchers have to wait two weeks to see if the vaccine is effective.

Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine in Houston, told CNN “there’s just no way” a vaccine will be available by Nov. 3. It’s more likely a vaccine will be available in 2021, he added.

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Gilead Seeks FDA Approval for Remdesivir

Gilead Sciences has applied to the U.S. Food and Drug Administration for approval for its COVID-19 treatment, remdesivir, CBS News reported Monday.

The antiviral drug will take the brand name Veklury, the company said.

“Today’s filing is an important milestone as we continue to partner with the U.S. government and health care authorities around the globe to address the treatment needs of patients with COVID-19,” Merdad Parsey, Gilead’s chief medical officer, said in a statement.

At the moment, remdesivir is available on an emergency basis for hospitalized patients with severe COVID-19. If the FDA approves it, however, the drug will gain wider use. Remdesivir is already approved in Europe and Japan, CNN reported.

The request for approval comes after the results of a phase 3 trial. The drug works by blocking the virus from copying itself.

Trials of the drug showed that it can cut recovery time from COVID-19 by nearly a third.

“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations,” Parsey said.

“Remdesivir isn’t a game changer, but it is a positive,” Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner with the FDA, told CBS MoneyWatch in April.

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Seller of Phony COVID-19 Drug Indicted

Federal prosecutors have indicted a Georgia man for selling a drug he claimed would cut the risk of being infected with COVID-19 by 50%, the Associated Press reported Monday.

In a statement, prosecutors said the drug sold by Matthew Ryncarz and his company, called Fusion Health and Vitality but operating as Pharm Origins, “bore false and misleading labeling.”

“Our office is committed to ensuring that businesses do not take advantage of a global health crisis and people’s fears in order to unlawfully make a buck,” Savannah-based U.S. Attorney Bobby Christine said in the press release.

The drug called ImmuneShot sold for $19 a bottle on a website Ryncarz created in March and was aimed at people over 50, prosecutors said.

The pitch included: “We are offering you the exclusive price of only $19 per bottle because we know that Immune Shot could be the most important formula in the WORLD right now due to the new pandemic,” the AP reported.

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