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FDA Says It Will Quickly Approve Moderna's COVID Vaccine

By Robin Foster HealthDay Reporter

FRIDAY, Dec. 18, 2020 (Healthday News) – The U.S. Food and Drug Administration said Thursday night that it will move quickly to authorize the emergency use of Moderna's coronavirus vaccine after one of its advisory panels voted to give its blessing to the shot.

"Following today's positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization," FDA Commissioner Dr. Stephen Hahn said in a statement. "The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution."

The FDA intends to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity, the Washington Post reported.

"I just want to make the point of what a remarkable scientific achievement this is, and pay thanks to all the scientists, present and past, who contributed to this," James Hildreth, president of Meharry Medical College and a member of the advisory panel, said at the close of the panel meeting on Thursday. "To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement."

Earlier this week, Gen. Gustave Perna, who is in charge of the federal effort to distribute vaccines, said the government was preparing to ship almost 6 million doses of the Moderna vaccine to 3,285 locations in the first week after approval.

"It will be a very similar cadence that was executed this week with Pfizer, where we're hitting initial sites on Monday, [followed] on Tuesday and Wednesday," Perna said, the Post reported.

The panel vote came the same day the country set three grim pandemic records: More than 250,000 new coronavirus cases; more than 114,000 hospitalized COVID-19 patients; and more than 3,400 deaths. In California, which is fast becoming the latest epicenter of the pandemic, more than 100,000 new infections have been reported in the past 48 hours and Gov. Gavin Newsom has prepared a mass fatality plan.

The Moderna vaccine was developed in partnership with the U.S. National Institute of Allergy and Infectious Diseases. The federal government invested in the research and development of the vaccine and bought 200 million doses in advance, bringing the government outlay to $4.1 billion, the Post reported.

Moderna's vaccine was shown to be 94 percent effective in its large clinical trial, while Pfizer's vaccine was 95 percent effective.

In Moderna's trial, 30,000 people were randomly assigned to receive either two shots of the vaccine given four weeks apart, or two saline shots. No one getting or giving the shots knew who was in which group.

Investigators then waited as people were exposed to coronavirus in their daily lives, to see if there were more cases of COVID-19 in the group that did not receive the real vaccine. They counted cases starting two weeks after the second dose.

The results were decisive: There were 196 cases in the trial, all but 11 of them in the group that received the placebo shots. There were 30 cases of severe COVID-19 and one death from COVID-19 in the trial, all in the group that received the placebo.

Vaccine campaign begins as poll shows 70% will get it

America launched a massive vaccination campaign to curb the spread of COVID-19 this week.

As the first doses of Pfizer's coronavirus vaccine made their way to the arms of health care workers around the United States, a new survey from the Kaiser Family Foundation showed that 71% of Americans say they will "definitely or probably" get a COVID-19 vaccine.

That's up from 63% in September, and it's a sign that a growing number of Americans are starting to trust the science behind the vaccines as they become more comfortable with the speed in which the vaccines are being developed.

Still, just over a quarter of Americans are hesitant to get a vaccine, saying they probably or definitely would not get a COVID-19 vaccine even if it were free and deemed safe by scientists. The greatest reluctance was seen among Black Americans, people living in rural areas and Republicans.

And not everyone wants a shot right away: A third of those surveyed said they want to get a vaccine "as soon as possible," while 39% of those surveyed said they would "wait and see" how initial vaccination efforts go before getting a vaccine themselves. Kaiser polled 1,676 adults for the survey.

U.S. officials said they are on track to meet initial vaccine delivery targets this week, and an additional 2 million Pfizer doses are scheduled for delivery next week. If approved by the FDA on Friday, 5.9 million Moderna doses are allocated for the first shipments, the Post reported.

Most of the first round of injections are to be given to high-risk health care workers, The New York Times said. Because the vaccines can cause side effects including fevers and aches, hospitals have said they will stagger vaccinations among their workers.

Residents of nursing homes, who have suffered a disproportionate share of COVID-19 deaths, will begin to get shots next week, the Times reported. A vast majority of Americans will not be eligible for vaccinations until the spring or later.

A global scourge

By Friday, the U.S. coronavirus case count passed 17.2 million while the death toll neared 311,000, according to a Times tally. By Friday, the top five states for coronavirus infections were California with over 1.7 million, Texas with more than 1.5 million cases, Florida with over 1.1 million cases; Illinois with over 888,000 cases and New York with over 814,000 cases.

Curbing the spread of the coronavirus in the rest of the world remains challenging.

In India, the coronavirus case count passed 9.9 million on Friday, a Johns Hopkins University tally showed. Nearly 145,400 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population. Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.

Meanwhile, Brazil had over 7.1 million cases and nearly 185,000 deaths as of Friday, the Hopkins tally showed.

Worldwide, the number of reported infections passed 75.3 million on Friday, with over 1.6 million deaths recorded, according to the Hopkins tally.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

SOURCES: Washington Post; The New York Times

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