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With less than two weeks left to fulfill President Biden’s promise to share 80 million doses of the coronavirus vaccine with countries in need, production problems at an Emergent BioSolutions manufacturing facility are forcing the government to revise its plan to send AstraZeneca doses overseas .
Officials are now working to replace tens of millions of doses of the AstraZeneca vaccine originally intended to be included in the donation with others from Pfizer and BioNTech, Moderna and Johnson & Johnson, according to people familiar with the discussions. These three vaccines are approved in the United States for emergency use; AstraZenecas isn’t.
A pattern of serious neglect at the Baltimore facility has challenged the fate of more than 100 million doses of AstraZeneca and Johnson & Johnson vaccines manufactured there. The Food and Drug Administration is going through the records of virtually every batch that Emergent has produced to determine if the cans are safe. The FDA has so far ruled that approximately 25 million Johnson & Johnson cans made at the factory can be cleared, but has not made a decision on the AstraZeneca cans.
AstraZeneca’s vaccine is significantly cheaper than the other three vaccines: the federal government paid less than $ 4 per dose, compared to $ 19.50 for Pfizer. A administration official said that if the AstraZeneca cans made by Emergent are declared safe, the supply will ultimately be shared with other nations.
The cans the government plans to ship overseas this month will be part of existing orders from other manufacturers that have not yet been shipped to states, said a person familiar with the planning. Dozens of millions of doses of the three US-approved vaccines that have already been shipped to states remain unused. Over 175 million people in the US have received at least one dose – more than 62 percent of the total population over 12 years old, according to the Centers for Disease Control and Prevention, and more than 148 million, or 52 percent, are fully vaccinated.
Until the White House announced last week it would share 500 million doses of the Pfizer vaccine with the rest of the world, the AstraZeneca doses made up the bulk of the government’s vaccine diplomacy.
Mr Biden pledged to share up to 60 million doses of AstraZeneca’s vaccine with other nations in late April pending the ongoing FDA review of Emergent. In May, the White House announced it would send at least another 20 million doses of other vaccines overseas, bringing the total to 80 million by the end of June.
Earlier this month, the White House stated how it would initially distribute 25 million of the 80 million cans across “a wide range of countries.” Millions of them have already been shipped and more will be shipped shortly, a White House spokesman said.
Jeffrey D. Zients, the White House’s Covid-19 response coordinator, said Thursday that 80 million doses would be allocated by the end of the month but did not specify the type. He said the government was working with other countries on complicated logistical issues, including securing needles, syringes and alcohol swabs that would fit the cans.
“We will allot all of the initial 80 million cans in the coming days and shipments will be sent out as soon as countries are ready to receive the cans,” Mr. Zients said at a press conference. “There will be an increasing number of broadcasts each week as we step up these efforts.”
To share vaccines other than AstraZeneca’s, said a person familiar with the plan, the administration will likely need permission from the manufacturers. These discussions are still going on, said the person.
A federal judge ruled Friday that as of July 18, the Centers for Disease Control and Prevention will no longer be able to enforce their rules to prevent the spread of the coronavirus on cruise ships docking in Florida.
Judge Steven D. Merryday of the US District Court for the Middle District of Florida granted Florida’s motion for an injunction preventing the CDC from enforcing the rules in Florida ports, finding that they were based on “stale dates.” and did not take into account the proliferation of effective vaccines.
The judge said that as of July 18, the rules “will remain in place only as a non-binding ‘consideration,’ ‘recommendation,’ or ‘guideline,’ the same tools the CDC uses to guide practices in other similar industries such as airlines, railways , Hotels, casinos, sports facilities, buses, subways and others. “
The ruling was a victory for Florida, a cruise industry hub, which in April questioned the rules, arguing that they would cripple the industry and lose hundreds of millions of dollars to the state. Florida also argued that the CDC exceeded its powers and acted “arbitrarily and capriciously” when it made the rules last year.
“Today’s ruling is a victory for the hard-working Floridians who depend on the cruise industry for a living,” said state attorney general Ashley Moody in a statement. “The federal government has and should never have the authority to single out an entire industry and to block it for an indefinite period of time.”
Florida Governor Ron DeSantis called the ruling a “victory for Florida families, for the cruise industry, and for any state that wants to preserve its rights in the face of unprecedented federal transgression.”
“The CDC was wrong all along and they knew it,” he said in a statement.
The CDC did not immediately respond to a request for comment on Friday evening. In his ruling, Judge Merryday gave the agency until July 2 to propose a “tighter injunction” that would allow cruise lines to sail on time.
Months after being infected with the coronavirus, hundreds of thousands of patients in the United States needed medical care for health problems that were not previously diagnosed before they became infected with the virus, according to a new study.
The largest study of its kind to date, examined the medical records of nearly two million people in the United States who contracted Covid-19 between February and December 2020, and tracked those patients through February 2021. Nearly searched for a month or more after contracting the virus 23 percent received medical treatment for new conditions, most commonly painful including nerves and muscles; Difficulty breathing; high cholesterol; Malaise and fatigue; and high blood pressure.
Those affected included people of all ages as well as those who showed no signs of Covid disease. While nearly half of the patients admitted to hospital with Covid-19 had later medical problems, 27 percent of people who reported having mild or moderate symptoms and 19 percent of people who said they were asymptomatic also occurred.
Experts not involved in the study said it further shed light on the ways in which even an asymptomatic case of coronavirus can affect almost every organ in the body and lead to lifelong chronic health problems. The information is important to both doctors and patients, said Robin Gelburd, president of FAIR Health, a nonprofit that conducted the study based on the nation’s largest database of private health insurance claims. According to FAIR Health, the analysis was assessed by an independent academic reviewer, but not formally assessed.
“There are some people who may not even have known they had Covid,” Ms. Gelburd said, “but if they continue to face some of these conditions that are unusual for their medical history, there could be another investigation by the agency worth the medic you work with. “
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The United States has surpassed 600,000 known coronavirus deaths, although the pace at which the country’s death toll has accumulated has slowed significantly since the pandemic began. The milestone came when the highly contagious Delta variant emerged in the United States and less than half the population is fully vaccinated.
California and New York lifted almost all remaining restrictions on business and social gatherings, a major sign that the United States is recovering from the pandemic. With both states giving at least one dose of vaccine to at least 70 percent of their populations, California Governor Gavin Newsom and New York Governor Andrew Cuomo treated the reopenings like political rallies, although companies in the states will still have the option to request health care on their premises.
China is about to administer its billionth Covid vaccination, a vaccination campaign that is global leader despite a sluggish start. Officials have increased vaccinations by offering modest incentives like free eggs and bottled water. However, a bigger driver in southern China is a recent outbreak in Guangzhou city.
Prime Minister Boris Johnson announced a four-week delay from a full reopening in England after a surge in the Delta variant. Restaurants and pubs in England must continue to limit capacity and comply with indoor social distancing rules while they are open, and nightclubs and theaters will remain closed.