Gilead Sciences on Monday announced it is seeking FDA's approval to sell the first Covid-19 treatment in the United States, while Russia on Tuesday became the first country to approve a vaccine against the novel coronavirus—sparking significant concerns from public health experts worldwide.
US new coronavirus cases near 5.1M, deaths top 163K
The announcements came as U.S. officials on Monday reported about 47,126 new cases of the novel coronavirus, bringing the total number of coronavirus cases reported in the country since the epidemic began to 5,101,300 as of Tuesday morning—up from 5,054,200 cases reported as of Monday morning.
Data from the New York Times shows that Guam, Puerto Rico, the U.S. Virgin Islands, and four states saw their average daily numbers of newly reported coronavirus cases rise over the past 14 days: Hawaii, Illinois, Massachusetts, and South Dakota.
The Times' data also shows that the average daily numbers of newly reported coronavirus cases over the past two weeks remained mostly stable in Washington, D.C., and 23 states: Arkansas, Connecticut, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oregon, Rhode Island, Texas, Virginia, Washington, West Virginia, and Wisconsin.
In addition, the Times' data shows that 23 states saw their average daily numbers of newly confirmed coronavirus cases decrease over the past 14 days: Alabama, Alaska, Arizona, California, Colorado, Delaware, Florida, Louisiana, Maine, Maryland, Mississippi, Missouri, Nebraska, Nevada, New Mexico, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Utah, Vermont, and Wyoming.
U.S. officials also reported about 537 new deaths tied to the coronavirus on Monday, bringing the country's total of reported coronavirus-linked deaths since the epidemic began to 163,018 as of Tuesday morning—up from 162,481 deaths reported as of Monday morning.
According to the Times' data, Puerto Rico and 20 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise over the past 14 days: Arkansas, California, Florida, Georgia, Hawaii, Iowa, Louisiana, Minnesota, Mississippi, Montana, Nebraska, Nevada, North Carolina, North Dakota, Puerto Rico, South Dakota, Texas, Virginia, Washington, and West Virginia.
Gilead seeks FDA approval to sell remdesivir as US' first Covid-19 treatment
As the coronavirus continues to spread throughout America, scientists have been scrambling to find a treatment for Covid-19, the disease caused by the new coronavirus, and to develop a vaccine against the virus. FDA has not yet approved any Covid-19 treatments or coronavirus vaccines to be sold in the United States. However, the agency has granted emergency use authorizations (EUAs) allowing providers to use some experimental treatments for Covid-19 patients.
One of those treatments is Gilead's remdesivir, which has been seen as the most promising experimental treatment for Covid-19 so far. Providers currently are allowed to use remdesivir to treat certain hospitalized patients with Covid-19 under an EUA that FDA issued in May.
But Gilead on Monday submitted an application seeking FDA's formal approval of remdesivir as Covid-19 treatment. FDA's formal approval would mark the agency's first for a Covid-19 treatment, allow Gilead to begin marketing remdesivir as a Covid-19 treatment in the United States, and make the therapy available to a broader patient population.
Gilead is seeking FDA's formal approval of remdesivir as a Covid-19 treatment based on data from two late-stage clinical trials conducted by the drugmaker and a separate clinical trial conducted by the National Institute of Allergy and Infectious Diseases (NAID). Data from the trials showed that remdesivir blocks the coronavirus from replicating and reduces the recovery time of patients hospitalized for Covid-19. Specifically, data from the trial conducted by NAID found that Covid-19 patients who received remdesivir recovered in a median of 11 days, while patients who received a placebo recovered in a median of 15 days.
Gilead CMO Merdad Parsey said, "Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of [remdesivir], 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."
Regulators in Australia, Europe, and Japan already have approved remdesivir as a Covid-19 treatment. If the drug gains FDA's formal approval, Gilead will sell the treatment under the under the brand name Veklury in the United States.
Russia becomes first country to approve a coronavirus vaccine—but experts have concerns
On Tuesday, Russian President Vladimir Putin announced that the country's Health Ministry has approved a vaccine against the novel coronavirus, making it the first coronavirus vaccine to gain regulatory approval.
According to the Washington Post, the vaccine, called Sputnik V and developed by the Gamaleya Institute in Moscow, "uses two doses to deliver different harmless cold viruses, or adenoviruses, that have been engineered to carry into cells the gene for the spiky protein that studs the outside of the coronavirus." The vaccine is similar to a coronavirus vaccine candidate currently under development by AstraZeneca and Oxford University, as well as a candidate under development by CanSino Biologics, the Associated Press reports.
Putin on Tuesday said the country's vaccine has undergone adequate testing and evidence has shown it is safe and effective, noting that one of his adult daughters has received the inoculation. He said the vaccine offers up to two years of immunity against the novel coronavirus.
"I know it has proven efficient and forms a stable immunity, and I would like to repeat that it has passed all the necessary tests," Putin said. "We must be grateful to those who made that first step very important for our country and the entire world."
However, public health experts worldwide have raised concerns about the vaccine's approval, noting that Russia has not yet published any data showing that the vaccine is safe and effective. Further, experts said the vaccine hasn't yet gone through a Phase 3 clinical trial, which would test the vaccine among thousands of patients over the course of a few months.
The World Health Organization said its records show Gamaleya is still Phase 1 clinical trials, which typically focus on safety, not efficacy, and involve just a few dozen participants. According to the AP, human clinical trials for the vaccine first began on June 17 among 76 volunteers, half of whom were injected with a liquid form of the vaccine and the other half of whom were treated with a soluble powder form of the vaccine.
Gamaleya has made few details on its research regarding the vaccine available to the public, and only some of its research has undergone peer review, the Post reports. To date, most of what is known about the vaccine comes from secondhand sources and has not been published as medical research, according to the Post.
Kirill Dmitriev—head of the Russian Direct Investment Fund, which financed Russia's vaccine development effort—attributed the dearth of public information on the vaccine to Russia being more secretive about its scientific research than other countries.
Gamaleya did not respond directly to requests for comment from the Post, instead directing the Post to Russia's Health Ministry—which also did not respond to requests for comment, the Post reports.
Peter Kremsner from the University Hospital in Tuebingen, which currently is evaluating a different coronavirus vaccine candidate under development by CureVac, said, "Normally you need a large number of people to be tested before you approve a vaccine. In that respect, I think it's reckless to [approve it] if lots of people haven't already been tested."
J. Stephen Morrison, SVP at the Center for Strategic and International Studies, said, "This is changing the rules. This is cutting corners. … I think this could backfire."
In Russia, the Moscow-based Association of Clinical Trials Organizations (ACTO), which is a trade organization representing Russia's top drugmakers, in a letter sent Monday to Russia's Health Ministry urged government officials to postpone the vaccine's approval until Phase 3 trials had been completed. ACTO wrote, "It is during [Phase 3 trials] that the main evidence of a vaccine's efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth."
Dmitriev said researchers will soon start Phase 3 clinical trials on the vaccine, and the trials will involve "several thousand people" across several different countries. However, in the meantime, Russia will make the vaccine available to tens of thousands of people in Russia who volunteer to receive it, Dmitriev said.
According to the AP, Russian officials have said medical workers, teachers, and other high-risk people will be among the first to receive the vaccination. Tatyana Golikova, Russia's deputy prime minister, said medical workers in the country could start receiving the vaccine as soon as this month (Gandel, CBS News, 8/10; Maddipatla, Reuters, 8/10; Isachenkov, Associated Press, 8/11; Khurshudyan/Johnson, Washington Post, 8/11; Tétrault-Farber/Soldatkin, Reuters, 8/11; New York Times, 8/11).