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FDA Clears Second COVID Vaccine for Emergency Use

By Robin Foster HealthDay Reporter

SATURDAY, Dec. 19, 2020 (Healthday News) -- Moderna's coronavirus vaccine was granted emergency use approval by the U.S. Food and Drug Administration on Friday, and it will now join Pfizer's vaccine in an unprecedented national campaign to inoculate enough Americans to stem the spread of COVID-19.

"With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day," FDA Commissioner Dr. Stephen Hahn said in a statement. "Through the FDA's open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA."

"To get another very important vaccine into play is just, yet again, another step toward what the ultimate goal is: to get enough people vaccinated so you could essentially end the epidemic as we know it in this country," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the Washington Post. "I believe that's possible."

The authorization of a second vaccine will double the number of Americans who will get a first shot before the end of the year to roughly 20 million, the Post reported.

Earlier this week, Gen. Gustave Perna, who is overseeing 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 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; Pfizer's vaccine was 95 percent effective. The efficacy was similar across age, gender and racial groups.

In Moderna's trial, 30,000 people were randomly assigned to receive either two shots of a vaccine given four weeks apart, or two saline shots. Neither the participants nor the people running the trial 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, to measure how well the vaccine protected participants after the immune system had mustered a full response.

The numbers were decisive: There were 196 cases in the trial, all but 11 of them were 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, with deliveries to 636 facilities so far and an additional 886 planned for Thursday, the Post reported.

An additional 2 million Pfizer doses are scheduled for delivery next week, and 5.9 million Moderna doses are allocated if the vaccine clears regulatory hurdles in the coming days, the Post reported.

Most of the first round of injections are to be given to high-risk health care workers, the 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.

Azar said the plan is to have 20 million people vaccinated by the end of December, up to 50 million by the end of January and 100 million by the end of February, the Post reported.

A global scourge

By Saturday, the U.S. coronavirus case count passed 17.5 million while the death toll neared 314,000, according to a Times tally. By Saturday, the top five states for coronavirus infections were California with over 1.8 million, Texas with more than 1.5 million cases, Florida with nearly 1.2 million cases; Illinois with over 888,400 cases and New York with over 832,000 cases.

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

In India, the coronavirus case count passed 10 million on Saturday, 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 185,600 deaths as of Saturday, the Hopkins tally showed.

Worldwide, the number of reported infections passed 75.7 million on Saturday, 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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