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FDA authorizes three more antibody tests


The latest:There have been more than 933,000 coronavirus cases in the United States, according to the Johns Hopkins University tally.The U.S. death toll has surpassed 53,000 people, according to Hopkins.Globally, there have been more than 2.8 million cases with more than 202,000 deaths.Georgia state officials are moving ahead with plans to allow some nonessential businesses to reopen, even as coronavirus deaths increase statewide. More evidence is emerging that far more New Yorkers have had the coronavirus than the number confirmed by lab tests.Spain, French prime ministers will announce easing strategies TuesdayIn a speech on Saturday evening, Spain Prime Minister Pedro Sánchez announced he will present his plan for the “de-escalation phase” in his country next Tuesday.Sánchez told Spaniards that the country has had a small and modest victory, but there is a still a long way to go before they win the battle against the coronavirus.French Prime Minister Edouard Philippe, likewise, will present the government’s plan to ease the country’s confinement measure to the French National Assembly on the same day, a spokesperson for the Prime Minister told CNN on Saturday.FDA authorizes three more antibody testsThe U.S. Food and Drug Administration has authorized three new coronavirus antibody tests, bringing the total number of FDA-authorized tests to seven.The tests were green-lit under emergency-use authorizations, a lower regulatory standard used when the FDA believes a test’s benefits could outweigh any risks.Three companies – DiaSorin, Ortho-Clinical Diagnostics and Autobio Diagnostics – received the authorizations. The tests were restricted to use in authorized laboratories, and the FDA cautioned that all three came with risks of false positives and negatives. The tests would ideally allow for the detection of past infections – indicating if someone has had the virus, regardless of whether they showed symptoms. But the tests may be less useful for diagnosing recent or current infections.“A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection,” the FDA wrote in fact sheets accompanying the tests.Countries risk easing lockdowns as global death toll surpasses 200,000As the global death toll from the coronavirus surpassed 200,000 on Saturday, countries took cautious steps toward easing some lockdowns, while fears of infection made even some pandemic-wounded businesses reluctant to reopen. The states of Georgia, Oklahoma and Alaska started loosening restrictions on businesses despite warnings from experts that such steps might be coming too soon. Some owners said they weren’t yet ready to reopen or were doing so only on a limited basis, worried about a second surge of COVID-19 infections. “We’ve sacrificed so much already,” said Shawn Gingrich, CEO and founder of Lion’s Den Fitness, who decided after the Georgia governor’s announcement that he would not be reopening his Atlanta gym right away. “I feel like if we do this too soon, we’ll see a spike in cases and we’re back to square one.”The worldwide death toll topped 200,000, according to a tally compiled by John Hopkins University from government figures. The actual death toll is believed to be far higher.Florida to receive shipment of antibody tests by next week, governor saysFlorida Gov. Ron DeSantis says Florida should receive a shipment of antibody test kits on May 1.The antibody testing kit company first had to send kits to New York before they could fulfill the order for Florida, DeSantis said.“We have now been confirmed that we will have the antibody tests that the state has ordered,” DeSantis told reporters today at a press conference.Florida has had at least 30,839 cases and 1,055 deaths due to coronavirus, according to a tally from Johns Hopkins University.New York testing more per capita than any other countryNew York is doing more tests per capita than any other country in the world, Gov. Andrew Cuomo said at a news conference Saturday.Cuomo said the state is currently testing an average of about 20,000 people per day. This includes both diagnostic and antibody tests.He said the goal is to expand testing even further with federal partnership to be able to conduct 40,000 tests per day.Cuomo said President Trump “understood the federal government had a role” in testing and that they came up with a “division of responsibility” when the two leaders met at the White House on April 21.”The states take responsibility for the labs in their state and getting those labs functioning,” Cuomo said.He said the states would regulate those labs while the federal government would ensure manufacturers were making enough supplies “to send to our labs so our labs can actually function,” Cuomo said.”We need the national manufacturers to have the reagents, the test kits and that’s what the federal government is doing,” he added.The number of hospitalizations across New York, the state hit the hardest by the pandemic, continue to fall, Cuomo said.Despite this positive development, 437 people died in New York yesterday from the virus, Cuomo added. That number is up from 422 on April 24.”This number is, as you can see, call it flat, call it flat with a slight decline, if you’re looking for a silver lining. But this is just terrible, terrible horrific news,” Cuomo said.In terms of hospitalizations, Cuomo said, “All the numbers are basically saying the same. That we are, in fact, on the down side of the mountain.”Does immunity exist?The World Health Organization is warning that people who have had coronavirus are not necessarily immune by the presence of antibodies from getting the virus again. “There is no evidence yet that people who have had COVID-19 will not get a second infection,” the WHO said in a new scientific brief. The WHO is warning against governments issuing “immunity passports” to people who have had COVID-19, assuming they are safe to resume normal life. “At this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ‘immunity passport’ or ‘risk-free certificate,'” the brief said.The WHO published the brief as guidance on adjusting public health and social measures for the next phase of the COVID-19 response. “People who assume that they are immune to a second infection because they have received a positive test result may ignore public health advice. The use of such certificates may therefore increase the risks of continued transmission,” the WHO said.The health agency says it is reviewing evidence on antibody responses to SARS-CoV-2, the virus that causes COVID-19-infection. The brief says “most” of the studies show that people who have “recovered from infection have antibodies to the virus.” But as of yesterday, no study has “evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans. US fatalities make up quarter of global coronavirus deathLess than three months since the first known coronavirus death in the U.S., the country’s fatalities make up more than quarter of the global death toll.More than 52,000 Americans have died of the virus so far — a number that increases daily as a result of new fatalities and states reviewing previous deaths that had not been tied to the disease. In the U.S., limited testing in early February was part of the reason California officials did not count two earlier deaths as coronavirus-related. This week, they confirmed the two victims — a 57-year-old woman who died Feb. 6 and a 69-year-old man who died Feb. 17 —are the earliest known U.S. COVID-19 deaths.New efforts by some states to trace more cases will give officials a better idea of the magnitude of the pandemic in the country. That, in addition to testing, which experts say is still not where it needs to be.The U.S. has conducted about 5.1 million tests, but Dr. Anthony Fauci, the nation’s leading epidemiologist, said this week the nation needs to ramp up testing. Two new reports from public health experts and economists highlight that in order to safely reopen states, the country needs to conduct millions of tests per week.And as health officials race to get the virus under control, state leaders are setting the date they’ll begin reopening their economies — decisions that President Donald Trump has said are entirely up to governors.Georgia Gov. Brian Kemp on Friday opened some businesses, including barber shops and hair salons, tattoo parlors, gyms and bowling alleys. The state has recorded more than 22,491 infections and at least 899 deaths, according to a tally by Johns Hopkins University. The Associated Press and CNN contributed to this report.

The latest:

  • There have been more than 933,000 coronavirus cases in the United States, according to the Johns Hopkins University tally.
  • The U.S. death toll has surpassed 53,000 people, according to Hopkins.
  • Globally, there have been more than 2.8 million cases with more than 202,000 deaths.
  • Georgia state officials are moving ahead with plans to allow some nonessential businesses to reopen, even as coronavirus deaths increase statewide.
  • More evidence is emerging that far more New Yorkers have had the coronavirus than the number confirmed by lab tests.

Spain, French prime ministers will announce easing strategies Tuesday

In a speech on Saturday evening, Spain Prime Minister Pedro Sánchez announced he will present his plan for the “de-escalation phase” in his country next Tuesday.

Sánchez told Spaniards that the country has had a small and modest victory, but there is a still a long way to go before they win the battle against the coronavirus.

French Prime Minister Edouard Philippe, likewise, will present the government’s plan to ease the country’s confinement measure to the French National Assembly on the same day, a spokesperson for the Prime Minister told CNN on Saturday.

FDA authorizes three more antibody tests

The U.S. Food and Drug Administration has authorized three new coronavirus antibody tests, bringing the total number of FDA-authorized tests to seven.

The tests were green-lit under emergency-use authorizations, a lower regulatory standard used when the FDA believes a test’s benefits could outweigh any risks.

Three companies – DiaSorin, Ortho-Clinical Diagnostics and Autobio Diagnostics – received the authorizations. The tests were restricted to use in authorized laboratories, and the FDA cautioned that all three came with risks of false positives and negatives.

The tests would ideally allow for the detection of past infections – indicating if someone has had the virus, regardless of whether they showed symptoms. But the tests may be less useful for diagnosing recent or current infections.

“A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection,” the FDA wrote in fact sheets accompanying the tests.

Countries risk easing lockdowns as global death toll surpasses 200,000

As the global death toll from the coronavirus surpassed 200,000 on Saturday, countries took cautious steps toward easing some lockdowns, while fears of infection made even some pandemic-wounded businesses reluctant to reopen.

The states of Georgia, Oklahoma and Alaska started loosening restrictions on businesses despite warnings from experts that such steps might be coming too soon. Some owners said they weren’t yet ready to reopen or were doing so only on a limited basis, worried about a second surge of COVID-19 infections.

“We’ve sacrificed so much already,” said Shawn Gingrich, CEO and founder of Lion’s Den Fitness, who decided after the Georgia governor’s announcement that he would not be reopening his Atlanta gym right away. “I feel like if we do this too soon, we’ll see a spike in cases and we’re back to square one.”

The worldwide death toll topped 200,000, according to a tally compiled by John Hopkins University from government figures. The actual death toll is believed to be far higher.

Florida to receive shipment of antibody tests by next week, governor says

Florida Gov. Ron DeSantis says Florida should receive a shipment of antibody test kits on May 1.

The antibody testing kit company first had to send kits to New York before they could fulfill the order for Florida, DeSantis said.

“We have now been confirmed that we will have the antibody tests that the state has ordered,” DeSantis told reporters today at a press conference.

Florida has had at least 30,839 cases and 1,055 deaths due to coronavirus, according to a tally from Johns Hopkins University.

New York testing more per capita than any other country

New York is doing more tests per capita than any other country in the world, Gov. Andrew Cuomo said at a news conference Saturday.

Cuomo said the state is currently testing an average of about 20,000 people per day. This includes both diagnostic and antibody tests.

He said the goal is to expand testing even further with federal partnership to be able to conduct 40,000 tests per day.

Cuomo said President Trump “understood the federal government had a role” in testing and that they came up with a “division of responsibility” when the two leaders met at the White House on April 21.

“The states take responsibility for the labs in their state and getting those labs functioning,” Cuomo said.

He said the states would regulate those labs while the federal government would ensure manufacturers were making enough supplies “to send to our labs so our labs can actually function,” Cuomo said.

“We need the national manufacturers to have the reagents, the test kits and that’s what the federal government is doing,” he added.

The number of hospitalizations across New York, the state hit the hardest by the pandemic, continue to fall, Cuomo said.

Despite this positive development, 437 people died in New York yesterday from the virus, Cuomo added. That number is up from 422 on April 24.

“This number is, as you can see, call it flat, call it flat with a slight decline, if you’re looking for a silver lining. But this is just terrible, terrible horrific news,” Cuomo said.

In terms of hospitalizations, Cuomo said, “All the numbers are basically saying the same. That we are, in fact, on the down side of the mountain.”

Does immunity exist?

The World Health Organization is warning that people who have had coronavirus are not necessarily immune by the presence of antibodies from getting the virus again.

“There is no evidence yet that people who have had COVID-19 will not get a second infection,” the WHO said in a new scientific brief.

The WHO is warning against governments issuing “immunity passports” to people who have had COVID-19, assuming they are safe to resume normal life.

“At this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ‘immunity passport’ or ‘risk-free certificate,'” the brief said.

The WHO published the brief as guidance on adjusting public health and social measures for the next phase of the COVID-19 response.

“People who assume that they are immune to a second infection because they have received a positive test result may ignore public health advice. The use of such certificates may therefore increase the risks of continued transmission,” the WHO said.

The health agency says it is reviewing evidence on antibody responses to SARS-CoV-2, the virus that causes COVID-19-infection. The brief says “most” of the studies show that people who have “recovered from infection have antibodies to the virus.”

But as of yesterday, no study has “evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.

US fatalities make up quarter of global coronavirus death

Less than three months since the first known coronavirus death in the U.S., the country’s fatalities make up more than quarter of the global death toll.

More than 52,000 Americans have died of the virus so far — a number that increases daily as a result of new fatalities and states reviewing previous deaths that had not been tied to the disease.

In the U.S., limited testing in early February was part of the reason California officials did not count two earlier deaths as coronavirus-related. This week, they confirmed the two victims — a 57-year-old woman who died Feb. 6 and a 69-year-old man who died Feb. 17 —are the earliest known U.S. COVID-19 deaths.

New efforts by some states to trace more cases will give officials a better idea of the magnitude of the pandemic in the country. That, in addition to testing, which experts say is still not where it needs to be.

The U.S. has conducted about 5.1 million tests, but Dr. Anthony Fauci, the nation’s leading epidemiologist, said this week the nation needs to ramp up testing. Two new reports from public health experts and economists highlight that in order to safely reopen states, the country needs to conduct millions of tests per week.

And as health officials race to get the virus under control, state leaders are setting the date they’ll begin reopening their economies — decisions that President Donald Trump has said are entirely up to governors.

Georgia Gov. Brian Kemp on Friday opened some businesses, including barber shops and hair salons, tattoo parlors, gyms and bowling alleys. The state has recorded more than 22,491 infections and at least 899 deaths, according to a tally by Johns Hopkins University.

The Associated Press and CNN contributed to this report.



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