June 15 coronavirus news

The US Food and Drug Administration said Tuesday it had released a third batch of Johnson & Johnson’s coronavirus vaccine from the troubled Emergent BioSolutions plant in Baltimore. 

But it has not cleared the plant itself as an authorized manufacturing facility.

The FDA released two batches of bulk vaccine from the facility on June 11, said it was reviewing more batches. It said some were not suitable for use. Last week, an official told CNN that five batches were rejected after quality reviews – representing an estimated 60 million doses.

“The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer,” the agency said.

“Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.”

The FDA suspended production at the plant in April after cross contamination was discovered between vaccines being made there for Johnson & Johnson and AstraZeneca. AstraZeneca later moved its production out of that plant.

The raw vaccine material is made at the plant and then shipped to other facilities to be bottled—a process known as fill and finish.

 

Arizona Gov. Doug Ducey signed an executive order Tuesday declaring students in the state’s higher education system cannot be mandated to receive a Covid-19 vaccine or be forced to submit vaccination documents.

The order also stipulates that students cannot be mandated to be tested for Coivd-19 or forced to wear masks “in order to participate in learning.” 

“The vaccine works, and we encourage Arizonans to take it. But it is a choice and we need to keep it that way,” Ducey said in a news release. “Public education is a public right, and taxpayers are paying for it. We need to make our public universities available for students to return to learning.” 

The executive order cites a policy Arizona State University (ASU) announced on June 14 requiring students returning to campus be fully vaccinated two weeks prior to the first day of classes on Aug. 19 and upload proof of vaccination to the university health portal. The policy also said students who for whatever reason can’t be vaccinated or don’t share their vaccination status will be required to participate in Covid-19 health management protocols of a daily health check, up to twice weekly Covid-19 testing and be required to wear masks in all indoor and outdoor spaces on ASU campuses.

ASU has not responded to CNN’s requests for comment.

The news release said Ducey plans to work with leadership in the state legislature to make the order into law.  

 

Many post-Covid conditions can be managed by primary care providers who should focus on optimizing patients' quality of life, according to new guidance from the US Centers for Disease Control and Prevention on treating post-Covid conditions.

The agency is also cautioning physicians against solely using objective diagnostic tests to diagnose long-haulers, who experience post-viral symptoms including fatigue and brain fog many months after initial infection. 

"Lack of laboratory or imaging abnormalities does not invalidate the existence, severity, or importance of a patient's symptoms or conditions," the guidance says, as many individuals with long-term symptoms were not able to get a positive test confirming their infection due to issues including testing shortages.

Long Covid patient groups have "raised concerns that some post-COVID conditions have been either misdiagnosed as or misattributed to psychiatric causes, particularly among persons who belong to marginalized or vulnerable groups," the agency says.

The recommendations include "creating a comprehensive rehabilitation plan" that can include physical and occupational therapy, speech and language therapy, vocational therapy, and neurological rehabilitation in order to address patients' cognitive symptoms.

The CDC notes that post-Covid symptoms can resemble those of myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia, post-treatment Lyme disease, dysautonomia, and mast cell activation syndrome.

It recommends physicians consider adapting treatment and symptom management approaches for those conditions, including pacing and activity management.

Post-Covid conditions are still not well understood, and the guidance is likely to change "as the evidence evolves," the CDC says.

  

Gov. John Carney announced Tuesday that Delaware expects to lift its Covid-19 state of emergency order on July 13.  

The emergency order was first signed by Carney over a year ago on March 12, 2020, in an effort to stop the spread of Covid-19 in the state. “We now have the tools to prevent COVID-19 infection, serious illness and hospitalization,” Carney said in a news release. “Get vaccinated. Ask your friends and family if they’ve received their shot. These vaccines are extremely safe and effective. ”

As of June 14, 68.3% of adults in Delaware have received at least one dose of Covid-19 vaccine, said Carney. "We really need people to step up, particularly our young adult demographics 18 to 35," he said during a news conference.  

Carney also signed a modification to the 29th emergency order that states that educators and staff in schools and child centers are not required to wear masks when children are not present. Students and staff are also not required to wear masks outdoors. 

Twelve states have fully vaccinated at least half of their residents against Covid-19, according to data published Tuesday by the US Centers for Disease Control and Prevention.

Oregon is the latest state to reach this threshold, reporting 50% of its residents fully vaccinated. Oregon joins Connecticut, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, and Washington.

All of these states have administered more than 75% of vaccines received, and all but Oregon have met the Biden administration’s goal of 70% of adult residents given at least one dose by July 4. Oregon is reporting 68% of adult residents with one dose of a vaccine.

Overall, 52.6% of the total US population has received at least one dose of Covid-19 vaccine, and more than 145 million people – 43.9% of the US population – are fully vaccinated, CDC data shows.

More than 311 million doses of vaccine have been administered in total, about 83.2% of the 374 million doses that have been delivered.

According to CDC data, more than 1.2 million doses have been reported administered since Monday. This gives the country a seven-day average of 1,137,572 doses administered per day, the highest this number has been since Saturday, and the third-highest the average has been since the beginning of June.

Note: Data published by the CDC may be delayed, and doses may not have been administered on the day reported.

Vice President Kamala Harris and Sec. Janet Yellen announced the Biden administration will award $1.25 billion to hundreds of small community lenders. It's a part of funding passed in last year’s coronavirus relief bill on Tuesday, in the South Court Auditorium.

In remarks, Harris argued that funding Community Development Financial Institutions that service minority and women owned businesses is an essential factor in rebuilding the economy from the pandemic. The money will be distributed through the newly created Rapid Recovery Program to 836 lenders and is just a small portion of the full $12 billion passed last December for CDFI’s and MDI’s. 

“Right now, small business owners don’t just need relief, they need access to capital,” Harris said. “And here's the truth traditional banks have not always seen or understood the vision of women small business owners, small business owners of color, small business owners who serve low-income communities. Sometimes their vision is something… outside of the experience of the big banks understand and see. Community lenders on the other hand, were founded to see that vision, to get it.”

This announcement fits into the larger narrative of one of Harris’ focuses as vice president, CNN has previously reported, focusing on small businesses—particularly minority and women-owned businesses—and trying to help small lenders obtain access to capital.

Harris said in the last month she had been in “direct contact,” with a multitude of active community lenders in different areas including rural, tribal, urban and low-income. And Harris added when she hosted Tulsa Race Massacre survivors at the White House last month, she also spoke of the need for capital.

For her part, Sec. Yellen said the US is missing out on growth because of lack of unequal lending, arguing that this effort seeks to offset that.

“When I started studying economics in 1963, the average black family owned 15% of what the average white family owned, and that number hasn't changed in half a century. It's as close to a constant as we come in economic data,” Yellen said, calling it both an “unfair” and “unhealthy” aspect of the US economy. 

“We, as a country, are missing out on so many venues for growth, because their capital is bottlenecked by race and region," she added.

The United States has surpassed 600,000 deaths since the coronavirus pandemic began, according to data compiled by Johns Hopkins University (JHU).

There have been at least 600,012 total deaths and 33,477,016 total Covid-19 cases in the US, the data shows.

With more than 600,000 deaths from Covid-19, that means about one in every 550 people in the US has died from the virus.

JHU recorded the first death from Covid-19 on Feb. 29, 2020, in Washington state. Later in the spring, two earlier deaths in California were posthumously confirmed to be from Covid-19.

• The US reported 1,000 total deaths on March 24, 2020.
• 84 days after the first death, the US surpassed 100,000 deaths on May 23, 2020.
• 120 days later, the US surpassed 200,000 deaths on Sept. 20, 2020.
• 82 days later, the US surpassed 300,000 deaths on Dec. 11, 2020.
• 35 days later, the US surpassed 400,000 deaths on Jan. 16, 2021.
• 37 days later, the US surpassed 500,000 deaths on Feb. 22, 2021.
• 113 days later, the US surpassed 600,000 deaths on June 15, 2021.

Eight other countries in the world have reported more than 100,000 total Covid-19 deaths, according to JHU:

• Brazil has 488,228 total deaths.
• India has 377,031 total deaths.
• Mexico has 230,187 total deaths.
• Peru, UK, Italy, Russia and France each have over 100,000 total deaths.

At least 70% of New Yorkers have now received at least one dose of a Covid-19 vaccine dose and effective immediately, all state-mandated Covid-19 restrictions will be lifted, Gov. Andrew Cuomo said during a press briefing in lower Manhattan Tuesday. 

“This is a momentous day, and we deserve it because it has been a long, long road,” Cuomo said. “We can now return to life as we know it.”

All state-mandated Covid-19 restrictions will now be immediately lifted across all commercial and social settings, including the requirements on social gatherings, capacity restrictions, social distancing, health screenings, cleaning and disinfection protocols, and contact tracing. Mask requirements will continue in pre-K settings, on public transit and in health care settings, Cuomo said. 

Cuomo noted that at one point, New York state had a Covid-19 positivity rate of 48.16% – once the highest positivity rates in the world. The governor said Tuesday that New York state now has a positivity rate of 0.40% – now the lowest rate in the country, according to Johns Hopkins University. 

“We were alone, and it was frightening. It was like living through a science fiction movie…people abandoned New York, but others stayed and others fought,” Cuomo said. “Where are we today? We have the lowest positivity rate in the United States of America…we went literally, from worst to first.”

Cuomo said that New York state has administered more than 20.2 million vaccine doses to date and has fully-vaccinated “a larger share of adults than any other big state in the country.”

The governor also announced that all of the state’s assets, including the Empire State Building, will be lit in blue and gold Tuesday night. Additionally, firework shows will occur at 9:15 pm ET at various sites across the state Tuesday night. 

“It’s our way of saving thank you all across to the state to our essential workers,” Cuomo said.

The US Centers for Disease Control and Prevention now considers the Delta variant of the novel coronavirus, also known as B.1.617.2, a “variant of concern.” 

What this means: The variant of concern designation is given to strains of the virus that scientists believe are more transmissible or it can cause more severe disease. Vaccines, treatments and tests that detect the virus may also be less effective against a variant of concern.

The CDC said the Delta variant, which was first identified in India, has attributes of increased transmissibility, potential reduction in neutralization by some EUA monoclonal antibody treatments and potential reduction in neutralization after vaccination in lab tests.

Previously, the CDC had considered the Delta variant a “variant of interest.” The World Health Organization classified the Delta variant as a variant of concern on May 10. 

A study on the Delta variant in Scotland published on Monday found that the variant was associated with about double the risk of hospitalization compared with the Alpha variant, B.1.1.7, that was first identified in the UK.

At a White House Covid-19 briefing last week, Dr. Anthony Fauci encouraged everyone to get vaccinated as quickly as possible, noting that the Delta variant is now in circulation in the United States at a rate similar to the tipping point seen in the UK, where the variant is now dominant.

Andy Slavitt, former White House senior adviser for Covid-19 response, said on CNN’s New Day today that the Delta variant is a reason to encourage unvaccinated people to “strongly consider” getting a Covid-19 vaccine, as communities with low rates of vaccine may be at risk for Covid-19 outbreaks.