July 13 coronavirus news

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9:35 a.m. ET, July 13, 2020

FDA gives "Fast Track" status to two Covid-19 vaccine candidates

From CNN Health’s Wes Bruer

Pfizer and BioNTech announced today that they have received "Fast Track" designations from the US Food and Drug Administration for two of their four Covid-19 vaccine candidates, according to a press release. 

“This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies,” the release stated. 

What this means: Fast Track designation allows for a more efficient development process between companies and regulatory agencies and makes drug developers eligible for accelerated approval with a rolling review process of submitted data.

Companies must request the designation and it is reserved for “any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need,” according to the FDA’s website. 

Next steps: Pfizer and BioNTech’s collaboration on Covid-19 vaccine development, dubbed “Project Lightspeed,” expects to begin phase 2b/3 of its trial later this month. The companies aim to enroll 30,000 participants, according to the press release.

Pending the success of ongoing studies, “the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.”

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president of global regulatory affairs for Pfizer, said in a statement. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Özlem Türeci, chief medical officer at BioNTech, said in the statement.

 

10:03 a.m. ET, July 13, 2020

White House doesn't offer any defense for Fauci as tensions rise

From CNN's Betsy Klein

White House press secretary Kayleigh McEnany holds a news conference at the White House on July 6.
White House press secretary Kayleigh McEnany holds a news conference at the White House on July 6. Kevin Dietsch/UPI/Bloomberg/Getty Images

White House press secretary Kayleigh McEnany didn’t offer any defense or pushback on the narrative of tension between the White House and Dr. Anthony Fauci when asked about his relationship with the task force Monday, instead saying the nation’s top infectious disease expert simply “represents one viewpoint in the administration.”

“The Admiral [Brett Giroir] hit the nail on the head on this yesterday. He was making the point that Dr. Fauci represents one viewpoint in the administration and he looks at things from a public health standpoint,” McEnany said during an appearance on Fox News.

She continued:

“The whole point of the task force is to be a whole of government look at what is best for this country. That includes Dr. Fauci’s opinion, it includes Adm. Giroir’s, and ultimately, those conclusions are taken to the President. So Dr. Fauci’s one member of a team, but rest assured his viewpoint is represented and the information gets to the President through the task force.” 

Remember: These remarks come as Trump and Fauci haven’t spoken in over a month. 

On school reopening, McEnany claimed House Speaker Nancy Pelosi isn’t looking at data or science when she was critical of the administration’s reopening plans and is “messing with our children.” 

She was asked how the administration’s guidelines would differ from CDC guidelines – though it’s unclear what Trump administration guidelines the host was referring to. Regardless, McEnany said, “We leave it to localities as to exactly what guidelines work.” She said CDC guidelines are “out there as a best case scenario,” but many of its measures are “not possible or not feasible.”

“These are perfect-world guidelines,” she said of the CDC’s recommendations. 

10:10 a.m. ET, July 13, 2020

Atlanta mayor says her husband is doing much better after testing positive for Covid-19

From CNN’s Jasmine Wright

Atlanta Mayor Keisha Lance Bottoms on CNN's "New Day" on July 13.
Atlanta Mayor Keisha Lance Bottoms on CNN's "New Day" on July 13. CNN

Atlanta Mayor Keisha Lance Bottoms says her husband is doing much better after he, one of her four children and she tested positive for Covid-19 last week

Appearing on CNN’s New Day with Alisyn Camerota on Monday, the mayor said she suspected something was off after her husband had been sleeping much more than usual and in the last week, he has lost over 20 pounds. She and her child are largely asymptomatic.

Since the diagnosis, Bottoms has railed against the lengthy time it took to get her previous test, as it would have shown she had an asymptomatic child in the houses 8 days before her own Covid-19 diagnosis.

“If it took my family eight days to get as a result I can only imagine what's happening with people across this country,” she said, adding when asked that there was a point she was fearful she would have to take her husband to hospital in part because he couldn’t finish a conversation without falling asleep.

Atlanta Mayor Keisha Lance Bottoms:

9:26 a.m. ET, July 13, 2020

Natural immunity to Covid-19 could decline within months, UK study suggests

From CNN's Jacqueline Howard

If you were infected with the novel coronavirus, a new study suggests that your immunity to the virus could decline within months.

The study, released on the pre-print medical server medrxiv.org on Saturday, suggests that antibody responses start to decline after 20 to 30 days following the first time showing symptoms of Covid-19. The study also found the severity of symptoms can determine the magnitude of the antibody response.  

The study, which has not been published in a peer-reviewed medical journal, included samples collected from 65 patients with confirmed Covid-19 up to 94 days after they started showing symptoms and from 31 health care workers who had antibody tests every one to two weeks between March and June.

Limitations of the study: More research is needed to determine whether similar results would emerge among a larger group of patients and to continue measuring antibody responses over a longer period of time.

"Whilst yet to be peer reviewed, the importance of this study is clear and the research has been rigorously undertaken. This work confirms that protective antibody responses in those infected with SARS-COV2, the coronavirus that causes COVID-19, appear to wane rapidly. Whilst longer lasting in those with more severe disease, this is still only a matter of months," Dr. Stephen Griffins, associate professor in the University of Leeds School of Medicine in the United Kingdom, who was not involved in the new study, said in a written statement distributed by the UK-based Science Media Centre on Monday.

"Similar short-lived responses are seen against other human coronaviruses that predominantly cause only mild illness, meaning that we can be re-infected as time goes by and outbreaks can adopt seasonality. With the more serious, sometimes fatal, outcomes of SARS-COV2, this is troubling indeed," Griffins said. "Vaccines in development will either need to generate stronger and longer lasting protection compared to natural infection, or they may need to be given regularly."

According to the World Health Organization, as of last week, there were at least 21 Covid-19 candidate vaccines in clinical evaluation globally.

9:49 a.m. ET, July 13, 2020

Daughter calls out politicians for "lack of leadership" following father's death from Covid-19

From CNN's Hollie Silverman

Mark Urquiza and his daughter Kristin Urquiza.
Mark Urquiza and his daughter Kristin Urquiza. Courtesy Kristin Urquiza

Mark Urquiza had been battling Covid-19 for more than three weeks before he died in an Arizona hospital on June 30, his daughter Kristin Urquiza wrote in an obituary.

The father of one was a former high school 400-meter-dash state champion and cross-country runner with no underlying health conditions, his daughter said.

"His death is due to the carelessness of the politicians who continue to jeopardize the health of brown bodies through a clear lack of leadership, refusal to acknowledge the severity of this crisis, and inability and unwillingness to give clear and decisive direction on how to minimize risk," Urquiza said in her father's obituary.

Communities of color have been disproportionately impacted by the coronavirus pandemic, with nearly half of deaths and two-thirds of all cases impacting people of color in the US, according to data from the Centers for Disease Control and Prevention.

Urquiza also wrote a letter to Arizona Gov. Doug Ducey inviting him to her father's funeral and blaming his lack of action in preventing the spread of the virus for the deaths of her father and others.

"I write to invite you to the burial of my father, Mark Anthony Urquiza. He was one of the 88 Arizonans who died on June 30, 2020 from COVID-19. Despite having a huge family and many friends he died alone with an ICU nurse holding his hand," the letter read.

Read the full story here.

Watch Urquiza's interview with CNN's Brianna Keilar:

9:03 a.m. ET, July 13, 2020

New York is monitoring a Covid-19 uptick that could be linked to people who traveled to Georgia

From CNN's Kristina Sgueglia

New York state is closely monitoring an uptick in Covid-19 cases in Rensselaer County, which is near Albany. A number of those new cases are being investigated as being linked to several individuals who tested positive for the virus after returning from Georgia, New York Gov. Andrew Cuomo’s office said in a news release.

“They are in isolation and the New York State Department of Health and Rensselaer County Health Department are conducting contact tracing,” the release said. 

Remember: Georgia is one of several states on New York’s travel advisory list, which requires individuals traveling from certain qualifying states to quarantine upon return.

Of the tests conducted statewide on Saturday, 677, or 1.08%, were positive, the governor’s office said.

Covid-19 deaths matched the state's previous low, with five reported in the state Saturday.

8:40 a.m. ET, July 13, 2020

Bulgaria reopens bars and clubs days after shutting down due to Covid-19 spike

From Nina Avramova

The Bulgarian government is reopening bars and clubs nationwide on Monday, according to a Health Ministry order, just three days after shutting them down due to an increase of coronavirus cases.

The order states that:

  • Indoor and outdoor bars and clubs are allowed to reopen to the public today.
  • These outdoor and indoor venues are allowed to reopen if the seats are occupied by one person per square meter and if they comply with safety measures.
  • Outdoor and indoor group celebrations, such as weddings and baptisms, will also now be permitted, as long as people maintain a 1.5-meter social distance and abide by safety measures. 

Last week, all indoors clubs, discos, bars and other similar establishments were shut down after an increase in coronavirus cases, according to the press office of the Ministry of Health.

The Ministry of Health reported at least 77 new coronavirus cases in the last 24 hours. There have been more than 7,200 confirmed Covid-19 cases in Bulgaria, according to the Ministry’s website.

8:38 a.m. ET, July 13, 2020

1 in 3 young adults is vulnerable to severe Covid-19, and smoking plays a big part, research finds

From CNN's Naomi Thomas

One in three young adults is at risk of severe Covid-19, and smoking plays a big part in that risk, according to new research published Monday in the Journal of Adolescent Health.

Researchers at the University of California, San Francisco, looked at more than 8,000 participants ages 18 to 25 who had participated in the National Health Interview Survey to see what their medical vulnerability to severe Covid-19 was in relation to risk indicators that had been set out by the US Centers for Disease Control and Prevention, including health conditions and smoking habits.

The researchers found 32% of the total study population were medically vulnerable for severe Covid-19. However, when the group of participants who smoked cigarettes or e-cigarettes were taken out of the analysis, the medically vulnerable percentage decreased by half, to 16%.

“The difference between estimates is driven largely by the sizeable portion of young adults who reported that they engaged in past 30-day smoking (1 in 10) and past 30-day e-cigarette use (1 in 14),” the report said. “By contrast, relatively fewer young adults reported medical conditions identified by the CDC as conferring severe illness risk.”

The research showed that in the whole study population, young adult men were at a higher risk for severe Covid-19. Although more women reported having asthma and immune conditions, higher rates of smoking in men overrode this. However, looking at just the non-smokers, women had a higher risk.

“Recent evidence indicates that smoking is associated with a higher likelihood of COVID-19 progression, including increased illness severity, ICU admission or death,” said Sally Adams, lead author of the study, in a press release. “Smoking may have significant effects in young adults, who typically have low rates for most chronic diseases.” 

Other findings: Another interesting finding from the research is that in the 18 to 25 age group, White young adults had the highest vulnerability. 

“Our finding of lower medical vulnerability of racial/ethnic minorities compared with the white subgroup, despite controlling for income and insurance status, was unexpected,” the study said. “It is also inconsistent with research showing higher rates of Covid-19 morbidity and mortality and other chronic illnesses among racial/ethnic minorities, specific to one age group.”

The researchers said it is also inconsistent with the 15 to 24 age group, where Hispanic and Black Americans were shown to have the highest rates of Covid-19 deaths.

“This suggest that factors other than the CDC’s medical vulnerability criteria play a role in the risk of severe Covid-19 illness in the young adult population,” the researchers said.

The study did have some limitations, including the lack of information about Covid-19 in the 18 to 25 population, and a chance that it could underestimate the vulnerability rates for certain ethnic or racial subgroups of young adults due to the data source.

8:48 a.m. ET, July 13, 2020

At least 35 US states are seeing a rise in new Covid-19 cases. Here's a look at the hard-hit areas. 

From CNN's Christina Maxouris

People cross a street in Santa Monica, California, on July 12.
People cross a street in Santa Monica, California, on July 12. Marcio Jose Sanchez/AP

At least 35 US states are seeing a rise in new cases compared to the previous week, according to data from Johns Hopkins University. Across the country, health officials are sounding the alarm over the number of infected patients seeking medical care.

Both local and state leaders have said in recent weeks new cases are largely driven by Americans who have opted to resume gatherings and outings to bars. In many states, the average age of new cases has shifted downward, with more young people testing positive than ever before.

In Louisiana, officials reported more than 1,300 new coronavirus cases Sunday  — 99% of which were spread through the community and more than a third of which were in people aged 29 or younger, officials said. 

In Florida, where there's no statewide mask mandate, health officials reported Sunday a staggering record of new cases in a single day: 15,300. In Miami Beach, hospitals are reaching full capacity, the mayor told CNN Sunday night.

"We're going to have to start moving regular beds into ICU beds. We're clearly being strained at this point," Miami Beach Mayor Dan Gelber said. "There's a total disconnect between what is happening and being said out of Washington and even Tallahassee and what is happening in some of these communities right here."

Across the state, there are more than 7,500 patients hospitalized with the virus, state data showed Sunday. In Florida's Orange County, where Disney World reopened over the weekend, more than 540 patients were in hospitals.

In California, Los Angeles County health officials reported more than 3,300 new cases Sunday — the second highest daily case count in the last week. There are nearly 2,100 people hospitalized, a number "substantially higher" than hospitalizations a month ago, officials said.

And in Arizona, Phoenix's mayor told CNN health care professionals are reporting they are "already tired" and worried about additional strains on hospitals stemming from the July 4 holiday, even as the city is already seeing record-breaking ventilator usage.

In efforts to prevent further spread, Mayor Kate Gallego said she's joined other leaders across the state to urge the governor to expand safety precautions in response to the virus.

Here's a look at where cases are increasing across the country: